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As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. 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Alabama Board of Pharmacy, and other jurisdictions.\u003c/p\u003e","\u003cp\u003eAdvised on the status and use of controlled substances\u0026nbsp;\u003cstrong\u003eand listed chemicals\u003c/strong\u003e, including:\u003c/p\u003e\n\u003cp\u003e- Administrative hearings concerning applicants for registration to import narcotic raw materials,\u003c/p\u003e\n\u003cp\u003e- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\u003c/p\u003e\n\u003cp\u003e- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\u003c/p\u003e\n\u003cp\u003e- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.smart_tags","index":1,"source":"smartTags"},{"id":107,"guid":"107.capabilities","index":2,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":3,"source":"smartTags"},{"id":105,"guid":"105.capabilities","index":4,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":5,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":6,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":7,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":8,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":9,"source":"capabilities"},{"id":33,"guid":"33.capabilities","index":10,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":11,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":12,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":13,"source":"capabilities"},{"id":764,"guid":"764.smart_tags","index":14,"source":"smartTags"}],"is_active":true,"last_name":"Markus","nick_name":"Chris","clerkships":[],"first_name":"Christina","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":"M.","name_suffix":"","recognitions":[{"title":"Client Service All-Star (unprompted survey of large company corporate counsel)","detail":"BTI Consulting, 2017"},{"title":"Who's Who Legal: Life Sciences","detail":"2017-2024"},{"title":"Leading Life Sciences Lawyer","detail":"LMG Life Sciences, 2012-2025"},{"title":"Best Lawyers in America - FDA Law","detail":"Best Lawyers/US News \u0026 World Report, 2015-2026"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eChris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\u003c/p\u003e\n\u003cp\u003eBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChris has been recognized by the\u0026nbsp;\u003cem\u003eBTI Consulting Group\u003c/em\u003e\u0026nbsp;as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by\u0026nbsp;\u003cem\u003eLMG Life Sciences.\u003c/em\u003e\u0026nbsp; She continues to be identified as one of\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;for FDA Law, and ranked as a life sciences practitioner by\u0026nbsp;\u003cem\u003eThe Legal 500\u003c/em\u003e.\u003c/p\u003e","matters":["\u003cp\u003eAdvised numerous pharmaceutical and device manufacturers and distributors on compliance with\u0026nbsp;\u003cstrong\u003estate laws\u003c/strong\u003e\u0026nbsp;governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.\u003c/p\u003e","\u003cp\u003eAdvised on range of clinical trial issues, including design, compliance and transparency disclosures.\u003c/p\u003e","\u003cp\u003eDeveloped responses to inspectional findings and import alerts, in close collaboration with technical experts.\u003c/p\u003e","\u003cp\u003eAdvised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003edozens of pharmaceutical and biological product companies\u003c/strong\u003e, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.\u003c/p\u003e","\u003cp\u003eDeveloped and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed\u0026nbsp;\u003cstrong\u003ebioequivalence standards, Hatch-Waxman 30-month stay provisions\u003c/strong\u003e, and other key regulatory topics.\u003c/p\u003e","\u003cp\u003ePerformed due diligence for\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eregulatory issues\u003c/strong\u003e\u0026nbsp;and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.\u003c/p\u003e","\u003cp\u003eEvaluated\u0026nbsp;\u003cstrong\u003eimpacts of the Drug Supply Chain Security Act (DSCSA)\u003c/strong\u003e\u0026nbsp;on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eproduct distributors\u003c/strong\u003e\u0026nbsp;against proposed disciplinary action by the California Board of Pharmacy; 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World Report, 2015-2026\"}{{ FIELD }}Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.{{ FIELD }}Advised on range of clinical trial issues, including design, compliance and transparency disclosures.{{ FIELD }}Developed responses to inspectional findings and import alerts, in close collaboration with technical experts.{{ FIELD }}Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.{{ FIELD }}Advised dozens of pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.{{ FIELD }}Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics.{{ FIELD }}Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.{{ FIELD }}Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.{{ FIELD }}Defended product distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.{{ FIELD }}Advised on the status and use of controlled substances and listed chemicals, including:\n- Administrative hearings concerning applicants for registration to import narcotic raw materials,\n- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\n- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\n- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.{{ FIELD }}Chris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.\nChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\nBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress. \nChris has been recognized by the BTI Consulting Group as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by LMG Life Sciences.  She continues to be identified as one of The Best Lawyers in America for FDA Law, and ranked as a life sciences practitioner by The Legal 500. Partner Client Service All-Star (unprompted survey of large company corporate counsel) BTI Consulting, 2017 Who's Who Legal: Life Sciences 2017-2024 Leading Life Sciences Lawyer LMG Life Sciences, 2012-2025 Best Lawyers in America - FDA Law Best Lawyers/US News \u0026amp; World Report, 2015-2026 College of William and Mary William \u0026amp; Mary Law School University of Virginia University of Virginia School of Law District of Columbia Virginia The District of Columbia Bar Virginia State Bar Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting. Advised on range of clinical trial issues, including design, compliance and transparency disclosures. Developed responses to inspectional findings and import alerts, in close collaboration with technical experts. Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples. Advised dozens of pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence. Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics. Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending. Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products. Defended product distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions. Advised on the status and use of controlled substances and listed chemicals, including:\n- Administrative hearings concerning applicants for registration to import narcotic raw materials,\n- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\n- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\n- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.","searchable_name":"Christina M. Markus (Chris)","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":444226,"version":1,"owner_type":"Person","owner_id":3179,"payload":{"bio":"\u003cp\u003eDavid Mattern\u0026nbsp;is an experienced trial and appellate lawyer who represents technology, media, and entertainment companies in complex litigation and intellectual property matters.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDavid has substantial experience defending technology platforms and other companies in suits related to user content, including in copyright litigation, matters involving Section 230, the DMCA, and trademark and trade secret claims.\u0026nbsp; David has also litigated\u0026nbsp;consumer class actions, securities cases,\u0026nbsp;and constitutional matters.\u003c/p\u003e\n\u003cp\u003eBefore rejoining King \u0026amp; Spalding, David was a law clerk to then-Chief Judge R. Guy Cole (Sixth Circuit). He received his J.D. from Columbia Law School, where he was a James Kent Scholar.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDavid has represented clients at trial and appeal in courts across the country. David has particular expertise in copyright law and platform defenses, including representing platforms in copyright litigation and\u0026nbsp;rate court disputes, and in defending platforms in suits related to user content and content moderation under the DMCA and Section 230.