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As a partner in our Environmental and Mass Tort and Toxic Tort practices, Matt represents energy, pharmaceutical, consumer product and chemical industry clients in state and federal courts throughout the country.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMatt\u0026rsquo;s experience ranges from large-scale multiparty litigation to individual product liability actions. He also advises clients on environmental laws and regulations, including the federal Insecticide, Fungicide and Rodenticide Act.\u003c/p\u003e","matters":["\u003cp\u003eCurrently representing \u003cstrong data-redactor-tag=\"strong\"\u003ea large energy company\u003c/strong\u003e in mass tort litigation arising from facility fire in California.\u003c/p\u003e","\u003cp\u003eMember of national coordinating team of lawyers representing \u003cstrong data-redactor-tag=\"strong\"\u003eGlaxoSmithKline\u003c/strong\u003e (\u0026ldquo;GSK\u0026rdquo;) in product liability litigation throughout the country, including allegations that the antidepressant Paxil\u0026reg; causes congenital defects. Matt has prepared numerous cases for trial; deposed plaintiffs as well as third-party witnesses and treating physicians; developed and executed pretrial strategy; briefed dispositive and procedural motions; and coordinated discovery.\u003c/p\u003e","\u003cp\u003eDefended \u003cstrong data-redactor-tag=\"strong\"\u003eGSK\u003c/strong\u003e before Pennsylvania appellate courts following summary judgment for GSK in product liability litigation including allegations that Paxil\u0026reg; caused congenital defects.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003ea\u003c/strong\u003e \u003cstrong data-redactor-tag=\"strong\"\u003emultinational pharmaceuticals manufacturer\u003c/strong\u003e in personal injury action filed in Florida State Court. Matt coordinated removal of the action to federal court and then successfully moved to dismiss the action at the pleadings stage.\u003c/p\u003e","\u003cp\u003eDefended \u003cstrong data-redactor-tag=\"strong\"\u003ethe Dow Chemical Company\u003c/strong\u003e (\"Dow\") in California product liability litigation in which plaintiffs allege that certain Dow products caused injuries to an employee at a manufacturing facility.\u003c/p\u003e","\u003cp\u003eDefended \u003cstrong data-redactor-tag=\"strong\"\u003eDow\u003c/strong\u003e in a commercial dispute in California involving product liability claims concerning a plastic resin formerly manufactured by Dow.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003econsumer product manufacturers\u003c/strong\u003e in enforcement actions brought by California's Department of Pesticide Regulation.\u003c/p\u003e","\u003cp\u003ePreparation for trial in \u003cstrong data-redactor-tag=\"strong\"\u003emultiple mass tort lawsuits\u003c/strong\u003e alleging health and property claims, including drafting discovery, interviewing witnesses, and preparing fact witnesses for deposition testimony; also responsible for interviewing and preparing expert witnesses in fields of toxicology and municipal water delivery systems.\u003c/p\u003e","\u003cp\u003eParticipated as part of a multi-disciplinary team of attorneys and consultants conducting a risk assessment for \u003cstrong data-redactor-tag=\"strong\"\u003ea multinational pharmaceutical manufacturer\u003c/strong\u003e in connection with the approval of a new medication. Matt assisted with Company by identifying and recommending steps to minimize product liability risk.\u003c/p\u003e","\u003cp\u003eParticipated in the defense of \u003cstrong data-redactor-tag=\"strong\"\u003ea bellwether lawsuit\u003c/strong\u003e alleging health claims arising from exposure to dioxins, vinyl chloride, TCE and other soil and groundwater contaminants, including drafting \u003cem data-redactor-tag=\"em\"\u003eDaubert\u003c/em\u003e motions to exclude plaintiffs\u0026rsquo; expert witnesses.\u003c/p\u003e","\u003cp\u003eDefended litigation arising under the Freedom of Information Act (FOIA) against \u003cstrong data-redactor-tag=\"strong\"\u003eclient in the healthcare industry,\u003c/strong\u003e including developing case strategy with codefendant federal agency, drafting dispositive motions, and negotiations with opposing counsel.\u003c/p\u003e","\u003cp\u003eDefended litigation arising under state freedom of information laws for \u003cstrong data-redactor-tag=\"strong\"\u003ea nuclear power trade group,\u003c/strong\u003e including drafting of dispositive motions, discovery responses, and settlement agreement to protect the confidentiality of client documents.\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":731}]},"capability_group_id":3},"created_at":"2025-05-26T05:03:16.000Z","updated_at":"2025-05-26T05:03:16.000Z","searchable_text":"Blaschke{{ FIELD }}Currently representing a large energy company in mass tort litigation arising from facility fire in California.{{ FIELD }}Member of national coordinating team of lawyers representing GlaxoSmithKline (“GSK”) in product liability litigation throughout the country, including allegations that the antidepressant Paxil® causes congenital defects. Matt has prepared numerous cases for trial; deposed plaintiffs as well as third-party witnesses and treating physicians; developed and executed pretrial strategy; briefed dispositive and procedural motions; and coordinated discovery.{{ FIELD }}Defended GSK before Pennsylvania appellate courts following summary judgment for GSK in product liability litigation including allegations that Paxil® caused congenital defects.{{ FIELD }}Represented a multinational pharmaceuticals manufacturer in personal injury action filed in Florida State Court. Matt coordinated removal of the action to federal court and then successfully moved to dismiss the action at the pleadings stage.{{ FIELD }}Defended the Dow Chemical Company (\"Dow\") in California product liability litigation in which plaintiffs allege that certain Dow products caused injuries to an employee at a manufacturing facility.{{ FIELD }}Defended Dow in a commercial dispute in California involving product liability claims concerning a plastic resin formerly manufactured by Dow.{{ FIELD }}Represented consumer product manufacturers in enforcement actions brought by California's Department of Pesticide Regulation.{{ FIELD }}Preparation for trial in multiple mass tort lawsuits alleging health and property claims, including drafting discovery, interviewing witnesses, and preparing fact witnesses for deposition testimony; also responsible for interviewing and preparing expert witnesses in fields of toxicology and municipal water delivery systems.{{ FIELD }}Participated as part of a multi-disciplinary team of attorneys and consultants conducting a risk assessment for a multinational pharmaceutical manufacturer in connection with the approval of a new medication. Matt assisted with Company by identifying and recommending steps to minimize product liability risk.{{ FIELD }}Participated in the defense of a bellwether lawsuit alleging health claims arising from exposure to dioxins, vinyl chloride, TCE and other soil and groundwater contaminants, including drafting Daubert motions to exclude plaintiffs’ expert witnesses.{{ FIELD }}Defended litigation arising under the Freedom of Information Act (FOIA) against client in the healthcare industry, including developing case strategy with codefendant federal agency, drafting dispositive motions, and negotiations with opposing counsel.{{ FIELD }}Defended litigation arising under state freedom of information laws for a nuclear power trade group, including drafting of dispositive motions, discovery responses, and settlement agreement to protect the confidentiality of client documents.{{ FIELD }}Matt Blaschke focuses on complex litigation involving scientific or technical issues, as well as general litigation. As a partner in our Environmental and Mass Tort and Toxic Tort practices, Matt represents energy, pharmaceutical, consumer product and chemical industry clients in state and federal courts throughout the country.\nMatt’s experience ranges from large-scale multiparty litigation to individual product liability actions. He also advises clients on environmental laws and regulations, including the federal Insecticide, Fungicide and Rodenticide Act. Matthew J Blaschke Partner Notre Dame  George Washington University George Washington University Law School U.S. District Court for the Central District of California U.S. District Court for the Eastern District of California U.S. District Court for the Northern District of California U.S. District Court for the Southern District of California California District of Columbia Currently representing a large energy company in mass tort litigation arising from facility fire in California. Member of national coordinating team of lawyers representing GlaxoSmithKline (“GSK”) in product liability litigation throughout the country, including allegations that the antidepressant Paxil® causes congenital defects. Matt has prepared numerous cases for trial; deposed plaintiffs as well as third-party witnesses and treating physicians; developed and executed pretrial strategy; briefed dispositive and procedural motions; and coordinated discovery. Defended GSK before Pennsylvania appellate courts following summary judgment for GSK in product liability litigation including allegations that Paxil® caused congenital defects. Represented a multinational pharmaceuticals manufacturer in personal injury action filed in Florida State Court. Matt coordinated removal of the action to federal court and then successfully moved to dismiss the action at the pleadings stage. Defended the Dow Chemical Company (\"Dow\") in California product liability litigation in which plaintiffs allege that certain Dow products caused injuries to an employee at a manufacturing facility. Defended Dow in a commercial dispute in California involving product liability claims concerning a plastic resin formerly manufactured by Dow. Represented consumer product manufacturers in enforcement actions brought by California's Department of Pesticide Regulation. Preparation for trial in multiple mass tort lawsuits alleging health and property claims, including drafting discovery, interviewing witnesses, and preparing fact witnesses for deposition testimony; also responsible for interviewing and preparing expert witnesses in fields of toxicology and municipal water delivery systems. Participated as part of a multi-disciplinary team of attorneys and consultants conducting a risk assessment for a multinational pharmaceutical manufacturer in connection with the approval of a new medication. Matt assisted with Company by identifying and recommending steps to minimize product liability risk. Participated in the defense of a bellwether lawsuit alleging health claims arising from exposure to dioxins, vinyl chloride, TCE and other soil and groundwater contaminants, including drafting Daubert motions to exclude plaintiffs’ expert witnesses. Defended litigation arising under the Freedom of Information Act (FOIA) against client in the healthcare industry, including developing case strategy with codefendant federal agency, drafting dispositive motions, and negotiations with opposing counsel. Defended litigation arising under state freedom of information laws for a nuclear power trade group, including drafting of dispositive motions, discovery responses, and settlement agreement to protect the confidentiality of client documents.","searchable_name":"Matthew J. Blaschke (Matt)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":32,"capability_group_featured":null,"home_page_featured":null},{"id":427703,"version":1,"owner_type":"Person","owner_id":1673,"payload":{"bio":"\u003cp\u003eBrian Bohnenkamp specializes in regulatory and compliance matters relating to drug, biotechnology and medical device companies. A partner in our FDA practice and a member of our Life Sciences group, Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith a master\u0026rsquo;s degree in healthcare administration, Brian provides counsel to companies on a variety of laws and regulations administered and enforced by FDA, OIG, DOJ, and CMS, as well as by state attorneys general, boards of pharmacy, departments of health, and similar administrative and enforcement authorities. He regularly assists manufacturers in designing and implementing comprehensive compliance programs, and conducts risk assessments, audits and other reviews of compliance programs and business activities/operations.\u003c/p\u003e\n\u003cp\u003eBrian is regarded as a national expert on life sciences transparency laws and regulations, including the federal Physician Payments Sunshine Act (aka Open Payments) and similar state laws. He provides counsel to the Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical, biotechnology and medical device manufacturers.\u003c/p\u003e","slug":"brian-bohnenkamp","email":"bbohnenkamp@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[{"id":25}]},"expertise":[{"id":103,"guid":"103.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":2,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":3,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":4,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":5,"source":"smartTags"},{"id":122,"guid":"122.capabilities","index":6,"source":"capabilities"},{"id":1199,"guid":"1199.smart_tags","index":7,"source":"smartTags"},{"id":1193,"guid":"1193.smart_tags","index":8,"source":"smartTags"}],"is_active":true,"last_name":"Bohnenkamp","nick_name":"Brian","clerkships":[],"first_name":"Brian","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"A.","name_suffix":"","recognitions":[{"title":"Up and Coming, Healthcare: Pharmaceutical /Medical Products Regulatory ","detail":"Chambers USA, District of Columbia (2020-2022)"},{"title":"\"Brian's knowledge and experience are invaluable.\" ","detail":"Chambers USA (2022) "},{"title":"Next Generation Partner","detail":"Legal 500"},{"title":"Up and Coming for Pharmaceutical/Medical Products Regulatory","detail":"Chambers"},{"title":"Rising Star ","detail":"Washington, D.C. Super Lawyers, 2017-2020"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eBrian Bohnenkamp specializes in regulatory and compliance matters relating to drug, biotechnology and medical device companies. A partner in our FDA practice and a member of our Life Sciences group, Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith a master\u0026rsquo;s degree in healthcare administration, Brian provides counsel to companies on a variety of laws and regulations administered and enforced by FDA, OIG, DOJ, and CMS, as well as by state attorneys general, boards of pharmacy, departments of health, and similar administrative and enforcement authorities. He regularly assists manufacturers in designing and implementing comprehensive compliance programs, and conducts risk assessments, audits and other reviews of compliance programs and business activities/operations.\u003c/p\u003e\n\u003cp\u003eBrian is regarded as a national expert on life sciences transparency laws and regulations, including the federal Physician Payments Sunshine Act (aka Open Payments) and similar state laws. He provides counsel to the Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical, biotechnology and medical device manufacturers.\u003c/p\u003e","recognitions":[{"title":"Up and Coming, Healthcare: Pharmaceutical /Medical Products Regulatory ","detail":"Chambers USA, District of Columbia (2020-2022)"},{"title":"\"Brian's knowledge and experience are invaluable.\" ","detail":"Chambers USA (2022) "},{"title":"Next Generation Partner","detail":"Legal 500"},{"title":"Up and Coming for Pharmaceutical/Medical Products Regulatory","detail":"Chambers"},{"title":"Rising Star ","detail":"Washington, D.C. Super Lawyers, 2017-2020"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":735}]},"capability_group_id":2},"created_at":"2025-05-26T05:03:56.000Z","updated_at":"2025-05-26T05:03:56.000Z","searchable_text":"Bohnenkamp{{ FIELD }}{:title=\u0026gt;\"Up and Coming, Healthcare: Pharmaceutical /Medical Products Regulatory \", :detail=\u0026gt;\"Chambers USA, District of Columbia (2020-2022)\"}{{ FIELD }}{:title=\u0026gt;\"\\\"Brian's knowledge and experience are invaluable.\\\" \", :detail=\u0026gt;\"Chambers USA (2022) \"}{{ FIELD }}{:title=\u0026gt;\"Next Generation Partner\", :detail=\u0026gt;\"Legal 500\"}{{ FIELD }}{:title=\u0026gt;\"Up and Coming for Pharmaceutical/Medical Products Regulatory\", :detail=\u0026gt;\"Chambers\"}{{ FIELD }}{:title=\u0026gt;\"Rising Star \", :detail=\u0026gt;\"Washington, D.C. Super Lawyers, 2017-2020\"}{{ FIELD }}Brian Bohnenkamp specializes in regulatory and compliance matters relating to drug, biotechnology and medical device companies. A partner in our FDA practice and a member of our Life Sciences group, Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions.\nWith a master’s degree in healthcare administration, Brian provides counsel to companies on a variety of laws and regulations administered and enforced by FDA, OIG, DOJ, and CMS, as well as by state attorneys general, boards of pharmacy, departments of health, and similar administrative and enforcement authorities. He regularly assists manufacturers in designing and implementing comprehensive compliance programs, and conducts risk assessments, audits and other reviews of compliance programs and business activities/operations.\nBrian is regarded as a national expert on life sciences transparency laws and regulations, including the federal Physician Payments Sunshine Act (aka Open Payments) and similar state laws. He provides counsel to the Ad Hoc Sunshine and State Law Compliance Group, a coalition of pharmaceutical, biotechnology and medical device manufacturers. Brian A Bohnenkamp Partner Up and Coming, Healthcare: Pharmaceutical /Medical Products Regulatory  Chambers USA, District of Columbia (2020-2022) \"Brian's knowledge and experience are invaluable.\"  Chambers USA (2022)  Next Generation Partner Legal 500 Up and Coming for Pharmaceutical/Medical Products Regulatory Chambers Rising Star  Washington, D.C. Super Lawyers, 2017-2020 Indiana University Indiana University School of Law St. Louis University  St. Louis University  District of Columbia Illinois","searchable_name":"Brian A. Bohnenkamp","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":443887,"version":1,"owner_type":"Person","owner_id":6347,"payload":{"bio":"\u003cp\u003eKeri Borders is a litigator who focuses her practice on defending food and beverage, dietary supplement and consumer packaged goods manufacturers, retailers, and distributors in complex competitor and consumer class action litigation. Clients rely on Keri and her creative problem solving skills because of her deep understanding of their business and her ability to achieve successful results.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKeri regularly practices in state, federal, and appellate courts in cases involving false advertising relating to product labeling and advertising, including nutrition and health claims, contaminants (heavy metals, PFAS, glyphosate, mycotoxins), product attributes, sustainability/environmental/green claims, and alleged violation of the FDCA/NLEA, PPIA, FMIA, Lanham Act, and FTC Green Guides (and state counterparts).\u003c/p\u003e\n\u003cp\u003eKeri also has significant experience litigating contract, accounting, and intellectual property disputes, and defending unfair business practices, unfair competition, misappropriation of trade secrets, breach of fiduciary duty, and business torts. Keri has experience in a broad spectrum of industries, including entertainment, personal care products, consumer electronics, telecommunications, pet food, and real estate.\u003c/p\u003e\n\u003cp\u003eKeri is ranked in\u0026nbsp;\u003cem\u003eChambers USA\u003c/em\u003e,\u0026nbsp;\u003cem\u003eLegal 500\u003c/em\u003e,\u0026nbsp;and was recognized by\u0026nbsp;\u003cem\u003eLaw360\u003c/em\u003e\u0026nbsp;as one of four MVP\u0026rsquo;s in the United States in Product Liability in 2020.\u003c/p\u003e","slug":"keri-borders","email":"kborders@kslaw.com","phone":null,"matters":["\u003cp\u003e\u003cem\u003e\u003cstrong\u003eBustamante v. KIND, LLC\u003c/strong\u003e,\u0026nbsp;\u003c/em\u003e--- F.4th ----, 2024 WL 1917155 (2d Cir. May 2, 2024),\u003cem\u003e\u0026nbsp;affirming In re: Kind LLC \u0026ldquo;Healthy and All Natural\u0026rdquo; Litigation\u003c/em\u003e\u003cem\u003e,\u003c/em\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e627 F. Supp. 3d 269 (S.D.N.Y. 2022). In a precedential decision following nine years of litigation, the Second Circuit\u003cem\u003e\u0026nbsp;\u003c/em\u003eaffirmed summary judgment and striking of plaintiffs\u0026rsquo; \u0026ldquo;natural\u0026rdquo; and consumer behavior experts in false advertising MDL class action challenging healthy, natural and non-GMO statements on the labels of snack products\u003cem\u003e.\u003c/em\u003e\u003c/p\u003e","\u003cp\u003e\u003cem\u003e\u003cstrong\u003eCleveland v. Campbell Soup Co.,\u003c/strong\u003e\u0026nbsp;\u003c/em\u003e647 F.Supp.3d 772, (N.D. Cal. 2022)\u003cem\u003e\u0026nbsp;Successive motions to dismiss granted in false advertising consumer class action challenging a front-of-pack 0g Total Sugars statement.\u003c/em\u003e\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eZurilene v. Dreyer\u0026rsquo;s Grand Ice Cream, Inc\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e.,\u003c/em\u003e\u0026nbsp;--- F.Supp.3d ---, 2022 WL 816636 (S.D. Ill. Mar. 17, 2022) Motion to dismiss granted in class action alleging false advertising under the Illinois Consumer Fraud and Deceptive Business Practices Act regarding Haagen-Dazs ice cream bars labeled \u0026ldquo;rich milk chocolate.\u0026rdquo; Plaintiff alleged that the use of coconut oil in the chocolate coating of \u0026ldquo;Vanilla Milk Chocolate Ice Cream Bars\u0026rdquo; without disclosing its presence on the front-of-pack was misleading and contrary to FDA regulations. The court ruled that plaintiff was attempting to impose label requirements that were in addition to or different from FDA regulations and, therefore, the theory of liability was preempted.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eYu v. Dreyer\u0026rsquo;s Grand Ice Cream, Inc\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e.\u003c/em\u003e\u0026nbsp;--- F.Supp.3d ---, 2022 WL 799563 (S.D.N.Y. Mar. 16, 2022) Motion to dismiss granted in class action alleging false advertising under the Illinois consumer protection laws regarding Haagen-Dazs ice cream bars labeled \u0026ldquo;rich milk chocolate.\u0026rdquo; Plaintiff alleged that the use of coconut oil in the chocolate coating of the ice cream bars without disclosing its presence on the front-of-pack was misleading and contrary to FDA regulations. The court ruled that plaintiff had no private right of action to enforce FDA regulations, and that plaintiff\u0026rsquo;s theory of deception was not plausible because, among other reasons, the coating does contain FDA standard-of-identify chocolate, the label fully discloses the presence of oil in the ingredient list, and the label never suggests that the product does not contain oil.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eKamara v. Pepperidge Farm, Inc.\u003c/em\u003e,\u003c/strong\u003e\u0026nbsp;--- F.Supp.4th, 2021 WL 5234882 (S.D.N.Y. 2021) Achieved a complete victory for Pepperidge Farm in a putative nationwide consumer class action under New York consumer protection law. The complaint alleged that Pepperidge\u0026rsquo;s Golden Butter Crackers misled consumers into believing that the product does not include oil. In a 2021 published decision dismissing the complaint with prejudice, the court clarified the principle that false advertising claims must be assessed in context. The court also assessed the plausibility of the complaint\u0026rsquo;s theory of deception against recent Second (Mantikas) and Seventh (Bell) Circuit precedents, and found the complaint deficient. See also\u0026nbsp;\u003cstrong\u003e\u003cem\u003eFloyd v. Pepperidge Farm, Incorporated\u003c/em\u003e\u003c/strong\u003e, -- F. Supp. 3d--, 2022 WL 203071 (S.D. Ill. Jan, 24, 2022).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eChong v. Kind LLC,\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e585 F. Supp. 3d 1215, (N.D. Cal. 2022). Motion to dismiss granted in class action challenging front-of-pack protein claim on plant-based product. Plaintiffs alleged that the quantitative statement was deceptive and contrary to FDA regulations because it wasn\u0026rsquo;t corrected for digestibility. Based on our arguments, court reversed a decision it had made on that same issue in a similar lawsuit just a year before. Court also ruled in favor of our client on Buckman preemption, holding that plaintiffs were not able to enforce FDA regulations under the guise of consumer deception claims.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eWong v. The Vons Companies, Inc.\u003c/em\u003e\u003c/strong\u003e, 2020 WL 5632305 (Alameda County Super. Ct. (Cal.) Sept. 14, 2020) \u0026amp; 2020 WL 6161875 (Alameda County Super. Ct. (Cal.) Oct. 13, 2020). Certification denied in consumer class action challenging label statement on fresh poultry products. Decision affirmed on appeal in unanimous opinion. 2022 WL 1210445 (Cal. Ct. App. Apr. 25, 2022).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCheslow v. Ghirardelli Chocolate Co\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e.,\u0026nbsp;\u003c/em\u003e472 F.Supp.3d 686 (N.D. Cal. 2020) \u0026amp; 445 F.Supp.3d 8 (N.D. Cal. 2020). Obtained dismissal on plausibility grounds of consumer class action false advertising action challenging white chips product.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrescott v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e,\u0026nbsp;\u003c/em\u003e2020 WL 3035798 (N.D. Cal. June 4, 2020). Obtained dismissal on plausibility grounds of consumer class action false advertising action challenging white morsels product.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eMacedonia Distributing, Inc. v. S-L Distribution Co., LLC\u003c/em\u003e\u003c/strong\u003e, 2020 WL 610702 (C.D. Cal. Feb. 7, 2020). Certification denied in distributor class action alleging underpayment for distribution businesses.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePorath v. Logitech, Inc\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e.\u003c/em\u003e, 2019 WL 6134936 (N.D. Cal. Nov. 18, 2019). Certification denied in consumer class action challenging labeling and advertising of electronics product.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eParker v. Logitech, Inc.\u003c/em\u003e\u003c/strong\u003e, 2017 WL 4701044 (Cal. Super., Alameda County Oct. 18, 2017). Certification denied in consumer class action challenging labeling and advertising of electronics product.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePelayo v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e, 989 F. Supp. 2d 973 (C.D. Cal. 2013). Defended Buitoni brand of products in case challenging \u0026ldquo;natural\u0026rdquo; label statements. Case dismissed with prejudice at the pleading stage. The court ruled that the plaintiff failed to offer an objective or plausible definition of the allegedly-deceptive phrase \u0026ldquo;all natural,\u0026rdquo; stating that \u0026ldquo;the reasonable consumer is aware that Buitoni pastas are not \u0026lsquo;springing fully formed from ravioli trees and tortellini bushes.\u0026rsquo;\u0026rdquo;\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eShin v. Campbell Soup\u003c/em\u003e, No. 17-1082 (C.D. Cal.).\u0026nbsp;\u003c/strong\u003eSecured a victory for Campbell Soup when a federal judge in the Central District of California dismissed a false advertising consumer class action complaint alleging that labeling of less sodium and fat-free products was deceptive. The court ruled that plaintiffs\u0026rsquo; theory of deception was not plausible because the challenged statements were accurate and were not likely to mislead a reasonable consumer.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eLucido v. Nestl\u0026eacute; Purina Petcare Company\u003c/em\u003e\u003c/strong\u003e, 217 F.Supp.3d 1098 (N.D. Cal. 2016). Successfully moved for summary judgment and to strike plaintiffs\u0026rsquo; experts in a consumer class action alleging that Purina failed to disclose that Beneful dog food was harmful. The court ruled that plaintiffs\u0026rsquo; case was entirely dependent on their experts\u0026rsquo; opinions, but the opinions were unreliable and inadmissible. Accordingly, plaintiffs\u0026rsquo; case had no evidentiary support and could not proceed.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eKane v. Chobani LLC\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e,\u003c/em\u003e645 Fed. App\u0026rsquo;x. 593 (9th Cir. 2016);\u0026nbsp;\u003cem\u003esee also\u0026nbsp;\u003c/em\u003e973 F. Supp. 2d 1120 (N.D. Cal. 2014), 2013 WL 5289253 (N.D. Cal. Sept. 19, 2013), and 2013 WL 3776172 (N.D. Cal. July 15, 2013). Defense of a putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to Greek yogurt products marketed as containing \u0026ldquo;only natural ingredients\u0026rdquo; and listing \u0026ldquo;evaporated cane juice\u0026rdquo; as an ingredient. A motion to dismiss was granted. 2013 WL 5289253. The plaintiffs\u0026rsquo; motion for preliminary injunction was denied. 2013 WL 3776172. A motion to disqualify the plaintiffs\u0026rsquo; expert was granted. 2013 WL 3991107. After a third amended complaint, a second motion to dismiss was granted with prejudice. 2014 WL 657300. The Ninth Circuit then stayed the case.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eWysong Corp. v. APN, Inc.\u003c/em\u003e\u003c/strong\u003e, 889 F.3d 267 (6th Cir. 2018). Secured a victory for Nestl\u0026eacute; Purina Petcare Company when a federal judge in the Eastern District of Michigan dismissed with prejudice a Lanham Act complaint alleging that using realistic images of meat and vegetables on pet food labels was deceptive. The court ruled that plaintiff\u0026rsquo;s theory of deception was not plausible because the challenged label images, especially when considered in context, were not false and were not likely to mislead a reasonable consumer. Significantly, the court denied further amendments and entered judgment in favor of our client.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eIn re KIND LLC \u0026ldquo;Healthy and All Natural\u0026rdquo; Litigation\u003c/em\u003e\u003c/strong\u003e, 209 F. Supp. 3d 689 (S.D.N.Y. Sept. 15, 2016). Secured a ground-breaking victory for KIND snack bars when a federal judge in the Southern District of New York dismissed claims in an MDL consumer class action challenging KIND\u0026rsquo;s \u0026ldquo;healthy\u0026rdquo; labeling and stayed claims challenging \u0026ldquo;natural\u0026rdquo; labeling pending FDA\u0026rsquo;s consideration of the issue.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCerreta v. Laclede, Inc\u003c/em\u003e\u003c/strong\u003e., No. 14-8066 (C.D. Cal.) (removed from L.A. Sup. Ct.). Defending consumer packaged goods company in nationwide consumer class action alleging false advertising under California consumer protection law regarding \u0026ldquo;natural\u0026rdquo; labeling of personal care products.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eGreenberg v. Galderma Laboratories\u003c/em\u003e\u003c/strong\u003e, L.P., No. 3:16cv6090 (N.D. Cal.). Defended personal care product company against allegations of false advertising re label statements.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eMagier v. Tribe Mediterranean Foods, Inc.\u003c/em\u003e\u003c/strong\u003e, No. 1:15cv5781 (S.D.N.Y.). Defended manufacturer of hummus against claims of false advertising relating to \u0026ldquo;natural\u0026rdquo; label statements.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRhinerson v. Van\u0026rsquo;s International Foods\u0026nbsp;\u003c/em\u003e,\u003c/strong\u003eNo. 3:13cv9523 (N.D. Cal.). Defended frozen waffle manufacturer against putative nationwide consumer class action challenging the \u0026ldquo;natural\u0026rdquo; labeling of the products.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBackus v. Nestl\u0026eacute; USA, Inc\u003c/em\u003e.\u003c/strong\u003e, 167 F. Supp. 3d 1068 (N.D. Cal. 2016). Secured a ground-breaking victory for Nestl\u0026eacute; USA and its iconic Coffee-mate brand when a federal judge in the Northern District of California dismissed with prejudice a consumer class action complaint. Plaintiffs alleged that Nestl\u0026eacute;\u0026rsquo;s mere use of partially hydrogenated oil in Coffee-mate was unlawful, and that labeling statements touting the product as having \u0026ldquo;0g Trans Fat\u0026rdquo; was misleading. The court ruled that plaintiff\u0026rsquo;s \u0026lsquo;use\u0026rsquo; theory was an obstacle to federal law and therefore preempted, and that plaintiff\u0026rsquo;s false advertising theory, which attempted to impose labeling requirements not identical to federal law was expressly preempted.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eWorkman v. Plum PBC\u003c/em\u003e\u003c/strong\u003e, 141 F. Supp. 3d 1032 (N.D. Cal. 2015). Secured a victory for Campbell Soup and its subsidiary Plum Organics when a federal judge in the Northern District of California dismissed with prejudice a false advertising consumer class action complaint alleging that food labeling was deceptive. The court ruled that plaintiffs\u0026rsquo; theory of deception was not plausible because the labels were not false and were not likely to mislead a reasonable consumer.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRoss v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e, No. 1:16-cv-09563 (S.D.N.Y.). Defended Lean Cuisine products against false advertising claims relating to \u0026ldquo;no preservatives\u0026rdquo; label statement and the presence of citric acid in products.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAstiana v. Dreyer\u0026rsquo;s Grand Ice Cream\u003c/em\u003e\u003c/strong\u003e, No. 11-2910 (N.D. Cal.). Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to H\u0026auml;agen-Dazs and Dreyer\u0026rsquo;s ice cream products labeled \u0026ldquo;All Natural.\u0026rdquo; This case was consolidated with the copy-cat case Rutledge-Muhs v. Dreyer\u0026rsquo;s Grand Ice Cream. The action was dismissed with prejudice.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStoltz v. Chobani, LLC\u003c/em\u003e\u003c/strong\u003e, No. 1:14cv3827 (E.D.N.Y.). Defended nationwide consumer class action alleging false advertising of Greek Yogurt products, marketed as \u0026ldquo;Greek Yogurt,\u0026rdquo; \u0026ldquo;0%,\u0026rdquo; \u0026ldquo;evaporated cane juice,\u0026rdquo; and natural and healthy.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eChavez v. Nestl\u0026eacute; USA\u003c/em\u003e\u003c/strong\u003e, No. 09-9192 (C.D. Cal.). Defended putative nationwide consumer class action against Nestl\u0026eacute; USA alleging false advertising under California consumer protection laws with respect to juice products marketed as supporting brain development, immunity and digestive health. Case dismissed following three successive, successful motions to dismiss (2011 WL 10565797 (C.D. Cal. Jan. 10, 2011), 2011 WL 2150128 (C.D. Cal. May 19, 2011)). Judgment in defendant\u0026rsquo;s favor affirmed in part and reversed in part. 511 Fed. App\u0026rsquo;x. 606 (9th Cir. 2013).