\u0026nbsp;His experience extends to a wide range of subject areas, including False Claims Act litigation,\u0026nbsp;product liability litigation, professional liability litigation, and many other types of business litigation.\u003c/p\u003e\n\u003cp\u003eDavid devotes a significant amount of time to pro bono civil rights litigation. Recent successful representations include obtaining reversal of a grant of qualified immunity to prison officials in a suit brought under Section 1983 in a case he argued in the Ninth Circuit, and in obtaining a reversal of a grant of summary judgment to prison officials on exhaustion under the PLRA in a case he argued in the Seventh Circuit.\u0026nbsp;\u003c/p\u003e","slug":"david-mattern","email":"dmattern@kslaw.com","phone":null,"matters":["\u003cp\u003eCo-Lead Counsel to \u003cstrong\u003eTikTok \u003c/strong\u003ein nationwide litigation in which personal injuries and school districts plaintiffs allege harms arising from adolescent use of social media and entertainment platforms, including in the Social Media MDL pending in N.D. Cal. and JCCP pending in Los Angeles Superior Court. 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BMI\u0026nbsp;\u003c/em\u003e(2015).\u0026nbsp;\u003c/strong\u003eMember of trial team representing Pandora against Broadcast Music, Inc. in rate court proceeding under antitrust consent decree to determine public performance royalties for Pandora\u0026rsquo;s internet radio service.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":74,"guid":"74.capabilities","index":0,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":1,"source":"capabilities"},{"id":2,"guid":"2.capabilities","index":2,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":3,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":4,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":5,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":6,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":7,"source":"capabilities"},{"id":1233,"guid":"1233.smart_tags","index":8,"source":"smartTags"},{"id":133,"guid":"133.capabilities","index":9,"source":"capabilities"},{"id":1248,"guid":"1248.smart_tags","index":10,"source":"smartTags"}],"is_active":true,"last_name":"Mattern","nick_name":"David","clerkships":[{"name":"Judicial Clerk, Chief Judge R. 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Guy Cole (Sixth Circuit). He received his J.D. from Columbia Law School, where he was a James Kent Scholar.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDavid has represented clients at trial and appeal in courts across the country. David has particular expertise in copyright law and platform defenses, including representing platforms in copyright litigation and\u0026nbsp;rate court disputes, and in defending platforms in suits related to user content and content moderation under the DMCA and Section 230.\u0026nbsp;His experience extends to a wide range of subject areas, including False Claims Act litigation,\u0026nbsp;product liability litigation, professional liability litigation, and many other types of business litigation.\u003c/p\u003e\n\u003cp\u003eDavid devotes a significant amount of time to pro bono civil rights litigation. Recent successful representations include obtaining reversal of a grant of qualified immunity to prison officials in a suit brought under Section 1983 in a case he argued in the Ninth Circuit, and in obtaining a reversal of a grant of summary judgment to prison officials on exhaustion under the PLRA in a case he argued in the Seventh Circuit.\u0026nbsp;\u003c/p\u003e","matters":["\u003cp\u003eCo-Lead Counsel to \u003cstrong\u003eTikTok \u003c/strong\u003ein nationwide litigation in which personal injuries and school districts plaintiffs allege harms arising from adolescent use of social media and entertainment platforms, including in the Social Media MDL pending in N.D. Cal. and JCCP pending in Los Angeles Superior Court. 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BMI\u0026nbsp;\u003c/em\u003e(2015).\u0026nbsp;\u003c/strong\u003eMember of trial team representing Pandora against Broadcast Music, Inc. in rate court proceeding under antitrust consent decree to determine public performance royalties for Pandora\u0026rsquo;s internet radio service.\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9106}]},"capability_group_id":3},"created_at":"2025-12-12T21:52:12.000Z","updated_at":"2025-12-12T21:52:12.000Z","searchable_text":"Mattern{{ FIELD }}Co-Lead Counsel to TikTok in nationwide litigation in which personal injuries and school districts plaintiffs allege harms arising from adolescent use of social media and entertainment platforms, including in the Social Media MDL pending in N.D. Cal. and JCCP pending in Los Angeles Superior Court. Runner-up for Litigator of the Week for obtaining dismissal of school district suits in the JCCP proceeding.{{ FIELD }}Counsel to Activision Blizzard in connection with nationwide lawsuits alleging a variety of harms arising from the purported addiction to video games.{{ FIELD }}Co-lead Counsel to the Radio Music License Committee in a series of rate-setting proceedings involving the performing rights’ organizations ASCAP, BMI, and SESAC{{ FIELD }}Counsel to Google/YouTube in a rate-setting proceeding before the Copyright Royalty Board to determine the rates non-interactive streaming services pay record labels, including arguing on behalf of Google/YouTube in the D.C. Circuit in support of affirming the rate determination{{ FIELD }}Represented a large technology company in litigation filed against Russian cybercriminals operating a botnet that employed blockchain technology.{{ FIELD }}Downtown v. Peloton (2019). Represents Peloton Interactive, Inc. in suit brought by music publishers in SDNY{{ FIELD }}Phonorecords III (2017). Represented Google before the Copyright Royalty Board in a proceeding to set the royalty rates paid to publishers for interactive streaming.{{ FIELD }}Pandora v. BMI (2015). Member of trial team representing Pandora against Broadcast Music, Inc. in rate court proceeding under antitrust consent decree to determine public performance royalties for Pandora’s internet radio service.{{ FIELD }}David Mattern is an experienced trial and appellate lawyer who represents technology, media, and entertainment companies in complex litigation and intellectual property matters.  \nDavid has substantial experience defending technology platforms and other companies in suits related to user content, including in copyright litigation, matters involving Section 230, the DMCA, and trademark and trade secret claims.  David has also litigated consumer class actions, securities cases, and constitutional matters.\nBefore rejoining King \u0026amp; Spalding, David was a law clerk to then-Chief Judge R. Guy Cole (Sixth Circuit). He received his J.D. from Columbia Law School, where he was a James Kent Scholar. \nDavid has represented clients at trial and appeal in courts across the country. David has particular expertise in copyright law and platform defenses, including representing platforms in copyright litigation and rate court disputes, and in defending platforms in suits related to user content and content moderation under the DMCA and Section 230. His experience extends to a wide range of subject areas, including False Claims Act litigation, product liability litigation, professional liability litigation, and many other types of business litigation.\nDavid devotes a significant amount of time to pro bono civil rights litigation. Recent successful representations include obtaining reversal of a grant of qualified immunity to prison officials in a suit brought under Section 1983 in a case he argued in the Ninth Circuit, and in obtaining a reversal of a grant of summary judgment to prison officials on exhaustion under the PLRA in a case he argued in the Seventh Circuit.  