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eIbarrola v. KIND LLC\u003c/em\u003e\u003c/strong\u003e, 83 F. Supp. 3d 751 (N.D. Ill. 2014). Secured a complete victory for client KIND LLC in the Northern District of Illinois when Judge Sara Ellis dismissed a putative nationwide consumer class action premised on allegations that KIND deceived consumers by including a \u0026ldquo;No Refined Sugars\u0026rdquo; statement on the label of snack foods. Judge Ellis granted KIND\u0026rsquo;s motion to dismiss an amended complaint with prejudice, holding that plaintiff failed to allege a plausible theory of deception.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBoyle v. KIND LLC\u003c/em\u003e\u003c/strong\u003e, No. 1:13cv8365 (S.D.N.Y). Defended nationwide consumer class action challenging the labeling of snack bar products as insinuating that consuming the products will not lead to weight gain and that the product is better-for-you product. Also defended copy-cat, follow-on action\u0026nbsp;\u003cem\u003eBailey v. KIND LLC\u003c/em\u003e, No. 8:16cv168(C.D. Cal.).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrazo v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e, No. 5:12cv2272 (N.D. Cal.) Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws regarding Coffee-mate powder products marketed as \u0026ldquo;0g trans fat.\u0026rdquo; This case is notable for the scope of its predecessor case at filing\u0026mdash;challenging an open-ended number of the products of a major food manufacturer. The broadside attack featured multiple misbranding allegations on diverse labeling statements. Of special significance, we dealt a massive blow when its separate and innovative motion to strike the plaintiffs' class allegations\u0026mdash;at the pleading stage\u0026mdash;was granted. 201 WL 4083218 (N.D. Cal. Aug. 9, 2013). The challenged products were subsequently reduced from \u0026ldquo;open-ended\u0026rdquo; to four and the misbranding theories have been reduced from nine to four.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBelli II v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e, No. 5:14cv283 (N.D. Cal.) Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws regarding Eskimo Pie products marketed as \u0026ldquo;No Sugar Added.\u0026rdquo;\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eIn re Gerber Probiotic Sales Practices Litigation\u003c/em\u003e\u003c/strong\u003e, No. 12-835 (D. N.J.). Defended Gerber in ten-case consolidated nationwide consumer class action alleging false advertising under consumer protection and warranty laws of multiple states with respect to baby formula and cereal products labeled as containing immune-supporting probiotics, digestion-supporting prebiotics, and brain and eye development-supporting DHA. Motions to consolidate cases granted.\u0026nbsp;\u003cem\u003eBurns v. Gerber Prods. Co\u003c/em\u003e., 922 F.Supp.2d 1168 (E.D. Wash. 2013);\u0026nbsp;\u003cem\u003eHawkins v. Gerber\u003c/em\u003e\u003cem\u003e\u0026nbsp;Prods. Co., 924 F.Supp.2d 1208 (S.D. Cal. 2013).\u003c/em\u003e\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eReilly v. Amy\u0026rsquo;s Kitchen\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e, 2 F. Supp. 3d 1300 (S.D. Fla. 2014);\u0026nbsp;\u003cem\u003esee also\u0026nbsp;\u003c/em\u003e2014 WL 905441 (S.D. Fla. Mar. 7, 2014) Defended against putative Florida consumer class action alleging false advertising under Florida consumer protection laws with respect to food products containing the ingredient \u0026ldquo;evaporated cane juice.\u0026rdquo; A federal judge first denied plaintiff\u0026rsquo;s request to reinstate claims over 57 products that the named plaintiff never purchased. The court then dismissed the case on jurisdictional grounds because the amount at issue for the three products the named plaintiff did purchase fell below the Class Action Fairness Act amount in controversy requirement.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFigy v. Amy\u0026rsquo;s Kitchen, Inc\u003c/em\u003e\u003c/strong\u003e., 2 F. Supp. 3d 1300 (N.D. Cal. 2014). Defended against putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to food products containing the ingredient \u0026ldquo;evaporated cane juice.\u0026rdquo; A federal judge dismissed action without leave to amend based on primary jurisdiction of FDA (later converted to stay).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSimpson v. California Pizza Kitchen\u003c/em\u003e\u003c/strong\u003e, 989 F. Supp. 2d 1015 (S.D. Cal. 2013), 2013, 2013 WL 5718479 (S.D. Cal Oct. 1, 2013). Defended a putative nationwide consumer class action against several frozen pizza brands owned by Nestl\u0026eacute; USA and California Pizza Kitchen alleging violation of California's Unfair Competition Law and statutory nuisance law. This was a bellwether case. Using the class action vehicle, plaintiffs sought to impose an unprecedented judicial ban on artificial trans fats in frozen pizza products. Any success could have \u0026ldquo;opened the floodgates\u0026rdquo; to numerous other cases seeking to ban individual ingredients. A motion to dismiss was granted as to the entire complaint, with prejudice and without leave to amend.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBrower v. Campbell Soup Company\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e,\u0026nbsp;\u003c/em\u003e243 F. Supp. 3d 1124, 2017 WL 1063470 (S.D. Cal. Mar. 21, 2017). Obtained a dismissal with prejudice for Campbell Soup in a consumer class challenging the labels of Chunky Healthy Request soup products. The court ruled that plaintiffs\u0026rsquo; state-law false advertising claims are preempted by the federal Poultry Products Inspection Act and the Federal Meat Inspection Act.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBell v. Campbell Soup Co.\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e,\u0026nbsp;\u003c/em\u003e65 F. Supp. 3d 1328 (N.D. Fla. 2014). Secured victory for Campbell Soup when a federal judge in Florida dismissed with prejudice an amended consumer class action complaint in an action that initially had challenged the labeling of more than 50 products from multiple product lines under Campbell\u0026rsquo;s iconic V8 brand. The court ruled that plaintiffs\u0026rsquo; amended claims (following an initial motion to dismiss) were expressly preempted as attempting to impose state-law labeling requirements that were not identical to federal labeling law and that Campbell\u0026rsquo;s labels complied with the federal requirements \u0026ldquo;to the letter.\u0026rdquo;\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.capabilities","index":1,"source":"capabilities"},{"id":764,"guid":"764.smart_tags","index":2,"source":"smartTags"},{"id":105,"guid":"105.capabilities","index":3,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":4,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":5,"source":"capabilities"}],"is_active":true,"last_name":"Borders","nick_name":"Keri","clerkships":[{"name":"Law Clerk, Judge Robert J. Timlin, U.S. District Court for the Central District of California","years_held":"1998 - 1998"}],"first_name":"Keri","title_rank":9999,"updated_by":32,"law_schools":[{"id":2158,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"1997-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Next Generation Partner","detail":"Legal 500, 2023"},{"title":"Ranked Band 4 for Food \u0026 Beverages: Regulatory \u0026 Litigation","detail":"Chambers USA (Nationwide), 2022, 2023"},{"title":"Named Law360 MVP (Product Liability)","detail":"2020"},{"title":"Named Leader of Influence: Litigators \u0026 Trial Attorneys","detail":"Los Angeles Business Journal – 2021"},{"title":"Named Women of Influence","detail":"Attorneys by Los Angeles Business Journal - 2021"},{"title":"2021 Women Worth Watching in Leadership Award Winner","detail":"Diversity Law Journal"}],"linked_in_url":"https://www.linkedin.com/in/keri-borders-36814112/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eKeri Borders is a litigator who focuses her practice on defending food and beverage, dietary supplement and consumer packaged goods manufacturers, retailers, and distributors in complex competitor and consumer class action litigation. Clients rely on Keri and her creative problem solving skills because of her deep understanding of their business and her ability to achieve successful results.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKeri regularly practices in state, federal, and appellate courts in cases involving false advertising relating to product labeling and advertising, including nutrition and health claims, contaminants (heavy metals, PFAS, glyphosate, mycotoxins), product attributes, sustainability/environmental/green claims, and alleged violation of the FDCA/NLEA, PPIA, FMIA, Lanham Act, and FTC Green Guides (and state counterparts).\u003c/p\u003e\n\u003cp\u003eKeri also has significant experience litigating contract, accounting, and intellectual property disputes, and defending unfair business practices, unfair competition, misappropriation of trade secrets, breach of fiduciary duty, and business torts. Keri has experience in a broad spectrum of industries, including entertainment, personal care products, consumer electronics, telecommunications, pet food, and real estate.\u003c/p\u003e\n\u003cp\u003eKeri is ranked in\u0026nbsp;\u003cem\u003eChambers USA\u003c/em\u003e,\u0026nbsp;\u003cem\u003eLegal 500\u003c/em\u003e,\u0026nbsp;and was recognized by\u0026nbsp;\u003cem\u003eLaw360\u003c/em\u003e\u0026nbsp;as one of four MVP\u0026rsquo;s in the United States in Product Liability in 2020.\u003c/p\u003e","matters":["\u003cp\u003e\u003cem\u003e\u003cstrong\u003eBustamante v. KIND, LLC\u003c/strong\u003e,\u0026nbsp;\u003c/em\u003e--- F.4th ----, 2024 WL 1917155 (2d Cir. May 2, 2024),\u003cem\u003e\u0026nbsp;affirming In re: Kind LLC \u0026ldquo;Healthy and All Natural\u0026rdquo; Litigation\u003c/em\u003e\u003cem\u003e,\u003c/em\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e627 F. Supp. 3d 269 (S.D.N.Y. 2022). In a precedential decision following nine years of litigation, the Second Circuit\u003cem\u003e\u0026nbsp;\u003c/em\u003eaffirmed summary judgment and striking of plaintiffs\u0026rsquo; \u0026ldquo;natural\u0026rdquo; and consumer behavior experts in false advertising MDL class action challenging healthy, natural and non-GMO statements on the labels of snack products\u003cem\u003e.\u003c/em\u003e\u003c/p\u003e","\u003cp\u003e\u003cem\u003e\u003cstrong\u003eCleveland v. Campbell Soup Co.,\u003c/strong\u003e\u0026nbsp;\u003c/em\u003e647 F.Supp.3d 772, (N.D. Cal. 2022)\u003cem\u003e\u0026nbsp;Successive motions to dismiss granted in false advertising consumer class action challenging a front-of-pack 0g Total Sugars statement.\u003c/em\u003e\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eZurilene v. Dreyer\u0026rsquo;s Grand Ice Cream, Inc\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e.,\u003c/em\u003e\u0026nbsp;--- F.Supp.3d ---, 2022 WL 816636 (S.D. Ill. Mar. 17, 2022) Motion to dismiss granted in class action alleging false advertising under the Illinois Consumer Fraud and Deceptive Business Practices Act regarding Haagen-Dazs ice cream bars labeled \u0026ldquo;rich milk chocolate.\u0026rdquo; Plaintiff alleged that the use of coconut oil in the chocolate coating of \u0026ldquo;Vanilla Milk Chocolate Ice Cream Bars\u0026rdquo; without disclosing its presence on the front-of-pack was misleading and contrary to FDA regulations. The court ruled that plaintiff was attempting to impose label requirements that were in addition to or different from FDA regulations and, therefore, the theory of liability was preempted.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eYu v. Dreyer\u0026rsquo;s Grand Ice Cream, Inc\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e.\u003c/em\u003e\u0026nbsp;--- F.Supp.3d ---, 2022 WL 799563 (S.D.N.Y. Mar. 16, 2022) Motion to dismiss granted in class action alleging false advertising under the Illinois consumer protection laws regarding Haagen-Dazs ice cream bars labeled \u0026ldquo;rich milk chocolate.\u0026rdquo; Plaintiff alleged that the use of coconut oil in the chocolate coating of the ice cream bars without disclosing its presence on the front-of-pack was misleading and contrary to FDA regulations. The court ruled that plaintiff had no private right of action to enforce FDA regulations, and that plaintiff\u0026rsquo;s theory of deception was not plausible because, among other reasons, the coating does contain FDA standard-of-identify chocolate, the label fully discloses the presence of oil in the ingredient list, and the label never suggests that the product does not contain oil.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eKamara v. Pepperidge Farm, Inc.\u003c/em\u003e,\u003c/strong\u003e\u0026nbsp;--- F.Supp.4th, 2021 WL 5234882 (S.D.N.Y. 2021) Achieved a complete victory for Pepperidge Farm in a putative nationwide consumer class action under New York consumer protection law. The complaint alleged that Pepperidge\u0026rsquo;s Golden Butter Crackers misled consumers into believing that the product does not include oil. In a 2021 published decision dismissing the complaint with prejudice, the court clarified the principle that false advertising claims must be assessed in context. The court also assessed the plausibility of the complaint\u0026rsquo;s theory of deception against recent Second (Mantikas) and Seventh (Bell) Circuit precedents, and found the complaint deficient. See also\u0026nbsp;\u003cstrong\u003e\u003cem\u003eFloyd v. Pepperidge Farm, Incorporated\u003c/em\u003e\u003c/strong\u003e, -- F. Supp. 3d--, 2022 WL 203071 (S.D. Ill. Jan, 24, 2022).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eChong v. Kind LLC,\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e585 F. Supp. 3d 1215, (N.D. Cal. 2022). Motion to dismiss granted in class action challenging front-of-pack protein claim on plant-based product. Plaintiffs alleged that the quantitative statement was deceptive and contrary to FDA regulations because it wasn\u0026rsquo;t corrected for digestibility. Based on our arguments, court reversed a decision it had made on that same issue in a similar lawsuit just a year before. Court also ruled in favor of our client on Buckman preemption, holding that plaintiffs were not able to enforce FDA regulations under the guise of consumer deception claims.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eWong v. The Vons Companies, Inc.\u003c/em\u003e\u003c/strong\u003e, 2020 WL 5632305 (Alameda County Super. Ct. (Cal.) Sept. 14, 2020) \u0026amp; 2020 WL 6161875 (Alameda County Super. Ct. (Cal.) Oct. 13, 2020). Certification denied in consumer class action challenging label statement on fresh poultry products. Decision affirmed on appeal in unanimous opinion. 2022 WL 1210445 (Cal. Ct. App. Apr. 25, 2022).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCheslow v. Ghirardelli Chocolate Co\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e.,\u0026nbsp;\u003c/em\u003e472 F.Supp.3d 686 (N.D. Cal. 2020) \u0026amp; 445 F.Supp.3d 8 (N.D. Cal. 2020). Obtained dismissal on plausibility grounds of consumer class action false advertising action challenging white chips product.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrescott v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e,\u0026nbsp;\u003c/em\u003e2020 WL 3035798 (N.D. Cal. June 4, 2020). Obtained dismissal on plausibility grounds of consumer class action false advertising action challenging white morsels product.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eMacedonia Distributing, Inc. v. S-L Distribution Co., LLC\u003c/em\u003e\u003c/strong\u003e, 2020 WL 610702 (C.D. Cal. Feb. 7, 2020). Certification denied in distributor class action alleging underpayment for distribution businesses.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePorath v. Logitech, Inc\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e.\u003c/em\u003e, 2019 WL 6134936 (N.D. Cal. Nov. 18, 2019). Certification denied in consumer class action challenging labeling and advertising of electronics product.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eParker v. Logitech, Inc.\u003c/em\u003e\u003c/strong\u003e, 2017 WL 4701044 (Cal. Super., Alameda County Oct. 18, 2017). Certification denied in consumer class action challenging labeling and advertising of electronics product.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePelayo v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e, 989 F. Supp. 2d 973 (C.D. Cal. 2013). Defended Buitoni brand of products in case challenging \u0026ldquo;natural\u0026rdquo; label statements. Case dismissed with prejudice at the pleading stage. The court ruled that the plaintiff failed to offer an objective or plausible definition of the allegedly-deceptive phrase \u0026ldquo;all natural,\u0026rdquo; stating that \u0026ldquo;the reasonable consumer is aware that Buitoni pastas are not \u0026lsquo;springing fully formed from ravioli trees and tortellini bushes.\u0026rsquo;\u0026rdquo;\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eShin v. Campbell Soup\u003c/em\u003e, No. 17-1082 (C.D. Cal.).\u0026nbsp;\u003c/strong\u003eSecured a victory for Campbell Soup when a federal judge in the Central District of California dismissed a false advertising consumer class action complaint alleging that labeling of less sodium and fat-free products was deceptive. The court ruled that plaintiffs\u0026rsquo; theory of deception was not plausible because the challenged statements were accurate and were not likely to mislead a reasonable consumer.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eLucido v. Nestl\u0026eacute; Purina Petcare Company\u003c/em\u003e\u003c/strong\u003e, 217 F.Supp.3d 1098 (N.D. Cal. 2016). Successfully moved for summary judgment and to strike plaintiffs\u0026rsquo; experts in a consumer class action alleging that Purina failed to disclose that Beneful dog food was harmful. The court ruled that plaintiffs\u0026rsquo; case was entirely dependent on their experts\u0026rsquo; opinions, but the opinions were unreliable and inadmissible. Accordingly, plaintiffs\u0026rsquo; case had no evidentiary support and could not proceed.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eKane v. Chobani LLC\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e,\u003c/em\u003e645 Fed. App\u0026rsquo;x. 593 (9th Cir. 2016);\u0026nbsp;\u003cem\u003esee also\u0026nbsp;\u003c/em\u003e973 F. Supp. 2d 1120 (N.D. Cal. 2014), 2013 WL 5289253 (N.D. Cal. Sept. 19, 2013), and 2013 WL 3776172 (N.D. Cal. July 15, 2013). Defense of a putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to Greek yogurt products marketed as containing \u0026ldquo;only natural ingredients\u0026rdquo; and listing \u0026ldquo;evaporated cane juice\u0026rdquo; as an ingredient. A motion to dismiss was granted. 2013 WL 5289253. The plaintiffs\u0026rsquo; motion for preliminary injunction was denied. 2013 WL 3776172. A motion to disqualify the plaintiffs\u0026rsquo; expert was granted. 2013 WL 3991107. After a third amended complaint, a second motion to dismiss was granted with prejudice. 2014 WL 657300. The Ninth Circuit then stayed the case.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eWysong Corp. v. APN, Inc.\u003c/em\u003e\u003c/strong\u003e, 889 F.3d 267 (6th Cir. 2018). Secured a victory for Nestl\u0026eacute; Purina Petcare Company when a federal judge in the Eastern District of Michigan dismissed with prejudice a Lanham Act complaint alleging that using realistic images of meat and vegetables on pet food labels was deceptive. The court ruled that plaintiff\u0026rsquo;s theory of deception was not plausible because the challenged label images, especially when considered in context, were not false and were not likely to mislead a reasonable consumer. Significantly, the court denied further amendments and entered judgment in favor of our client.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eIn re KIND LLC \u0026ldquo;Healthy and All Natural\u0026rdquo; Litigation\u003c/em\u003e\u003c/strong\u003e, 209 F. Supp. 3d 689 (S.D.N.Y. Sept. 15, 2016). Secured a ground-breaking victory for KIND snack bars when a federal judge in the Southern District of New York dismissed claims in an MDL consumer class action challenging KIND\u0026rsquo;s \u0026ldquo;healthy\u0026rdquo; labeling and stayed claims challenging \u0026ldquo;natural\u0026rdquo; labeling pending FDA\u0026rsquo;s consideration of the issue.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCerreta v. Laclede, Inc\u003c/em\u003e\u003c/strong\u003e., No. 14-8066 (C.D. Cal.) (removed from L.A. Sup. Ct.). Defending consumer packaged goods company in nationwide consumer class action alleging false advertising under California consumer protection law regarding \u0026ldquo;natural\u0026rdquo; labeling of personal care products.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eGreenberg v. Galderma Laboratories\u003c/em\u003e\u003c/strong\u003e, L.P., No. 3:16cv6090 (N.D. Cal.). Defended personal care product company against allegations of false advertising re label statements.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eMagier v. Tribe Mediterranean Foods, Inc.\u003c/em\u003e\u003c/strong\u003e, No. 1:15cv5781 (S.D.N.Y.). Defended manufacturer of hummus against claims of false advertising relating to \u0026ldquo;natural\u0026rdquo; label statements.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRhinerson v. Van\u0026rsquo;s International Foods\u0026nbsp;\u003c/em\u003e,\u003c/strong\u003eNo. 3:13cv9523 (N.D. Cal.). Defended frozen waffle manufacturer against putative nationwide consumer class action challenging the \u0026ldquo;natural\u0026rdquo; labeling of the products.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBackus v. Nestl\u0026eacute; USA, Inc\u003c/em\u003e.\u003c/strong\u003e, 167 F. Supp. 3d 1068 (N.D. Cal. 2016). Secured a ground-breaking victory for Nestl\u0026eacute; USA and its iconic Coffee-mate brand when a federal judge in the Northern District of California dismissed with prejudice a consumer class action complaint. Plaintiffs alleged that Nestl\u0026eacute;\u0026rsquo;s mere use of partially hydrogenated oil in Coffee-mate was unlawful, and that labeling statements touting the product as having \u0026ldquo;0g Trans Fat\u0026rdquo; was misleading. The court ruled that plaintiff\u0026rsquo;s \u0026lsquo;use\u0026rsquo; theory was an obstacle to federal law and therefore preempted, and that plaintiff\u0026rsquo;s false advertising theory, which attempted to impose labeling requirements not identical to federal law was expressly preempted.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eWorkman v. Plum PBC\u003c/em\u003e\u003c/strong\u003e, 141 F. Supp. 3d 1032 (N.D. Cal. 2015). Secured a victory for Campbell Soup and its subsidiary Plum Organics when a federal judge in the Northern District of California dismissed with prejudice a false advertising consumer class action complaint alleging that food labeling was deceptive. The court ruled that plaintiffs\u0026rsquo; theory of deception was not plausible because the labels were not false and were not likely to mislead a reasonable consumer.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRoss v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e, No. 1:16-cv-09563 (S.D.N.Y.). Defended Lean Cuisine products against false advertising claims relating to \u0026ldquo;no preservatives\u0026rdquo; label statement and the presence of citric acid in products.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAstiana v. Dreyer\u0026rsquo;s Grand Ice Cream\u003c/em\u003e\u003c/strong\u003e, No. 11-2910 (N.D. Cal.). Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to H\u0026auml;agen-Dazs and Dreyer\u0026rsquo;s ice cream products labeled \u0026ldquo;All Natural.\u0026rdquo; This case was consolidated with the copy-cat case Rutledge-Muhs v. Dreyer\u0026rsquo;s Grand Ice Cream. The action was dismissed with prejudice.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStoltz v. Chobani, LLC\u003c/em\u003e\u003c/strong\u003e, No. 1:14cv3827 (E.D.N.Y.). Defended nationwide consumer class action alleging false advertising of Greek Yogurt products, marketed as \u0026ldquo;Greek Yogurt,\u0026rdquo; \u0026ldquo;0%,\u0026rdquo; \u0026ldquo;evaporated cane juice,\u0026rdquo; and natural and healthy.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eChavez v. Nestl\u0026eacute; USA\u003c/em\u003e\u003c/strong\u003e, No. 09-9192 (C.D. Cal.). Defended putative nationwide consumer class action against Nestl\u0026eacute; USA alleging false advertising under California consumer protection laws with respect to juice products marketed as supporting brain development, immunity and digestive health. Case dismissed following three successive, successful motions to dismiss (2011 WL 10565797 (C.D. Cal. Jan. 10, 2011), 2011 WL 2150128 (C.D. Cal. May 19, 2011)). Judgment in defendant\u0026rsquo;s favor affirmed in part and reversed in part. 511 Fed. App\u0026rsquo;x. 606 (9th Cir. 2013).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eIbarrola v. KIND LLC\u003c/em\u003e\u003c/strong\u003e, 83 F. Supp. 3d 751 (N.D. Ill. 2014). Secured a complete victory for client KIND LLC in the Northern District of Illinois when Judge Sara Ellis dismissed a putative nationwide consumer class action premised on allegations that KIND deceived consumers by including a \u0026ldquo;No Refined Sugars\u0026rdquo; statement on the label of snack foods. Judge Ellis granted KIND\u0026rsquo;s motion to dismiss an amended complaint with prejudice, holding that plaintiff failed to allege a plausible theory of deception.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBoyle v. KIND LLC\u003c/em\u003e\u003c/strong\u003e, No. 1:13cv8365 (S.D.N.Y). Defended nationwide consumer class action challenging the labeling of snack bar products as insinuating that consuming the products will not lead to weight gain and that the product is better-for-you product. Also defended copy-cat, follow-on action\u0026nbsp;\u003cem\u003eBailey v. KIND LLC\u003c/em\u003e, No. 8:16cv168(C.D. Cal.).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrazo v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e, No. 5:12cv2272 (N.D. Cal.) Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws regarding Coffee-mate powder products marketed as \u0026ldquo;0g trans fat.\u0026rdquo; This case is notable for the scope of its predecessor case at filing\u0026mdash;challenging an open-ended number of the products of a major food manufacturer. The broadside attack featured multiple misbranding allegations on diverse labeling statements. Of special significance, we dealt a massive blow when its separate and innovative motion to strike the plaintiffs' class allegations\u0026mdash;at the pleading stage\u0026mdash;was granted. 201 WL 4083218 (N.D. Cal. Aug. 9, 2013). The challenged products were subsequently reduced from \u0026ldquo;open-ended\u0026rdquo; to four and the misbranding theories have been reduced from nine to four.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBelli II v. Nestl\u0026eacute; USA, Inc.\u003c/em\u003e\u003c/strong\u003e, No. 5:14cv283 (N.D. Cal.) Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws regarding Eskimo Pie products marketed as \u0026ldquo;No Sugar Added.\u0026rdquo;\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eIn re Gerber Probiotic Sales Practices Litigation\u003c/em\u003e\u003c/strong\u003e, No. 12-835 (D. N.J.). Defended Gerber in ten-case consolidated nationwide consumer class action alleging false advertising under consumer protection and warranty laws of multiple states with respect to baby formula and cereal products labeled as containing immune-supporting probiotics, digestion-supporting prebiotics, and brain and eye development-supporting DHA. Motions to consolidate cases granted.\u0026nbsp;\u003cem\u003eBurns v. Gerber Prods. Co\u003c/em\u003e., 922 F.Supp.2d 1168 (E.D. Wash. 2013);\u0026nbsp;\u003cem\u003eHawkins v. Gerber\u003c/em\u003e\u003cem\u003e\u0026nbsp;Prods. Co., 924 F.Supp.2d 1208 (S.D. Cal. 2013).\u003c/em\u003e\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eReilly v. Amy\u0026rsquo;s Kitchen\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e, 2 F. Supp. 3d 1300 (S.D. Fla. 2014);\u0026nbsp;\u003cem\u003esee also\u0026nbsp;\u003c/em\u003e2014 WL 905441 (S.D. Fla. Mar. 7, 2014) Defended against putative Florida consumer class action alleging false advertising under Florida consumer protection laws with respect to food products containing the ingredient \u0026ldquo;evaporated cane juice.\u0026rdquo; A federal judge first denied plaintiff\u0026rsquo;s request to reinstate claims over 57 products that the named plaintiff never purchased. The court then dismissed the case on jurisdictional grounds because the amount at issue for the three products the named plaintiff did purchase fell below the Class Action Fairness Act amount in controversy requirement.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFigy v. Amy\u0026rsquo;s Kitchen, Inc\u003c/em\u003e\u003c/strong\u003e., 2 F. Supp. 3d 1300 (N.D. Cal. 2014). Defended against putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to food products containing the ingredient \u0026ldquo;evaporated cane juice.\u0026rdquo; A federal judge dismissed action without leave to amend based on primary jurisdiction of FDA (later converted to stay).\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSimpson v. California Pizza Kitchen\u003c/em\u003e\u003c/strong\u003e, 989 F. Supp. 2d 1015 (S.D. Cal. 2013), 2013, 2013 WL 5718479 (S.D. Cal Oct. 1, 2013). Defended a putative nationwide consumer class action against several frozen pizza brands owned by Nestl\u0026eacute; USA and California Pizza Kitchen alleging violation of California's Unfair Competition Law and statutory nuisance law. This was a bellwether case. Using the class action vehicle, plaintiffs sought to impose an unprecedented judicial ban on artificial trans fats in frozen pizza products. Any success could have \u0026ldquo;opened the floodgates\u0026rdquo; to numerous other cases seeking to ban individual ingredients. A motion to dismiss was granted as to the entire complaint, with prejudice and without leave to amend.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBrower v. Campbell Soup Company\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e,\u0026nbsp;\u003c/em\u003e243 F. Supp. 3d 1124, 2017 WL 1063470 (S.D. Cal. Mar. 21, 2017). Obtained a dismissal with prejudice for Campbell Soup in a consumer class challenging the labels of Chunky Healthy Request soup products. The court ruled that plaintiffs\u0026rsquo; state-law false advertising claims are preempted by the federal Poultry Products Inspection Act and the Federal Meat Inspection Act.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBell v. Campbell Soup Co.\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e,\u0026nbsp;\u003c/em\u003e65 F. Supp. 3d 1328 (N.D. Fla. 2014). Secured victory for Campbell Soup when a federal judge in Florida dismissed with prejudice an amended consumer class action complaint in an action that initially had challenged the labeling of more than 50 products from multiple product lines under Campbell\u0026rsquo;s iconic V8 brand. The court ruled that plaintiffs\u0026rsquo; amended claims (following an initial motion to dismiss) were expressly preempted as attempting to impose state-law labeling requirements that were not identical to federal labeling law and that Campbell\u0026rsquo;s labels complied with the federal requirements \u0026ldquo;to the letter.\u0026rdquo;\u003c/p\u003e"],"recognitions":[{"title":"Next Generation Partner","detail":"Legal 500, 2023"},{"title":"Ranked Band 4 for Food \u0026 Beverages: Regulatory \u0026 Litigation","detail":"Chambers USA (Nationwide), 2022, 2023"},{"title":"Named Law360 MVP (Product Liability)","detail":"2020"},{"title":"Named Leader of Influence: Litigators \u0026 Trial Attorneys","detail":"Los Angeles Business Journal – 2021"},{"title":"Named Women of Influence","detail":"Attorneys by Los Angeles Business Journal - 2021"},{"title":"2021 Women Worth Watching in Leadership Award Winner","detail":"Diversity Law Journal"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9734}]},"capability_group_id":2},"created_at":"2025-12-05T05:00:07.000Z","updated_at":"2025-12-05T05:00:07.000Z","searchable_text":"Borders{{ FIELD }}{:title=\u0026gt;\"Next Generation Partner\", :detail=\u0026gt;\"Legal 500, 2023\"}{{ FIELD }}{:title=\u0026gt;\"Ranked Band 4 for Food \u0026amp; Beverages: Regulatory \u0026amp; Litigation\", :detail=\u0026gt;\"Chambers USA (Nationwide), 2022, 2023\"}{{ FIELD }}{:title=\u0026gt;\"Named Law360 MVP (Product Liability)\", :detail=\u0026gt;\"2020\"}{{ FIELD }}{:title=\u0026gt;\"Named Leader of Influence: Litigators \u0026amp; Trial Attorneys\", :detail=\u0026gt;\"Los Angeles Business Journal – 2021\"}{{ FIELD }}{:title=\u0026gt;\"Named Women of Influence\", :detail=\u0026gt;\"Attorneys by Los Angeles Business Journal - 2021\"}{{ FIELD }}{:title=\u0026gt;\"2021 Women Worth Watching in Leadership Award Winner\", :detail=\u0026gt;\"Diversity Law Journal\"}{{ FIELD }}Bustamante v. KIND, LLC, --- F.4th ----, 2024 WL 1917155 (2d Cir. May 2, 2024), affirming In re: Kind LLC “Healthy and All Natural” Litigation, 627 F. Supp. 3d 269 (S.D.N.Y. 2022). In a precedential decision following nine years of litigation, the Second Circuit affirmed summary judgment and striking of plaintiffs’ “natural” and consumer behavior experts in false advertising MDL class action challenging healthy, natural and non-GMO statements on the labels of snack products.{{ FIELD }}Cleveland v. Campbell Soup Co., 647 F.Supp.3d 772, (N.D. Cal. 2022) Successive motions to dismiss granted in false advertising consumer class action challenging a front-of-pack 0g Total Sugars statement.{{ FIELD }}Zurilene v. Dreyer’s Grand Ice Cream, Inc., --- F.Supp.3d ---, 2022 WL 816636 (S.D. Ill. Mar. 17, 2022) Motion to dismiss granted in class action alleging false advertising under the Illinois Consumer Fraud and Deceptive Business Practices Act regarding Haagen-Dazs ice cream bars labeled “rich milk chocolate.” Plaintiff alleged that the use of coconut oil in the chocolate coating of “Vanilla Milk Chocolate Ice Cream Bars” without disclosing its presence on the front-of-pack was misleading and contrary to FDA regulations. The court ruled that plaintiff was attempting to impose label requirements that were in addition to or different from FDA regulations and, therefore, the theory of liability was preempted.{{ FIELD }}Yu v. Dreyer’s Grand Ice Cream, Inc. --- F.Supp.3d ---, 2022 WL 799563 (S.D.N.Y. Mar. 16, 2022) Motion to dismiss granted in class action alleging false advertising under the Illinois consumer protection laws regarding Haagen-Dazs ice cream bars labeled “rich milk chocolate.” Plaintiff alleged that the use of coconut oil in the chocolate coating of the ice cream bars without disclosing its presence on the front-of-pack was misleading and contrary to FDA regulations. The court ruled that plaintiff had no private right of action to enforce FDA regulations, and that plaintiff’s theory of deception was not plausible because, among other reasons, the coating does contain FDA standard-of-identify chocolate, the label fully discloses the presence of oil in the ingredient list, and the label never suggests that the product does not contain oil.{{ FIELD }}Kamara v. Pepperidge Farm, Inc., --- F.Supp.4th, 2021 WL 5234882 (S.D.N.Y. 2021) Achieved a complete victory for Pepperidge Farm in a putative nationwide consumer class action under New York consumer protection law. The complaint alleged that Pepperidge’s Golden Butter Crackers misled consumers into believing that the product does not include oil. In a 2021 published decision dismissing the complaint with prejudice, the court clarified the principle that false advertising claims must be assessed in context. The court also assessed the plausibility of the complaint’s theory of deception against recent Second (Mantikas) and Seventh (Bell) Circuit precedents, and found the complaint deficient. See also Floyd v. Pepperidge Farm, Incorporated, -- F. Supp. 3d--, 2022 WL 203071 (S.D. Ill. Jan, 24, 2022).{{ FIELD }}Chong v. Kind LLC, 585 F. Supp. 3d 1215, (N.D. Cal. 2022). Motion to dismiss granted in class action challenging front-of-pack protein claim on plant-based product. Plaintiffs alleged that the quantitative statement was deceptive and contrary to FDA regulations because it wasn’t corrected for digestibility. Based on our arguments, court reversed a decision it had made on that same issue in a similar lawsuit just a year before. Court also ruled in favor of our client on Buckman preemption, holding that plaintiffs were not able to enforce FDA regulations under the guise of consumer deception claims.{{ FIELD }}Wong v. The Vons Companies, Inc., 2020 WL 5632305 (Alameda County Super. Ct. (Cal.) Sept. 14, 2020) \u0026amp; 2020 WL 6161875 (Alameda County Super. Ct. (Cal.) Oct. 13, 2020). Certification denied in consumer class action challenging label statement on fresh poultry products. Decision affirmed on appeal in unanimous opinion. 2022 WL 1210445 (Cal. Ct. App. Apr. 25, 2022).{{ FIELD }}Cheslow v. Ghirardelli Chocolate Co., 472 F.Supp.3d 686 (N.D. Cal. 2020) \u0026amp; 445 F.Supp.3d 8 (N.D. Cal. 2020). Obtained dismissal on plausibility grounds of consumer class action false advertising action challenging white chips product.{{ FIELD }}Prescott v. Nestlé USA, Inc., 2020 WL 3035798 (N.D. Cal. June 4, 2020). Obtained dismissal on plausibility grounds of consumer class action false advertising action challenging white morsels product.{{ FIELD }}Macedonia Distributing, Inc. v. S-L Distribution Co., LLC, 2020 WL 610702 (C.D. Cal. Feb. 7, 2020). Certification denied in distributor class action alleging underpayment for distribution businesses.{{ FIELD }}Porath v. Logitech, Inc., 2019 WL 6134936 (N.D. Cal. Nov. 18, 2019). Certification denied in consumer class action challenging labeling and advertising of electronics product.{{ FIELD }}Parker v. Logitech, Inc., 2017 WL 4701044 (Cal. Super., Alameda County Oct. 18, 2017). Certification denied in consumer class action challenging labeling and advertising of electronics product.{{ FIELD }}Pelayo v. Nestlé USA, Inc., 989 F. Supp. 2d 973 (C.D. Cal. 2013). Defended Buitoni brand of products in case challenging “natural” label statements. Case dismissed with prejudice at the pleading stage. The court ruled that the plaintiff failed to offer an objective or plausible definition of the allegedly-deceptive phrase “all natural,” stating that “the reasonable consumer is aware that Buitoni pastas are not ‘springing fully formed from ravioli trees and tortellini bushes.’”{{ FIELD }}Shin v. Campbell Soup, No. 17-1082 (C.D. Cal.). Secured a victory for Campbell Soup when a federal judge in the Central District of California dismissed a false advertising consumer class action complaint alleging that labeling of less sodium and fat-free products was deceptive. The court ruled that plaintiffs’ theory of deception was not plausible because the challenged statements were accurate and were not likely to mislead a reasonable consumer.{{ FIELD }}Lucido v. Nestlé Purina Petcare Company, 217 F.Supp.3d 1098 (N.D. Cal. 2016). Successfully moved for summary judgment and to strike plaintiffs’ experts in a consumer class action alleging that Purina failed to disclose that Beneful dog food was harmful. The court ruled that plaintiffs’ case was entirely dependent on their experts’ opinions, but the opinions were unreliable and inadmissible. Accordingly, plaintiffs’ case had no evidentiary support and could not proceed.{{ FIELD }}Kane v. Chobani LLC,645 Fed. App’x. 593 (9th Cir. 2016); see also 973 F. Supp. 2d 1120 (N.D. Cal. 2014), 2013 WL 5289253 (N.D. Cal. Sept. 19, 2013), and 2013 WL 3776172 (N.D. Cal. July 15, 2013). Defense of a putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to Greek yogurt products marketed as containing “only natural ingredients” and listing “evaporated cane juice” as an ingredient. A motion to dismiss was granted. 2013 WL 5289253. The plaintiffs’ motion for preliminary injunction was denied. 2013 WL 3776172. A motion to disqualify the plaintiffs’ expert was granted. 2013 WL 3991107. After a third amended complaint, a second motion to dismiss was granted with prejudice. 2014 WL 657300. The Ninth Circuit then stayed the case.{{ FIELD }}Wysong Corp. v. APN, Inc., 889 F.3d 267 (6th Cir. 2018). Secured a victory for Nestlé Purina Petcare Company when a federal judge in the Eastern District of Michigan dismissed with prejudice a Lanham Act complaint alleging that using realistic images of meat and vegetables on pet food labels was deceptive. The court ruled that plaintiff’s theory of deception was not plausible because the challenged label images, especially when considered in context, were not false and were not likely to mislead a reasonable consumer. Significantly, the court denied further amendments and entered judgment in favor of our client.{{ FIELD }}In re KIND LLC “Healthy and All Natural” Litigation, 209 F. Supp. 3d 689 (S.D.N.Y. Sept. 15, 2016). Secured a ground-breaking victory for KIND snack bars when a federal judge in the Southern District of New York dismissed claims in an MDL consumer class action challenging KIND’s “healthy” labeling and stayed claims challenging “natural” labeling pending FDA’s consideration of the issue.{{ FIELD }}Cerreta v. Laclede, Inc., No. 14-8066 (C.D. Cal.) (removed from L.A. Sup. Ct.). Defending consumer packaged goods company in nationwide consumer class action alleging false advertising under California consumer protection law regarding “natural” labeling of personal care products.{{ FIELD }}Greenberg v. Galderma Laboratories, L.P., No. 3:16cv6090 (N.D. Cal.). Defended personal care product company against allegations of false advertising re label statements.{{ FIELD }}Magier v. Tribe Mediterranean Foods, Inc., No. 1:15cv5781 (S.D.N.Y.). Defended manufacturer of hummus against claims of false advertising relating to “natural” label statements.{{ FIELD }}Rhinerson v. Van’s International Foods ,No. 3:13cv9523 (N.D. Cal.). Defended frozen waffle manufacturer against putative nationwide consumer class action challenging the “natural” labeling of the products.{{ FIELD }}Backus v. Nestlé USA, Inc., 167 F. Supp. 3d 1068 (N.D. Cal. 2016). Secured a ground-breaking victory for Nestlé USA and its iconic Coffee-mate brand when a federal judge in the Northern District of California dismissed with prejudice a consumer class action complaint. Plaintiffs alleged that Nestlé’s mere use of partially hydrogenated oil in Coffee-mate was unlawful, and that labeling statements touting the product as having “0g Trans Fat” was misleading. The court ruled that plaintiff’s ‘use’ theory was an obstacle to federal law and therefore preempted, and that plaintiff’s false advertising theory, which attempted to impose labeling requirements not identical to federal law was expressly preempted.{{ FIELD }}Workman v. Plum PBC, 141 F. Supp. 3d 1032 (N.D. Cal. 2015). Secured a victory for Campbell Soup and its subsidiary Plum Organics when a federal judge in the Northern District of California dismissed with prejudice a false advertising consumer class action complaint alleging that food labeling was deceptive. The court ruled that plaintiffs’ theory of deception was not plausible because the labels were not false and were not likely to mislead a reasonable consumer.{{ FIELD }}Ross v. Nestlé USA, Inc., No. 1:16-cv-09563 (S.D.N.Y.). Defended Lean Cuisine products against false advertising claims relating to “no preservatives” label statement and the presence of citric acid in products.{{ FIELD }}Astiana v. Dreyer’s Grand Ice Cream, No. 11-2910 (N.D. Cal.). Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to Häagen-Dazs and Dreyer’s ice cream products labeled “All Natural.” This case was consolidated with the copy-cat case Rutledge-Muhs v. Dreyer’s Grand Ice Cream. The action was dismissed with prejudice.{{ FIELD }}Stoltz v. Chobani, LLC, No. 1:14cv3827 (E.D.N.Y.). Defended nationwide consumer class action alleging false advertising of Greek Yogurt products, marketed as “Greek Yogurt,” “0%,” “evaporated cane juice,” and natural and healthy.{{ FIELD }}Chavez v. Nestlé USA, No. 09-9192 (C.D. Cal.). Defended putative nationwide consumer class action against Nestlé USA alleging false advertising under California consumer protection laws with respect to juice products marketed as supporting brain development, immunity and digestive health. Case dismissed following three successive, successful motions to dismiss (2011 WL 10565797 (C.D. Cal. Jan. 10, 2011), 2011 WL 2150128 (C.D. Cal. May 19, 2011)). Judgment in defendant’s favor affirmed in part and reversed in part. 511 Fed. App’x. 606 (9th Cir. 2013).{{ FIELD }}Ibarrola v. KIND LLC, 83 F. Supp. 3d 751 (N.D. Ill. 2014). Secured a complete victory for client KIND LLC in the Northern District of Illinois when Judge Sara Ellis dismissed a putative nationwide consumer class action premised on allegations that KIND deceived consumers by including a “No Refined Sugars” statement on the label of snack foods. Judge Ellis granted KIND’s motion to dismiss an amended complaint with prejudice, holding that plaintiff failed to allege a plausible theory of deception.{{ FIELD }}Boyle v. KIND LLC, No. 1:13cv8365 (S.D.N.Y). Defended nationwide consumer class action challenging the labeling of snack bar products as insinuating that consuming the products will not lead to weight gain and that the product is better-for-you product. Also defended copy-cat, follow-on action Bailey v. KIND LLC, No. 8:16cv168(C.D. Cal.).{{ FIELD }}Trazo v. Nestlé USA, Inc., No. 5:12cv2272 (N.D. Cal.) Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws regarding Coffee-mate powder products marketed as “0g trans fat.” This case is notable for the scope of its predecessor case at filing—challenging an open-ended number of the products of a major food manufacturer. The broadside attack featured multiple misbranding allegations on diverse labeling statements. Of special significance, we dealt a massive blow when its separate and innovative motion to strike the plaintiffs' class allegations—at the pleading stage—was granted. 201 WL 4083218 (N.D. Cal. Aug. 9, 2013). The challenged products were subsequently reduced from “open-ended” to four and the misbranding theories have been reduced from nine to four.{{ FIELD }}Belli II v. Nestlé USA, Inc., No. 5:14cv283 (N.D. Cal.) Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws regarding Eskimo Pie products marketed as “No Sugar Added.”{{ FIELD }}In re Gerber Probiotic Sales Practices Litigation, No. 12-835 (D. N.J.). Defended Gerber in ten-case consolidated nationwide consumer class action alleging false advertising under consumer protection and warranty laws of multiple states with respect to baby formula and cereal products labeled as containing immune-supporting probiotics, digestion-supporting prebiotics, and brain and eye development-supporting DHA. Motions to consolidate cases granted. Burns v. Gerber Prods. Co., 922 F.Supp.2d 1168 (E.D. Wash. 2013); Hawkins v. Gerber Prods. Co., 924 F.Supp.2d 1208 (S.D. Cal. 2013).{{ FIELD }}Reilly v. Amy’s Kitchen , 2 F. Supp. 3d 1300 (S.D. Fla. 2014); see also 2014 WL 905441 (S.D. Fla. Mar. 7, 2014) Defended against putative Florida consumer class action alleging false advertising under Florida consumer protection laws with respect to food products containing the ingredient “evaporated cane juice.” A federal judge first denied plaintiff’s request to reinstate claims over 57 products that the named plaintiff never purchased. The court then dismissed the case on jurisdictional grounds because the amount at issue for the three products the named plaintiff did purchase fell below the Class Action Fairness Act amount in controversy requirement.{{ FIELD }}Figy v. Amy’s Kitchen, Inc., 2 F. Supp. 3d 1300 (N.D. Cal. 2014). Defended against putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to food products containing the ingredient “evaporated cane juice.” A federal judge dismissed action without leave to amend based on primary jurisdiction of FDA (later converted to stay).{{ FIELD }}Simpson v. California Pizza Kitchen, 989 F. Supp. 2d 1015 (S.D. Cal. 2013), 2013, 2013 WL 5718479 (S.D. Cal Oct. 1, 2013). Defended a putative nationwide consumer class action against several frozen pizza brands owned by Nestlé USA and California Pizza Kitchen alleging violation of California's Unfair Competition Law and statutory nuisance law. This was a bellwether case. Using the class action vehicle, plaintiffs sought to impose an unprecedented judicial ban on artificial trans fats in frozen pizza products. Any success could have “opened the floodgates” to numerous other cases seeking to ban individual ingredients. A motion to dismiss was granted as to the entire complaint, with prejudice and without leave to amend.{{ FIELD }}Brower v. Campbell Soup Company, 243 F. Supp. 3d 1124, 2017 WL 1063470 (S.D. Cal. Mar. 21, 2017). Obtained a dismissal with prejudice for Campbell Soup in a consumer class challenging the labels of Chunky Healthy Request soup products. The court ruled that plaintiffs’ state-law false advertising claims are preempted by the federal Poultry Products Inspection Act and the Federal Meat Inspection Act.{{ FIELD }}Bell v. Campbell Soup Co., 65 F. Supp. 3d 1328 (N.D. Fla. 2014). Secured victory for Campbell Soup when a federal judge in Florida dismissed with prejudice an amended consumer class action complaint in an action that initially had challenged the labeling of more than 50 products from multiple product lines under Campbell’s iconic V8 brand. The court ruled that plaintiffs’ amended claims (following an initial motion to dismiss) were expressly preempted as attempting to impose state-law labeling requirements that were not identical to federal labeling law and that Campbell’s labels complied with the federal requirements “to the letter.”{{ FIELD }}Keri Borders is a litigator who focuses her practice on defending food and beverage, dietary supplement and consumer packaged goods manufacturers, retailers, and distributors in complex competitor and consumer class action litigation. Clients rely on Keri and her creative problem solving skills because of her deep understanding of their business and her ability to achieve successful results.\nKeri regularly practices in state, federal, and appellate courts in cases involving false advertising relating to product labeling and advertising, including nutrition and health claims, contaminants (heavy metals, PFAS, glyphosate, mycotoxins), product attributes, sustainability/environmental/green claims, and alleged violation of the FDCA/NLEA, PPIA, FMIA, Lanham Act, and FTC Green Guides (and state counterparts).\nKeri also has significant experience litigating contract, accounting, and intellectual property disputes, and defending unfair business practices, unfair competition, misappropriation of trade secrets, breach of fiduciary duty, and business torts. Keri has experience in a broad spectrum of industries, including entertainment, personal care products, consumer electronics, telecommunications, pet food, and real estate.\nKeri is ranked in Chambers USA, Legal 500, and was recognized by Law360 as one of four MVP’s in the United States in Product Liability in 2020. Partner Next Generation Partner Legal 500, 2023 Ranked Band 4 for Food \u0026amp; Beverages: Regulatory \u0026amp; Litigation Chambers USA (Nationwide), 2022, 2023 Named Law360 MVP (Product Liability) 2020 Named Leader of Influence: Litigators \u0026amp; Trial Attorneys Los Angeles Business Journal – 2021 Named Women of Influence Attorneys by Los Angeles Business Journal - 2021 2021 Women Worth Watching in Leadership Award Winner Diversity Law Journal University of California  University of California Hastings College of Law University of California Hastings College of Law U.S. Court of Appeals for the Second Circuit U.S. Court of Appeals for the Sixth Circuit U.S. Court of Appeals for the Ninth Circuit U.S. District Court for the Southern District of Illinois U.S. District Court for the Eastern District of Missouri U.S. District Court for the Central District of California U.S. District Court for the Eastern District of California U.S. District Court for the Northern District of California U.S. District Court for the Southern District of California California Member, American Bar Association Board of Governors, Association of Business Trial Lawyers, Los Angeles Chapter Member, Food and Drug Law Institute Member, Consumer Brands Association Law Clerk, Judge Robert J. Timlin, U.S. District Court for the Central District of California Bustamante v. KIND, LLC, --- F.4th ----, 2024 WL 1917155 (2d Cir. May 2, 2024), affirming In re: Kind LLC “Healthy and All Natural” Litigation, 627 F. Supp. 3d 269 (S.D.N.Y. 2022). In a precedential decision following nine years of litigation, the Second Circuit affirmed summary judgment and striking of plaintiffs’ “natural” and consumer behavior experts in false advertising MDL class action challenging healthy, natural and non-GMO statements on the labels of snack products. Cleveland v. Campbell Soup Co., 647 F.Supp.3d 772, (N.D. Cal. 2022) Successive motions to dismiss granted in false advertising consumer class action challenging a front-of-pack 0g Total Sugars statement. Zurilene v. Dreyer’s Grand Ice Cream, Inc., --- F.Supp.3d ---, 2022 WL 816636 (S.D. Ill. Mar. 17, 2022) Motion to dismiss granted in class action alleging false advertising under the Illinois Consumer Fraud and Deceptive Business Practices Act regarding Haagen-Dazs ice cream bars labeled “rich milk chocolate.” Plaintiff alleged that the use of coconut oil in the chocolate coating of “Vanilla Milk Chocolate Ice Cream Bars” without disclosing its presence on the front-of-pack was misleading and contrary to FDA regulations. The court ruled that plaintiff was attempting to impose label requirements that were in addition to or different from FDA regulations and, therefore, the theory of liability was preempted. Yu v. Dreyer’s Grand Ice Cream, Inc. --- F.Supp.3d ---, 2022 WL 799563 (S.D.N.Y. Mar. 16, 2022) Motion to dismiss granted in class action alleging false advertising under the Illinois consumer protection laws regarding Haagen-Dazs ice cream bars labeled “rich milk chocolate.” Plaintiff alleged that the use of coconut oil in the chocolate coating of the ice cream bars without disclosing its presence on the front-of-pack was misleading and contrary to FDA regulations. The court ruled that plaintiff had no private right of action to enforce FDA regulations, and that plaintiff’s theory of deception was not plausible because, among other reasons, the coating does contain FDA standard-of-identify chocolate, the label fully discloses the presence of oil in the ingredient list, and the label never suggests that the product does not contain oil. Kamara v. Pepperidge Farm, Inc., --- F.Supp.4th, 2021 WL 5234882 (S.D.N.Y. 2021) Achieved a complete victory for Pepperidge Farm in a putative nationwide consumer class action under New York consumer protection law. The complaint alleged that Pepperidge’s Golden Butter Crackers misled consumers into believing that the product does not include oil. In a 2021 published decision dismissing the complaint with prejudice, the court clarified the principle that false advertising claims must be assessed in context. The court also assessed the plausibility of the complaint’s theory of deception against recent Second (Mantikas) and Seventh (Bell) Circuit precedents, and found the complaint deficient. See also Floyd v. Pepperidge Farm, Incorporated, -- F. Supp. 3d--, 2022 WL 203071 (S.D. Ill. Jan, 24, 2022). Chong v. Kind LLC, 585 F. Supp. 3d 1215, (N.D. Cal. 2022). Motion to dismiss granted in class action challenging front-of-pack protein claim on plant-based product. Plaintiffs alleged that the quantitative statement was deceptive and contrary to FDA regulations because it wasn’t corrected for digestibility. Based on our arguments, court reversed a decision it had made on that same issue in a similar lawsuit just a year before. Court also ruled in favor of our client on Buckman preemption, holding that plaintiffs were not able to enforce FDA regulations under the guise of consumer deception claims. Wong v. The Vons Companies, Inc., 2020 WL 5632305 (Alameda County Super. Ct. (Cal.) Sept. 14, 2020) \u0026amp; 2020 WL 6161875 (Alameda County Super. Ct. (Cal.) Oct. 13, 2020). Certification denied in consumer class action challenging label statement on fresh poultry products. Decision affirmed on appeal in unanimous opinion. 2022 WL 1210445 (Cal. Ct. App. Apr. 25, 2022). Cheslow v. Ghirardelli Chocolate Co., 472 F.Supp.3d 686 (N.D. Cal. 2020) \u0026amp; 445 F.Supp.3d 8 (N.D. Cal. 2020). Obtained dismissal on plausibility grounds of consumer class action false advertising action challenging white chips product. Prescott v. Nestlé USA, Inc., 2020 WL 3035798 (N.D. Cal. June 4, 2020). Obtained dismissal on plausibility grounds of consumer class action false advertising action challenging white morsels product. Macedonia Distributing, Inc. v. S-L Distribution Co., LLC, 2020 WL 610702 (C.D. Cal. Feb. 7, 2020). Certification denied in distributor class action alleging underpayment for distribution businesses. Porath v. Logitech, Inc., 2019 WL 6134936 (N.D. Cal. Nov. 18, 2019). Certification denied in consumer class action challenging labeling and advertising of electronics product. Parker v. Logitech, Inc., 2017 WL 4701044 (Cal. Super., Alameda County Oct. 18, 2017). Certification denied in consumer class action challenging labeling and advertising of electronics product. Pelayo v. Nestlé USA, Inc., 989 F. Supp. 2d 973 (C.D. Cal. 2013). Defended Buitoni brand of products in case challenging “natural” label statements. Case dismissed with prejudice at the pleading stage. The court ruled that the plaintiff failed to offer an objective or plausible definition of the allegedly-deceptive phrase “all natural,” stating that “the reasonable consumer is aware that Buitoni pastas are not ‘springing fully formed from ravioli trees and tortellini bushes.’” Shin v. Campbell Soup, No. 17-1082 (C.D. Cal.). Secured a victory for Campbell Soup when a federal judge in the Central District of California dismissed a false advertising consumer class action complaint alleging that labeling of less sodium and fat-free products was deceptive. The court ruled that plaintiffs’ theory of deception was not plausible because the challenged statements were accurate and were not likely to mislead a reasonable consumer. Lucido v. Nestlé Purina Petcare Company, 217 F.Supp.3d 1098 (N.D. Cal. 2016). Successfully moved for summary judgment and to strike plaintiffs’ experts in a consumer class action alleging that Purina failed to disclose that Beneful dog food was harmful. The court ruled that plaintiffs’ case was entirely dependent on their experts’ opinions, but the opinions were unreliable and inadmissible. Accordingly, plaintiffs’ case had no evidentiary support and could not proceed. Kane v. Chobani LLC,645 Fed. App’x. 593 (9th Cir. 2016); see also 973 F. Supp. 2d 1120 (N.D. Cal. 2014), 2013 WL 5289253 (N.D. Cal. Sept. 19, 2013), and 2013 WL 3776172 (N.D. Cal. July 15, 2013). Defense of a putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to Greek yogurt products marketed as containing “only natural ingredients” and listing “evaporated cane juice” as an ingredient. A motion to dismiss was granted. 2013 WL 5289253. The plaintiffs’ motion for preliminary injunction was denied. 2013 WL 3776172. A motion to disqualify the plaintiffs’ expert was granted. 2013 WL 3991107. After a third amended complaint, a second motion to dismiss was granted with prejudice. 2014 WL 657300. The Ninth Circuit then stayed the case. Wysong Corp. v. APN, Inc., 889 F.3d 267 (6th Cir. 2018). Secured a victory for Nestlé Purina Petcare Company when a federal judge in the Eastern District of Michigan dismissed with prejudice a Lanham Act complaint alleging that using realistic images of meat and vegetables on pet food labels was deceptive. The court ruled that plaintiff’s theory of deception was not plausible because the challenged label images, especially when considered in context, were not false and were not likely to mislead a reasonable consumer. Significantly, the court denied further amendments and entered judgment in favor of our client. In re KIND LLC “Healthy and All Natural” Litigation, 209 F. Supp. 3d 689 (S.D.N.Y. Sept. 15, 2016). Secured a ground-breaking victory for KIND snack bars when a federal judge in the Southern District of New York dismissed claims in an MDL consumer class action challenging KIND’s “healthy” labeling and stayed claims challenging “natural” labeling pending FDA’s consideration of the issue. Cerreta v. Laclede, Inc., No. 14-8066 (C.D. Cal.) (removed from L.A. Sup. Ct.). Defending consumer packaged goods company in nationwide consumer class action alleging false advertising under California consumer protection law regarding “natural” labeling of personal care products. Greenberg v. Galderma Laboratories, L.P., No. 3:16cv6090 (N.D. Cal.). Defended personal care product company against allegations of false advertising re label statements. Magier v. Tribe Mediterranean Foods, Inc., No. 1:15cv5781 (S.D.N.Y.). Defended manufacturer of hummus against claims of false advertising relating to “natural” label statements. Rhinerson v. Van’s International Foods ,No. 3:13cv9523 (N.D. Cal.). Defended frozen waffle manufacturer against putative nationwide consumer class action challenging the “natural” labeling of the products. Backus v. Nestlé USA, Inc., 167 F. Supp. 3d 1068 (N.D. Cal. 2016). Secured a ground-breaking victory for Nestlé USA and its iconic Coffee-mate brand when a federal judge in the Northern District of California dismissed with prejudice a consumer class action complaint. Plaintiffs alleged that Nestlé’s mere use of partially hydrogenated oil in Coffee-mate was unlawful, and that labeling statements touting the product as having “0g Trans Fat” was misleading. The court ruled that plaintiff’s ‘use’ theory was an obstacle to federal law and therefore preempted, and that plaintiff’s false advertising theory, which attempted to impose labeling requirements not identical to federal law was expressly preempted. Workman v. Plum PBC, 141 F. Supp. 3d 1032 (N.D. Cal. 2015). Secured a victory for Campbell Soup and its subsidiary Plum Organics when a federal judge in the Northern District of California dismissed with prejudice a false advertising consumer class action complaint alleging that food labeling was deceptive. The court ruled that plaintiffs’ theory of deception was not plausible because the labels were not false and were not likely to mislead a reasonable consumer. Ross v. Nestlé USA, Inc., No. 1:16-cv-09563 (S.D.N.Y.). Defended Lean Cuisine products against false advertising claims relating to “no preservatives” label statement and the presence of citric acid in products. Astiana v. Dreyer’s Grand Ice Cream, No. 11-2910 (N.D. Cal.). Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to Häagen-Dazs and Dreyer’s ice cream products labeled “All Natural.” This case was consolidated with the copy-cat case Rutledge-Muhs v. Dreyer’s Grand Ice Cream. The action was dismissed with prejudice. Stoltz v. Chobani, LLC, No. 1:14cv3827 (E.D.N.Y.). Defended nationwide consumer class action alleging false advertising of Greek Yogurt products, marketed as “Greek Yogurt,” “0%,” “evaporated cane juice,” and natural and healthy. Chavez v. Nestlé USA, No. 09-9192 (C.D. Cal.). Defended putative nationwide consumer class action against Nestlé USA alleging false advertising under California consumer protection laws with respect to juice products marketed as supporting brain development, immunity and digestive health. Case dismissed following three successive, successful motions to dismiss (2011 WL 10565797 (C.D. Cal. Jan. 10, 2011), 2011 WL 2150128 (C.D. Cal. May 19, 2011)). Judgment in defendant’s favor affirmed in part and reversed in part. 511 Fed. App’x. 606 (9th Cir. 2013). Ibarrola v. KIND LLC, 83 F. Supp. 3d 751 (N.D. Ill. 2014). Secured a complete victory for client KIND LLC in the Northern District of Illinois when Judge Sara Ellis dismissed a putative nationwide consumer class action premised on allegations that KIND deceived consumers by including a “No Refined Sugars” statement on the label of snack foods. Judge Ellis granted KIND’s motion to dismiss an amended complaint with prejudice, holding that plaintiff failed to allege a plausible theory of deception. Boyle v. KIND LLC, No. 1:13cv8365 (S.D.N.Y). Defended nationwide consumer class action challenging the labeling of snack bar products as insinuating that consuming the products will not lead to weight gain and that the product is better-for-you product. Also defended copy-cat, follow-on action Bailey v. KIND LLC, No. 8:16cv168(C.D. Cal.). Trazo v. Nestlé USA, Inc., No. 5:12cv2272 (N.D. Cal.) Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws regarding Coffee-mate powder products marketed as “0g trans fat.” This case is notable for the scope of its predecessor case at filing—challenging an open-ended number of the products of a major food manufacturer. The broadside attack featured multiple misbranding allegations on diverse labeling statements. Of special significance, we dealt a massive blow when its separate and innovative motion to strike the plaintiffs' class allegations—at the pleading stage—was granted. 201 WL 4083218 (N.D. Cal. Aug. 9, 2013). The challenged products were subsequently reduced from “open-ended” to four and the misbranding theories have been reduced from nine to four. Belli II v. Nestlé USA, Inc., No. 5:14cv283 (N.D. Cal.) Defended putative nationwide consumer class action alleging false advertising under California consumer protection laws regarding Eskimo Pie products marketed as “No Sugar Added.” In re Gerber Probiotic Sales Practices Litigation, No. 12-835 (D. N.J.). Defended Gerber in ten-case consolidated nationwide consumer class action alleging false advertising under consumer protection and warranty laws of multiple states with respect to baby formula and cereal products labeled as containing immune-supporting probiotics, digestion-supporting prebiotics, and brain and eye development-supporting DHA. Motions to consolidate cases granted. Burns v. Gerber Prods. Co., 922 F.Supp.2d 1168 (E.D. Wash. 2013); Hawkins v. Gerber Prods. Co., 924 F.Supp.2d 1208 (S.D. Cal. 2013). Reilly v. Amy’s Kitchen , 2 F. Supp. 3d 1300 (S.D. Fla. 2014); see also 2014 WL 905441 (S.D. Fla. Mar. 7, 2014) Defended against putative Florida consumer class action alleging false advertising under Florida consumer protection laws with respect to food products containing the ingredient “evaporated cane juice.” A federal judge first denied plaintiff’s request to reinstate claims over 57 products that the named plaintiff never purchased. The court then dismissed the case on jurisdictional grounds because the amount at issue for the three products the named plaintiff did purchase fell below the Class Action Fairness Act amount in controversy requirement. Figy v. Amy’s Kitchen, Inc., 2 F. Supp. 3d 1300 (N.D. Cal. 2014). Defended against putative nationwide consumer class action alleging false advertising under California consumer protection laws with respect to food products containing the ingredient “evaporated cane juice.” A federal judge dismissed action without leave to amend based on primary jurisdiction of FDA (later converted to stay). Simpson v. California Pizza Kitchen, 989 F. Supp. 2d 1015 (S.D. Cal. 2013), 2013, 2013 WL 5718479 (S.D. Cal Oct. 1, 2013). Defended a putative nationwide consumer class action against several frozen pizza brands owned by Nestlé USA and California Pizza Kitchen alleging violation of California's Unfair Competition Law and statutory nuisance law. This was a bellwether case. Using the class action vehicle, plaintiffs sought to impose an unprecedented judicial ban on artificial trans fats in frozen pizza products. Any success could have “opened the floodgates” to numerous other cases seeking to ban individual ingredients. A motion to dismiss was granted as to the entire complaint, with prejudice and without leave to amend. Brower v. Campbell Soup Company, 243 F. Supp. 3d 1124, 2017 WL 1063470 (S.D. Cal. Mar. 21, 2017). Obtained a dismissal with prejudice for Campbell Soup in a consumer class challenging the labels of Chunky Healthy Request soup products. The court ruled that plaintiffs’ state-law false advertising claims are preempted by the federal Poultry Products Inspection Act and the Federal Meat Inspection Act. Bell v. Campbell Soup Co., 65 F. Supp. 3d 1328 (N.D. Fla. 2014). Secured victory for Campbell Soup when a federal judge in Florida dismissed with prejudice an amended consumer class action complaint in an action that initially had challenged the labeling of more than 50 products from multiple product lines under Campbell’s iconic V8 brand. The court ruled that plaintiffs’ amended claims (following an initial motion to dismiss) were expressly preempted as attempting to impose state-law labeling requirements that were not identical to federal labeling law and that Campbell’s labels complied with the federal requirements “to the letter.”","searchable_name":"Keri Borders","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":32,"capability_group_featured":null,"home_page_featured":null},{"id":447104,"version":1,"owner_type":"Person","owner_id":6224,"payload":{"bio":"\u003cp\u003eSara Brinkmann represents healthcare and life sciences clients in investigations and litigation in federal courts, state courts, arbitrations, and administrative proceedings across the country.\u0026nbsp; Sara has particular expertise in handling matters that arise under the federal False Claims Act and its state law analogues.\u0026nbsp; Sara also focuses on managed care litigation and has successfully recovered millions of dollars for healthcare providers in disputes against heath plans.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAn experienced litigator, Sara also represents her clients in disputes involving contracts, business torts, antitrust, and products liability issues. Sara's clients include hospitals, academic medical centers, medical groups, retail pharmacies, medical device companies, pharmaceutical companies, and other life sciences companies.