Partner Case Western Reserve University Case Western Reserve University School of Law Columbia University Columbia University School of Law 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 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 Ninth 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 New York Judicial Clerk, Chief Judge R. Guy Cole, U.S. Court of Appeals for the Sixth Circuit Co-Lead Counsel to TikTok in nationwide litigation in which personal injuries and school districts plaintiffs allege harms arising from adolescent use of social media and entertainment platforms, including in the Social Media MDL pending in N.D. Cal. and JCCP pending in Los Angeles Superior Court. Runner-up for Litigator of the Week for obtaining dismissal of school district suits in the JCCP proceeding. Counsel to Activision Blizzard in connection with nationwide lawsuits alleging a variety of harms arising from the purported addiction to video games. Co-lead Counsel to the Radio Music License Committee in a series of rate-setting proceedings involving the performing rights’ organizations ASCAP, BMI, and SESAC Counsel to Google/YouTube in a rate-setting proceeding before the Copyright Royalty Board to determine the rates non-interactive streaming services pay record labels, including arguing on behalf of Google/YouTube in the D.C. Circuit in support of affirming the rate determination Represented a large technology company in litigation filed against Russian cybercriminals operating a botnet that employed blockchain technology. Downtown v. Peloton (2019). Represents Peloton Interactive, Inc. in suit brought by music publishers in SDNY Phonorecords III (2017). Represented Google before the Copyright Royalty Board in a proceeding to set the royalty rates paid to publishers for interactive streaming. Pandora v. BMI (2015). Member of trial team representing Pandora against Broadcast Music, Inc. in rate court proceeding under antitrust consent decree to determine public performance royalties for Pandora’s internet radio service.","searchable_name":"David P. Mattern","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":444450,"version":1,"owner_type":"Person","owner_id":2728,"payload":{"bio":"\u003cp\u003eAmelia Medina represents\u0026nbsp;corporations, nonprofit organizations,\u0026nbsp;and board committees in major\u0026nbsp;investigations and disputes with government authorities.\u0026nbsp; A\u0026nbsp;partner in\u0026nbsp;King \u0026amp; Spalding's \u003cem\u003eChambers\u003c/em\u003e Band 1-ranked practice in Corporate Crime \u0026amp; Investigations, Amelia also specializes in litigation\u0026nbsp;involving\u0026nbsp;civil fraud,\u0026nbsp;national security, the\u0026nbsp;False Claims Act and \u003cem\u003equi tam \u003c/em\u003ewhistleblowers. Executives in regulated industries -- especially\u0026nbsp;life sciences, healthcare,\u0026nbsp;defense, technology, financial services, artificial intelligence, and government contracting --\u0026nbsp;turn to Amelia for her current insights about\u0026nbsp;domestic and\u0026nbsp;international law enforcement trends.\u003c/p\u003e\n\u003cp\u003ePrior to rejoining King \u0026amp; Spalding, Amelia served as Deputy Chief of Staff to the Director of the FBI, and as Senior Counsel to the U.S. Deputy Attorney General (DAG) at the Department of Justice.\u0026nbsp;\u0026nbsp;She also served as a federal criminal prosecutor\u0026nbsp;in the Financial Crimes \u0026amp; Public Corruption Unit of the U.S. Attorney\u0026rsquo;s Office for the Eastern District of Virginia.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAt the FBI, Amelia advised the Director and FBI leadership on all aspects of\u0026nbsp;investigations regarding complex financial fraud, healthcare fraud, procurement fraud and collusion,\u0026nbsp;trade sanctions and export controls,\u0026nbsp;cyber and security-related critical incidents, official corruption, counterintelligence, and issues before the National Security Council.\u0026nbsp; Amelia also prepared and advised\u0026nbsp;the FBI Director during numerous congressional hearings, including\u0026nbsp;at\u0026nbsp;\u0026ldquo;members only\u0026rdquo; classified briefings to the full U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Senior Counsel in the Office of the Deputy Attorney General from 2017-2018, Amelia managed a department-wide portfolio of corporate enforcement priorities, compliance initiatives, and\u0026nbsp;case-specific issues arising across Main Justice divisions and U.S. Attorneys\u0026rsquo; Offices, as well as multi-agency efforts with SEC, CFTC,\u0026nbsp;DHS, HHS, FDA,\u0026nbsp;and various agency Offices of Inspector General.\u0026nbsp; Amelia served as the first Chair of the Corporate Enforcement \u0026amp; Accountability Working Group, a leadership committee responsible for guiding the DOJ\u0026rsquo;s strategy and policies to combat corporate criminal and civil fraud nationwide. She played an integral part in the development and implementation of the Foreign Corrupt Practices Act Corporate Enforcement Policy and served as the principal staff counselor to the DAG on approvals of corporate compliance monitorships.\u003c/p\u003e\n\u003cp\u003eIn private practice, Amelia is experienced in steering responses to oversight requests by\u0026nbsp;congressional committees in the U.S. House and Senate. She also\u0026nbsp;prepares business leaders to give testimony at televised hearings before federal\u0026nbsp;and state legislative bodies.\u003c/p\u003e\n\u003cp\u003eAmelia\u0026nbsp;is a member of the invitation-only Edward Bennett Williams Inn of Court for\u0026nbsp;white collar practitioners in Washington, D.C. She serves on the boards of the Atlanta Police Foundation and The Goizueta Foundation.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAmelia\u0026nbsp;graduated Phi Beta Kappa from Princeton University, with a degree from the School of Public \u0026amp; International Affairs.\u0026nbsp; She holds a J.D. from Yale Law School and was a member of The Yale Law Journal.\u003c/p\u003e","slug":"amelia-medina","email":"amedina@kslaw.com","phone":"+1 202 900 0822","matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":1,"source":"smartTags"},{"id":110,"guid":"110.capabilities","index":2,"source":"capabilities"},{"id":687,"guid":"687.smart_tags","index":3,"source":"smartTags"},{"id":20,"guid":"20.capabilities","index":4,"source":"capabilities"},{"id":5,"guid":"5.smart_tags","index":5,"source":"smartTags"},{"id":118,"guid":"118.capabilities","index":6,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":7,"source":"capabilities"},{"id":1147,"guid":"1147.smart_tags","index":8,"source":"smartTags"},{"id":81,"guid":"81.capabilities","index":9,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":10,"source":"capabilities"},{"id":106,"guid":"106.capabilities","index":11,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":12,"source":"capabilities"},{"id":132,"guid":"132.capabilities","index":13,"source":"capabilities"},{"id":1199,"guid":"1199.smart_tags","index":14,"source":"smartTags"},{"id":1327,"guid":"1327.smart_tags","index":15,"source":"smartTags"},{"id":1248,"guid":"1248.smart_tags","index":16,"source":"smartTags"},{"id":1715,"guid":"1715.smart_tags","index":17,"source":"smartTags"}],"is_active":true,"last_name":"Medina","nick_name":"Amelia","clerkships":[{"name":"Law Clerk, Jose A. Cabranes, U.S. Court of Appeals for the Second Circuit","years_held":"2010-2011"},{"name":"Law Clerk, Michael M. Baylson, U.S. District Court for the Eastern District of Pennsylvania","years_held":"2011-2012"}],"first_name":"Amelia","title_rank":9999,"updated_by":202,"law_schools":[{"id":2605,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"2010-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"R.","name_suffix":"","recognitions":[{"title":"Selected for the White Collar Crime Editorial Advisory Board","detail":"Law360, 2024"},{"title":"Recommended nationally for Government: State Attorneys General","detail":"Legal 500, 2024"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eAmelia Medina represents\u0026nbsp;corporations, nonprofit organizations,\u0026nbsp;and board committees in major\u0026nbsp;investigations and disputes with government authorities.\u0026nbsp; A\u0026nbsp;partner in\u0026nbsp;King \u0026amp; Spalding's \u003cem\u003eChambers\u003c/em\u003e Band 1-ranked practice in Corporate Crime \u0026amp; Investigations, Amelia also specializes in litigation\u0026nbsp;involving\u0026nbsp;civil fraud,\u0026nbsp;national security, the\u0026nbsp;False Claims Act and \u003cem\u003equi tam \u003c/em\u003ewhistleblowers. Executives in regulated industries -- especially\u0026nbsp;life sciences, healthcare,\u0026nbsp;defense, technology, financial services, artificial intelligence, and government contracting --\u0026nbsp;turn to Amelia for her current insights about\u0026nbsp;domestic and\u0026nbsp;international law enforcement trends.\u003c/p\u003e\n\u003cp\u003ePrior to rejoining King \u0026amp; Spalding, Amelia served as Deputy Chief of Staff to the Director of the FBI, and as Senior Counsel to the U.S. Deputy Attorney General (DAG) at the Department of Justice.\u0026nbsp;\u0026nbsp;She also served as a federal criminal prosecutor\u0026nbsp;in the Financial Crimes \u0026amp; Public Corruption Unit of the U.S. Attorney\u0026rsquo;s Office for the Eastern District of Virginia.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAt the FBI, Amelia advised the Director and FBI leadership on all aspects of\u0026nbsp;investigations regarding complex financial fraud, healthcare fraud, procurement fraud and collusion,\u0026nbsp;trade sanctions and export controls,\u0026nbsp;cyber and security-related critical incidents, official corruption, counterintelligence, and issues before the National Security Council.\u0026nbsp; Amelia also prepared and advised\u0026nbsp;the FBI Director during numerous congressional hearings, including\u0026nbsp;at\u0026nbsp;\u0026ldquo;members only\u0026rdquo; classified briefings to the full U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Senior Counsel in the Office of the Deputy Attorney General from 2017-2018, Amelia managed a department-wide portfolio of corporate enforcement priorities, compliance initiatives, and\u0026nbsp;case-specific issues arising across Main Justice divisions and U.S. Attorneys\u0026rsquo; Offices, as well as multi-agency efforts with SEC, CFTC,\u0026nbsp;DHS, HHS, FDA,\u0026nbsp;and various agency Offices of Inspector General.\u0026nbsp; Amelia served as the first Chair of the Corporate Enforcement \u0026amp; Accountability Working Group, a leadership committee responsible for guiding the DOJ\u0026rsquo;s strategy and policies to combat corporate criminal and civil fraud nationwide. She played an integral part in the development and implementation of the Foreign Corrupt Practices Act Corporate Enforcement Policy and served as the principal staff counselor to the DAG on approvals of corporate compliance monitorships.\u003c/p\u003e\n\u003cp\u003eIn private practice, Amelia is experienced in steering responses to oversight requests by\u0026nbsp;congressional committees in the U.S. House and Senate. She also\u0026nbsp;prepares business leaders to give testimony at televised hearings before federal\u0026nbsp;and state legislative bodies.\u003c/p\u003e\n\u003cp\u003eAmelia\u0026nbsp;is a member of the invitation-only Edward Bennett Williams Inn of Court for\u0026nbsp;white collar practitioners in Washington, D.C. She serves on the boards of the Atlanta Police Foundation and The Goizueta Foundation.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAmelia\u0026nbsp;graduated Phi Beta Kappa from Princeton University, with a degree from the School of Public \u0026amp; International Affairs.\u0026nbsp; She holds a J.D. from Yale Law School and was a member of The Yale Law Journal.\u003c/p\u003e","recognitions":[{"title":"Selected for the White Collar Crime Editorial Advisory Board","detail":"Law360, 2024"},{"title":"Recommended nationally for Government: State Attorneys General","detail":"Legal 500, 2024"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12849}]},"capability_group_id":2},"created_at":"2025-12-18T22:13:05.000Z","updated_at":"2025-12-18T22:13:05.000Z","searchable_text":"Medina{{ FIELD }}{:title=\u0026gt;\"Selected for the White Collar Crime Editorial Advisory Board\", :detail=\u0026gt;\"Law360, 2024\"}{{ FIELD }}{:title=\u0026gt;\"Recommended nationally for Government: State Attorneys General\", :detail=\u0026gt;\"Legal 500, 2024\"}{{ FIELD }}Amelia Medina represents corporations, nonprofit organizations, and board committees in major investigations and disputes with government authorities.  A partner in King \u0026amp; Spalding's Chambers Band 1-ranked practice in Corporate Crime \u0026amp; Investigations, Amelia also specializes in litigation involving civil fraud, national security, the False Claims Act and qui tam whistleblowers. Executives in regulated industries -- especially life sciences, healthcare, defense, technology, financial services, artificial intelligence, and government contracting -- turn to Amelia for her current insights about domestic and international law enforcement trends.\nPrior to rejoining King \u0026amp; Spalding, Amelia served as Deputy Chief of Staff to the Director of the FBI, and as Senior Counsel to the U.S. Deputy Attorney General (DAG) at the Department of Justice.  She also served as a federal criminal prosecutor in the Financial Crimes \u0026amp; Public Corruption Unit of the U.S. Attorney’s Office for the Eastern District of Virginia. \nAt the FBI, Amelia advised the Director and FBI leadership on all aspects of investigations regarding complex financial fraud, healthcare fraud, procurement fraud and collusion, trade sanctions and export controls, cyber and security-related critical incidents, official corruption, counterintelligence, and issues before the National Security Council.  Amelia also prepared and advised the FBI Director during numerous congressional hearings, including at “members only” classified briefings to the full U.S. Congress. \nAs Senior Counsel in the Office of the Deputy Attorney General from 2017-2018, Amelia managed a department-wide portfolio of corporate enforcement priorities, compliance initiatives, and case-specific issues arising across Main Justice divisions and U.S. Attorneys’ Offices, as well as multi-agency efforts with SEC, CFTC, DHS, HHS, FDA, and various agency Offices of Inspector General.  Amelia served as the first Chair of the Corporate Enforcement \u0026amp; Accountability Working Group, a leadership committee responsible for guiding the DOJ’s strategy and policies to combat corporate criminal and civil fraud nationwide. She played an integral part in the development and implementation of the Foreign Corrupt Practices Act Corporate Enforcement Policy and served as the principal staff counselor to the DAG on approvals of corporate compliance monitorships.\nIn private practice, Amelia is experienced in steering responses to oversight requests by congressional committees in the U.S. House and Senate. She also prepares business leaders to give testimony at televised hearings before federal and state legislative bodies.\nAmelia is a member of the invitation-only Edward Bennett Williams Inn of Court for white collar practitioners in Washington, D.C. She serves on the boards of the Atlanta Police Foundation and The Goizueta Foundation.  \nAmelia graduated Phi Beta Kappa from Princeton University, with a degree from the School of Public \u0026amp; International Affairs.  She holds a J.D. from Yale Law School and was a member of The Yale Law Journal. Partner Selected for the White Collar Crime Editorial Advisory Board Law360, 2024 Recommended nationally for Government: State Attorneys General Legal 500, 2024 Princeton University  Yale University Yale Law School U.S. Court of Appeals for the Second Circuit U.S. District Court for the Northern District of Georgia District of Columbia Georgia Court of Appeals of Georgia Supreme Court of Georgia Hispanic National Bar Association Board of Directors, The Goizueta Foundation (2019-Present) Board of Directors, Latin American Association (2015-2017) Law Clerk, Jose A. Cabranes, U.S. Court of Appeals for the Second Circuit Law Clerk, Michael M. Baylson, U.S. District Court for the Eastern District of Pennsylvania","searchable_name":"Amelia R. Medina","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":426536,"version":1,"owner_type":"Person","owner_id":4090,"payload":{"bio":"\u003cp\u003eGary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food\u0026nbsp;and Drug Administration and other federal and state agencies.\u0026nbsp; Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes.\u0026nbsp; In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management.\u0026nbsp; Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.\u003c/p\u003e\n\u003cp\u003ePreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\u003c/p\u003e\n\u003cp\u003eA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by\u0026nbsp;\u003cem\u003eSuper Lawyers Washington, DC\u003c/em\u003e.\u003c/p\u003e","slug":"gary-messplay","email":"gmessplay@kslaw.com","phone":"+1 703 973 7500","matters":["\u003cp\u003eDeveloped customized, comprehensive healthcare compliance programs for numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and medical device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eServed as outside general counsel to \u003cstrong data-redactor-tag=\"strong\"\u003especialty pharmaceutical companies and emerging drug and device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eLed significant multi-year investigation for \u003cstrong data-redactor-tag=\"strong\"\u003ea large pharmaceutical company\u003c/strong\u003e involving complex data integrity issues related to their bioanalytics laboratory.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.\u003c/p\u003e","\u003cp\u003eConducted a significant number of compliance investigations on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies,\u003c/strong\u003e including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.\u003c/p\u003e","\u003cp\u003eRepresented Board of Directors of \u003cstrong data-redactor-tag=\"strong\"\u003epublicly traded pharmaceutical company\u003c/strong\u003e in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e on all aspects of compliance with their corporate integrity agreements.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea specialty pharmaceutical company\u003c/strong\u003e in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to clinical trial regulatory and compliance issues.\u003c/p\u003e","\u003cp\u003eAssisted \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e in developing and implementing specialty pharmacy programs.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with adverse FDA inspections, including responding to 483s and warning letters.