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn additional to her litigation practice, she regularly advises clients on regulatory and compliance matters, including those that involved the Stark Law, the Anti-Kickback Statute, and other fraud and abuse laws. She also provides counseling and training regarding policies, compliance programs, self-disclosures, and billing matters.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThrough \u003cem\u003eChambers USA\u003c/em\u003e, her clients have said:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; \"Sara Brinkmann is an excellent litigator. She is very knowledgeable, highly organized, and a pleasure to work with.\"\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; \"She cares about each of her cases and comes up with creative ideas to problem-solve.\" \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; \"Sara Brinkmann is a fantastic lawyer.\"\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSara is regularly recognized by publications like \u003cem\u003eChambers,\u0026nbsp;\u003c/em\u003e\u003cem\u003eBest Lawyers in America, \u003c/em\u003eand \u003cem\u003eSuper Lawyers\u003c/em\u003e. She is the past\u0026nbsp;Chair of the Health Law Section of the Houston Bar Association. She is also a frequent speaker and presenter on a variety of healthcare topics.\u003c/p\u003e","slug":"sara-brinkmann","email":"sbrinkmann@kslaw.com","phone":"+1 713 295 9930","matters":["\u003cp\u003eSuccessfully defended a nationwide retail pharmacy client in a False Claims Act case in the Southern District of Texas and on appeal in the Fifth Circuit Court of Appeals involving allegations of regulatory violations related to the dispensing of certain pharmaceuticals, resulting in a full dismissal of the case prior to discovery and was affirmed on appeal at the Fifth Circuit.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a hospital system in a False Claims Act case in the Southern District of Texas involving allegations of Stark Law and Anti-Kickback Statute violations related to physician recruitment and compensation arrangements, resulting in a favorable settlement for the client.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a hospital system in a False Claims Act case in the Eastern District of Wisconsin involving allegations of Stark Law and Anti-Kickback Statute violations related to physician group compensation, resulting in a favorable settlement for the client.\u003c/p\u003e","\u003cp\u003eSuccessfully defended an international medical device company in a False Claims Act case in the District of New Jersey involving allegations of coding errors on claim submissions, resulting in a favorable settlement for the client.\u003c/p\u003e","\u003cp\u003eSuccessfully defended nationwide retail pharmacy in a False Claims Act case in the Central District of Illinois involving allegations related to usual and customary pricing, resulting in the Court\u0026rsquo;s grant of a Motion for Summary Judgment and dismissal of case.\u003c/p\u003e","\u003cp\u003eSuccessfully defended several higher education institutions, academic medical centers, and life sciences companies in responding to Civil Investigative Demands and other government investigation, including conducting internal investigations and presenting to the government.\u003c/p\u003e","\u003cp\u003eAdvised several higher education institutions on legal and compliance issues, including developing, implementing, and providing training to employees.\u003c/p\u003e","\u003cp\u003eAdvised hospital systems regarding affiliation agreements and other complex transactions.\u003c/p\u003e","\u003cp\u003eAdvised and provided due diligence support to healthcare companies and hospital systems for mergers and acquisitions.\u003c/p\u003e","\u003cp\u003eAdvised hospital system regarding data privacy and HIPAA compliance issues in responding to third-party subpoenas.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a government defense contractor in a False Claims Act case in the Eastern District of Texas involving allegations of kickbacks and failure to comply with certain Federal Acquisition Regulations.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a pharmaceutical company in several product liability cases in federal and state courts across the country.\u003c/p\u003e","\u003cp\u003eSuccessfully represented hospitals systems and other healthcare providers in Texas federal and state court cases involving allegations of breach of contract, violations of Texas Deceptive Trade Practices Act and Texas Uniform Fraudulent Transfer Act, and health care liability claim cases.\u003c/p\u003e","\u003cp\u003eSuccessfully represented a hospital system in responding to Medicare RAC audits, securing full reimbursements for hospital system.\u003c/p\u003e","\u003cp\u003eRepresented a Louisiana hospital system in federal antitrust case.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a managed care organization in response to investigation by the Texas Office of Inspector General, resulting in a favorable result for the client.\u003c/p\u003e","\u003cp\u003eSuccessfully represented a hospital system in responding to third-party subpoenas successfully securing full reimbursements for hospital systems, including obtaining recovery of attorneys\u0026rsquo; fees after prosecuting numerous motions to quash and motions for protection of medical and forensic records in civil, family, and criminal cases.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":1,"source":"capabilities"},{"id":11,"guid":"11.capabilities","index":2,"source":"capabilities"},{"id":74,"guid":"74.capabilities","index":3,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":4,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":5,"source":"capabilities"},{"id":109,"guid":"109.capabilities","index":6,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":7,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":8,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":9,"source":"smartTags"},{"id":780,"guid":"780.smart_tags","index":10,"source":"smartTags"}],"is_active":true,"last_name":"Brinkmann","nick_name":"Sara","clerkships":[{"name":"Law Clerk, Hon. David Hittner, Texas","years_held":"2009 - 2011"}],"first_name":"Sara","title_rank":9999,"updated_by":202,"law_schools":[{"id":2197,"meta":{"degree":"J.D.","honors":"cum laude","is_law_school":"1","graduation_date":"2009-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"\"She is very calm, organized and responsive.\"","detail":"Chambers USA, 2025"},{"title":"\"Sara has a very service-oriented ethos in how she practices.\"","detail":"Chambers USA, 2025"},{"title":"Ranked as a Band 3 lawyer for Healthcare: Government Matters \u0026 Regulation","detail":"Chambers USA, 2025"},{"title":"Ranked as a Key Lawyer for Healthcare: Service Providers","detail":"Legal 500 USA, 2025"},{"title":"\"Sara is very good at keeping larger business outcomes in mind.\"","detail":"Chambers USA 2024"},{"title":"\"Sara is intelligent and customer-focused, responsive and competent.\"","detail":"Chambers USA 2024"},{"title":"\"Sara is an exceptional attorney who provided outstanding legal analysis.\"","detail":"Chambers USA 2024"},{"title":"Ranked Band 3 for Healthcare in Texas","detail":"Chambers USA 2024"},{"title":"Women in the Law","detail":"Best Lawyers, 2022"},{"title":"Top Rated Houston, TX Health Care Attorney","detail":"Super Lawyers, 2023-2024"},{"title":"Top Women Attorneys in Texas","detail":"2024"},{"title":"Best Lawyers in America","detail":"Best Lawyers - Texas, 2021 - 2023"},{"title":"Top Ranked Lawyer, Healthcare","detail":"Chambers USA, Texas, 2021-2023"},{"title":"“Sara Brinkmann comes recommended for her expert handling of qui tam actions brought under the False Claims Act.”","detail":"Chambers USA 2022"},{"title":"“Sara offers notable experience in litigation and administrative proceedings.”","detail":"Chambers USA 2022"},{"title":"“Sara Brinkmann possesses significant experience and knowledge on complex issues.”","detail":"Chambers USA 2022"},{"title":"Sara is “organized and approachable, and offers thoughtful approaches on ways to achieve the desired result.”","detail":"Chambers USA 2022"},{"title":"“She is a really sharp lawyer.”","detail":"Chambers USA 2022"}],"linked_in_url":"https://www.linkedin.com/in/sara-brinkmann-23b78335","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eSara Brinkmann represents healthcare and life sciences clients in investigations and litigation in federal courts, state courts, arbitrations, and administrative proceedings across the country.\u0026nbsp; Sara has particular expertise in handling matters that arise under the federal False Claims Act and its state law analogues.\u0026nbsp; Sara also focuses on managed care litigation and has successfully recovered millions of dollars for healthcare providers in disputes against heath plans.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAn experienced litigator, Sara also represents her clients in disputes involving contracts, business torts, antitrust, and products liability issues. Sara's clients include hospitals, academic medical centers, medical groups, retail pharmacies, medical device companies, pharmaceutical companies, and other life sciences companies.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn additional to her litigation practice, she regularly advises clients on regulatory and compliance matters, including those that involved the Stark Law, the Anti-Kickback Statute, and other fraud and abuse laws. She also provides counseling and training regarding policies, compliance programs, self-disclosures, and billing matters.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThrough \u003cem\u003eChambers USA\u003c/em\u003e, her clients have said:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; \"Sara Brinkmann is an excellent litigator. She is very knowledgeable, highly organized, and a pleasure to work with.\"\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; \"She cares about each of her cases and comes up with creative ideas to problem-solve.\" \u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; \"Sara Brinkmann is a fantastic lawyer.\"\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSara is regularly recognized by publications like \u003cem\u003eChambers,\u0026nbsp;\u003c/em\u003e\u003cem\u003eBest Lawyers in America, \u003c/em\u003eand \u003cem\u003eSuper Lawyers\u003c/em\u003e. She is the past\u0026nbsp;Chair of the Health Law Section of the Houston Bar Association. She is also a frequent speaker and presenter on a variety of healthcare topics.\u003c/p\u003e","matters":["\u003cp\u003eSuccessfully defended a nationwide retail pharmacy client in a False Claims Act case in the Southern District of Texas and on appeal in the Fifth Circuit Court of Appeals involving allegations of regulatory violations related to the dispensing of certain pharmaceuticals, resulting in a full dismissal of the case prior to discovery and was affirmed on appeal at the Fifth Circuit.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a hospital system in a False Claims Act case in the Southern District of Texas involving allegations of Stark Law and Anti-Kickback Statute violations related to physician recruitment and compensation arrangements, resulting in a favorable settlement for the client.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a hospital system in a False Claims Act case in the Eastern District of Wisconsin involving allegations of Stark Law and Anti-Kickback Statute violations related to physician group compensation, resulting in a favorable settlement for the client.\u003c/p\u003e","\u003cp\u003eSuccessfully defended an international medical device company in a False Claims Act case in the District of New Jersey involving allegations of coding errors on claim submissions, resulting in a favorable settlement for the client.\u003c/p\u003e","\u003cp\u003eSuccessfully defended nationwide retail pharmacy in a False Claims Act case in the Central District of Illinois involving allegations related to usual and customary pricing, resulting in the Court\u0026rsquo;s grant of a Motion for Summary Judgment and dismissal of case.\u003c/p\u003e","\u003cp\u003eSuccessfully defended several higher education institutions, academic medical centers, and life sciences companies in responding to Civil Investigative Demands and other government investigation, including conducting internal investigations and presenting to the government.\u003c/p\u003e","\u003cp\u003eAdvised several higher education institutions on legal and compliance issues, including developing, implementing, and providing training to employees.\u003c/p\u003e","\u003cp\u003eAdvised hospital systems regarding affiliation agreements and other complex transactions.\u003c/p\u003e","\u003cp\u003eAdvised and provided due diligence support to healthcare companies and hospital systems for mergers and acquisitions.\u003c/p\u003e","\u003cp\u003eAdvised hospital system regarding data privacy and HIPAA compliance issues in responding to third-party subpoenas.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a government defense contractor in a False Claims Act case in the Eastern District of Texas involving allegations of kickbacks and failure to comply with certain Federal Acquisition Regulations.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a pharmaceutical company in several product liability cases in federal and state courts across the country.\u003c/p\u003e","\u003cp\u003eSuccessfully represented hospitals systems and other healthcare providers in Texas federal and state court cases involving allegations of breach of contract, violations of Texas Deceptive Trade Practices Act and Texas Uniform Fraudulent Transfer Act, and health care liability claim cases.\u003c/p\u003e","\u003cp\u003eSuccessfully represented a hospital system in responding to Medicare RAC audits, securing full reimbursements for hospital system.\u003c/p\u003e","\u003cp\u003eRepresented a Louisiana hospital system in federal antitrust case.\u003c/p\u003e","\u003cp\u003eSuccessfully defended a managed care organization in response to investigation by the Texas Office of Inspector General, resulting in a favorable result for the client.\u003c/p\u003e","\u003cp\u003eSuccessfully represented a hospital system in responding to third-party subpoenas successfully securing full reimbursements for hospital systems, including obtaining recovery of attorneys\u0026rsquo; fees after prosecuting numerous motions to quash and motions for protection of medical and forensic records in civil, family, and criminal cases.\u003c/p\u003e"],"recognitions":[{"title":"\"She is very calm, organized and responsive.\"","detail":"Chambers USA, 2025"},{"title":"\"Sara has a very service-oriented ethos in how she practices.\"","detail":"Chambers USA, 2025"},{"title":"Ranked as a Band 3 lawyer for Healthcare: Government Matters \u0026 Regulation","detail":"Chambers USA, 2025"},{"title":"Ranked as a Key Lawyer for Healthcare: Service Providers","detail":"Legal 500 USA, 2025"},{"title":"\"Sara is very good at keeping larger business outcomes in mind.\"","detail":"Chambers USA 2024"},{"title":"\"Sara is intelligent and customer-focused, responsive and competent.\"","detail":"Chambers USA 2024"},{"title":"\"Sara is an exceptional attorney who provided outstanding legal analysis.\"","detail":"Chambers USA 2024"},{"title":"Ranked Band 3 for Healthcare in Texas","detail":"Chambers USA 2024"},{"title":"Women in the Law","detail":"Best Lawyers, 2022"},{"title":"Top Rated Houston, TX Health Care Attorney","detail":"Super Lawyers, 2023-2024"},{"title":"Top Women Attorneys in Texas","detail":"2024"},{"title":"Best Lawyers in America","detail":"Best Lawyers - Texas, 2021 - 2023"},{"title":"Top Ranked Lawyer, Healthcare","detail":"Chambers USA, Texas, 2021-2023"},{"title":"“Sara Brinkmann comes recommended for her expert handling of qui tam actions brought under the False Claims Act.”","detail":"Chambers USA 2022"},{"title":"“Sara offers notable experience in litigation and administrative proceedings.”","detail":"Chambers USA 2022"},{"title":"“Sara Brinkmann possesses significant experience and knowledge on complex issues.”","detail":"Chambers USA 2022"},{"title":"Sara is “organized and approachable, and offers thoughtful approaches on ways to achieve the desired result.”","detail":"Chambers USA 2022"},{"title":"“She is a really sharp lawyer.”","detail":"Chambers USA 2022"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9607}]},"capability_group_id":2},"created_at":"2026-03-27T19:04:30.000Z","updated_at":"2026-03-27T19:04:30.000Z","searchable_text":"Brinkmann{{ FIELD }}{:title=\u0026gt;\"\\\"She is very calm, organized and responsive.\\\"\", :detail=\u0026gt;\"Chambers USA, 2025\"}{{ FIELD }}{:title=\u0026gt;\"\\\"Sara has a very service-oriented ethos in how she practices.\\\"\", :detail=\u0026gt;\"Chambers USA, 2025\"}{{ FIELD }}{:title=\u0026gt;\"Ranked as a Band 3 lawyer for Healthcare: Government Matters \u0026amp; Regulation\", :detail=\u0026gt;\"Chambers USA, 2025\"}{{ FIELD }}{:title=\u0026gt;\"Ranked as a Key Lawyer for Healthcare: Service Providers\", :detail=\u0026gt;\"Legal 500 USA, 2025\"}{{ FIELD }}{:title=\u0026gt;\"\\\"Sara is very good at keeping larger business outcomes in mind.\\\"\", :detail=\u0026gt;\"Chambers USA 2024\"}{{ FIELD }}{:title=\u0026gt;\"\\\"Sara is intelligent and customer-focused, responsive and competent.\\\"\", :detail=\u0026gt;\"Chambers USA 2024\"}{{ FIELD }}{:title=\u0026gt;\"\\\"Sara is an exceptional attorney who provided outstanding legal analysis.\\\"\", :detail=\u0026gt;\"Chambers USA 2024\"}{{ FIELD }}{:title=\u0026gt;\"Ranked Band 3 for Healthcare in Texas\", :detail=\u0026gt;\"Chambers USA 2024\"}{{ FIELD }}{:title=\u0026gt;\"Women in the Law\", :detail=\u0026gt;\"Best Lawyers, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Top Rated Houston, TX Health Care Attorney\", :detail=\u0026gt;\"Super Lawyers, 2023-2024\"}{{ FIELD }}{:title=\u0026gt;\"Top Women Attorneys in Texas\", :detail=\u0026gt;\"2024\"}{{ FIELD }}{:title=\u0026gt;\"Best Lawyers in America\", :detail=\u0026gt;\"Best Lawyers - Texas, 2021 - 2023\"}{{ FIELD }}{:title=\u0026gt;\"Top Ranked Lawyer, Healthcare\", :detail=\u0026gt;\"Chambers USA, Texas, 2021-2023\"}{{ FIELD }}{:title=\u0026gt;\"“Sara Brinkmann comes recommended for her expert handling of qui tam actions brought under the False Claims Act.”\", :detail=\u0026gt;\"Chambers USA 2022\"}{{ FIELD }}{:title=\u0026gt;\"“Sara offers notable experience in litigation and administrative proceedings.”\", :detail=\u0026gt;\"Chambers USA 2022\"}{{ FIELD }}{:title=\u0026gt;\"“Sara Brinkmann possesses significant experience and knowledge on complex issues.”\", :detail=\u0026gt;\"Chambers USA 2022\"}{{ FIELD }}{:title=\u0026gt;\"Sara is “organized and approachable, and offers thoughtful approaches on ways to achieve the desired result.”\", :detail=\u0026gt;\"Chambers USA 2022\"}{{ FIELD }}{:title=\u0026gt;\"“She is a really sharp lawyer.”\", :detail=\u0026gt;\"Chambers USA 2022\"}{{ FIELD }}Successfully defended a nationwide retail pharmacy client in a False Claims Act case in the Southern District of Texas and on appeal in the Fifth Circuit Court of Appeals involving allegations of regulatory violations related to the dispensing of certain pharmaceuticals, resulting in a full dismissal of the case prior to discovery and was affirmed on appeal at the Fifth Circuit.{{ FIELD }}Successfully defended a hospital system in a False Claims Act case in the Southern District of Texas involving allegations of Stark Law and Anti-Kickback Statute violations related to physician recruitment and compensation arrangements, resulting in a favorable settlement for the client.{{ FIELD }}Successfully defended a hospital system in a False Claims Act case in the Eastern District of Wisconsin involving allegations of Stark Law and Anti-Kickback Statute violations related to physician group compensation, resulting in a favorable settlement for the client.{{ FIELD }}Successfully defended an international medical device company in a False Claims Act case in the District of New Jersey involving allegations of coding errors on claim submissions, resulting in a favorable settlement for the client.{{ FIELD }}Successfully defended nationwide retail pharmacy in a False Claims Act case in the Central District of Illinois involving allegations related to usual and customary pricing, resulting in the Court’s grant of a Motion for Summary Judgment and dismissal of case.{{ FIELD }}Successfully defended several higher education institutions, academic medical centers, and life sciences companies in responding to Civil Investigative Demands and other government investigation, including conducting internal investigations and presenting to the government.{{ FIELD }}Advised several higher education institutions on legal and compliance issues, including developing, implementing, and providing training to employees.{{ FIELD }}Advised hospital systems regarding affiliation agreements and other complex transactions.{{ FIELD }}Advised and provided due diligence support to healthcare companies and hospital systems for mergers and acquisitions.{{ FIELD }}Advised hospital system regarding data privacy and HIPAA compliance issues in responding to third-party subpoenas.{{ FIELD }}Successfully defended a government defense contractor in a False Claims Act case in the Eastern District of Texas involving allegations of kickbacks and failure to comply with certain Federal Acquisition Regulations.{{ FIELD }}Successfully defended a pharmaceutical company in several product liability cases in federal and state courts across the country.{{ FIELD }}Successfully represented hospitals systems and other healthcare providers in Texas federal and state court cases involving allegations of breach of contract, violations of Texas Deceptive Trade Practices Act and Texas Uniform Fraudulent Transfer Act, and health care liability claim cases.{{ FIELD }}Successfully represented a hospital system in responding to Medicare RAC audits, securing full reimbursements for hospital system.{{ FIELD }}Represented a Louisiana hospital system in federal antitrust case.{{ FIELD }}Successfully defended a managed care organization in response to investigation by the Texas Office of Inspector General, resulting in a favorable result for the client.{{ FIELD }}Successfully represented a hospital system in responding to third-party subpoenas successfully securing full reimbursements for hospital systems, including obtaining recovery of attorneys’ fees after prosecuting numerous motions to quash and motions for protection of medical and forensic records in civil, family, and criminal cases.{{ FIELD }}Sara Brinkmann represents healthcare and life sciences clients in investigations and litigation in federal courts, state courts, arbitrations, and administrative proceedings across the country.  Sara has particular expertise in handling matters that arise under the federal False Claims Act and its state law analogues.  Sara also focuses on managed care litigation and has successfully recovered millions of dollars for healthcare providers in disputes against heath plans. \nAn experienced litigator, Sara also represents her clients in disputes involving contracts, business torts, antitrust, and products liability issues. Sara's clients include hospitals, academic medical centers, medical groups, retail pharmacies, medical device companies, pharmaceutical companies, and other life sciences companies.  \nIn additional to her litigation practice, she regularly advises clients on regulatory and compliance matters, including those that involved the Stark Law, the Anti-Kickback Statute, and other fraud and abuse laws. She also provides counseling and training regarding policies, compliance programs, self-disclosures, and billing matters.  \nThrough Chambers USA, her clients have said: \n     \"Sara Brinkmann is an excellent litigator. She is very knowledgeable, highly organized, and a pleasure to work with.\"\n     \"She cares about each of her cases and comes up with creative ideas to problem-solve.\" \n     \"Sara Brinkmann is a fantastic lawyer.\"\nSara is regularly recognized by publications like Chambers, Best Lawyers in America, and Super Lawyers. She is the past Chair of the Health Law Section of the Houston Bar Association. She is also a frequent speaker and presenter on a variety of healthcare topics. Partner \"She is very calm, organized and responsive.\" Chambers USA, 2025 \"Sara has a very service-oriented ethos in how she practices.\" Chambers USA, 2025 Ranked as a Band 3 lawyer for Healthcare: Government Matters \u0026amp; Regulation Chambers USA, 2025 Ranked as a Key Lawyer for Healthcare: Service Providers Legal 500 USA, 2025 \"Sara is very good at keeping larger business outcomes in mind.\" Chambers USA 2024 \"Sara is intelligent and customer-focused, responsive and competent.\" Chambers USA 2024 \"Sara is an exceptional attorney who provided outstanding legal analysis.\" Chambers USA 2024 Ranked Band 3 for Healthcare in Texas Chambers USA 2024 Women in the Law Best Lawyers, 2022 Top Rated Houston, TX Health Care Attorney Super Lawyers, 2023-2024 Top Women Attorneys in Texas 2024 Best Lawyers in America Best Lawyers - Texas, 2021 - 2023 Top Ranked Lawyer, Healthcare Chambers USA, Texas, 2021-2023 “Sara Brinkmann comes recommended for her expert handling of qui tam actions brought under the False Claims Act.” Chambers USA 2022 “Sara offers notable experience in litigation and administrative proceedings.” Chambers USA 2022 “Sara Brinkmann possesses significant experience and knowledge on complex issues.” Chambers USA 2022 Sara is “organized and approachable, and offers thoughtful approaches on ways to achieve the desired result.” Chambers USA 2022 “She is a really sharp lawyer.” Chambers USA 2022 Baylor University Baylor University School of Law University of Houston University of Houston Law Center University of Houston University of Houston Law Center Texas Houston Bar Association, Member (Health Law Section, Chair 2021-2022; Campaign for the Homeless Committee, Former Member; Law Week Committee, Former Member) Federal Bar Association, Member State Bar of Texas, Member Texas Bar Foundation, Fellow Defense Research Institute, Member Greater Houston Society for Healthcare Risk Management Law Clerk, Hon. David Hittner, Texas Successfully defended a nationwide retail pharmacy client in a False Claims Act case in the Southern District of Texas and on appeal in the Fifth Circuit Court of Appeals involving allegations of regulatory violations related to the dispensing of certain pharmaceuticals, resulting in a full dismissal of the case prior to discovery and was affirmed on appeal at the Fifth Circuit. Successfully defended a hospital system in a False Claims Act case in the Southern District of Texas involving allegations of Stark Law and Anti-Kickback Statute violations related to physician recruitment and compensation arrangements, resulting in a favorable settlement for the client. Successfully defended a hospital system in a False Claims Act case in the Eastern District of Wisconsin involving allegations of Stark Law and Anti-Kickback Statute violations related to physician group compensation, resulting in a favorable settlement for the client. Successfully defended an international medical device company in a False Claims Act case in the District of New Jersey involving allegations of coding errors on claim submissions, resulting in a favorable settlement for the client. Successfully defended nationwide retail pharmacy in a False Claims Act case in the Central District of Illinois involving allegations related to usual and customary pricing, resulting in the Court’s grant of a Motion for Summary Judgment and dismissal of case. Successfully defended several higher education institutions, academic medical centers, and life sciences companies in responding to Civil Investigative Demands and other government investigation, including conducting internal investigations and presenting to the government. Advised several higher education institutions on legal and compliance issues, including developing, implementing, and providing training to employees. Advised hospital systems regarding affiliation agreements and other complex transactions. Advised and provided due diligence support to healthcare companies and hospital systems for mergers and acquisitions. Advised hospital system regarding data privacy and HIPAA compliance issues in responding to third-party subpoenas. Successfully defended a government defense contractor in a False Claims Act case in the Eastern District of Texas involving allegations of kickbacks and failure to comply with certain Federal Acquisition Regulations. Successfully defended a pharmaceutical company in several product liability cases in federal and state courts across the country. Successfully represented hospitals systems and other healthcare providers in Texas federal and state court cases involving allegations of breach of contract, violations of Texas Deceptive Trade Practices Act and Texas Uniform Fraudulent Transfer Act, and health care liability claim cases. Successfully represented a hospital system in responding to Medicare RAC audits, securing full reimbursements for hospital system. Represented a Louisiana hospital system in federal antitrust case. Successfully defended a managed care organization in response to investigation by the Texas Office of Inspector General, resulting in a favorable result for the client. Successfully represented a hospital system in responding to third-party subpoenas successfully securing full reimbursements for hospital systems, including obtaining recovery of attorneys’ fees after prosecuting numerous motions to quash and motions for protection of medical and forensic records in civil, family, and criminal cases.","searchable_name":"Sara Brinkmann","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":442372,"version":1,"owner_type":"Person","owner_id":883,"payload":{"bio":"\u003cp\u003eMark Brown is nationally recognized in Food \u0026amp; Drug Administration regulatory matters, civil litigation, criminal investigations and prosecutions, compliance matters and comprehensive risk assessments. Mark advises pharmaceutical, medical device and biotech companies, and pharmacies, on a broad range of FDA requirements and FDA regulatory issues that arise in products liability litigation and other disputes. A former Associate Chief Counsel for FDA, Mark is the Chair of the FDA and Life Sciences practice.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMark has developed a national reputation for successfully resolving difficult and complex FDA compliance matters and enforcement actions. For pharmaceutical, medical device and food companies, and pharmacies, he has successfully negotiated and managed numerous complex consent decrees of injunction, successfully defended an injunction action brought by FDA, and persuaded the government not to bring enforcement actions in other civil and criminal matters.\u003c/p\u003e\n\u003cp\u003eMark regularly counsels clients on drug safety issues, clinical trials, adverse event reporting, quality systems and manufacturing practices for drugs and devices. He also provides guidance concerning product failure investigations, factory inspections, recalls, product labeling, drug compounding, advertising, promotion, sales and marketing practices, and regularly advises clients on strategies for obtaining FDA approval and clearance for medical products.\u003c/p\u003e\n\u003cp\u003eMark also handles FDA-related issues in product liability and commercial litigation. He was an architect of the preemption defense for both pharmaceutical and medical device clients, developing supporting evidence, briefing and arguing federal preemption motions in various federal and state courts.\u003c/p\u003e\n\u003cp\u003eBefore joining the FDA, Mark was an attorney in the Bureau of Consumer Protection at the Federal Trade Commission, where he concentrated on consumer fraud, healthcare advertising and promotional activities. He developed FTC enforcement actions against weight-loss centers, in vitro fertilization clinics and Northern Virginia infertility doctor Cecil B. Jacobson, who was later convicted of defrauding patients.\u003c/p\u003e","slug":"mark-brown","email":"mbrown@kslaw.com","phone":null,"matters":["\u003cp\u003e\u003cem data-redactor-tag=\"em\"\u003e\u003cstrong data-redactor-tag=\"strong\"\u003ePhillip Morris USA\u003c/strong\u003e v. FDA\u003c/em\u003e, 202 F.Supp. 3d (D.D.C. 2016). Represented one of the plaintiffs in a successful legal challenge to an FDA guidance governing the Substantial Equivalence Review process for tobacco products.\u003c/p\u003e","\u003cp\u003e\u003cem data-redactor-tag=\"em\"\u003eUnited States v. \u003cstrong data-redactor-tag=\"strong\"\u003eFranck's Lab\u003c/strong\u003e\u003c/em\u003e\u003cstrong data-redactor-tag=\"strong\"\u003e,\u003c/strong\u003e 2011 WL 4031102 (M.D. Fla., Sept. 12, 2011). Lead counsel in successful defense of FDA enforcement action against pharmacy compounder of veterinary drugs.\u003c/p\u003e","\u003cp\u003eDuring his 30-year career, he has served as lead counsel and negotiator for numerous consent decrees of injunction, both during his tenure with FDA (1990\u0026ndash;1994), and since 1994 in private practice. For example, he has negotiated consent decrees some of the world's largest device manufacturers, including \u003cstrong data-redactor-tag=\"strong\"\u003eMedtronic\u003c/strong\u003e (2008 and 2015), \u003cstrong data-redactor-tag=\"strong\"\u003eThe General Electric Company\u003c/strong\u003e (2007) and \u003cstrong data-redactor-tag=\"strong\"\u003eBaxter Healthcare\u003c/strong\u003e (2006).\u003c/p\u003e","\u003cp\u003eSince 2002, served on the national counsel team for \u003cstrong data-redactor-tag=\"strong\"\u003eGlaxoSmithKline\u003c/strong\u003e in the Paxil Products Liability Litigation. Represented GSK on all FDA-related issues, including federal preemption. Argued and won a summary judgment motion on federal preemption grounds in \u003cem data-redactor-tag=\"em\"\u003eO'Neal v. \u003cstrong data-redactor-tag=\"strong\"\u003eSmithKline Beecham\u003c/strong\u003e\u003c/em\u003e (E.D. Cal 2008). In 2002, represented GSK in successfully defending an injunction seeking to enjoin GSK from making claims in direct-to-consumer television advertising for Paxil.\u003c/p\u003e","\u003cp\u003eFrom 1995 to 2001, served on \u003cstrong data-redactor-tag=\"strong\"\u003e3M\u003c/strong\u003e's National Trial Team in the Silicone Gel-Filled Breast Implant Litigation. Responsible for virtually all FDA issues and had primary responsibility for preparation and handling of defense expert witnesses, and cross-examination of adverse witnesses on FDA issues.\u003c/p\u003e","\u003cp\u003e\u003cem data-redactor-tag=\"em\"\u003eConnaught Laboratories v. \u003cstrong data-redactor-tag=\"strong\"\u003eSmithKline Beecham\u003c/strong\u003e\u003c/em\u003e\u003cstrong data-redactor-tag=\"strong\"\u003e,\u003c/strong\u003e 7 F.Supp. 2d 477 (D.Del. 1998), appeal dismissed, 165 F.3d 1368 (1999). Represented SmithKline Beecham in winning one of the few successful motions to compel FDA to provide testimony by its research scientists in patent litigation relating to purified form of pertactin, a component of the pertussis vaccine.