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements.\u003c/p\u003e","\u003cp\u003eLed numerous regulatory and compliance due diligence teams in \u003cstrong data-redactor-tag=\"strong\"\u003edrug, device, tobacco and food transactions.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug, biotechnology, device, food and tobacco companies\u003c/strong\u003e on legislative matters including drafting and commenting on legislation.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":2,"guid":"2.capabilities","index":0,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":5,"source":"smartTags"},{"id":17,"guid":"17.capabilities","index":6,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":7,"source":"capabilities"},{"id":109,"guid":"109.capabilities","index":8,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":9,"source":"smartTags"}],"is_active":true,"last_name":"Messplay","nick_name":"Gary","clerkships":[],"first_name":"Gary","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"C.","name_suffix":"","recognitions":[{"title":"","detail":"Super 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A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food\u0026nbsp;and Drug Administration and other federal and state agencies.\u0026nbsp; Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes.\u0026nbsp; In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management.\u0026nbsp; Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.\u003c/p\u003e\n\u003cp\u003ePreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\u003c/p\u003e\n\u003cp\u003eA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by\u0026nbsp;\u003cem\u003eSuper Lawyers Washington, DC\u003c/em\u003e.\u003c/p\u003e","matters":["\u003cp\u003eDeveloped customized, comprehensive healthcare compliance programs for numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and medical device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eServed as outside general counsel to \u003cstrong data-redactor-tag=\"strong\"\u003especialty pharmaceutical companies and emerging drug and device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eLed significant multi-year investigation for \u003cstrong data-redactor-tag=\"strong\"\u003ea large pharmaceutical company\u003c/strong\u003e involving complex data integrity issues related to their bioanalytics laboratory.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.\u003c/p\u003e","\u003cp\u003eConducted a significant number of compliance investigations on behalf of \u003cstrong 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strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea specialty pharmaceutical company\u003c/strong\u003e in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to clinical trial regulatory and compliance issues.\u003c/p\u003e","\u003cp\u003eAssisted \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e in developing and implementing specialty pharmacy programs.\u003c/p\u003e","\u003cp\u003eRepresented 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data-redactor-tag=\"strong\"\u003edrug, biotechnology, device, food and tobacco companies\u003c/strong\u003e on legislative matters including drafting and commenting on legislation.\u003c/p\u003e"],"recognitions":[{"title":"","detail":"Super Lawyers, 2014, 2015 \u0026 2016"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4357}]},"capability_group_id":2},"created_at":"2025-05-26T04:54:29.000Z","updated_at":"2025-05-26T04:54:29.000Z","searchable_text":"Messplay{{ FIELD }}{:title=\u0026gt;\"\", :detail=\u0026gt;\"Super Lawyers, 2014, 2015 \u0026amp; 2016\"}{{ FIELD }}Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies.{{ FIELD }}Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies.{{ FIELD }}Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory.{{ FIELD }}Advised numerous drug and device companies related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.{{ FIELD }}Conducted a significant number of compliance investigations on behalf of drug and device companies, including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.{{ FIELD }}Represented Board of Directors of publicly traded pharmaceutical company in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.{{ FIELD }}Advised drug and device companies on all aspects of compliance with their corporate integrity agreements.{{ FIELD }}Advised numerous pharmaceutical companies on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.{{ FIELD }}Successfully represented a specialty pharmaceutical company in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.{{ FIELD }}Represented drug and device companies in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.{{ FIELD }}Advised drug and device companies related to clinical trial regulatory and compliance issues.{{ FIELD }}Assisted pharmaceutical companies in developing and implementing specialty pharmacy programs.{{ FIELD }}Represented drug and device companies in connection with adverse FDA inspections, including responding to 483s and warning letters.{{ FIELD }}Represented drug and device companies in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements.{{ FIELD }}Led numerous regulatory and compliance due diligence teams in drug, device, tobacco and food transactions.{{ FIELD }}Represented drug and device companies in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.{{ FIELD }}Advised drug, biotechnology, device, food and tobacco companies on legislative matters including drafting and commenting on legislation.{{ FIELD }}Gary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.\nGary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food and Drug Administration and other federal and state agencies.  Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes.  In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management.  Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.\nPreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\nA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by Super Lawyers Washington, DC. Partner  Super Lawyers, 2014, 2015 \u0026amp; 2016 District of Columbia Indiana Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies. Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies. Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory. Advised numerous drug and device companies related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement. Conducted a significant number of compliance investigations on behalf of drug and device companies, including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling. Represented Board of Directors of publicly traded pharmaceutical company in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute. Advised drug and device companies on all aspects of compliance with their corporate integrity agreements. Advised numerous pharmaceutical companies on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues. Successfully represented a specialty pharmaceutical company in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication. Represented drug and device companies in connection with FDA, OCI, Department of Justice, SEC and congressional investigations. Advised drug and device companies related to clinical trial regulatory and compliance issues. Assisted pharmaceutical companies in developing and implementing specialty pharmacy programs. Represented drug and device companies in connection with adverse FDA inspections, including responding to 483s and warning letters. Represented drug and device companies in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements. Led numerous regulatory and compliance due diligence teams in drug, device, tobacco and food transactions. Represented drug and device companies in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation. Advised drug, biotechnology, device, food and tobacco companies on legislative matters including drafting and commenting on legislation.","searchable_name":"Gary C. Messplay","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":426357,"version":1,"owner_type":"Person","owner_id":2817,"payload":{"bio":"\u003cp\u003eAs a partner in our Appellate, Constitutional and Administrative Law practice, Paul Mezzina focuses on appeals, critical motions and strategic counseling in connection with complex litigation.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePaul represents clients in a variety of matters, including those involving the False Claims Act, intellectual property, class actions, medical drugs and devices, antitrust, and professional liability.\u003c/p\u003e\n\u003cp\u003ePaul has authored briefs in numerous cases before the U.S. Supreme Court, federal courts of appeals and federal trial courts, and has presented oral argument in the Second, Fourth, Tenth, Eleventh, D.C. and Federal Circuits, as well as multiple state courts.