\u003c/p\u003e","\u003cp\u003e\u003cem data-redactor-tag=\"em\"\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eNext Nutrition\u003c/strong\u003e\u003cstrong data-redactor-tag=\"strong\"\u003e, Inc.\u003c/strong\u003e\u003c/em\u003e \u003cem data-redactor-tag=\"em\"\u003ev. SportPharma USA, Inc.\u003c/em\u003e, No. 97-CV-1898J (1997). Served as lead counsel to a dietary supplement company that brought an action under the Lanham Act alleging false and misleading comparative advertising relating to competing products. Successfully negotiated a favorable settlement by obtaining a consent decree of permanent injunction and a damage award.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical manufacturers\u003c/strong\u003e in grand jury investigations regarding data integrity concerns in regulatory submissions to FDA, and alleged cGMP violations. In both cases, the U.S. Department of Justice declined to prosecute the company and individuals under investigation.\u003c/p\u003e","\u003cp\u003eConducted internal investigations into the sales and marketing practices of \u003cstrong data-redactor-tag=\"strong\"\u003emultiple international pharmaceutical and biotech companies\u003c/strong\u003e to develop a risk profile and recommendations for reducing potential liability and risk exposure.\u003c/p\u003e","\u003cp\u003eConducted comprehensive prelaunch risk assessments for \u003cstrong data-redactor-tag=\"strong\"\u003ea Top 10 pharmaceutical company\u003c/strong\u003e\u003cstrong data-redactor-tag=\"strong\"\u003e\u0026rsquo;s\u003c/strong\u003e blockbuster drug to identify potential medical, scientific, regulatory and products liability risk areas.\u003c/p\u003e","\u003cp\u003eConducted a risk assessment for \u003cstrong data-redactor-tag=\"strong\"\u003ea top tier biotechnology company\u0026rsquo;s\u003c/strong\u003e drug safety system to identify areas for possible improvement in pharmacovigilence planning, postmarket signal detection and investigation, and business decision-making.\u003c/p\u003e","\u003cp\u003eLed numerous internal investigations for \u003cstrong data-redactor-tag=\"strong\"\u003ebiotechnology, pharmaceutical and medical device manufacturers\u003c/strong\u003e into allegations made by current and former employees regarding product integrity issues, sales and marketing activities, and manufacturing quality issues.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eseveral drug and device manufacturers\u003c/strong\u003e concerning product approvals, and in responding to FDA requests for information relating to promotion and advertising, manufacturing practices, field alerts, recalls and numerous post-market issues.\u003c/p\u003e","\u003cp\u003eRepresented one of the nation\u0026rsquo;s foremost cardiovascular institutes and some of the leading interventional cardiologists in responding to deficiencies identified during FDA inspections and developing appropriate corrective action to avoid further FDA regulatory enforcement.\u003c/p\u003e","\u003cp\u003eRepresented a device manufacturer in obtaining expedited PMA review and approval in 90 days for a first-of-a-kind device to treat aneurysms in the renal vascular arteries. Successfully obtained approval for a major PMA supplement for the same product.\u003c/p\u003e","\u003cp\u003eRepresented a device manufacturer and coordinated an extensive product investigation into reported failures of an implantable device featuring sophisticated failure analyses and clinical assessments.\u003c/p\u003e","\u003cp\u003eConducted extensive training on FDA regulatory, IRB and protocol requirements for clinical investigators participating in the study of implantable devices.\u003c/p\u003e","\u003cp\u003eAssisted numerous companies in preparing for FDA inspections, developing responses to FDA observations (FDA-483 forms) and warning letters related to manufacturing practices, quality systems, adverse event reporting, deviations from approved drug master files and manufacturing processes, and a variety of other regulatory matters. Assisted these companies in preparing for meetings with FDA compliance officials in District Offices, centers for drugs and devices, and the Office of Chief Counsel.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":51}]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":11,"guid":"11.capabilities","index":1,"source":"capabilities"},{"id":2,"guid":"2.capabilities","index":2,"source":"capabilities"},{"id":106,"guid":"106.capabilities","index":3,"source":"capabilities"},{"id":3,"guid":"3.capabilities","index":4,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":5,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":6,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":7,"source":"capabilities"},{"id":80,"guid":"80.capabilities","index":8,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":9,"source":"capabilities"},{"id":1303,"guid":"1303.smart_tags","index":10,"source":"smartTags"},{"id":970,"guid":"970.smart_tags","index":11,"source":"smartTags"},{"id":114,"guid":"114.capabilities","index":12,"source":"capabilities"}],"is_active":true,"last_name":"Brown","nick_name":"Mark","clerkships":[],"first_name":"Mark","title_rank":9999,"updated_by":196,"law_schools":[],"middle_name":"S.","name_suffix":"","recognitions":[{"title":"Recognized by Super Lawyers as Top Rated FDA Attorney ","detail":"Law \u0026 Politics, 2007, 2010–2011, 2013–2017"},{"title":"Ranked Among the Best Life Sciences Lawyers in the U.S. ","detail":"Legal 500, 2016"},{"title":"Named Life Sciences Star ","detail":"LMG Life Sciences, 2012–2016"},{"title":"Recognized as one of Washington’s Best Lawyers ","detail":"Washingtonian magazine, 2004–2016"},{"title":"Superior Achievement Award ","detail":"U.S. Department of Health \u0026 Human Services, 1992"},{"title":"Commendable Service Award ","detail":"FDA, 1992–1994"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eMark Brown is nationally recognized in Food \u0026amp; Drug Administration regulatory matters, civil litigation, criminal investigations and prosecutions, compliance matters and comprehensive risk assessments. Mark advises pharmaceutical, medical device and biotech companies, and pharmacies, on a broad range of FDA requirements and FDA regulatory issues that arise in products liability litigation and other disputes. A former Associate Chief Counsel for FDA, Mark is the Chair of the FDA and Life Sciences practice.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMark has developed a national reputation for successfully resolving difficult and complex FDA compliance matters and enforcement actions. For pharmaceutical, medical device and food companies, and pharmacies, he has successfully negotiated and managed numerous complex consent decrees of injunction, successfully defended an injunction action brought by FDA, and persuaded the government not to bring enforcement actions in other civil and criminal matters.\u003c/p\u003e\n\u003cp\u003eMark regularly counsels clients on drug safety issues, clinical trials, adverse event reporting, quality systems and manufacturing practices for drugs and devices. He also provides guidance concerning product failure investigations, factory inspections, recalls, product labeling, drug compounding, advertising, promotion, sales and marketing practices, and regularly advises clients on strategies for obtaining FDA approval and clearance for medical products.\u003c/p\u003e\n\u003cp\u003eMark also handles FDA-related issues in product liability and commercial litigation. He was an architect of the preemption defense for both pharmaceutical and medical device clients, developing supporting evidence, briefing and arguing federal preemption motions in various federal and state courts.\u003c/p\u003e\n\u003cp\u003eBefore joining the FDA, Mark was an attorney in the Bureau of Consumer Protection at the Federal Trade Commission, where he concentrated on consumer fraud, healthcare advertising and promotional activities. He developed FTC enforcement actions against weight-loss centers, in vitro fertilization clinics and Northern Virginia infertility doctor Cecil B. Jacobson, who was later convicted of defrauding patients.\u003c/p\u003e","matters":["\u003cp\u003e\u003cem data-redactor-tag=\"em\"\u003e\u003cstrong data-redactor-tag=\"strong\"\u003ePhillip Morris USA\u003c/strong\u003e v. FDA\u003c/em\u003e, 202 F.Supp. 3d (D.D.C. 2016). Represented one of the plaintiffs in a successful legal challenge to an FDA guidance governing the Substantial Equivalence Review process for tobacco products.\u003c/p\u003e","\u003cp\u003e\u003cem data-redactor-tag=\"em\"\u003eUnited States v. \u003cstrong data-redactor-tag=\"strong\"\u003eFranck's Lab\u003c/strong\u003e\u003c/em\u003e\u003cstrong data-redactor-tag=\"strong\"\u003e,\u003c/strong\u003e 2011 WL 4031102 (M.D. Fla., Sept. 12, 2011). Lead counsel in successful defense of FDA enforcement action against pharmacy compounder of veterinary drugs.\u003c/p\u003e","\u003cp\u003eDuring his 30-year career, he has served as lead counsel and negotiator for numerous consent decrees of injunction, both during his tenure with FDA (1990\u0026ndash;1994), and since 1994 in private practice. For example, he has negotiated consent decrees some of the world's largest device manufacturers, including \u003cstrong data-redactor-tag=\"strong\"\u003eMedtronic\u003c/strong\u003e (2008 and 2015), \u003cstrong data-redactor-tag=\"strong\"\u003eThe General Electric Company\u003c/strong\u003e (2007) and \u003cstrong data-redactor-tag=\"strong\"\u003eBaxter Healthcare\u003c/strong\u003e (2006).\u003c/p\u003e","\u003cp\u003eSince 2002, served on the national counsel team for \u003cstrong data-redactor-tag=\"strong\"\u003eGlaxoSmithKline\u003c/strong\u003e in the Paxil Products Liability Litigation. Represented GSK on all FDA-related issues, including federal preemption. Argued and won a summary judgment motion on federal preemption grounds in \u003cem data-redactor-tag=\"em\"\u003eO'Neal v. \u003cstrong data-redactor-tag=\"strong\"\u003eSmithKline Beecham\u003c/strong\u003e\u003c/em\u003e (E.D. Cal 2008). In 2002, represented GSK in successfully defending an injunction seeking to enjoin GSK from making claims in direct-to-consumer television advertising for Paxil.\u003c/p\u003e","\u003cp\u003eFrom 1995 to 2001, served on \u003cstrong data-redactor-tag=\"strong\"\u003e3M\u003c/strong\u003e's National Trial Team in the Silicone Gel-Filled Breast Implant Litigation. Responsible for virtually all FDA issues and had primary responsibility for preparation and handling of defense expert witnesses, and cross-examination of adverse witnesses on FDA issues.\u003c/p\u003e","\u003cp\u003e\u003cem data-redactor-tag=\"em\"\u003eConnaught Laboratories v. \u003cstrong data-redactor-tag=\"strong\"\u003eSmithKline Beecham\u003c/strong\u003e\u003c/em\u003e\u003cstrong data-redactor-tag=\"strong\"\u003e,\u003c/strong\u003e 7 F.Supp. 2d 477 (D.Del. 1998), appeal dismissed, 165 F.3d 1368 (1999). Represented SmithKline Beecham in winning one of the few successful motions to compel FDA to provide testimony by its research scientists in patent litigation relating to purified form of pertactin, a component of the pertussis vaccine.\u003c/p\u003e","\u003cp\u003e\u003cem data-redactor-tag=\"em\"\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eNext Nutrition\u003c/strong\u003e\u003cstrong data-redactor-tag=\"strong\"\u003e, Inc.\u003c/strong\u003e\u003c/em\u003e \u003cem data-redactor-tag=\"em\"\u003ev. SportPharma USA, Inc.\u003c/em\u003e, No. 97-CV-1898J (1997). Served as lead counsel to a dietary supplement company that brought an action under the Lanham Act alleging false and misleading comparative advertising relating to competing products. Successfully negotiated a favorable settlement by obtaining a consent decree of permanent injunction and a damage award.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical manufacturers\u003c/strong\u003e in grand jury investigations regarding data integrity concerns in regulatory submissions to FDA, and alleged cGMP violations. In both cases, the U.S. Department of Justice declined to prosecute the company and individuals under investigation.\u003c/p\u003e","\u003cp\u003eConducted internal investigations into the sales and marketing practices of \u003cstrong data-redactor-tag=\"strong\"\u003emultiple international pharmaceutical and biotech companies\u003c/strong\u003e to develop a risk profile and recommendations for reducing potential liability and risk exposure.\u003c/p\u003e","\u003cp\u003eConducted comprehensive prelaunch risk assessments for \u003cstrong data-redactor-tag=\"strong\"\u003ea Top 10 pharmaceutical company\u003c/strong\u003e\u003cstrong data-redactor-tag=\"strong\"\u003e\u0026rsquo;s\u003c/strong\u003e blockbuster drug to identify potential medical, scientific, regulatory and products liability risk areas.\u003c/p\u003e","\u003cp\u003eConducted a risk assessment for \u003cstrong data-redactor-tag=\"strong\"\u003ea top tier biotechnology company\u0026rsquo;s\u003c/strong\u003e drug safety system to identify areas for possible improvement in pharmacovigilence planning, postmarket signal detection and investigation, and business decision-making.\u003c/p\u003e","\u003cp\u003eLed numerous internal investigations for \u003cstrong data-redactor-tag=\"strong\"\u003ebiotechnology, pharmaceutical and medical device manufacturers\u003c/strong\u003e into allegations made by current and former employees regarding product integrity issues, sales and marketing activities, and manufacturing quality issues.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eseveral drug and device manufacturers\u003c/strong\u003e concerning product approvals, and in responding to FDA requests for information relating to promotion and advertising, manufacturing practices, field alerts, recalls and numerous post-market issues.\u003c/p\u003e","\u003cp\u003eRepresented one of the nation\u0026rsquo;s foremost cardiovascular institutes and some of the leading interventional cardiologists in responding to deficiencies identified during FDA inspections and developing appropriate corrective action to avoid further FDA regulatory enforcement.\u003c/p\u003e","\u003cp\u003eRepresented a device manufacturer in obtaining expedited PMA review and approval in 90 days for a first-of-a-kind device to treat aneurysms in the renal vascular arteries. Successfully obtained approval for a major PMA supplement for the same product.\u003c/p\u003e","\u003cp\u003eRepresented a device manufacturer and coordinated an extensive product investigation into reported failures of an implantable device featuring sophisticated failure analyses and clinical assessments.\u003c/p\u003e","\u003cp\u003eConducted extensive training on FDA regulatory, IRB and protocol requirements for clinical investigators participating in the study of implantable devices.\u003c/p\u003e","\u003cp\u003eAssisted numerous companies in preparing for FDA inspections, developing responses to FDA observations (FDA-483 forms) and warning letters related to manufacturing practices, quality systems, adverse event reporting, deviations from approved drug master files and manufacturing processes, and a variety of other regulatory matters. Assisted these companies in preparing for meetings with FDA compliance officials in District Offices, centers for drugs and devices, and the Office of Chief Counsel.\u003c/p\u003e"],"recognitions":[{"title":"Recognized by Super Lawyers as Top Rated FDA Attorney ","detail":"Law \u0026 Politics, 2007, 2010–2011, 2013–2017"},{"title":"Ranked Among the Best Life Sciences Lawyers in the U.S. ","detail":"Legal 500, 2016"},{"title":"Named Life Sciences Star ","detail":"LMG Life Sciences, 2012–2016"},{"title":"Recognized as one of Washington’s Best Lawyers ","detail":"Washingtonian magazine, 2004–2016"},{"title":"Superior Achievement Award ","detail":"U.S. Department of Health \u0026 Human Services, 1992"},{"title":"Commendable Service Award ","detail":"FDA, 1992–1994"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":746}]},"capability_group_id":2},"created_at":"2025-11-05T05:03:44.000Z","updated_at":"2025-11-05T05:03:44.000Z","searchable_text":"Brown{{ FIELD }}{:title=\u0026gt;\"Recognized by Super Lawyers as Top Rated FDA Attorney \", :detail=\u0026gt;\"Law \u0026amp; Politics, 2007, 2010–2011, 2013–2017\"}{{ FIELD }}{:title=\u0026gt;\"Ranked Among the Best Life Sciences Lawyers in the U.S. \", :detail=\u0026gt;\"Legal 500, 2016\"}{{ FIELD }}{:title=\u0026gt;\"Named Life Sciences Star \", :detail=\u0026gt;\"LMG Life Sciences, 2012–2016\"}{{ FIELD }}{:title=\u0026gt;\"Recognized as one of Washington’s Best Lawyers \", :detail=\u0026gt;\"Washingtonian magazine, 2004–2016\"}{{ FIELD }}{:title=\u0026gt;\"Superior Achievement Award \", :detail=\u0026gt;\"U.S. Department of Health \u0026amp; Human Services, 1992\"}{{ FIELD }}{:title=\u0026gt;\"Commendable Service Award \", :detail=\u0026gt;\"FDA, 1992–1994\"}{{ FIELD }}Phillip Morris USA v. FDA, 202 F.Supp. 3d (D.D.C. 2016). Represented one of the plaintiffs in a successful legal challenge to an FDA guidance governing the Substantial Equivalence Review process for tobacco products.{{ FIELD }}United States v. Franck's Lab, 2011 WL 4031102 (M.D. Fla., Sept. 12, 2011). Lead counsel in successful defense of FDA enforcement action against pharmacy compounder of veterinary drugs.{{ FIELD }}During his 30-year career, he has served as lead counsel and negotiator for numerous consent decrees of injunction, both during his tenure with FDA (1990–1994), and since 1994 in private practice. For example, he has negotiated consent decrees some of the world's largest device manufacturers, including Medtronic (2008 and 2015), The General Electric Company (2007) and Baxter Healthcare (2006).{{ FIELD }}Since 2002, served on the national counsel team for GlaxoSmithKline in the Paxil Products Liability Litigation. Represented GSK on all FDA-related issues, including federal preemption. Argued and won a summary judgment motion on federal preemption grounds in O'Neal v. SmithKline Beecham (E.D. Cal 2008). In 2002, represented GSK in successfully defending an injunction seeking to enjoin GSK from making claims in direct-to-consumer television advertising for Paxil.{{ FIELD }}From 1995 to 2001, served on 3M's National Trial Team in the Silicone Gel-Filled Breast Implant Litigation. Responsible for virtually all FDA issues and had primary responsibility for preparation and handling of defense expert witnesses, and cross-examination of adverse witnesses on FDA issues.{{ FIELD }}Connaught Laboratories v. SmithKline Beecham, 7 F.Supp. 2d 477 (D.Del. 1998), appeal dismissed, 165 F.3d 1368 (1999). Represented SmithKline Beecham in winning one of the few successful motions to compel FDA to provide testimony by its research scientists in patent litigation relating to purified form of pertactin, a component of the pertussis vaccine.{{ FIELD }}Next Nutrition, Inc. v. SportPharma USA, Inc., No. 97-CV-1898J (1997). Served as lead counsel to a dietary supplement company that brought an action under the Lanham Act alleging false and misleading comparative advertising relating to competing products. Successfully negotiated a favorable settlement by obtaining a consent decree of permanent injunction and a damage award.{{ FIELD }}Represented pharmaceutical manufacturers in grand jury investigations regarding data integrity concerns in regulatory submissions to FDA, and alleged cGMP violations. In both cases, the U.S. Department of Justice declined to prosecute the company and individuals under investigation.{{ FIELD }}Conducted internal investigations into the sales and marketing practices of multiple international pharmaceutical and biotech companies to develop a risk profile and recommendations for reducing potential liability and risk exposure.{{ FIELD }}Conducted comprehensive prelaunch risk assessments for a Top 10 pharmaceutical company’s blockbuster drug to identify potential medical, scientific, regulatory and products liability risk areas.{{ FIELD }}Conducted a risk assessment for a top tier biotechnology company’s drug safety system to identify areas for possible improvement in pharmacovigilence planning, postmarket signal detection and investigation, and business decision-making.{{ FIELD }}Led numerous internal investigations for biotechnology, pharmaceutical and medical device manufacturers into allegations made by current and former employees regarding product integrity issues, sales and marketing activities, and manufacturing quality issues.{{ FIELD }}Represented several drug and device manufacturers concerning product approvals, and in responding to FDA requests for information relating to promotion and advertising, manufacturing practices, field alerts, recalls and numerous post-market issues.{{ FIELD }}Represented one of the nation’s foremost cardiovascular institutes and some of the leading interventional cardiologists in responding to deficiencies identified during FDA inspections and developing appropriate corrective action to avoid further FDA regulatory enforcement.{{ FIELD }}Represented a device manufacturer in obtaining expedited PMA review and approval in 90 days for a first-of-a-kind device to treat aneurysms in the renal vascular arteries. Successfully obtained approval for a major PMA supplement for the same product.{{ FIELD }}Represented a device manufacturer and coordinated an extensive product investigation into reported failures of an implantable device featuring sophisticated failure analyses and clinical assessments.{{ FIELD }}Conducted extensive training on FDA regulatory, IRB and protocol requirements for clinical investigators participating in the study of implantable devices.{{ FIELD }}Assisted numerous companies in preparing for FDA inspections, developing responses to FDA observations (FDA-483 forms) and warning letters related to manufacturing practices, quality systems, adverse event reporting, deviations from approved drug master files and manufacturing processes, and a variety of other regulatory matters. Assisted these companies in preparing for meetings with FDA compliance officials in District Offices, centers for drugs and devices, and the Office of Chief Counsel.{{ FIELD }}Mark Brown is nationally recognized in Food \u0026amp; Drug Administration regulatory matters, civil litigation, criminal investigations and prosecutions, compliance matters and comprehensive risk assessments. Mark advises pharmaceutical, medical device and biotech companies, and pharmacies, on a broad range of FDA requirements and FDA regulatory issues that arise in products liability litigation and other disputes. A former Associate Chief Counsel for FDA, Mark is the Chair of the FDA and Life Sciences practice.\nMark has developed a national reputation for successfully resolving difficult and complex FDA compliance matters and enforcement actions. For pharmaceutical, medical device and food companies, and pharmacies, he has successfully negotiated and managed numerous complex consent decrees of injunction, successfully defended an injunction action brought by FDA, and persuaded the government not to bring enforcement actions in other civil and criminal matters.\nMark regularly counsels clients on drug safety issues, clinical trials, adverse event reporting, quality systems and manufacturing practices for drugs and devices. He also provides guidance concerning product failure investigations, factory inspections, recalls, product labeling, drug compounding, advertising, promotion, sales and marketing practices, and regularly advises clients on strategies for obtaining FDA approval and clearance for medical products.\nMark also handles FDA-related issues in product liability and commercial litigation. He was an architect of the preemption defense for both pharmaceutical and medical device clients, developing supporting evidence, briefing and arguing federal preemption motions in various federal and state courts.\nBefore joining the FDA, Mark was an attorney in the Bureau of Consumer Protection at the Federal Trade Commission, where he concentrated on consumer fraud, healthcare advertising and promotional activities. He developed FTC enforcement actions against weight-loss centers, in vitro fertilization clinics and Northern Virginia infertility doctor Cecil B. Jacobson, who was later convicted of defrauding patients. Mark S Brown Partner Recognized by Super Lawyers as Top Rated FDA Attorney  Law \u0026amp; Politics, 2007, 2010–2011, 2013–2017 Ranked Among the Best Life Sciences Lawyers in the U.S.  Legal 500, 2016 Named Life Sciences Star  LMG Life Sciences, 2012–2016 Recognized as one of Washington’s Best Lawyers  Washingtonian magazine, 2004–2016 Superior Achievement Award  U.S. Department of Health \u0026amp; Human Services, 1992 Commendable Service Award  FDA, 1992–1994 University of Michigan University of Michigan Law School St. Louis University  U.S. Court of Appeals for the Federal Circuit U.S. Court of Appeals for the Second Circuit U.S. Court of Appeals for the Seventh Circuit U.S. Court of Appeals for the Ninth Circuit U.S. Court of Appeals for the Tenth Circuit U.S. District Court for the District of Maryland U.S. District Court for the Eastern District of Wisconsin District of Columbia Maryland Pennsylvania District of Columbia Bar Maryland State Bar Phillip Morris USA v. FDA, 202 F.Supp. 3d (D.D.C. 2016). Represented one of the plaintiffs in a successful legal challenge to an FDA guidance governing the Substantial Equivalence Review process for tobacco products. United States v. Franck's Lab, 2011 WL 4031102 (M.D. Fla., Sept. 12, 2011). Lead counsel in successful defense of FDA enforcement action against pharmacy compounder of veterinary drugs. During his 30-year career, he has served as lead counsel and negotiator for numerous consent decrees of injunction, both during his tenure with FDA (1990–1994), and since 1994 in private practice. For example, he has negotiated consent decrees some of the world's largest device manufacturers, including Medtronic (2008 and 2015), The General Electric Company (2007) and Baxter Healthcare (2006). Since 2002, served on the national counsel team for GlaxoSmithKline in the Paxil Products Liability Litigation. Represented GSK on all FDA-related issues, including federal preemption. Argued and won a summary judgment motion on federal preemption grounds in O'Neal v. SmithKline Beecham (E.D. Cal 2008). In 2002, represented GSK in successfully defending an injunction seeking to enjoin GSK from making claims in direct-to-consumer television advertising for Paxil. From 1995 to 2001, served on 3M's National Trial Team in the Silicone Gel-Filled Breast Implant Litigation. Responsible for virtually all FDA issues and had primary responsibility for preparation and handling of defense expert witnesses, and cross-examination of adverse witnesses on FDA issues. Connaught Laboratories v. SmithKline Beecham, 7 F.Supp. 2d 477 (D.Del. 1998), appeal dismissed, 165 F.3d 1368 (1999). Represented SmithKline Beecham in winning one of the few successful motions to compel FDA to provide testimony by its research scientists in patent litigation relating to purified form of pertactin, a component of the pertussis vaccine. Next Nutrition, Inc. v. SportPharma USA, Inc., No. 97-CV-1898J (1997). Served as lead counsel to a dietary supplement company that brought an action under the Lanham Act alleging false and misleading comparative advertising relating to competing products. Successfully negotiated a favorable settlement by obtaining a consent decree of permanent injunction and a damage award. Represented pharmaceutical manufacturers in grand jury investigations regarding data integrity concerns in regulatory submissions to FDA, and alleged cGMP violations. In both cases, the U.S. Department of Justice declined to prosecute the company and individuals under investigation. Conducted internal investigations into the sales and marketing practices of multiple international pharmaceutical and biotech companies to develop a risk profile and recommendations for reducing potential liability and risk exposure. Conducted comprehensive prelaunch risk assessments for a Top 10 pharmaceutical company’s blockbuster drug to identify potential medical, scientific, regulatory and products liability risk areas. Conducted a risk assessment for a top tier biotechnology company’s drug safety system to identify areas for possible improvement in pharmacovigilence planning, postmarket signal detection and investigation, and business decision-making. Led numerous internal investigations for biotechnology, pharmaceutical and medical device manufacturers into allegations made by current and former employees regarding product integrity issues, sales and marketing activities, and manufacturing quality issues. Represented several drug and device manufacturers concerning product approvals, and in responding to FDA requests for information relating to promotion and advertising, manufacturing practices, field alerts, recalls and numerous post-market issues. Represented one of the nation’s foremost cardiovascular institutes and some of the leading interventional cardiologists in responding to deficiencies identified during FDA inspections and developing appropriate corrective action to avoid further FDA regulatory enforcement. Represented a device manufacturer in obtaining expedited PMA review and approval in 90 days for a first-of-a-kind device to treat aneurysms in the renal vascular arteries. Successfully obtained approval for a major PMA supplement for the same product. Represented a device manufacturer and coordinated an extensive product investigation into reported failures of an implantable device featuring sophisticated failure analyses and clinical assessments. Conducted extensive training on FDA regulatory, IRB and protocol requirements for clinical investigators participating in the study of implantable devices. Assisted numerous companies in preparing for FDA inspections, developing responses to FDA observations (FDA-483 forms) and warning letters related to manufacturing practices, quality systems, adverse event reporting, deviations from approved drug master files and manufacturing processes, and a variety of other regulatory matters. Assisted these companies in preparing for meetings with FDA compliance officials in District Offices, centers for drugs and devices, and the Office of Chief Counsel.","searchable_name":"Mark S. Brown","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":196,"capability_group_featured":null,"home_page_featured":null},{"id":427629,"version":1,"owner_type":"Person","owner_id":1020,"payload":{"bio":"\u003cp\u003eJeff Bucholtz focuses on appeals and legal issues before federal and state courts across the country. As a partner in our Appellate, Constitutional and Administrative Law and Contracts and Business Torts practices, Jeff represents clients in a wide range of civil, regulatory and criminal matters.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJeff has argued over 40 appeals spanning nearly every federal circuit and several state courts, including two arguments before the U.S. Supreme Court. Jeff's experience extends to a wide range of subject areas, including False Claims Act investigations and litigation, First Amendment and other constitutional issues, product liability litigation, administrative law, and many other types of business litigation. Jeff has particular expertise in Life Sciences and represents numerous FDA-regulated companies in civil, regulatory and criminal matters.\u003c/p\u003e\n\u003cp\u003ePreviously, Jeff served at the U.S. Department of Justice in a number of senior roles, including the Acting Assistant Attorney General and Principal Deputy Assistant Attorney General for the Civil Division, the department\u0026rsquo;s largest litigating division. Jeff was also the Deputy Assistant Attorney General overseeing the Consumer Protection Branch, which brings criminal and civil enforcement actions on behalf of FDA and defends FDA in administrative law challenges, as well as the Torts Branch, which defends constitutional and common-law tort claims against the government and federal employees and officers.\u003c/p\u003e\n\u003cp\u003eJeff represents clients in a variety of industries in appeals as well as trial court litigation, and government investigations and regulatory matters that require exceptional legal analysis and creative and strategic advocacy.\u003c/p\u003e","slug":"jeffrey-bucholtz","email":"jbucholtz@kslaw.com","phone":null,"matters":["\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eVascular Solutions\u003c/strong\u003e in successful defense of a federal criminal prosecution in Texas alleging off-label promotion.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003ePandora Media\u003c/strong\u003e in successful defense in the Second Circuit of an important rate-court decision against ASCAP.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eChevron\u003c/strong\u003e in a successful action in DC federal court to confirm a $100M international arbitral award against Ecuador.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA KBR subsidiary\u003c/strong\u003e in a successful action in NY federal court to confirm a $400M international arbitral award against Mexico's state oil company, despite a Mexican court's annulment of the award.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eHuntington Ingalls\u003c/strong\u003e in obtaining dismissal (and affirmance on appeal and the denial of certiorari) of a qui tam suit under the False Claims Act in Mississippi, based on the relator's ethical violations.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eSeveral leading companies\u003c/strong\u003e in life sciences, healthcare, transportation, and other sectors in defense of criminal and civil government investigations, obtaining declinations of criminal charges, dismissal of False Claims Act claims, and favorable resolutions.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eAllergan\u003c/strong\u003e in its First Amendment declaratory judgment action challenging the government\u0026rsquo;s restrictions on truthful speech about off-label uses of FDA-approved drugs.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eR.J. Reynolds\u003c/strong\u003e in several successful appeals in product liability cases in state courts in Florida and Missouri.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eGlaxoSmithKline\u003c/strong\u003e in opposing plaintiffs' lawyers' attempts to bring large numbers of claims in jurisdictions having no relationship to the claims.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA DEA agent\u003c/strong\u003e in successfully obtaining a grant of certiorari from the U.S. Supreme Court and then reversal after oral argument in Walden v. Fiore, a case presenting important issues of personal jurisdiction.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA medical imaging provider\u003c/strong\u003e in a successful Sixth Circuit appeal of an adverse judgment in a government-intervened False Claims Act case.\u003c/p\u003e","\u003cp\u003eSeveral hospitals in a successful DC Circuit appeal seeking relief for CMS\u0026rsquo;s erroneous adjustments to hospitals' payments.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003ePODS\u003c/strong\u003e in obtaining a favorable settlement in an Eleventh Circuit appeal of a trademark infringement action against a competitor.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eAllergan\u003c/strong\u003e and \u003cstrong data-redactor-tag=\"strong\"\u003eShire\u003c/strong\u003e in separate Lanham Act false advertising cases against competitors.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA software company\u003c/strong\u003e in a successful Ninth Circuit appeal of an order refusing to compel arbitration.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eEquifax\u003c/strong\u003e in a successful Fourth Circuit appeal of an order granting class certification.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eTwo wrongfully convicted individuals\u003c/strong\u003e who spent 25 years in prison, in a civil rights action against the prosecutors who framed them for murder, after the U.S. Supreme Court granted certiorari to decide whether prosecutorial immunity barred our clients\u0026rsquo; claims.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eGE Capital Aviation Services\u003c/strong\u003e in a successful Alabama Supreme Court appeal of a large punitive damages award in a commercial dispute.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA large REIT\u003c/strong\u003e in a successful Eleventh Circuit appeal of a class certification order in a securities case.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA dietary supplement manufacturer\u003c/strong\u003e in successful defense of an Eleventh Circuit appeal by the FTC.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA leading chemical company\u003c/strong\u003e in obtaining a favorable settlement of a Second Circuit appeal in a CERCLA action.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":105}]},"expertise":[{"id":74,"guid":"74.capabilities","index":0,"source":"capabilities"},{"id":2,"guid":"2.capabilities","index":1,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":2,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":5,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":6,"source":"smartTags"},{"id":17,"guid":"17.capabilities","index":7,"source":"capabilities"},{"id":764,"guid":"764.smart_tags","index":8,"source":"smartTags"},{"id":970,"guid":"970.smart_tags","index":9,"source":"smartTags"},{"id":112,"guid":"112.capabilities","index":10,"source":"capabilities"}],"is_active":true,"last_name":"Bucholtz","nick_name":"Jeffrey","clerkships":[{"name":"Judicial Clerk, Samuel A. Alito, Jr., U.S. Court of Appeals for the Third Circuit","years_held":"1996 - 1997"},{"name":"Judicial Clerk, Stephen V. Wilson, U.S. District Court for the Central District of California","years_held":"1995 - 1996"}],"first_name":"Jeffrey","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"S.","name_suffix":"","recognitions":[{"title":"Firm of the Year for Supreme Court and Appellate Practice ","detail":"Legal 500, 2015"},{"title":"Practice of the Year, Appellate practice ","detail":"Law360, 2014"},{"title":"Exemplar of Good Legal Writing, for a Supreme Court brief ","detail":"Green Bag, 2013"},{"title":"Litigator of the Week, for Second Circuit Win for Pandora Media ","detail":"American Lawyer, 2015"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJeff Bucholtz focuses on appeals and legal issues before federal and state courts across the country. As a partner in our Appellate, Constitutional and Administrative Law and Contracts and Business Torts practices, Jeff represents clients in a wide range of civil, regulatory and criminal matters.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJeff has argued over 40 appeals spanning nearly every federal circuit and several state courts, including two arguments before the U.S. Supreme Court. Jeff's experience extends to a wide range of subject areas, including False Claims Act investigations and litigation, First Amendment and other constitutional issues, product liability litigation, administrative law, and many other types of business litigation. Jeff has particular expertise in Life Sciences and represents numerous FDA-regulated companies in civil, regulatory and criminal matters.\u003c/p\u003e\n\u003cp\u003ePreviously, Jeff served at the U.S. Department of Justice in a number of senior roles, including the Acting Assistant Attorney General and Principal Deputy Assistant Attorney General for the Civil Division, the department\u0026rsquo;s largest litigating division. Jeff was also the Deputy Assistant Attorney General overseeing the Consumer Protection Branch, which brings criminal and civil enforcement actions on behalf of FDA and defends FDA in administrative law challenges, as well as the Torts Branch, which defends constitutional and common-law tort claims against the government and federal employees and officers.\u003c/p\u003e\n\u003cp\u003eJeff represents clients in a variety of industries in appeals as well as trial court litigation, and government investigations and regulatory matters that require exceptional legal analysis and creative and strategic advocacy.\u003c/p\u003e","matters":["\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eVascular Solutions\u003c/strong\u003e in successful defense of a federal criminal prosecution in Texas alleging off-label promotion.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003ePandora Media\u003c/strong\u003e in successful defense in the Second Circuit of an important rate-court decision against ASCAP.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eChevron\u003c/strong\u003e in a successful action in DC federal court to confirm a $100M international arbitral award against Ecuador.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA KBR subsidiary\u003c/strong\u003e in a successful action in NY federal court to confirm a $400M international arbitral award against Mexico's state oil company, despite a Mexican court's annulment of the award.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eHuntington Ingalls\u003c/strong\u003e in obtaining dismissal (and affirmance on appeal and the denial of certiorari) of a qui tam suit under the False Claims Act in Mississippi, based on the relator's ethical violations.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eSeveral leading companies\u003c/strong\u003e in life sciences, healthcare, transportation, and other sectors in defense of criminal and civil government investigations, obtaining declinations of criminal charges, dismissal of False Claims Act claims, and favorable resolutions.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eAllergan\u003c/strong\u003e in its First Amendment declaratory judgment action challenging the government\u0026rsquo;s restrictions on truthful speech about off-label uses of FDA-approved drugs.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eR.J. Reynolds\u003c/strong\u003e in several successful appeals in product liability cases in state courts in Florida and Missouri.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eGlaxoSmithKline\u003c/strong\u003e in opposing plaintiffs' lawyers' attempts to bring large numbers of claims in jurisdictions having no relationship to the claims.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA DEA agent\u003c/strong\u003e in successfully obtaining a grant of certiorari from the U.S. Supreme Court and then reversal after oral argument in Walden v. Fiore, a case presenting important issues of personal jurisdiction.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA medical imaging provider\u003c/strong\u003e in a successful Sixth Circuit appeal of an adverse judgment in a government-intervened False Claims Act case.\u003c/p\u003e","\u003cp\u003eSeveral hospitals in a successful DC Circuit appeal seeking relief for CMS\u0026rsquo;s erroneous adjustments to hospitals' payments.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003ePODS\u003c/strong\u003e in obtaining a favorable settlement in an Eleventh Circuit appeal of a trademark infringement action against a competitor.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eAllergan\u003c/strong\u003e and \u003cstrong data-redactor-tag=\"strong\"\u003eShire\u003c/strong\u003e in separate Lanham Act false advertising cases against competitors.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA software company\u003c/strong\u003e in a successful Ninth Circuit appeal of an order refusing to compel arbitration.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eEquifax\u003c/strong\u003e in a successful Fourth Circuit appeal of an order granting class certification.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eTwo wrongfully convicted individuals\u003c/strong\u003e who spent 25 years in prison, in a civil rights action against the prosecutors who framed them for murder, after the U.S. Supreme Court granted certiorari to decide whether prosecutorial immunity barred our clients\u0026rsquo; claims.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eGE Capital Aviation Services\u003c/strong\u003e in a successful Alabama Supreme Court appeal of a large punitive damages award in a commercial dispute.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA large REIT\u003c/strong\u003e in a successful Eleventh Circuit appeal of a class certification order in a securities case.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA dietary supplement manufacturer\u003c/strong\u003e in successful defense of an Eleventh Circuit appeal by the FTC.\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eA leading chemical company\u003c/strong\u003e in obtaining a favorable settlement of a Second Circuit appeal in a CERCLA action.\u003c/p\u003e"],"recognitions":[{"title":"Firm of the Year for Supreme Court and Appellate Practice ","detail":"Legal 500, 2015"},{"title":"Practice of the Year, Appellate practice ","detail":"Law360, 2014"},{"title":"Exemplar of Good Legal Writing, for a Supreme Court brief ","detail":"Green Bag, 2013"},{"title":"Litigator of the Week, for Second Circuit Win for Pandora Media ","detail":"American Lawyer, 2015"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":749}]},"capability_group_id":3},"created_at":"2025-05-26T05:02:57.000Z","updated_at":"2025-05-26T05:02:57.000Z","searchable_text":"Bucholtz{{ FIELD }}{:title=\u0026gt;\"Firm of the Year for Supreme Court and Appellate Practice \", :detail=\u0026gt;\"Legal 500, 2015\"}{{ FIELD }}{:title=\u0026gt;\"Practice of the Year, Appellate practice \", :detail=\u0026gt;\"Law360, 2014\"}{{ FIELD }}{:title=\u0026gt;\"Exemplar of Good Legal Writing, for a Supreme Court brief \", :detail=\u0026gt;\"Green Bag, 2013\"}{{ FIELD }}{:title=\u0026gt;\"Litigator of the Week, for Second Circuit Win for Pandora Media \", :detail=\u0026gt;\"American Lawyer, 2015\"}{{ FIELD }}Vascular Solutions in successful defense of a federal criminal prosecution in Texas alleging off-label promotion.{{ FIELD }}Pandora Media in successful defense in the Second Circuit of an important rate-court decision against ASCAP.{{ FIELD }}Chevron in a successful action in DC federal court to confirm a $100M international arbitral award against Ecuador.{{ FIELD }}A KBR subsidiary in a successful action in NY federal court to confirm a $400M international arbitral award against Mexico's state oil company, despite a Mexican court's annulment of the award.{{ FIELD }}Huntington Ingalls in obtaining dismissal (and affirmance on appeal and the denial of certiorari) of a qui tam suit under the False Claims Act in Mississippi, based on the relator's ethical violations.{{ FIELD }}Several leading companies in life sciences, healthcare, transportation, and other sectors in defense of criminal and civil government investigations, obtaining declinations of criminal charges, dismissal of False Claims Act claims, and favorable resolutions.{{ FIELD }}Allergan in its First Amendment declaratory judgment action challenging the government’s restrictions on truthful speech about off-label uses of FDA-approved drugs.{{ FIELD }}R.J. Reynolds in several successful appeals in product liability cases in state courts in Florida and Missouri.{{ FIELD }}GlaxoSmithKline in opposing plaintiffs' lawyers' attempts to bring large numbers of claims in jurisdictions having no relationship to the claims.{{ FIELD }}A DEA agent in successfully obtaining a grant of certiorari from the U.S. Supreme Court and then reversal after oral argument in Walden v. Fiore, a case presenting important issues of personal jurisdiction.{{ FIELD }}A medical imaging provider in a successful Sixth Circuit appeal of an adverse judgment in a government-intervened False Claims Act case.{{ FIELD }}Several hospitals in a successful DC Circuit appeal seeking relief for CMS’s erroneous adjustments to hospitals' payments.{{ FIELD }}PODS in obtaining a favorable settlement in an Eleventh Circuit appeal of a trademark infringement action against a competitor.{{ FIELD }}Allergan and Shire in separate Lanham Act false advertising cases against competitors.{{ FIELD }}A software company in a successful Ninth Circuit appeal of an order refusing to compel arbitration.{{ FIELD }}Equifax in a successful Fourth Circuit appeal of an order granting class certification.{{ FIELD }}Two wrongfully convicted individuals who spent 25 years in prison, in a civil rights action against the prosecutors who framed them for murder, after the U.S. Supreme Court granted certiorari to decide whether prosecutorial immunity barred our clients’ claims.{{ FIELD }}GE Capital Aviation Services in a successful Alabama Supreme Court appeal of a large punitive damages award in a commercial dispute.{{ FIELD }}A large REIT in a successful Eleventh Circuit appeal of a class certification order in a securities case.{{ FIELD }}A dietary supplement manufacturer in successful defense of an Eleventh Circuit appeal by the FTC.{{ FIELD }}A leading chemical company in obtaining a favorable settlement of a Second Circuit appeal in a CERCLA action.{{ FIELD }}Jeff Bucholtz focuses on appeals and legal issues before federal and state courts across the country. As a partner in our Appellate, Constitutional and Administrative Law and Contracts and Business Torts practices, Jeff represents clients in a wide range of civil, regulatory and criminal matters.\nJeff has argued over 40 appeals spanning nearly every federal circuit and several state courts, including two arguments before the U.S. Supreme Court. Jeff's experience extends to a wide range of subject areas, including False Claims Act investigations and litigation, First Amendment and other constitutional issues, product liability litigation, administrative law, and many other types of business litigation. Jeff has particular expertise in Life Sciences and represents numerous FDA-regulated companies in civil, regulatory and criminal matters.\nPreviously, Jeff served at the U.S. Department of Justice in a number of senior roles, including the Acting Assistant Attorney General and Principal Deputy Assistant Attorney General for the Civil Division, the department’s largest litigating division. Jeff was also the Deputy Assistant Attorney General overseeing the Consumer Protection Branch, which brings criminal and civil enforcement actions on behalf of FDA and defends FDA in administrative law challenges, as well as the Torts Branch, which defends constitutional and common-law tort claims against the government and federal employees and officers.\nJeff represents clients in a variety of industries in appeals as well as trial court litigation, and government investigations and regulatory matters that require exceptional legal analysis and creative and strategic advocacy. Jeffrey S Bucholtz Partner Firm of the Year for Supreme Court and Appellate Practice  Legal 500, 2015 Practice of the Year, Appellate practice  Law360, 2014 Exemplar of Good Legal Writing, for a Supreme Court brief  Green Bag, 2013 Litigator of the Week, for Second Circuit Win for Pandora Media  American Lawyer, 2015 University of Pennsylvania University of Pennsylvania Law School Harvard University Harvard Law School U.S. Court of Appeals for the Federal Circuit Supreme Court of the United States U.S. Court of Appeals for the First Circuit U.S. Court of Appeals for the Second Circuit U.S. Court of Appeals for the Third Circuit U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the Fifth Circuit U.S. Court of Appeals for the Sixth Circuit U.S. Court of Appeals for the Seventh Circuit U.S. Court of Appeals for the Eighth Circuit U.S. Court of Appeals for the Ninth Circuit U.S. Court of Appeals for the Tenth Circuit U.S. Court of Appeals for the Eleventh Circuit U.S. Court of Appeals for the D.C. Circuit U.S. District Court for the District of Columbia District of Columbia Virginia Judicial Clerk, Samuel A. Alito, Jr., U.S. Court of Appeals for the Third Circuit Judicial Clerk, Stephen V. Wilson, U.S. District Court for the Central District of California Vascular Solutions in successful defense of a federal criminal prosecution in Texas alleging off-label promotion. Pandora Media in successful defense in the Second Circuit of an important rate-court decision against ASCAP. Chevron in a successful action in DC federal court to confirm a $100M international arbitral award against Ecuador. A KBR subsidiary in a successful action in NY federal court to confirm a $400M international arbitral award against Mexico's state oil company, despite a Mexican court's annulment of the award. Huntington Ingalls in obtaining dismissal (and affirmance on appeal and the denial of certiorari) of a qui tam suit under the False Claims Act in Mississippi, based on the relator's ethical violations. Several leading companies in life sciences, healthcare, transportation, and other sectors in defense of criminal and civil government investigations, obtaining declinations of criminal charges, dismissal of False Claims Act claims, and favorable resolutions. Allergan in its First Amendment declaratory judgment action challenging the government’s restrictions on truthful speech about off-label uses of FDA-approved drugs. R.J. Reynolds in several successful appeals in product liability cases in state courts in Florida and Missouri. GlaxoSmithKline in opposing plaintiffs' lawyers' attempts to bring large numbers of claims in jurisdictions having no relationship to the claims. A DEA agent in successfully obtaining a grant of certiorari from the U.S. Supreme Court and then reversal after oral argument in Walden v. Fiore, a case presenting important issues of personal jurisdiction. A medical imaging provider in a successful Sixth Circuit appeal of an adverse judgment in a government-intervened False Claims Act case. Several hospitals in a successful DC Circuit appeal seeking relief for CMS’s erroneous adjustments to hospitals' payments. PODS in obtaining a favorable settlement in an Eleventh Circuit appeal of a trademark infringement action against a competitor. Allergan and Shire in separate Lanham Act false advertising cases against competitors. A software company in a successful Ninth Circuit appeal of an order refusing to compel arbitration. Equifax in a successful Fourth Circuit appeal of an order granting class certification. Two wrongfully convicted individuals who spent 25 years in prison, in a civil rights action against the prosecutors who framed them for murder, after the U.S. Supreme Court granted certiorari to decide whether prosecutorial immunity barred our clients’ claims. GE Capital Aviation Services in a successful Alabama Supreme Court appeal of a large punitive damages award in a commercial dispute. A large REIT in a successful Eleventh Circuit appeal of a class certification order in a securities case. A dietary supplement manufacturer in successful defense of an Eleventh Circuit appeal by the FTC. A leading chemical company in obtaining a favorable settlement of a Second Circuit appeal in a CERCLA action.","searchable_name":"Jeffrey S. Bucholtz","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":442354,"version":1,"owner_type":"Person","owner_id":121,"payload":{"bio":"\u003cp\u003eJack Capers is a partner focused on corporate transactions for companies in the technology and life sciences industries. He advises these companies on a broad range of domestic and cross-border corporate transactions including mergers, acquisitions, dispositions, joint ventures, strategic alliances and strategic investments, complex in-licensing and out-licensing transactions, collaboration and development agreements, and commercial contracts.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eHe also represents clients in the consumer products, retail, industrial and manufacturing, real estate, food and beverage, telecommunications and transportation industries in corporate transactions. 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He advises these companies on a broad range of domestic and cross-border corporate transactions including mergers, acquisitions, dispositions, joint ventures, strategic alliances and strategic investments, complex in-licensing and out-licensing transactions, collaboration and development agreements, and commercial contracts.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eHe also represents clients in the consumer products, retail, industrial and manufacturing, real estate, food and beverage, telecommunications and transportation industries in corporate transactions. 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Acquisitions\", :detail=\u0026gt;\"LMG Life Sciences\"}{{ FIELD }}{:title=\u0026gt;\"The Best Lawyers in America\", :detail=\u0026gt;\"Chambers\"}{{ FIELD }}{:title=\u0026gt;\"America’s Leading Lawyers for Business\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"Georgia Super Lawyer\", :detail=\u0026gt;\"Atlanta Magazine\"}{{ FIELD }}Represented Eisai Pharmaceuticals in a restructuring of its worldwide collaboration with Biogen for the development of products for the treatment of Alzheimer’s and related commercial arrangements.{{ FIELD }}Represented Belk Stores, a 300-store department store company, in the sale of the company to Sycamore Partners for US$3.1 billion.{{ FIELD }}Represented Aurrion, a developer of silicon photonics, in the sale of the company to Juniper Networks.{{ FIELD }}Represented Cognea Pty, a developer of artificial intelligence software and technology, in the sale of the company to IBM.{{ FIELD }}Represented Arbor Pharmaceuticals, a specialty pharmaceutical company, in a control investment in the company by KKR.{{ FIELD }}Represented GlaxoSmithKline in the acquisition of Basilea, S.A., a pharmaceutical company in Switzerland, for £200 million.{{ FIELD }}Represented GlaxoSmithKline in the acquisition of Okairos AG, a developer of vaccines products based in Italy and Switzerland, for US$324 million.{{ FIELD }}Represented Inmar, a data analytics company, in a joint venture with an international provider of point-of-sale technology to develop a platform for the collection and evaluation of customer purchasing data.{{ FIELD }}Represented Immucor, a blood diagnostics company, in its US$1.9 million merger with TPG.{{ FIELD }}Jack Capers is a partner focused on corporate transactions for companies in the technology and life sciences industries. He advises these companies on a broad range of domestic and cross-border corporate transactions including mergers, acquisitions, dispositions, joint ventures, strategic alliances and strategic investments, complex in-licensing and out-licensing transactions, collaboration and development agreements, and commercial contracts.\nHe also represents clients in the consumer products, retail, industrial and manufacturing, real estate, food and beverage, telecommunications and transportation industries in corporate transactions. In addition, Jack advises boards of directors and board committees on corporate governance, M\u0026amp;A transactions, and takeover defenses.\nA frequent speaker and author, Jack addresses important topics and trends in M\u0026amp;A and other corporate matters, bringing clients a valuable perspective that allows then to get the most out of their transactions.\n \nAdmitted only in Georgia. Jack D Capers Partner Named a leading lawyer for M\u0026amp;A and Corporate Law  Best Lawyers, 2022 Notable Lawyer IFLR 1000, 2020 Life Sciences Star in Mergers \u0026amp; Acquisitions LMG Life Sciences The Best Lawyers in America Chambers America’s Leading Lawyers for Business Chambers USA Georgia Super Lawyer Atlanta Magazine Vanderbilt University Vanderbilt University School of Law University of Georgia University of Georgia School of Law California Georgia American Bar Association Best Lawyers In America State Bar of Georgia Atlanta Bar Association California Bar Association Chambers Ranked IFLR 1000 LMG Life Sciences Star Represented Eisai Pharmaceuticals in a restructuring of its worldwide collaboration with Biogen for the development of products for the treatment of Alzheimer’s and related commercial arrangements. Represented Belk Stores, a 300-store department store company, in the sale of the company to Sycamore Partners for US$3.1 billion. Represented Aurrion, a developer of silicon photonics, in the sale of the company to Juniper Networks. Represented Cognea Pty, a developer of artificial intelligence software and technology, in the sale of the company to IBM. Represented Arbor Pharmaceuticals, a specialty pharmaceutical company, in a control investment in the company by KKR. Represented GlaxoSmithKline in the acquisition of Basilea, S.A., a pharmaceutical company in Switzerland, for £200 million. Represented GlaxoSmithKline in the acquisition of Okairos AG, a developer of vaccines products based in Italy and Switzerland, for US$324 million. Represented Inmar, a data analytics company, in a joint venture with an international provider of point-of-sale technology to develop a platform for the collection and evaluation of customer purchasing data. Represented Immucor, a blood diagnostics company, in its US$1.9 million merger with TPG.","searchable_name":"Jack Capers","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":35,"capability_group_featured":null,"home_page_featured":null},{"id":426829,"version":1,"owner_type":"Person","owner_id":5863,"payload":{"bio":"\u003cp\u003eChristine M. Carletta is a\u0026nbsp;partner in the Washington, D.C. office of King \u0026amp; Spalding. As\u0026nbsp;a member of the firm\u0026rsquo;s Appellate, Constitutional, and Administrative Law practice group, Christine develops creative litigation strategies to best serve her clients\u0026rsquo; objectives through all phases of litigation and appeal. Christine\u0026rsquo;s extensive experience covers a broad range of subjects including\u0026nbsp;Medicare and Medicaid regulation, Food and Drug Administration regulation, the False Claims Act, fraud and abuse matters, state and federal privacy laws, securities regulations, contract disputes, consumer protection claims, and\u0026nbsp;class actions.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePrior to joining King \u0026amp; Spalding, Christine served as a law clerk to the Honorable Chad A Readler, United States Court of Appeals for the Sixth Circuit and the Honorable James C. Mahan, United States District Court for the District of Nevada. She received her J.D. from Vanderbilt Law School, where she served as Editor-in-Chief of\u0026nbsp;the Vanderbilt Journal of Entertainment and Technology Law.\u0026nbsp;\u0026nbsp;\u003c/p\u003e","slug":"christine-carletta","email":"ccarletta@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":74,"guid":"74.capabilities","index":0,"source":"capabilities"},{"id":2,"guid":"2.capabilities","index":1,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":2,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":3,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":4,"source":"capabilities"},{"id":6,"guid":"6.capabilities","index":5,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":6,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":7,"source":"capabilities"},{"id":118,"guid":"118.capabilities","index":8,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":9,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":10,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":11,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":12,"source":"smartTags"}],"is_active":true,"last_name":"Carletta","nick_name":"Christine","clerkships":[{"name":"Law Clerk, The Honorable Chad A. 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Christine\u0026rsquo;s extensive experience covers a broad range of subjects including\u0026nbsp;Medicare and Medicaid regulation, Food and Drug Administration regulation, the False Claims Act, fraud and abuse matters, state and federal privacy laws, securities regulations, contract disputes, consumer protection claims, and\u0026nbsp;class actions.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePrior to joining King \u0026amp; Spalding, Christine served as a law clerk to the Honorable Chad A Readler, United States Court of Appeals for the Sixth Circuit and the Honorable James C. Mahan, United States District Court for the District of Nevada. She received her J.D. from Vanderbilt Law School, where she served as Editor-in-Chief of\u0026nbsp;the Vanderbilt Journal of Entertainment and Technology Law.\u0026nbsp;\u0026nbsp;\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9711}]},"capability_group_id":3},"created_at":"2025-05-26T04:57:14.000Z","updated_at":"2025-05-26T04:57:14.000Z","searchable_text":"Carletta{{ FIELD }}Christine M. Carletta is a partner in the Washington, D.C. office of King \u0026amp; Spalding. As a member of the firm’s Appellate, Constitutional, and Administrative Law practice group, Christine develops creative litigation strategies to best serve her clients’ objectives through all phases of litigation and appeal. Christine’s extensive experience covers a broad range of subjects including Medicare and Medicaid regulation, Food and Drug Administration regulation, the False Claims Act, fraud and abuse matters, state and federal privacy laws, securities regulations, contract disputes, consumer protection claims, and class actions. \nPrior to joining King \u0026amp; Spalding, Christine served as a law clerk to the Honorable Chad A Readler, United States Court of Appeals for the Sixth Circuit and the Honorable James C. Mahan, United States District Court for the District of Nevada. She received her J.D. from Vanderbilt Law School, where she served as Editor-in-Chief of the Vanderbilt Journal of Entertainment and Technology Law.   Partner Bowdoin College  Vanderbilt University Vanderbilt University School of Law U.S. Court of Appeals for the Second Circuit U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the Sixth Circuit U.S. Court of Appeals for the Seventh Circuit U.S. Court of Appeals for the Tenth Circuit U.S. Court of Appeals for the D.C. Circuit U.S. District Court for the Eastern District of New York U.S. District Court for the Northern District of New York U.S. District Court for the Southern District of New York U.S. District Court for the Northern District of Illinois District of Columbia New York Law Clerk, The Honorable Chad A. Readler, U.S. Court of Appeals for the Sixth Circuit Law Clerk, The Honorable James C. Mahan, U.S. District Court for the District of Nevada","searchable_name":"Christine Carletta","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":32,"capability_group_featured":null,"home_page_featured":null},{"id":436476,"version":1,"owner_type":"Person","owner_id":5058,"payload":{"bio":"\u003cp\u003ePatrick Collins is a highly accomplished former federal prosecutor who represents companies and individuals in government and internal investigations as well as in complex civil and criminal matters in federal courts throughout the United States. A Fellow in the American College of Trial Lawyers, Patrick is a Partner in the firm\u0026rsquo;s Special Matters \u0026amp; Government Investigations Group, twice named \u0026ldquo;White Collar Practice Group of the Year\u0026rdquo; by\u0026nbsp;\u003cem\u003eLaw360\u003c/em\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWidely recognized as a top trial lawyer and passionate advocate for his clients, Patrick has tried 26 cases successfully to verdict. His experience spans civil and criminal claims, as well as high-profile investigations and other matters before United States Attorneys\u0026rsquo; Offices across the country and before the U.S. Department of Justice and Securities and Exchange Commission. 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He is a straight-forward communicator, a style which is very much appreciated.\"\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;has recognized Patrick every year since 2013 noting his \u0026ldquo;impressive track record in taking criminal and civil cases to verdict\u0026rdquo; and as well as client feedback that he is \u0026ldquo;very knowledgeable in internal investigations. He's very candid and rigorous. He has a great deal of integrity in the work that he does.\"\u003c/p\u003e\n\u003cp\u003eThroughout his professional career, Patrick has been deeply involved in the Chicago community. In 1991, he founded Horizons for Youth, the only organization in Chicago that provides scholarship, mentoring, enrichment programs, and other support for children from kindergarten through college. He served as the organization\u0026rsquo;s President and as Co-Chair of its Leadership Council, currently serves on the Board of Directors and continues to serve as a volunteer. Patrick has served as a Supervising Attorney for Cabrini Green Legal Aid and a member of the Board of Trustees for Sacred Heart Schools in Chicago.\u0026nbsp; Since 2013, Patrick has participated in the annual National Hellenic Museum Trial Series, presenting arguments for the prosecution or defense before a panel of judges.\u0026nbsp; Each year's trial is unique and unscripted, attracting prominent legal minds to try ancient cases with modern consequences in front of a live audience.\u003c/p\u003e","slug":"patrick-collins","email":"pcollins@kslaw.com","phone":"+1 312 282 9609","matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":103,"guid":"103.