\u003c/p\u003e\n\u003cp\u003ePaul is one of few attorneys in the country to have clerked for three U.S. Supreme Court Justices.\u003c/p\u003e","slug":"paul-mezzina","email":"pmezzina@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":952,"guid":"952.smart_tags","index":2,"source":"smartTags"},{"id":21,"guid":"21.capabilities","index":3,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":4,"source":"smartTags"},{"id":18,"guid":"18.capabilities","index":5,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":6,"source":"capabilities"},{"id":3,"guid":"3.capabilities","index":7,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":8,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":9,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":10,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":11,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":12,"source":"capabilities"},{"id":764,"guid":"764.smart_tags","index":13,"source":"smartTags"}],"is_active":true,"last_name":"Mezzina","nick_name":"Paul","clerkships":[{"name":"Law Clerk, Justice Antonin Scalia, Supreme Court of the United States","years_held":"2013-2014"},{"name":"Law Clerk, Judge Brett Kavanaugh, U.S. Court of Appeals for the D.C. Circuit","years_held":"2009-2010"},{"name":"Law Clerk, Justice Neil Gorsuch, Supreme Court of the United States","years_held":"2018 - 2019"}],"first_name":"Paul","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"Alessio","name_suffix":"","recognitions":null,"linked_in_url":"https://www.linkedin.com/in/paulmezzina/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eAs a partner in our Appellate, Constitutional and Administrative Law practice, Paul Mezzina focuses on appeals, critical motions and strategic counseling in connection with complex litigation.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePaul represents clients in a variety of matters, including those involving the False Claims Act, intellectual property, class actions, medical drugs and devices, antitrust, and professional liability.\u003c/p\u003e\n\u003cp\u003ePaul has authored briefs in numerous cases before the U.S. Supreme Court, federal courts of appeals and federal trial courts, and has presented oral argument in the Second, Fourth, Tenth, Eleventh, D.C. and Federal Circuits, as well as multiple state courts.\u003c/p\u003e\n\u003cp\u003ePaul is one of few attorneys in the country to have clerked for three U.S. Supreme Court Justices.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":70}]},"capability_group_id":3},"created_at":"2025-05-26T04:51:47.000Z","updated_at":"2025-05-26T04:51:47.000Z","searchable_text":"Mezzina{{ FIELD }}As a partner in our Appellate, Constitutional and Administrative Law practice, Paul Mezzina focuses on appeals, critical motions and strategic counseling in connection with complex litigation.\nPaul represents clients in a variety of matters, including those involving the False Claims Act, intellectual property, class actions, medical drugs and devices, antitrust, and professional liability.\nPaul has authored briefs in numerous cases before the U.S. Supreme Court, federal courts of appeals and federal trial courts, and has presented oral argument in the Second, Fourth, Tenth, Eleventh, D.C. and Federal Circuits, as well as multiple state courts.\nPaul is one of few attorneys in the country to have clerked for three U.S. Supreme Court Justices. Partner Harvard University Harvard 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 Central District of California U.S. District Court for the District of Columbia District of Columbia Law Clerk, Justice Antonin Scalia, Supreme Court of the United States Law Clerk, Judge Brett Kavanaugh, U.S. Court of Appeals for the D.C. Circuit Law Clerk, Justice Neil Gorsuch, Supreme Court of the United States","searchable_name":"Paul Alessio Mezzina","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":442801,"version":1,"owner_type":"Person","owner_id":5630,"payload":{"bio":"\u003cp\u003eGenevi\u0026egrave;ve Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\u003c/p\u003e\n\u003cp\u003eRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Genevi\u0026egrave;ve assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve\u0026rsquo;s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\u003c/p\u003e\n\u003cp\u003eShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 2019, \u0026ldquo;Are the paediatric rewards adapted? \u0026ldquo;, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\u003c/li\u003e\n\u003cli\u003eMay 30, 2019, \u0026ldquo;The regulation of advanced therapy medicinal products\u0026rdquo;\u0026nbsp;\u003cem\u003eLexisNexis.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2017, \u0026ldquo;Pediatric Regulation \u0026ndash; A Better application for more efficient incentives,\u0026rdquo;\u0026nbsp;\u003cem\u003eThe European Files, Medicines of the Future.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eSeptember 2016, \u0026ldquo;Should Anthroposophic Medicinal Products Be Regulated in Europe?\u0026rdquo;\u0026nbsp;\u003cem\u003eJournal of European Health Law\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJune 8, 2016, \u0026ldquo;Demonstrating Significant Benefit For Orphan Medicines \u0026ndash; Is It Time For A Drastic Change?\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;EU Pediatric Rewards \u0026ndash; More Questions than Answers,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eFebruary 2016, \u0026ldquo;The Need For Clarification On Post-Market Requirements For Pediatric Medicines,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSeptember 9, 2019, \u0026ldquo;\u003cem\u003eSummary of Key EUCJ Decisions\u003c/em\u003e,\u0026rdquo; European Pharmaceutical Law Academy.\u003c/li\u003e\n\u003cli\u003eJune 5, 2019, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eSeptember 10, 2018, \u0026ldquo;ATMP Regulatory Framework\u003cem\u003e,\u0026rdquo;\u0026nbsp;\u003c/em\u003eEuropean Pharmaceutical Law Academy, Cambridge, UK.\u003c/li\u003e\n\u003cli\u003eJune 2018, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eMay 15, 2018, \u0026ldquo;International Labeling Regulatory Requirements,\u0026rdquo; co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\u003c/li\u003e\n\u003cli\u003eMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\u003c/li\u003e\n\u003cli\u003eMarch 2018, ATMPs \u0026ndash; Challenges and Promises, ERA, EU Pharmaceutical Law.\u003c/li\u003e\n\u003cli\u003eNovember 2017, Borderline issues, Congr\u0026egrave;s Parfums \u0026amp; Cosm\u0026eacute;tiques, Enjeux r\u0026eacute;glementaires, Chartres.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\u003c/li\u003e\n\u003cli\u003eJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\u003c/li\u003e\n\u003cli\u003eMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\u003c/li\u003e\n\u003cli\u003eNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Protection for Mature Product,\u0026rdquo; DIA, 28th Annual EuroMeeting, Hamburg.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Interactions between regulatory and intellectual property, product liability and data privacy,\u0026rdquo; DIA, 28th Annual EuroMeeting in Hamburg.\u003c/li\u003e\n\u003c/ul\u003e","slug":"genevieve-michaux","email":"gmichaux@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":1,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":5,"source":"capabilities"},{"id":780,"guid":"780.smart_tags","index":6,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":7,"source":"smartTags"},{"id":970,"guid":"970.smart_tags","index":8,"source":"smartTags"},{"id":112,"guid":"112.capabilities","index":9,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":10,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":11,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":12,"source":"smartTags"},{"id":128,"guid":"128.capabilities","index":13,"source":"capabilities"}],"is_active":true,"last_name":"Michaux","nick_name":"Geneviève","clerkships":[],"first_name":"Geneviève","title_rank":9999,"updated_by":101,"law_schools":[{"id":824,"meta":{"degree":"Law Degree","honors":null,"is_law_school":1,"graduation_date":"1996-01-01 00:00:00 UTC"},"order":0,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Ranked in the Regulatory Practice","detail":"Best Lawyers Belgium, 2022"},{"title":"Global Elite Thought Leaders EMEA","detail":"WWL Life Sciences Report, 2022"},{"title":"Who's Who Legal, Life Sciences","detail":"2011–2022"},{"title":"Excellent in Healthcare, pharmaceuticals \u0026 biotech","detail":"Leadersleague Décideurs Belgium Life Sciences guide, 2021"},{"title":"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology","detail":"2012"},{"title":"PLC Which Lawyer?, Life Sciences","detail":"Regulatory, EU, 2012"},{"title":"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study","detail":"1988"}],"linked_in_url":"https://www.linkedin.com/in/geneviève-michaux-165829/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eGenevi\u0026egrave;ve Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\u003c/p\u003e\n\u003cp\u003eRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Genevi\u0026egrave;ve assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve\u0026rsquo;s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\u003c/p\u003e\n\u003cp\u003eShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 2019, \u0026ldquo;Are the paediatric rewards adapted? \u0026ldquo;, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\u003c/li\u003e\n\u003cli\u003eMay 30, 2019, \u0026ldquo;The regulation of advanced therapy medicinal products\u0026rdquo;\u0026nbsp;\u003cem\u003eLexisNexis.