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":20,"guid":"20.capabilities","index":2,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":3,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":4,"source":"capabilities"},{"id":19,"guid":"19.capabilities","index":5,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":6,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":7,"source":"capabilities"},{"id":766,"guid":"766.smart_tags","index":8,"source":"smartTags"},{"id":780,"guid":"780.smart_tags","index":9,"source":"smartTags"},{"id":11,"guid":"11.capabilities","index":10,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":11,"source":"smartTags"},{"id":973,"guid":"973.smart_tags","index":12,"source":"smartTags"},{"id":109,"guid":"109.capabilities","index":13,"source":"capabilities"},{"id":113,"guid":"113.capabilities","index":14,"source":"capabilities"},{"id":1199,"guid":"1199.smart_tags","index":15,"source":"smartTags"}],"is_active":true,"last_name":"Collins","nick_name":"Patrick","clerkships":[],"first_name":"Patrick","title_rank":9999,"updated_by":101,"law_schools":[{"id":2174,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"1991-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"M.","name_suffix":"","recognitions":[{"title":"Top Ranked Lawyer, Litigation: White-Collar Crime \u0026 Government Investigations","detail":"Chambers 2013-2022"},{"title":"Ranked for Commercial Litigation, Illinois","detail":"Best Lawyers in America, 2010-2020"},{"title":"One of Chicago's \"Top Ten\" attorneys of the decade","detail":"Chicago Law Bulletin, 2010"},{"title":"Appointed Co-Chair of the Criminal Justice Section White Collar Crime Committee","detail":"ABA, Public Corruption and Extortion Subcommittee, 2010-2012"},{"title":"Listed as a \"Illinois Super Lawyer\"","detail":"Law \u0026 Politics, 2008-2020"},{"title":"The Judge Robert Smith Ethics in Government Award","detail":"Justinian Society of Lake County, 2010"},{"title":"Master of the Bench Member","detail":"The Chicago Inn of Court"},{"title":"Award for Superior Performance by Litigative Team","detail":"U.S. Attorney General, 2006"},{"title":"Stars of Distinction Award","detail":"Chicago Crime Commission, 2006"},{"title":"Director's Award for Superior Performance as an AUSA","detail":"U.S. Department of Justice, 2003"},{"title":"Chief Postal Inspector Award for \"his work on Operation Safe Road\"","detail":"U.S. Department of Justice, 2003"}],"linked_in_url":"https://www.linkedin.com/in/patrick-m-collins-1090a01b/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003ePatrick Collins is a highly accomplished former federal prosecutor who represents companies and individuals in government and internal investigations as well as in complex civil and criminal matters in federal courts throughout the United States. A Fellow in the American College of Trial Lawyers, Patrick is a Partner in the firm\u0026rsquo;s Special Matters \u0026amp; Government Investigations Group, twice named \u0026ldquo;White Collar Practice Group of the Year\u0026rdquo; by\u0026nbsp;\u003cem\u003eLaw360\u003c/em\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWidely recognized as a top trial lawyer and passionate advocate for his clients, Patrick has tried 26 cases successfully to verdict. His experience spans civil and criminal claims, as well as high-profile investigations and other matters before United States Attorneys\u0026rsquo; Offices across the country and before the U.S. Department of Justice and Securities and Exchange Commission. In 2022,\u0026nbsp;\u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;recognized Patrick and noted client feedback that\u003cem\u003e\u0026nbsp;\u003c/em\u003e\"Patrick\u0026nbsp;Collins\u0026nbsp;is a consummate trial lawyer.\"\u003c/p\u003e\n\u003cp\u003eEarlier in his career, Patrick served for 12 years as an Assistant U.S. Attorney in Chicago including four years as Deputy Chief of the Public Corruption Section. He spearheaded the eight-year Operation Safe Road investigation and, with former U.S. Attorney and now K\u0026amp;S partner Zach Fardon, led the prosecution team in the six-month trial and conviction of former Illinois Governor George Ryan.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePrior to joining King \u0026amp; Spalding, Patrick was a partner in the Chicago office of an AmLaw 50 law firm. He has been recognized by\u0026nbsp;\u003cem\u003eBest Lawyers of America\u003c/em\u003e\u0026nbsp;for bringing \u0026ldquo;tremendous ability and credibility to bear. He is a straight-forward communicator, a style which is very much appreciated.\"\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;has recognized Patrick every year since 2013 noting his \u0026ldquo;impressive track record in taking criminal and civil cases to verdict\u0026rdquo; and as well as client feedback that he is \u0026ldquo;very knowledgeable in internal investigations. He's very candid and rigorous. He has a great deal of integrity in the work that he does.\"\u003c/p\u003e\n\u003cp\u003eThroughout his professional career, Patrick has been deeply involved in the Chicago community. In 1991, he founded Horizons for Youth, the only organization in Chicago that provides scholarship, mentoring, enrichment programs, and other support for children from kindergarten through college. He served as the organization\u0026rsquo;s President and as Co-Chair of its Leadership Council, currently serves on the Board of Directors and continues to serve as a volunteer. Patrick has served as a Supervising Attorney for Cabrini Green Legal Aid and a member of the Board of Trustees for Sacred Heart Schools in Chicago.\u0026nbsp; Since 2013, Patrick has participated in the annual National Hellenic Museum Trial Series, presenting arguments for the prosecution or defense before a panel of judges.\u0026nbsp; Each year's trial is unique and unscripted, attracting prominent legal minds to try ancient cases with modern consequences in front of a live audience.\u003c/p\u003e","recognitions":[{"title":"Top Ranked Lawyer, Litigation: White-Collar Crime \u0026 Government Investigations","detail":"Chambers 2013-2022"},{"title":"Ranked for Commercial Litigation, Illinois","detail":"Best Lawyers in America, 2010-2020"},{"title":"One of Chicago's \"Top Ten\" attorneys of the decade","detail":"Chicago Law Bulletin, 2010"},{"title":"Appointed Co-Chair of the Criminal Justice Section White Collar Crime Committee","detail":"ABA, Public Corruption and Extortion Subcommittee, 2010-2012"},{"title":"Listed as a \"Illinois Super Lawyer\"","detail":"Law \u0026 Politics, 2008-2020"},{"title":"The Judge Robert Smith Ethics in Government Award","detail":"Justinian Society of Lake County, 2010"},{"title":"Master of the Bench Member","detail":"The Chicago Inn of Court"},{"title":"Award for Superior Performance by Litigative Team","detail":"U.S. Attorney General, 2006"},{"title":"Stars of Distinction Award","detail":"Chicago Crime Commission, 2006"},{"title":"Director's Award for Superior Performance as an AUSA","detail":"U.S. Department of Justice, 2003"},{"title":"Chief Postal Inspector Award for \"his work on Operation Safe Road\"","detail":"U.S. Department of Justice, 2003"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":5386}]},"capability_group_id":2},"created_at":"2025-09-02T04:55:27.000Z","updated_at":"2025-09-02T04:55:27.000Z","searchable_text":"Collins{{ FIELD }}{:title=\u0026gt;\"Top Ranked Lawyer, Litigation: White-Collar Crime \u0026amp; Government Investigations\", :detail=\u0026gt;\"Chambers 2013-2022\"}{{ FIELD }}{:title=\u0026gt;\"Ranked for Commercial Litigation, Illinois\", :detail=\u0026gt;\"Best Lawyers in America, 2010-2020\"}{{ FIELD }}{:title=\u0026gt;\"One of Chicago's \\\"Top Ten\\\" attorneys of the decade\", :detail=\u0026gt;\"Chicago Law Bulletin, 2010\"}{{ FIELD }}{:title=\u0026gt;\"Appointed Co-Chair of the Criminal Justice Section White Collar Crime Committee\", :detail=\u0026gt;\"ABA, Public Corruption and Extortion Subcommittee, 2010-2012\"}{{ FIELD }}{:title=\u0026gt;\"Listed as a \\\"Illinois Super Lawyer\\\"\", :detail=\u0026gt;\"Law \u0026amp; Politics, 2008-2020\"}{{ FIELD }}{:title=\u0026gt;\"The Judge Robert Smith Ethics in Government Award\", :detail=\u0026gt;\"Justinian Society of Lake County, 2010\"}{{ FIELD }}{:title=\u0026gt;\"Master of the Bench Member\", :detail=\u0026gt;\"The Chicago Inn of Court\"}{{ FIELD }}{:title=\u0026gt;\"Award for Superior Performance by Litigative Team\", :detail=\u0026gt;\"U.S. Attorney General, 2006\"}{{ FIELD }}{:title=\u0026gt;\"Stars of Distinction Award\", :detail=\u0026gt;\"Chicago Crime Commission, 2006\"}{{ FIELD }}{:title=\u0026gt;\"Director's Award for Superior Performance as an AUSA\", :detail=\u0026gt;\"U.S. Department of Justice, 2003\"}{{ FIELD }}{:title=\u0026gt;\"Chief Postal Inspector Award for \\\"his work on Operation Safe Road\\\"\", :detail=\u0026gt;\"U.S. Department of Justice, 2003\"}{{ FIELD }}Patrick Collins is a highly accomplished former federal prosecutor who represents companies and individuals in government and internal investigations as well as in complex civil and criminal matters in federal courts throughout the United States. A Fellow in the American College of Trial Lawyers, Patrick is a Partner in the firm’s Special Matters \u0026amp; Government Investigations Group, twice named “White Collar Practice Group of the Year” by Law360. \nWidely recognized as a top trial lawyer and passionate advocate for his clients, Patrick has tried 26 cases successfully to verdict. His experience spans civil and criminal claims, as well as high-profile investigations and other matters before United States Attorneys’ Offices across the country and before the U.S. Department of Justice and Securities and Exchange Commission. In 2022, Chambers USA recognized Patrick and noted client feedback that \"Patrick Collins is a consummate trial lawyer.\"\nEarlier in his career, Patrick served for 12 years as an Assistant U.S. Attorney in Chicago including four years as Deputy Chief of the Public Corruption Section. He spearheaded the eight-year Operation Safe Road investigation and, with former U.S. Attorney and now K\u0026amp;S partner Zach Fardon, led the prosecution team in the six-month trial and conviction of former Illinois Governor George Ryan.\nPrior to joining King \u0026amp; Spalding, Patrick was a partner in the Chicago office of an AmLaw 50 law firm. He has been recognized by Best Lawyers of America for bringing “tremendous ability and credibility to bear. He is a straight-forward communicator, a style which is very much appreciated.\" \nChambers USA has recognized Patrick every year since 2013 noting his “impressive track record in taking criminal and civil cases to verdict” and as well as client feedback that he is “very knowledgeable in internal investigations. He's very candid and rigorous. He has a great deal of integrity in the work that he does.\"\nThroughout his professional career, Patrick has been deeply involved in the Chicago community. In 1991, he founded Horizons for Youth, the only organization in Chicago that provides scholarship, mentoring, enrichment programs, and other support for children from kindergarten through college. He served as the organization’s President and as Co-Chair of its Leadership Council, currently serves on the Board of Directors and continues to serve as a volunteer. Patrick has served as a Supervising Attorney for Cabrini Green Legal Aid and a member of the Board of Trustees for Sacred Heart Schools in Chicago.  Since 2013, Patrick has participated in the annual National Hellenic Museum Trial Series, presenting arguments for the prosecution or defense before a panel of judges.  Each year's trial is unique and unscripted, attracting prominent legal minds to try ancient cases with modern consequences in front of a live audience. Partner Top Ranked Lawyer, Litigation: White-Collar Crime \u0026amp; Government Investigations Chambers 2013-2022 Ranked for Commercial Litigation, Illinois Best Lawyers in America, 2010-2020 One of Chicago's \"Top Ten\" attorneys of the decade Chicago Law Bulletin, 2010 Appointed Co-Chair of the Criminal Justice Section White Collar Crime Committee ABA, Public Corruption and Extortion Subcommittee, 2010-2012 Listed as a \"Illinois Super Lawyer\" Law \u0026amp; Politics, 2008-2020 The Judge Robert Smith Ethics in Government Award Justinian Society of Lake County, 2010 Master of the Bench Member The Chicago Inn of Court Award for Superior Performance by Litigative Team U.S. Attorney General, 2006 Stars of Distinction Award Chicago Crime Commission, 2006 Director's Award for Superior Performance as an AUSA U.S. Department of Justice, 2003 Chief Postal Inspector Award for \"his work on Operation Safe Road\" U.S. Department of Justice, 2003 University of Notre Dame Notre Dame Law School University of Chicago University of Chicago Law School U.S. District Court for the Northern District of Illinois U.S. District Court for the Southern District of Illinois Supreme Court of Illinois American College of Trial Lawyers, Member","searchable_name":"Patrick M. Collins","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":442361,"version":1,"owner_type":"Person","owner_id":853,"payload":{"bio":"\u003cp\u003eTodd Davis is a partner with King \u0026amp; Spalding's Trial \u0026amp; Global Disputes practice group. For the last twenty-eight years, Mr. Davis' practice has been devoted to trying high-stakes products liability cases, including those involving medications, medical devices and consumer products.\u0026nbsp; His involvement includes cross-examining plaintiffs\u0026rsquo; key causation and medical expert witnesses at trial and in deposition. \u0026nbsp;Mr. Davis\u0026rsquo; practice\u0026nbsp;involves representing pharmaceutical and medical device companies, as well as other product manufacturers, in mass tort, consumer fraud and class action litigation.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMr. Davis has been recognized in Legal 500\u0026rsquo;s Product Liability and Mass Tort Defense in the Pharma and Medical Device category.\u003c/p\u003e","slug":"todd-davis","email":"tdavis@kslaw.com","phone":null,"matters":["\u003cp\u003eTrying three cases for\u0026nbsp;\u003cstrong\u003eGlaxoSmithKline\u003c/strong\u003e\u0026nbsp;in the Philadelphia Court of Common Pleas, Pennsylvania, alleging that Paxil causes birth defects (2016, 2010, 2009). In two trials, the courts dismissed plaintiffs' claims because plaintiffs could not prove proximate causation. In the third, which was plaintiffs' No. 1 pick for trial, plaintiffs were awarded compensatory damages less than the actual medical expenses incurred and no punitive damages.\u003c/p\u003e","\u003cp\u003eTrying the first \u0026ldquo;innovator liability\u0026rdquo; prescription drug case to go to trial (\u003cem\u003eDolin v. GSK,\u0026nbsp;\u003c/em\u003e2017\u003cem\u003e).\u003c/em\u003e\u003c/p\u003e","\u003cp\u003eTrying cases for R.J. Reynolds Tobacco Company as part of the\u0026nbsp;\u003cem\u003eEngle\u003c/em\u003e-progeny litigation in Florida (2013, 2014, 2018, 2019 and 2020).\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong\u003emedical device and pharmaceutical companies\u003c/strong\u003e\u0026nbsp;in federal multi-district litigation and state consolidated proceedings. Defeating efforts to certify a\u0026nbsp;\u003cstrong\u003enationwide class\u003c/strong\u003e\u0026nbsp;of Paxil users under personal injury and consumer fraud theories.\u0026nbsp;\u003cem\u003eIn re Paxil,\u003c/em\u003e\u0026nbsp;212 F.R.D. 539 (C.D. Cal. 2003). This decision has been referred to as one of the \u0026ldquo;Big Four\u0026rdquo; federal court rulings denying class certification in pharmaceutical cases.\u0026nbsp;\u003cem\u003eSee\u003c/em\u003e\u0026nbsp;\u003cem\u003eIn\u003c/em\u003e\u0026nbsp;\u003cem\u003ere\u003c/em\u003e\u0026nbsp;\u003cem\u003ePrempro\u003c/em\u003e\u0026nbsp;\u003cem\u003eProds. Liab. Lit.\u003c/em\u003e, 230 F.R.D. 555 (E.D. Ark. 2005).\u003c/p\u003e","\u003cp\u003eDefeating efforts to certify\u0026nbsp;\u003cstrong\u003ea statewide claim\u003c/strong\u003e\u0026nbsp;of Paxil users under California\u0026rsquo;s Unfair Competition Law, \u0026sect; 17200\u003cem\u003e.\u003c/em\u003e\u0026nbsp;\u003cem\u003eIn re Paxil,\u003c/em\u003e\u0026nbsp;218 F.R.D. 242 (C.D. Cal. 2003).\u003c/p\u003e","\u003cp\u003eDefeating efforts to certify a\u0026nbsp;\u003cstrong\u003enationwide class\u003c/strong\u003e\u0026nbsp;of pediatric patients who were prescribed a medication not approved by the FDA to treat patients under 18.\u0026nbsp;\u003cem\u003ePamela Blain, et al. v. SmithKline Beecham Corp\u003c/em\u003e., 240 F.R.D. 179 (E.D. Pa. 2007).\u003c/p\u003e","\u003cp\u003eObtaining summary judgments based on federal preemption of state law\u0026nbsp;\u003cstrong\u003efailure-to-warn claims\u003c/strong\u003e\u0026nbsp;in cases involving a prescription medication.\u0026nbsp;\u003cem\u003eE.g., O\u0026rsquo;Neal v. SmithKline Beecham Corp.\u003c/em\u003e, 551 F.Supp.2d 993 (E.D. Cal. 2008);\u0026nbsp;\u003cem\u003eCandace Miller et al v. SmithKline Beecham Corporation, d/b/a GlaxoSmithKline\u003c/em\u003e, slip op., 2008 WL 510449 (N.D. Okla).\u003c/p\u003e","\u003cp\u003eSuccessfully excluding plaintiff\u0026rsquo;s experts\u0026rsquo; opinions that breast implants cause systemic illness on\u0026nbsp;\u003cstrong\u003e\u003cem\u003eDaubert\u003c/em\u003e\u0026nbsp;grounds\u003c/strong\u003e\u0026nbsp;in the first breast implant case set for trial in Georgia. Mr. Davis successfully defended that decision on appeal in the first federal appellate decision in the country addressing\u0026nbsp;\u003cem\u003eDaubert\u003c/em\u003e\u0026nbsp;issues in the breast implant litigation.\u0026nbsp;\u003cem\u003eAllison v. McGhan Medical Corp.\u003c/em\u003e\u0026nbsp;184 F.3d 1300 (11th Cir. 1999).\u003c/p\u003e","\u003cp\u003eSuccessfully defending\u0026nbsp;\u003cstrong\u003ea product liability lawsuit\u003c/strong\u003e\u0026nbsp;filed in the \u0026ldquo;rocket-docket\u0026rdquo; of the U.S.D.C., Eastern District of Virginia that involved allegations that a uniformed officer of the Secret Service committed murder and then suicide because of a prescription medication. After an intensive 2-1/2 month discovery period, plaintiff dismissed his lawsuit on the eve of trial. The defendant paid nothing in settlement.\u003c/p\u003e","\u003cp\u003eSuccessfully defending on appeal summary judgment for\u0026nbsp;\u003cstrong\u003ea pharmaceutical manufacturer\u003c/strong\u003e\u0026nbsp;based upon the learned intermediary doctrine.\u0026nbsp;\u003cem\u003eAllgood v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline\u003c/em\u003e, No. 06-cv-3506, 2008 WL 483574 (E.D. La. Feb. 20, 2008),\u0026nbsp;\u003cem\u003eaff\u0026rsquo;d by\u003c/em\u003e\u0026nbsp;No. 08- 30329, 2009 WL 646285 (5th Cir. Mar. 13, 2009),\u0026nbsp;\u003cem\u003ereh\u0026rsquo;g denied by\u003c/em\u003e\u0026nbsp;No. 08-30329 (5th Cir. May 6, 2009).\u003c/p\u003e","\u003cp\u003eObtaining summary judgment in\u0026nbsp;\u003cstrong\u003ea product liability lawsuit\u003c/strong\u003e\u0026nbsp;involving a prescription medication within four months after plaintiff filed his lawsuit,\u0026nbsp;\u003cem\u003eHoward v. GlaxoSmithKline\u003c/em\u003e, Case No. 05-1525 (U.S.D.C., E.D. Cal.)\u0026nbsp;\u003cem\u003eaff\u0026rsquo;d\u003c/em\u003e\u0026nbsp;(9th Cir. 2007), and obtaining summary judgments in two product liability wrongful death lawsuits when plaintiffs\u0026rsquo; claimed they did not timely file their lawsuit because of the defendant\u0026rsquo;s \u0026ldquo;fraudulent concealment.\u0026rdquo;\u0026nbsp;\u003cem\u003ePamela Blain, et al., v. SmithKline Beecham Corporation d/b/a GlaxoSmithKline\u003c/em\u003e, Civil Action No. 07-1157- MLB-DWB (U.S.D.C., D. Kan.);\u0026nbsp;\u003cem\u003eCollins v. SmithKlineBeecham Corp.,\u003c/em\u003e\u0026nbsp;Philadelphia Court of Common Pleas, Pennsylvania,\u0026nbsp;\u003cem\u003eaff'd\u003c/em\u003e\u0026nbsp;on appeal.\u003c/p\u003e","\u003cp\u003eManaging massive electronic discovery and hard copy productions and coordinating discovery of plaintiffs\u0026rsquo; claims.\u003c/p\u003e","\u003cp\u003eSuccessfully defending against motions to compel that sought thousands of privileged documents in\u0026nbsp;\u003cstrong\u003epersonal injury lawsuits\u003c/strong\u003e\u0026nbsp;involving prescription medications.\u003c/p\u003e","\u003cp\u003eMajor responsibility in\u0026nbsp;\u003cstrong\u003eseveral hundred breast implant cases\u003c/strong\u003e\u0026nbsp;in Georgia, Florida, Alabama, Mississippi, Tennessee, South Carolina, North Carolina, Virginia and the District of Columbia. Mr. Davis second-chaired the trial of the first breast implant case tried in Tennessee. The trial lasted five-and-a-half weeks and included claims of both local and systemic injury. The jury returned a defense verdict.\u003c/p\u003e","\u003cp\u003eSuccessfully arguing for\u0026nbsp;\u003cstrong\u003etransfer of a host of cases\u003c/strong\u003e\u0026nbsp;to the plaintiffs\u0026rsquo; home states under 28 U.S.C. \u0026sect; 1404. (Plaintiffs attempted to bring their lawsuits in the state of the pharmaceutical company\u0026rsquo;s business office as opposed to the states of their residence.)\u003c/p\u003e","\u003cp\u003eDefending\u0026nbsp;\u003cstrong\u003ehigh-ranking company executives\u003c/strong\u003e\u0026nbsp;in depositions.\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong\u003ea manufacturer\u003c/strong\u003e\u0026nbsp;in an emergency appeal of an order allowing plaintiffs to depose the manufacturer\u0026rsquo;s in-house litigation counsel. In an appeal to the Kentucky Supreme Court, Mr. Davis successfully argued for reversal of the trial court\u0026rsquo;s order.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":63}]},"expertise":[{"id":74,"guid":"74.capabilities","index":0,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":1,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":2,"source":"smartTags"},{"id":764,"guid":"764.smart_tags","index":3,"source":"smartTags"},{"id":3,"guid":"3.capabilities","index":4,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":5,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":6,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":7,"source":"capabilities"},{"id":16,"guid":"16.capabilities","index":8,"source":"capabilities"},{"id":112,"guid":"112.capabilities","index":9,"source":"capabilities"}],"is_active":true,"last_name":"Davis","nick_name":"Todd","clerkships":[],"first_name":"Todd","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"P.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eTodd Davis is a partner with King \u0026amp; Spalding's Trial \u0026amp; Global Disputes practice group. For the last twenty-eight years, Mr. Davis' practice has been devoted to trying high-stakes products liability cases, including those involving medications, medical devices and consumer products.\u0026nbsp; His involvement includes cross-examining plaintiffs\u0026rsquo; key causation and medical expert witnesses at trial and in deposition. \u0026nbsp;Mr. Davis\u0026rsquo; practice\u0026nbsp;involves representing pharmaceutical and medical device companies, as well as other product manufacturers, in mass tort, consumer fraud and class action litigation.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMr. Davis has been recognized in Legal 500\u0026rsquo;s Product Liability and Mass Tort Defense in the Pharma and Medical Device category.\u003c/p\u003e","matters":["\u003cp\u003eTrying three cases for\u0026nbsp;\u003cstrong\u003eGlaxoSmithKline\u003c/strong\u003e\u0026nbsp;in the Philadelphia Court of Common Pleas, Pennsylvania, alleging that Paxil causes birth defects (2016, 2010, 2009). In two trials, the courts dismissed plaintiffs' claims because plaintiffs could not prove proximate causation. In the third, which was plaintiffs' No. 1 pick for trial, plaintiffs were awarded compensatory damages less than the actual medical expenses incurred and no punitive damages.\u003c/p\u003e","\u003cp\u003eTrying the first \u0026ldquo;innovator liability\u0026rdquo; prescription drug case to go to trial (\u003cem\u003eDolin v. GSK,\u0026nbsp;\u003c/em\u003e2017\u003cem\u003e).\u003c/em\u003e\u003c/p\u003e","\u003cp\u003eTrying cases for R.J. Reynolds Tobacco Company as part of the\u0026nbsp;\u003cem\u003eEngle\u003c/em\u003e-progeny litigation in Florida (2013, 2014, 2018, 2019 and 2020).\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong\u003emedical device and pharmaceutical companies\u003c/strong\u003e\u0026nbsp;in federal multi-district litigation and state consolidated proceedings. Defeating efforts to certify a\u0026nbsp;\u003cstrong\u003enationwide class\u003c/strong\u003e\u0026nbsp;of Paxil users under personal injury and consumer fraud theories.\u0026nbsp;\u003cem\u003eIn re Paxil,\u003c/em\u003e\u0026nbsp;212 F.R.D. 539 (C.D. Cal. 2003). This decision has been referred to as one of the \u0026ldquo;Big Four\u0026rdquo; federal court rulings denying class certification in pharmaceutical cases.\u0026nbsp;\u003cem\u003eSee\u003c/em\u003e\u0026nbsp;\u003cem\u003eIn\u003c/em\u003e\u0026nbsp;\u003cem\u003ere\u003c/em\u003e\u0026nbsp;\u003cem\u003ePrempro\u003c/em\u003e\u0026nbsp;\u003cem\u003eProds. Liab. Lit.\u003c/em\u003e, 230 F.R.D. 555 (E.D. Ark. 2005).\u003c/p\u003e","\u003cp\u003eDefeating efforts to certify\u0026nbsp;\u003cstrong\u003ea statewide claim\u003c/strong\u003e\u0026nbsp;of Paxil users under California\u0026rsquo;s Unfair Competition Law, \u0026sect; 17200\u003cem\u003e.\u003c/em\u003e\u0026nbsp;\u003cem\u003eIn re Paxil,\u003c/em\u003e\u0026nbsp;218 F.R.D. 242 (C.D. Cal. 2003).\u003c/p\u003e","\u003cp\u003eDefeating efforts to certify a\u0026nbsp;\u003cstrong\u003enationwide class\u003c/strong\u003e\u0026nbsp;of pediatric patients who were prescribed a medication not approved by the FDA to treat patients under 18.\u0026nbsp;\u003cem\u003ePamela Blain, et al. v. SmithKline Beecham Corp\u003c/em\u003e., 240 F.R.D. 179 (E.D. Pa. 2007).\u003c/p\u003e","\u003cp\u003eObtaining summary judgments based on federal preemption of state law\u0026nbsp;\u003cstrong\u003efailure-to-warn claims\u003c/strong\u003e\u0026nbsp;in cases involving a prescription medication.\u0026nbsp;\u003cem\u003eE.g., O\u0026rsquo;Neal v. SmithKline Beecham Corp.\u003c/em\u003e, 551 F.Supp.2d 993 (E.D. Cal. 2008);\u0026nbsp;\u003cem\u003eCandace Miller et al v. SmithKline Beecham Corporation, d/b/a GlaxoSmithKline\u003c/em\u003e, slip op., 2008 WL 510449 (N.D. Okla).\u003c/p\u003e","\u003cp\u003eSuccessfully excluding plaintiff\u0026rsquo;s experts\u0026rsquo; opinions that breast implants cause systemic illness on\u0026nbsp;\u003cstrong\u003e\u003cem\u003eDaubert\u003c/em\u003e\u0026nbsp;grounds\u003c/strong\u003e\u0026nbsp;in the first breast implant case set for trial in Georgia. Mr. Davis successfully defended that decision on appeal in the first federal appellate decision in the country addressing\u0026nbsp;\u003cem\u003eDaubert\u003c/em\u003e\u0026nbsp;issues in the breast implant litigation.\u0026nbsp;\u003cem\u003eAllison v. McGhan Medical Corp.\u003c/em\u003e\u0026nbsp;184 F.3d 1300 (11th Cir. 1999).\u003c/p\u003e","\u003cp\u003eSuccessfully defending\u0026nbsp;\u003cstrong\u003ea product liability lawsuit\u003c/strong\u003e\u0026nbsp;filed in the \u0026ldquo;rocket-docket\u0026rdquo; of the U.S.D.C., Eastern District of Virginia that involved allegations that a uniformed officer of the Secret Service committed murder and then suicide because of a prescription medication. After an intensive 2-1/2 month discovery period, plaintiff dismissed his lawsuit on the eve of trial. The defendant paid nothing in settlement.\u003c/p\u003e","\u003cp\u003eSuccessfully defending on appeal summary judgment for\u0026nbsp;\u003cstrong\u003ea pharmaceutical manufacturer\u003c/strong\u003e\u0026nbsp;based upon the learned intermediary doctrine.\u0026nbsp;\u003cem\u003eAllgood v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline\u003c/em\u003e, No. 06-cv-3506, 2008 WL 483574 (E.D. La. Feb. 20, 2008),\u0026nbsp;\u003cem\u003eaff\u0026rsquo;d by\u003c/em\u003e\u0026nbsp;No. 08- 30329, 2009 WL 646285 (5th Cir. Mar. 13, 2009),\u0026nbsp;\u003cem\u003ereh\u0026rsquo;g denied by\u003c/em\u003e\u0026nbsp;No. 08-30329 (5th Cir. May 6, 2009).\u003c/p\u003e","\u003cp\u003eObtaining summary judgment in\u0026nbsp;\u003cstrong\u003ea product liability lawsuit\u003c/strong\u003e\u0026nbsp;involving a prescription medication within four months after plaintiff filed his lawsuit,\u0026nbsp;\u003cem\u003eHoward v. GlaxoSmithKline\u003c/em\u003e, Case No. 05-1525 (U.S.D.C., E.D. Cal.)\u0026nbsp;\u003cem\u003eaff\u0026rsquo;d\u003c/em\u003e\u0026nbsp;(9th Cir. 2007), and obtaining summary judgments in two product liability wrongful death lawsuits when plaintiffs\u0026rsquo; claimed they did not timely file their lawsuit because of the defendant\u0026rsquo;s \u0026ldquo;fraudulent concealment.\u0026rdquo;\u0026nbsp;\u003cem\u003ePamela Blain, et al., v. SmithKline Beecham Corporation d/b/a GlaxoSmithKline\u003c/em\u003e, Civil Action No. 07-1157- MLB-DWB (U.S.D.C., D. Kan.);\u0026nbsp;\u003cem\u003eCollins v. SmithKlineBeecham Corp.,\u003c/em\u003e\u0026nbsp;Philadelphia Court of Common Pleas, Pennsylvania,\u0026nbsp;\u003cem\u003eaff'd\u003c/em\u003e\u0026nbsp;on appeal.\u003c/p\u003e","\u003cp\u003eManaging massive electronic discovery and hard copy productions and coordinating discovery of plaintiffs\u0026rsquo; claims.\u003c/p\u003e","\u003cp\u003eSuccessfully defending against motions to compel that sought thousands of privileged documents in\u0026nbsp;\u003cstrong\u003epersonal injury lawsuits\u003c/strong\u003e\u0026nbsp;involving prescription medications.\u003c/p\u003e","\u003cp\u003eMajor responsibility in\u0026nbsp;\u003cstrong\u003eseveral hundred breast implant cases\u003c/strong\u003e\u0026nbsp;in Georgia, Florida, Alabama, Mississippi, Tennessee, South Carolina, North Carolina, Virginia and the District of Columbia. Mr. Davis second-chaired the trial of the first breast implant case tried in Tennessee. The trial lasted five-and-a-half weeks and included claims of both local and systemic injury. The jury returned a defense verdict.\u003c/p\u003e","\u003cp\u003eSuccessfully arguing for\u0026nbsp;\u003cstrong\u003etransfer of a host of cases\u003c/strong\u003e\u0026nbsp;to the plaintiffs\u0026rsquo; home states under 28 U.S.C. \u0026sect; 1404. (Plaintiffs attempted to bring their lawsuits in the state of the pharmaceutical company\u0026rsquo;s business office as opposed to the states of their residence.)\u003c/p\u003e","\u003cp\u003eDefending\u0026nbsp;\u003cstrong\u003ehigh-ranking company executives\u003c/strong\u003e\u0026nbsp;in depositions.\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong\u003ea manufacturer\u003c/strong\u003e\u0026nbsp;in an emergency appeal of an order allowing plaintiffs to depose the manufacturer\u0026rsquo;s in-house litigation counsel. In an appeal to the Kentucky Supreme Court, Mr. Davis successfully argued for reversal of the trial court\u0026rsquo;s order.\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":805}]},"capability_group_id":3},"created_at":"2025-11-05T05:03:30.000Z","updated_at":"2025-11-05T05:03:30.000Z","searchable_text":"Davis{{ FIELD }}Trying three cases for GlaxoSmithKline in the Philadelphia Court of Common Pleas, Pennsylvania, alleging that Paxil causes birth defects (2016, 2010, 2009). In two trials, the courts dismissed plaintiffs' claims because plaintiffs could not prove proximate causation. In the third, which was plaintiffs' No. 1 pick for trial, plaintiffs were awarded compensatory damages less than the actual medical expenses incurred and no punitive damages.{{ FIELD }}Trying the first “innovator liability” prescription drug case to go to trial (Dolin v. GSK, 2017).{{ FIELD }}Trying cases for R.J. Reynolds Tobacco Company as part of the Engle-progeny litigation in Florida (2013, 2014, 2018, 2019 and 2020).{{ FIELD }}Representing medical device and pharmaceutical companies in federal multi-district litigation and state consolidated proceedings. Defeating efforts to certify a nationwide class of Paxil users under personal injury and consumer fraud theories. In re Paxil, 212 F.R.D. 539 (C.D. Cal. 2003). This decision has been referred to as one of the “Big Four” federal court rulings denying class certification in pharmaceutical cases. See In re Prempro Prods. Liab. Lit., 230 F.R.D. 555 (E.D. Ark. 2005).{{ FIELD }}Defeating efforts to certify a statewide claim of Paxil users under California’s Unfair Competition Law, § 17200. In re Paxil, 218 F.R.D. 242 (C.D. Cal. 2003).{{ FIELD }}Defeating efforts to certify a nationwide class of pediatric patients who were prescribed a medication not approved by the FDA to treat patients under 18. Pamela Blain, et al. v. SmithKline Beecham Corp., 240 F.R.D. 179 (E.D. Pa. 2007).{{ FIELD }}Obtaining summary judgments based on federal preemption of state law failure-to-warn claims in cases involving a prescription medication. E.g., O’Neal v. SmithKline Beecham Corp., 551 F.Supp.2d 993 (E.D. Cal. 2008); Candace Miller et al v. SmithKline Beecham Corporation, d/b/a GlaxoSmithKline, slip op., 2008 WL 510449 (N.D. Okla).{{ FIELD }}Successfully excluding plaintiff’s experts’ opinions that breast implants cause systemic illness on Daubert grounds in the first breast implant case set for trial in Georgia. Mr. Davis successfully defended that decision on appeal in the first federal appellate decision in the country addressing Daubert issues in the breast implant litigation. Allison v. McGhan Medical Corp. 184 F.3d 1300 (11th Cir. 1999).{{ FIELD }}Successfully defending a product liability lawsuit filed in the “rocket-docket” of the U.S.D.C., Eastern District of Virginia that involved allegations that a uniformed officer of the Secret Service committed murder and then suicide because of a prescription medication. After an intensive 2-1/2 month discovery period, plaintiff dismissed his lawsuit on the eve of trial. The defendant paid nothing in settlement.{{ FIELD }}Successfully defending on appeal summary judgment for a pharmaceutical manufacturer based upon the learned intermediary doctrine. Allgood v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline, No. 06-cv-3506, 2008 WL 483574 (E.D. La. Feb. 20, 2008), aff’d by No. 08- 30329, 2009 WL 646285 (5th Cir. Mar. 13, 2009), reh’g denied by No. 08-30329 (5th Cir. May 6, 2009).{{ FIELD }}Obtaining summary judgment in a product liability lawsuit involving a prescription medication within four months after plaintiff filed his lawsuit, Howard v. GlaxoSmithKline, Case No. 05-1525 (U.S.D.C., E.D. Cal.) aff’d (9th Cir. 2007), and obtaining summary judgments in two product liability wrongful death lawsuits when plaintiffs’ claimed they did not timely file their lawsuit because of the defendant’s “fraudulent concealment.” Pamela Blain, et al., v. SmithKline Beecham Corporation d/b/a GlaxoSmithKline, Civil Action No. 07-1157- MLB-DWB (U.S.D.C., D. Kan.); Collins v. SmithKlineBeecham Corp., Philadelphia Court of Common Pleas, Pennsylvania, aff'd on appeal.{{ FIELD }}Managing massive electronic discovery and hard copy productions and coordinating discovery of plaintiffs’ claims.{{ FIELD }}Successfully defending against motions to compel that sought thousands of privileged documents in personal injury lawsuits involving prescription medications.{{ FIELD }}Major responsibility in several hundred breast implant cases in Georgia, Florida, Alabama, Mississippi, Tennessee, South Carolina, North Carolina, Virginia and the District of Columbia. Mr. Davis second-chaired the trial of the first breast implant case tried in Tennessee. The trial lasted five-and-a-half weeks and included claims of both local and systemic injury. The jury returned a defense verdict.{{ FIELD }}Successfully arguing for transfer of a host of cases to the plaintiffs’ home states under 28 U.S.C. § 1404. (Plaintiffs attempted to bring their lawsuits in the state of the pharmaceutical company’s business office as opposed to the states of their residence.){{ FIELD }}Defending high-ranking company executives in depositions.{{ FIELD }}Representing a manufacturer in an emergency appeal of an order allowing plaintiffs to depose the manufacturer’s in-house litigation counsel. In an appeal to the Kentucky Supreme Court, Mr. Davis successfully argued for reversal of the trial court’s order.{{ FIELD }}Todd Davis is a partner with King \u0026amp; Spalding's Trial \u0026amp; Global Disputes practice group. For the last twenty-eight years, Mr. Davis' practice has been devoted to trying high-stakes products liability cases, including those involving medications, medical devices and consumer products.  