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2017, \u0026ldquo;Pediatric Regulation \u0026ndash; A Better application for more efficient incentives,\u0026rdquo;\u0026nbsp;\u003cem\u003eThe European Files, Medicines of the Future.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eSeptember 2016, \u0026ldquo;Should Anthroposophic Medicinal Products Be Regulated in Europe?\u0026rdquo;\u0026nbsp;\u003cem\u003eJournal of European Health Law\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJune 8, 2016, \u0026ldquo;Demonstrating Significant Benefit For Orphan Medicines \u0026ndash; Is It Time For A Drastic Change?\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;EU Pediatric Rewards \u0026ndash; More Questions than Answers,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eFebruary 2016, \u0026ldquo;The Need For Clarification On Post-Market Requirements For Pediatric Medicines,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSeptember 9, 2019, \u0026ldquo;\u003cem\u003eSummary of Key EUCJ Decisions\u003c/em\u003e,\u0026rdquo; European Pharmaceutical Law Academy.\u003c/li\u003e\n\u003cli\u003eJune 5, 2019, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eSeptember 10, 2018, \u0026ldquo;ATMP Regulatory Framework\u003cem\u003e,\u0026rdquo;\u0026nbsp;\u003c/em\u003eEuropean Pharmaceutical Law Academy, Cambridge, UK.\u003c/li\u003e\n\u003cli\u003eJune 2018, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eMay 15, 2018, \u0026ldquo;International Labeling Regulatory Requirements,\u0026rdquo; co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\u003c/li\u003e\n\u003cli\u003eMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\u003c/li\u003e\n\u003cli\u003eMarch 2018, ATMPs \u0026ndash; Challenges and Promises, ERA, EU Pharmaceutical Law.\u003c/li\u003e\n\u003cli\u003eNovember 2017, Borderline issues, Congr\u0026egrave;s Parfums \u0026amp; Cosm\u0026eacute;tiques, Enjeux r\u0026eacute;glementaires, Chartres.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\u003c/li\u003e\n\u003cli\u003eJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\u003c/li\u003e\n\u003cli\u003eMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\u003c/li\u003e\n\u003cli\u003eNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Protection for Mature Product,\u0026rdquo; DIA, 28th Annual EuroMeeting, Hamburg.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Interactions between regulatory and intellectual property, product liability and data privacy,\u0026rdquo; DIA, 28th Annual EuroMeeting in Hamburg.\u003c/li\u003e\n\u003c/ul\u003e","recognitions":[{"title":"Ranked in the Regulatory Practice","detail":"Best Lawyers Belgium, 2022"},{"title":"Global Elite Thought Leaders EMEA","detail":"WWL Life Sciences Report, 2022"},{"title":"Who's Who Legal, Life Sciences","detail":"2011–2022"},{"title":"Excellent in Healthcare, pharmaceuticals \u0026 biotech","detail":"Leadersleague Décideurs Belgium Life Sciences guide, 2021"},{"title":"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology","detail":"2012"},{"title":"PLC Which Lawyer?, Life Sciences","detail":"Regulatory, EU, 2012"},{"title":"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study","detail":"1988"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":8884}]},"capability_group_id":2},"created_at":"2025-11-13T04:57:39.000Z","updated_at":"2025-11-13T04:57:39.000Z","searchable_text":"Michaux{{ FIELD }}{:title=\u0026gt;\"Ranked in the Regulatory Practice\", :detail=\u0026gt;\"Best Lawyers Belgium, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Global Elite Thought Leaders EMEA\", :detail=\u0026gt;\"WWL Life Sciences Report, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Who's Who Legal, Life Sciences\", :detail=\u0026gt;\"2011–2022\"}{{ FIELD }}{:title=\u0026gt;\"Excellent in Healthcare, pharmaceuticals \u0026amp; biotech\", :detail=\u0026gt;\"Leadersleague Décideurs Belgium Life Sciences guide, 2021\"}{{ FIELD }}{:title=\u0026gt;\"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology\", :detail=\u0026gt;\"2012\"}{{ FIELD }}{:title=\u0026gt;\"PLC Which Lawyer?, Life Sciences\", :detail=\u0026gt;\"Regulatory, EU, 2012\"}{{ FIELD }}{:title=\u0026gt;\"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study\", :detail=\u0026gt;\"1988\"}{{ FIELD }}Geneviève Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\nRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.\nGeneviève’s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\nShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\nGeneviève has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\nGeneviève is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\nPublications\n\nOctober 2019, “Are the paediatric rewards adapted? “, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\nMay 30, 2019, “The regulation of advanced therapy medicinal products” LexisNexis.\nApril 2017, “Pediatric Regulation – A Better application for more efficient incentives,” The European Files, Medicines of the Future.\nSeptember 2016, “Should Anthroposophic Medicinal Products Be Regulated in Europe?” Journal of European Health Law\nJune 8, 2016, “Demonstrating Significant Benefit For Orphan Medicines – Is It Time For A Drastic Change?” Scrip Regulatory Affairs.\nApril 2016, “EU Pediatric Rewards – More Questions than Answers,” Scrip Regulatory Affairs.\nFebruary 2016, “The Need For Clarification On Post-Market Requirements For Pediatric Medicines,” Scrip Regulatory Affairs.\n\nSpeaking Engagements\n\nSeptember 9, 2019, “Summary of Key EUCJ Decisions,” European Pharmaceutical Law Academy.\nJune 5, 2019, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.\nSeptember 10, 2018, “ATMP Regulatory Framework,” European Pharmaceutical Law Academy, Cambridge, UK.\nJune 2018, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.\nMay 15, 2018, “International Labeling Regulatory Requirements,” co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\nMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\nMarch 2018, ATMPs – Challenges and Promises, ERA, EU Pharmaceutical Law.\nNovember 2017, Borderline issues, Congrès Parfums \u0026amp; Cosmétiques, Enjeux réglementaires, Chartres.\nSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\nSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\nJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London. \nMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\nMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\nNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\nApril 2016, “Protection for Mature Product,” DIA, 28th Annual EuroMeeting, Hamburg.\nApril 2016, “Interactions between regulatory and intellectual property, product liability and data privacy,” DIA, 28th Annual EuroMeeting in Hamburg.\n Partner Ranked in the Regulatory Practice Best Lawyers Belgium, 2022 Global Elite Thought Leaders EMEA WWL Life Sciences Report, 2022 Who's Who Legal, Life Sciences 2011–2022 Excellent in Healthcare, pharmaceuticals \u0026amp; biotech Leadersleague Décideurs Belgium Life Sciences guide, 2021 Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology 2012 PLC Which Lawyer?, Life Sciences Regulatory, EU, 2012 de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study 1988 Harvard University Harvard Law School Universite Libre de Bruxelles, Belgium  Paris Brussels Member of the editorial board of SCRIP Regulatory Affairs Mediator with the Brussels Business Mediation Center Member of the DIA Advisory Committee for Europe Middle East Africa Foreign Correspondent Member of the National Academy of Pharmacy (France)","searchable_name":"Geneviève Michaux","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":424306,"version":1,"owner_type":"Person","owner_id":7087,"payload":{"bio":"\u003cp\u003eA partner on the Special Matters \u0026amp; Government Investigations team, Pat Murphy leverages over two decades of high-level in-house and public sector experience to provide strategic solutions for clients. He focuses on high profile corporate internal investigations, complex litigation, enforcement actions and compliance matters, particularly for clients in the pharmaceutical, medical device, and broader life sciences sectors. He is recognized as a trusted advisor to boards, senior executives and legal teams for his work in internal investigations, particularly the Anti-Kickback Statute, False Claims Act, the Foreign Corrupt Practices Act and global crisis management. Pat rejoined King \u0026amp; Spalding after serving in senior legal leadership roles at two major healthcare companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePat is a 20 year veteran of the General Electric legal department where he spent 5 years in the Corporate Litigation group and nearly 15 years as GE Healthcare\u0026rsquo;s Global Chief Litigation Counsel. He has an acute understanding of the challenges and cost pressures facing in-house legal departments. He has a strong background personally handling and managing all aspects of high-profile investigations, is a trusted advisor in the implementation of effective Compliance programs, and the efficient managing of litigation matters. He also has extensive experience directly interfacing with government enforcement authorities worldwide.