His involvement includes cross-examining plaintiffs’ key causation and medical expert witnesses at trial and in deposition.  Mr. Davis’ practice involves representing pharmaceutical and medical device companies, as well as other product manufacturers, in mass tort, consumer fraud and class action litigation.\nMr. Davis has been recognized in Legal 500’s Product Liability and Mass Tort Defense in the Pharma and Medical Device category. Todd P Davis Partner Stetson University Stetson University College of Law Mercer University Mercer University Walter F. George School of Law U.S. Court of Appeals for the Fifth Circuit U.S. Court of Appeals for the Sixth Circuit U.S. Court of Appeals for the Ninth Circuit U.S. Court of Appeals for the Tenth Circuit U.S. Court of Appeals for the Eleventh Circuit U.S. District Court for the Middle District of Florida U.S. District Court for the Middle District of Georgia U.S. District Court for the Northern District of Georgia U.S. District Court for the Southern District of Georgia Florida Georgia American Bar Association State Bar of Georgia Atlanta Bar Association The Florida Bar Sixth and Eleventh Circuit Court of Appeals Trying three cases for GlaxoSmithKline in the Philadelphia Court of Common Pleas, Pennsylvania, alleging that Paxil causes birth defects (2016, 2010, 2009). In two trials, the courts dismissed plaintiffs' claims because plaintiffs could not prove proximate causation. In the third, which was plaintiffs' No. 1 pick for trial, plaintiffs were awarded compensatory damages less than the actual medical expenses incurred and no punitive damages. Trying the first “innovator liability” prescription drug case to go to trial (Dolin v. GSK, 2017). Trying cases for R.J. Reynolds Tobacco Company as part of the Engle-progeny litigation in Florida (2013, 2014, 2018, 2019 and 2020). Representing medical device and pharmaceutical companies in federal multi-district litigation and state consolidated proceedings. Defeating efforts to certify a nationwide class of Paxil users under personal injury and consumer fraud theories. In re Paxil, 212 F.R.D. 539 (C.D. Cal. 2003). This decision has been referred to as one of the “Big Four” federal court rulings denying class certification in pharmaceutical cases. See In re Prempro Prods. Liab. Lit., 230 F.R.D. 555 (E.D. Ark. 2005). Defeating efforts to certify a statewide claim of Paxil users under California’s Unfair Competition Law, § 17200. In re Paxil, 218 F.R.D. 242 (C.D. Cal. 2003). Defeating efforts to certify a nationwide class of pediatric patients who were prescribed a medication not approved by the FDA to treat patients under 18. Pamela Blain, et al. v. SmithKline Beecham Corp., 240 F.R.D. 179 (E.D. Pa. 2007). Obtaining summary judgments based on federal preemption of state law failure-to-warn claims in cases involving a prescription medication. E.g., O’Neal v. SmithKline Beecham Corp., 551 F.Supp.2d 993 (E.D. Cal. 2008); Candace Miller et al v. SmithKline Beecham Corporation, d/b/a GlaxoSmithKline, slip op., 2008 WL 510449 (N.D. Okla). Successfully excluding plaintiff’s experts’ opinions that breast implants cause systemic illness on Daubert grounds in the first breast implant case set for trial in Georgia. Mr. Davis successfully defended that decision on appeal in the first federal appellate decision in the country addressing Daubert issues in the breast implant litigation. Allison v. McGhan Medical Corp. 184 F.3d 1300 (11th Cir. 1999). Successfully defending a product liability lawsuit filed in the “rocket-docket” of the U.S.D.C., Eastern District of Virginia that involved allegations that a uniformed officer of the Secret Service committed murder and then suicide because of a prescription medication. After an intensive 2-1/2 month discovery period, plaintiff dismissed his lawsuit on the eve of trial. The defendant paid nothing in settlement. Successfully defending on appeal summary judgment for a pharmaceutical manufacturer based upon the learned intermediary doctrine. Allgood v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline, No. 06-cv-3506, 2008 WL 483574 (E.D. La. Feb. 20, 2008), aff’d by No. 08- 30329, 2009 WL 646285 (5th Cir. Mar. 13, 2009), reh’g denied by No. 08-30329 (5th Cir. May 6, 2009). Obtaining summary judgment in a product liability lawsuit involving a prescription medication within four months after plaintiff filed his lawsuit, Howard v. GlaxoSmithKline, Case No. 05-1525 (U.S.D.C., E.D. Cal.) aff’d (9th Cir. 2007), and obtaining summary judgments in two product liability wrongful death lawsuits when plaintiffs’ claimed they did not timely file their lawsuit because of the defendant’s “fraudulent concealment.” Pamela Blain, et al., v. SmithKline Beecham Corporation d/b/a GlaxoSmithKline, Civil Action No. 07-1157- MLB-DWB (U.S.D.C., D. Kan.); Collins v. SmithKlineBeecham Corp., Philadelphia Court of Common Pleas, Pennsylvania, aff'd on appeal. Managing massive electronic discovery and hard copy productions and coordinating discovery of plaintiffs’ claims. Successfully defending against motions to compel that sought thousands of privileged documents in personal injury lawsuits involving prescription medications. Major responsibility in several hundred breast implant cases in Georgia, Florida, Alabama, Mississippi, Tennessee, South Carolina, North Carolina, Virginia and the District of Columbia. Mr. Davis second-chaired the trial of the first breast implant case tried in Tennessee. The trial lasted five-and-a-half weeks and included claims of both local and systemic injury. The jury returned a defense verdict. Successfully arguing for transfer of a host of cases to the plaintiffs’ home states under 28 U.S.C. § 1404. (Plaintiffs attempted to bring their lawsuits in the state of the pharmaceutical company’s business office as opposed to the states of their residence.) Defending high-ranking company executives in depositions. Representing a manufacturer in an emergency appeal of an order allowing plaintiffs to depose the manufacturer’s in-house litigation counsel. In an appeal to the Kentucky Supreme Court, Mr. Davis successfully argued for reversal of the trial court’s order.","searchable_name":"Todd P. Davis","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":444001,"version":1,"owner_type":"Person","owner_id":7205,"payload":{"bio":"\u003cp\u003eRob DeConti is a partner in King \u0026amp; Spalding\u0026rsquo;s healthcare practice, specializing in government healthcare fraud investigations, compliance, diligence, the False Claims Act, the Anti-Kickback Statute (AKS), and regulatory compliance and enforcement issues in relation to healthcare transactions. Rob is an expert on all aspects of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) administrative remedies and initiatives, including mandatory and permissive exclusion authorities, the Civil Monetary Penalties Law, the Emergency Medical Treatment and Labor Act (EMTALA), corporate integrity agreements, Select Agent investigations, drug price reporting cases, and HHS OIG\u0026rsquo;s health care, grant, and contractor self-disclosure protocols. Rob has been a frequent presenter for many years at major national healthcare and life sciences conferences, conveying the government\u0026rsquo;s enforcement and compliance priorities.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith over 25 years of experience, including as the former Chief Counsel to HHS OIG, Rob advises healthcare and life sciences companies on complex regulatory and compliance issues. As the highest-ranking attorney for OIG, Rob served as a nationwide expert on the federal government\u0026rsquo;s development and implementation of health care compliance strategies for health care entities and compliance oversight by health care boards of directors. Rob oversaw all OIG legal services related to audits, investigations, fraud enforcement, and industry guidance. From early in his career as a line attorney with primary responsibility for OIG\u0026rsquo;s pneumonia upcoding national project, Rob has been significantly involved in many of the federal government\u0026rsquo;s major healthcare fraud and compliance initiatives over the past 25 years. As Chief Counsel, Rob served as the lead Deputy Inspector General for OIG\u0026rsquo;s updated compliance program guidance documents, setting forth best practices for entities that do business with the Federal health care programs, including Medicare and Medicaid.\u003c/p\u003e\n\u003cp\u003eBefore his role as Chief Counsel, he served for more than a decade as an Assistant Inspector General (AIG) for Legal Affairs. In that position, he was the signatory for OIG advisory opinions on the application of OIG's fraud and abuse authorities, including under the AKS, to the requesting party's existing or proposed business arrangements. He was also responsible for leading OIG\u0026rsquo;s legal work related to waivers of certain fraud and abuse laws for purposes of testing new health care payment and service delivery models developed by CMS. He has led OIG\u0026rsquo;s negotiation of Corporate Integrity Agreements (CIAs), with a wide range of providers from across the health care industry. From 2012 to 2016, he served as the OIG signatory on behalf of HHS for all False Claims Act (including qui tam) settlements and CIAs nationwide.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePrior to becoming AIG in 2012, Rob was the Chief of the Administrative and Civil Remedies Branch, the largest of three branches in the Office of Counsel.\u003c/p\u003e\n\u003cp\u003eIn 2007, Rob served as a Special Trial Attorney in DOJ\u0026rsquo;s Fraud Section, Criminal Division, where he prosecuted matters in connection with phase one of the Medicare Fraud Strike Force in the Southern District of Florida. In that role, Rob was co-counsel for the jury trial leading to conviction on all five criminal counts, including soliciting and receiving kickbacks, of a durable medical equipment company owner who conspired with two Miami pharmacies in a scheme to bill Medicare for expensive inhalation medications. Prior to working at OIG, he worked in the general counsel\u0026rsquo;s office at a managed care organization.\u003c/p\u003e","slug":"robert-deconti","email":"rdeconti@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":24,"guid":"24.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":3,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":4,"source":"capabilities"},{"id":826,"guid":"826.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"DeConti","nick_name":"Rob","clerkships":[],"first_name":"Robert","title_rank":9999,"updated_by":202,"law_schools":[{"id":3042,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"1999-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"K.","name_suffix":"","recognitions":[{"title":"HHS Secretary’s Award for Distinguished Service","detail":""},{"title":"HHS Secretary’s Award for Meritorious Service","detail":""},{"title":"Inspector General’s Bronze Medal for Outstanding Employee of the Year (multiple awards)","detail":""},{"title":"Inspector General’s Award for Fighting Fraud, Waste, and Abuse","detail":""},{"title":"President’s Council on Integrity and Efficiency Award for Excellence","detail":""},{"title":"Office of Inspector General Cooperative Achievement Award (multiple awards)","detail":""},{"title":"Inspector General’s Exceptional Achievement Award (multiple awards)","detail":""}],"linked_in_url":"https://www.linkedin.com/in/robertdeconti","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eRob DeConti is a partner in King \u0026amp; Spalding\u0026rsquo;s healthcare practice, specializing in government healthcare fraud investigations, compliance, diligence, the False Claims Act, the Anti-Kickback Statute (AKS), and regulatory compliance and enforcement issues in relation to healthcare transactions. Rob is an expert on all aspects of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) administrative remedies and initiatives, including mandatory and permissive exclusion authorities, the Civil Monetary Penalties Law, the Emergency Medical Treatment and Labor Act (EMTALA), corporate integrity agreements, Select Agent investigations, drug price reporting cases, and HHS OIG\u0026rsquo;s health care, grant, and contractor self-disclosure protocols. Rob has been a frequent presenter for many years at major national healthcare and life sciences conferences, conveying the government\u0026rsquo;s enforcement and compliance priorities.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith over 25 years of experience, including as the former Chief Counsel to HHS OIG, Rob advises healthcare and life sciences companies on complex regulatory and compliance issues. As the highest-ranking attorney for OIG, Rob served as a nationwide expert on the federal government\u0026rsquo;s development and implementation of health care compliance strategies for health care entities and compliance oversight by health care boards of directors. Rob oversaw all OIG legal services related to audits, investigations, fraud enforcement, and industry guidance. From early in his career as a line attorney with primary responsibility for OIG\u0026rsquo;s pneumonia upcoding national project, Rob has been significantly involved in many of the federal government\u0026rsquo;s major healthcare fraud and compliance initiatives over the past 25 years. As Chief Counsel, Rob served as the lead Deputy Inspector General for OIG\u0026rsquo;s updated compliance program guidance documents, setting forth best practices for entities that do business with the Federal health care programs, including Medicare and Medicaid.\u003c/p\u003e\n\u003cp\u003eBefore his role as Chief Counsel, he served for more than a decade as an Assistant Inspector General (AIG) for Legal Affairs. In that position, he was the signatory for OIG advisory opinions on the application of OIG's fraud and abuse authorities, including under the AKS, to the requesting party's existing or proposed business arrangements. He was also responsible for leading OIG\u0026rsquo;s legal work related to waivers of certain fraud and abuse laws for purposes of testing new health care payment and service delivery models developed by CMS. He has led OIG\u0026rsquo;s negotiation of Corporate Integrity Agreements (CIAs), with a wide range of providers from across the health care industry. From 2012 to 2016, he served as the OIG signatory on behalf of HHS for all False Claims Act (including qui tam) settlements and CIAs nationwide.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePrior to becoming AIG in 2012, Rob was the Chief of the Administrative and Civil Remedies Branch, the largest of three branches in the Office of Counsel.\u003c/p\u003e\n\u003cp\u003eIn 2007, Rob served as a Special Trial Attorney in DOJ\u0026rsquo;s Fraud Section, Criminal Division, where he prosecuted matters in connection with phase one of the Medicare Fraud Strike Force in the Southern District of Florida. In that role, Rob was co-counsel for the jury trial leading to conviction on all five criminal counts, including soliciting and receiving kickbacks, of a durable medical equipment company owner who conspired with two Miami pharmacies in a scheme to bill Medicare for expensive inhalation medications. Prior to working at OIG, he worked in the general counsel\u0026rsquo;s office at a managed care organization.\u003c/p\u003e","recognitions":[{"title":"HHS Secretary’s Award for Distinguished Service","detail":""},{"title":"HHS Secretary’s Award for Meritorious Service","detail":""},{"title":"Inspector General’s Bronze Medal for Outstanding Employee of the Year (multiple awards)","detail":""},{"title":"Inspector General’s Award for Fighting Fraud, Waste, and Abuse","detail":""},{"title":"President’s Council on Integrity and Efficiency Award for Excellence","detail":""},{"title":"Office of Inspector General Cooperative Achievement Award (multiple awards)","detail":""},{"title":"Inspector General’s Exceptional Achievement Award (multiple awards)","detail":""}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12841}]},"capability_group_id":2},"created_at":"2025-12-05T05:02:32.000Z","updated_at":"2025-12-05T05:02:32.000Z","searchable_text":"DeConti{{ FIELD }}{:title=\u0026gt;\"HHS Secretary’s Award for Distinguished Service\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"HHS Secretary’s Award for Meritorious Service\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Inspector General’s Bronze Medal for Outstanding Employee of the Year (multiple awards)\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Inspector General’s Award for Fighting Fraud, Waste, and Abuse\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"President’s Council on Integrity and Efficiency Award for Excellence\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Office of Inspector General Cooperative Achievement Award (multiple awards)\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Inspector General’s Exceptional Achievement Award (multiple awards)\", :detail=\u0026gt;\"\"}{{ FIELD }}Rob DeConti is a partner in King \u0026amp; Spalding’s healthcare practice, specializing in government healthcare fraud investigations, compliance, diligence, the False Claims Act, the Anti-Kickback Statute (AKS), and regulatory compliance and enforcement issues in relation to healthcare transactions. Rob is an expert on all aspects of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) administrative remedies and initiatives, including mandatory and permissive exclusion authorities, the Civil Monetary Penalties Law, the Emergency Medical Treatment and Labor Act (EMTALA), corporate integrity agreements, Select Agent investigations, drug price reporting cases, and HHS OIG’s health care, grant, and contractor self-disclosure protocols. Rob has been a frequent presenter for many years at major national healthcare and life sciences conferences, conveying the government’s enforcement and compliance priorities. \nWith over 25 years of experience, including as the former Chief Counsel to HHS OIG, Rob advises healthcare and life sciences companies on complex regulatory and compliance issues. As the highest-ranking attorney for OIG, Rob served as a nationwide expert on the federal government’s development and implementation of health care compliance strategies for health care entities and compliance oversight by health care boards of directors. Rob oversaw all OIG legal services related to audits, investigations, fraud enforcement, and industry guidance. From early in his career as a line attorney with primary responsibility for OIG’s pneumonia upcoding national project, Rob has been significantly involved in many of the federal government’s major healthcare fraud and compliance initiatives over the past 25 years. As Chief Counsel, Rob served as the lead Deputy Inspector General for OIG’s updated compliance program guidance documents, setting forth best practices for entities that do business with the Federal health care programs, including Medicare and Medicaid.\nBefore his role as Chief Counsel, he served for more than a decade as an Assistant Inspector General (AIG) for Legal Affairs. In that position, he was the signatory for OIG advisory opinions on the application of OIG's fraud and abuse authorities, including under the AKS, to the requesting party's existing or proposed business arrangements. He was also responsible for leading OIG’s legal work related to waivers of certain fraud and abuse laws for purposes of testing new health care payment and service delivery models developed by CMS. He has led OIG’s negotiation of Corporate Integrity Agreements (CIAs), with a wide range of providers from across the health care industry. From 2012 to 2016, he served as the OIG signatory on behalf of HHS for all False Claims Act (including qui tam) settlements and CIAs nationwide. \nPrior to becoming AIG in 2012, Rob was the Chief of the Administrative and Civil Remedies Branch, the largest of three branches in the Office of Counsel.\nIn 2007, Rob served as a Special Trial Attorney in DOJ’s Fraud Section, Criminal Division, where he prosecuted matters in connection with phase one of the Medicare Fraud Strike Force in the Southern District of Florida. In that role, Rob was co-counsel for the jury trial leading to conviction on all five criminal counts, including soliciting and receiving kickbacks, of a durable medical equipment company owner who conspired with two Miami pharmacies in a scheme to bill Medicare for expensive inhalation medications. Prior to working at OIG, he worked in the general counsel’s office at a managed care organization. Partner HHS Secretary’s Award for Distinguished Service  HHS Secretary’s Award for Meritorious Service  Inspector General’s Bronze Medal for Outstanding Employee of the Year (multiple awards)  Inspector General’s Award for Fighting Fraud, Waste, and Abuse  President’s Council on Integrity and Efficiency Award for Excellence  Office of Inspector General Cooperative Achievement Award (multiple awards)  Inspector General’s Exceptional Achievement Award (multiple awards)  University of Virginia  American University Washington College of Law American University Washington College of Law District of Columbia Virginia Virginia State Bar American Health Law Association Government Attorney-at-Large, American Bar Association Health Law Section Council, 2022-2025 Government Liaison to the Health Care Compliance Association, Board of Directors, 2008-2012","searchable_name":"Robert K. DeConti (Rob)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":431883,"version":1,"owner_type":"Person","owner_id":3969,"payload":{"bio":"\u003cp\u003eA partner in our FDA and Life Sciences practice, Lisa has almost 25\u0026nbsp;years of experience developing regulatory, legislative and litigation solutions for companies selling FDA-regulated products (i.e., drugs, devices, biologics, cosmetics, and tobacco). \u0026nbsp;She has served as an advisor to high-level public officials and C-suite executives on complex regulatory, policy, and litigation issues.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePreviously, Lisa served as a Senior Policy Advisor in the FDA Commissioner\u0026rsquo;s Office and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, she provided strategic counsel on the agency\u0026rsquo;s most significant and complex issues. These included off-label marketing, mobile medical apps/digital health, opioid misuse and abuse, in vitro diagnostics and next generation sequencing, cosmetic legislation and regulation, and antimicrobial drug development and use. During her tenure at the FDA, she also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA).\u003c/p\u003e\n\u003cp\u003eLisa is a frequent author and speaker on topics including:\u0026nbsp; digital health, advertising and promoting drugs and devices, remedying unfair competition in the drug and device space, women\u0026rsquo;s health issues, admissibility of 510(k)s in product liability lawsuits, preemption, in vitro diagnostics, the 21st Century Cures Act, and other topics. Lisa is Chambers ranked for Pharmaceutical/Medical Products Law. She also has been repeatedly recognized by Legal 500 as a Next Generation Partner and as a Recommended Key Lawyer for FDA Regulatory Law (2017, 2019, 2020, 2021, 2022, 2023, 2024) and for Government Relations (2016). Legal 500 has distinguished her for her expertise in digital health/AI and in pre-market strategies, and praised for her \u0026ldquo;unending enthusiasm to take on client\u0026rsquo;s causes as her own.\"\u003c/p\u003e","slug":"lisa-dwyer","email":"ldwyer@kslaw.com","phone":null,"matters":["\u003cp\u003eFocus on Digital Health/Telehealth\u003c/p\u003e","\u003cp\u003eFocus on In Vitro Diagnostic Tests and Laboratory Developed Tests\u003c/p\u003e","\u003cp\u003eFDA/FTC regulation of advertising and promotion\u003c/p\u003e","\u003cp\u003ePre-market development (drugs and devices (including digital health products))\u003c/p\u003e","\u003cp\u003eFDA product submissions (drugs and devices (including digital health products))\u003c/p\u003e","\u003cp\u003eDevelops regulatory, legislative and litigation solutions for unfair competition in the drug/device space\u003c/p\u003e\n\u003cp\u003e- Lanham Act\u003c/p\u003e\n\u003cp\u003e- Unfair trade practice statutes (state and federal)\u003c/p\u003e","\u003cp\u003eEngages FDA and Congress on key issues related to FDA-regulated products\u003c/p\u003e","\u003cp\u003eResponds to FDA/FTC inquires, FDA warning letters, and FDA 483s\u003c/p\u003e","\u003cp\u003eExperience remedying cGMP issues at facilities making OTC and Rx drugs and cosmetics\u003c/p\u003e","\u003cp\u003eCo-Chairs Women's Health Initiative\u003c/p\u003e","\u003cp\u003eMember of Cannabis Steering Committee\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":53}]},"expertise":[{"id":2,"guid":"2.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.smart_tags","index":1,"source":"smartTags"},{"id":23,"guid":"23.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":5,"source":"capabilities"},{"id":970,"guid":"970.smart_tags","index":6,"source":"smartTags"},{"id":112,"guid":"112.capabilities","index":7,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":8,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":9,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":10,"source":"smartTags"},{"id":1206,"guid":"1206.smart_tags","index":11,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":12,"source":"smartTags"},{"id":133,"guid":"133.capabilities","index":13,"source":"capabilities"}],"is_active":true,"last_name":"Dwyer","nick_name":"Lisa","clerkships":[],"first_name":"Lisa","title_rank":9999,"updated_by":202,"law_schools":[{"id":753,"meta":{"degree":"J.D.","honors":"honors","is_law_school":"1","graduation_date":"1998-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"M.","name_suffix":"","recognitions":[{"title":"Next Generation Lawyer","detail":"Legal 500, 2017 and 2019"},{"title":"Recognition for Government Relations ","detail":"Legal 500, 2016"},{"title":"FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests ","detail":"FDA Award Ceremony, 2015"},{"title":"FDA Group Recognition Award, Publishing FDA Strategic Priorities 2014–2018 Document","detail":"FDA Award Ceremony, 2015"},{"title":"FDA Commissioner’s Special Citation, Issuance of the Unique Device Identification (UDI) System Final Rule ","detail":"FDA Award Ceremony, 2014"},{"title":"FDA Group Recognition Award, FDA Language Access Plan Working Group","detail":"FDA Award Ceremony, 2014"},{"title":"FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader)","detail":"FDA Award Ceremony, 2012"},{"title":"FDA Group Recognition Award, Menu Labeling Working Group","detail":"CFSAN/FDA Award Ceremony, 2011"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eA partner in our FDA and Life Sciences practice, Lisa has almost 25\u0026nbsp;years of experience developing regulatory, legislative and litigation solutions for companies selling FDA-regulated products (i.e., drugs, devices, biologics, cosmetics, and tobacco). \u0026nbsp;She has served as an advisor to high-level public officials and C-suite executives on complex regulatory, policy, and litigation issues.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePreviously, Lisa served as a Senior Policy Advisor in the FDA Commissioner\u0026rsquo;s Office and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, she provided strategic counsel on the agency\u0026rsquo;s most significant and complex issues. These included off-label marketing, mobile medical apps/digital health, opioid misuse and abuse, in vitro diagnostics and next generation sequencing, cosmetic legislation and regulation, and antimicrobial drug development and use. During her tenure at the FDA, she also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA).\u003c/p\u003e\n\u003cp\u003eLisa is a frequent author and speaker on topics including:\u0026nbsp; digital health, advertising and promoting drugs and devices, remedying unfair competition in the drug and device space, women\u0026rsquo;s health issues, admissibility of 510(k)s in product liability lawsuits, preemption, in vitro diagnostics, the 21st Century Cures Act, and other topics. Lisa is Chambers ranked for Pharmaceutical/Medical Products Law. She also has been repeatedly recognized by Legal 500 as a Next Generation Partner and as a Recommended Key Lawyer for FDA Regulatory Law (2017, 2019, 2020, 2021, 2022, 2023, 2024) and for Government Relations (2016). Legal 500 has distinguished her for her expertise in digital health/AI and in pre-market strategies, and praised for her \u0026ldquo;unending enthusiasm to take on client\u0026rsquo;s causes as her own.\"\u003c/p\u003e","matters":["\u003cp\u003eFocus on Digital Health/Telehealth\u003c/p\u003e","\u003cp\u003eFocus on In Vitro Diagnostic Tests and Laboratory Developed Tests\u003c/p\u003e","\u003cp\u003eFDA/FTC regulation of advertising and promotion\u003c/p\u003e","\u003cp\u003ePre-market development (drugs and devices (including digital health products))\u003c/p\u003e","\u003cp\u003eFDA product submissions (drugs and devices (including digital health products))\u003c/p\u003e","\u003cp\u003eDevelops regulatory, legislative and litigation solutions for unfair competition in the drug/device space\u003c/p\u003e\n\u003cp\u003e- Lanham Act\u003c/p\u003e\n\u003cp\u003e- Unfair trade practice statutes (state and federal)\u003c/p\u003e","\u003cp\u003eEngages FDA and Congress on key issues 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2014"},{"title":"FDA Group Recognition Award, FDA Language Access Plan Working Group","detail":"FDA Award Ceremony, 2014"},{"title":"FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader)","detail":"FDA Award Ceremony, 2012"},{"title":"FDA Group Recognition Award, Menu Labeling Working Group","detail":"CFSAN/FDA Award Ceremony, 2011"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":11487}]},"capability_group_id":2},"created_at":"2025-07-09T20:54:25.000Z","updated_at":"2025-07-09T20:54:25.000Z","searchable_text":"Dwyer{{ FIELD }}{:title=\u0026gt;\"Next Generation Lawyer\", :detail=\u0026gt;\"Legal 500, 2017 and 2019\"}{{ FIELD }}{:title=\u0026gt;\"Recognition for Government Relations \", :detail=\u0026gt;\"Legal 500, 2016\"}{{ FIELD }}{:title=\u0026gt;\"FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests \", :detail=\u0026gt;\"FDA Award Ceremony, 2015\"}{{ FIELD }}{:title=\u0026gt;\"FDA Group Recognition Award, Publishing FDA Strategic Priorities 2014–2018 Document\", :detail=\u0026gt;\"FDA Award Ceremony, 2015\"}{{ FIELD }}{:title=\u0026gt;\"FDA Commissioner’s Special Citation, Issuance of the Unique Device Identification (UDI) System Final Rule \", :detail=\u0026gt;\"FDA Award Ceremony, 2014\"}{{ FIELD }}{:title=\u0026gt;\"FDA Group Recognition Award, FDA Language Access Plan Working Group\", :detail=\u0026gt;\"FDA Award Ceremony, 2014\"}{{ FIELD }}{:title=\u0026gt;\"FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader)\", :detail=\u0026gt;\"FDA Award Ceremony, 2012\"}{{ FIELD }}{:title=\u0026gt;\"FDA Group Recognition Award, Menu Labeling Working Group\", :detail=\u0026gt;\"CFSAN/FDA Award Ceremony, 2011\"}{{ FIELD }}Focus on Digital Health/Telehealth{{ FIELD }}Focus on In Vitro Diagnostic Tests and Laboratory Developed Tests{{ FIELD }}FDA/FTC regulation of advertising and promotion{{ FIELD }}Pre-market development (drugs and devices (including digital health products)){{ FIELD }}FDA product submissions (drugs and devices (including digital health products)){{ FIELD }}Develops regulatory, legislative and litigation solutions for unfair competition in the drug/device space\n- Lanham Act\n- Unfair trade practice statutes (state and federal){{ FIELD }}Engages FDA and Congress on key issues related to FDA-regulated products{{ FIELD }}Responds to FDA/FTC inquires, FDA warning letters, and FDA 483s{{ FIELD }}Experience remedying cGMP issues at facilities making OTC and Rx drugs and cosmetics{{ FIELD }}Co-Chairs Women's Health Initiative{{ FIELD }}Member of Cannabis Steering Committee{{ FIELD }}A partner in our FDA and Life Sciences practice, Lisa has almost 25 years of experience developing regulatory, legislative and litigation solutions for companies selling FDA-regulated products (i.e., drugs, devices, biologics, cosmetics, and tobacco).  She has served as an advisor to high-level public officials and C-suite executives on complex regulatory, policy, and litigation issues.\nPreviously, Lisa served as a Senior Policy Advisor in the FDA Commissioner’s Office and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, she provided strategic counsel on the agency’s most significant and complex issues. These included off-label marketing, mobile medical apps/digital health, opioid misuse and abuse, in vitro diagnostics and next generation sequencing, cosmetic legislation and regulation, and antimicrobial drug development and use. During her tenure at the FDA, she also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA).\nLisa is a frequent author and speaker on topics including:  digital health, advertising and promoting drugs and devices, remedying unfair competition in the drug and device space, women’s health issues, admissibility of 510(k)s in product liability lawsuits, preemption, in vitro diagnostics, the 21st Century Cures Act, and other topics. Lisa is Chambers ranked for Pharmaceutical/Medical Products Law. She also has been repeatedly recognized by Legal 500 as a Next Generation Partner and as a Recommended Key Lawyer for FDA Regulatory Law (2017, 2019, 2020, 2021, 2022, 2023, 2024) and for Government Relations (2016). Legal 500 has distinguished her for her expertise in digital health/AI and in pre-market strategies, and praised for her “unending enthusiasm to take on client’s causes as her own.\" Lisa M Dwyer Partner Next Generation Lawyer Legal 500, 2017 and 2019 Recognition for Government Relations  Legal 500, 2016 FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests  FDA Award Ceremony, 2015 FDA Group Recognition Award, Publishing FDA Strategic Priorities 2014–2018 Document FDA Award Ceremony, 2015 FDA Commissioner’s Special Citation, Issuance of the Unique Device Identification (UDI) System Final Rule  FDA Award Ceremony, 2014 FDA Group Recognition Award, FDA Language Access Plan Working Group FDA Award Ceremony, 2014 FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader) FDA Award Ceremony, 2012 FDA Group Recognition Award, Menu Labeling Working Group CFSAN/FDA Award Ceremony, 2011 Wesleyan University  George Washington University George Washington University Law School District of Columbia Massachusetts Pennsylvania Focus on Digital Health/Telehealth Focus on In Vitro Diagnostic Tests and Laboratory Developed Tests FDA/FTC regulation of advertising and promotion Pre-market development (drugs and devices (including digital health products)) FDA product submissions (drugs and devices (including digital health products)) Develops regulatory, legislative and litigation solutions for unfair competition in the drug/device space\n- Lanham Act\n- Unfair trade practice statutes (state and federal) Engages FDA and Congress on key issues related to FDA-regulated products Responds to FDA/FTC inquires, FDA warning letters, and FDA 483s Experience remedying cGMP issues at facilities making OTC and Rx drugs and cosmetics Co-Chairs Women's Health Initiative Member of Cannabis Steering Committee","searchable_name":"Lisa M. 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