\u003c/p\u003e\n\u003cp\u003ePat is a leading authority in the structuring, managing and implementing cost effective strategies around Independent Monitorships. Prior to rejoining K\u0026amp;S, Pat served as Global Chief Litigation Counsel to Fresenius Medical Care, the world\u0026rsquo;s largest renal care provider with operations in more than 100 countries. He led the Company through the resolution of a major FCPA matter, including managing the appointment of the DOJ and SEC required Monitorship. In addition, he drove the DOJ and SEC certification of Fresenius\u0026rsquo; effective Compliance program following the implementation of over 100 improvements.\u003c/p\u003e\n\u003cp\u003ePat\u0026rsquo;s public service includes roles as Chief Counsel to the Crime and Technology Unit of the U.S. Senate Judiciary Committee Majority Staff and Assistant General Counsel to the FBI. He was a principal drafter of the Economic Espionage Act and began his legal career as a Judge Advocate in the U.S. Marine Corps, attaining the rank of Major. He later served in the Pentagon as the liaison between the Secretary of Defense\u0026rsquo;s Office and the Solicitor General\u0026rsquo;s Office on terrorism related litigation.\u003c/p\u003e\n\u003cp\u003ePat is also an adjunct professor at Catholic University, where he developed a course on Global In-House Practice. Outside of work, Pat enjoys coaching football and rugby and competing in triathlons.\u003c/p\u003e","slug":"patrick-murphy","email":"pjmurphy@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":3,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":4,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"Murphy","nick_name":"Pat","clerkships":[],"first_name":"Patrick","title_rank":9999,"updated_by":34,"law_schools":[{"id":3010,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"1989-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"J.","name_suffix":"","recognitions":null,"linked_in_url":"https://www.linkedin.com/in/patrick-murphy-2451a99/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eA partner on the Special Matters \u0026amp; Government Investigations team, Pat Murphy leverages over two decades of high-level in-house and public sector experience to provide strategic solutions for clients. He focuses on high profile corporate internal investigations, complex litigation, enforcement actions and compliance matters, particularly for clients in the pharmaceutical, medical device, and broader life sciences sectors. He is recognized as a trusted advisor to boards, senior executives and legal teams for his work in internal investigations, particularly the Anti-Kickback Statute, False Claims Act, the Foreign Corrupt Practices Act and global crisis management. Pat rejoined King \u0026amp; Spalding after serving in senior legal leadership roles at two major healthcare companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePat is a 20 year veteran of the General Electric legal department where he spent 5 years in the Corporate Litigation group and nearly 15 years as GE Healthcare\u0026rsquo;s Global Chief Litigation Counsel. He has an acute understanding of the challenges and cost pressures facing in-house legal departments. He has a strong background personally handling and managing all aspects of high-profile investigations, is a trusted advisor in the implementation of effective Compliance programs, and the efficient managing of litigation matters. He also has extensive experience directly interfacing with government enforcement authorities worldwide.\u003c/p\u003e\n\u003cp\u003ePat is a leading authority in the structuring, managing and implementing cost effective strategies around Independent Monitorships. Prior to rejoining K\u0026amp;S, Pat served as Global Chief Litigation Counsel to Fresenius Medical Care, the world\u0026rsquo;s largest renal care provider with operations in more than 100 countries. He led the Company through the resolution of a major FCPA matter, including managing the appointment of the DOJ and SEC required Monitorship. In addition, he drove the DOJ and SEC certification of Fresenius\u0026rsquo; effective Compliance program following the implementation of over 100 improvements.\u003c/p\u003e\n\u003cp\u003ePat\u0026rsquo;s public service includes roles as Chief Counsel to the Crime and Technology Unit of the U.S. Senate Judiciary Committee Majority Staff and Assistant General Counsel to the FBI. He was a principal drafter of the Economic Espionage Act and began his legal career as a Judge Advocate in the U.S. Marine Corps, attaining the rank of Major. He later served in the Pentagon as the liaison between the Secretary of Defense\u0026rsquo;s Office and the Solicitor General\u0026rsquo;s Office on terrorism related litigation.\u003c/p\u003e\n\u003cp\u003ePat is also an adjunct professor at Catholic University, where he developed a course on Global In-House Practice. Outside of work, Pat enjoys coaching football and rugby and competing in triathlons.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12766}]},"capability_group_id":2},"created_at":"2025-05-16T22:02:33.000Z","updated_at":"2025-05-16T22:02:33.000Z","searchable_text":"Murphy{{ FIELD }}A partner on the Special Matters \u0026amp; Government Investigations team, Pat Murphy leverages over two decades of high-level in-house and public sector experience to provide strategic solutions for clients. He focuses on high profile corporate internal investigations, complex litigation, enforcement actions and compliance matters, particularly for clients in the pharmaceutical, medical device, and broader life sciences sectors. He is recognized as a trusted advisor to boards, senior executives and legal teams for his work in internal investigations, particularly the Anti-Kickback Statute, False Claims Act, the Foreign Corrupt Practices Act and global crisis management. Pat rejoined King \u0026amp; Spalding after serving in senior legal leadership roles at two major healthcare companies.\nPat is a 20 year veteran of the General Electric legal department where he spent 5 years in the Corporate Litigation group and nearly 15 years as GE Healthcare’s Global Chief Litigation Counsel. He has an acute understanding of the challenges and cost pressures facing in-house legal departments. He has a strong background personally handling and managing all aspects of high-profile investigations, is a trusted advisor in the implementation of effective Compliance programs, and the efficient managing of litigation matters. He also has extensive experience directly interfacing with government enforcement authorities worldwide.\nPat is a leading authority in the structuring, managing and implementing cost effective strategies around Independent Monitorships. Prior to rejoining K\u0026amp;S, Pat served as Global Chief Litigation Counsel to Fresenius Medical Care, the world’s largest renal care provider with operations in more than 100 countries. He led the Company through the resolution of a major FCPA matter, including managing the appointment of the DOJ and SEC required Monitorship. In addition, he drove the DOJ and SEC certification of Fresenius’ effective Compliance program following the implementation of over 100 improvements.\nPat’s public service includes roles as Chief Counsel to the Crime and Technology Unit of the U.S. Senate Judiciary Committee Majority Staff and Assistant General Counsel to the FBI. He was a principal drafter of the Economic Espionage Act and began his legal career as a Judge Advocate in the U.S. Marine Corps, attaining the rank of Major. He later served in the Pentagon as the liaison between the Secretary of Defense’s Office and the Solicitor General’s Office on terrorism related litigation.\nPat is also an adjunct professor at Catholic University, where he developed a course on Global In-House Practice. Outside of work, Pat enjoys coaching football and rugby and competing in triathlons. Partner Catholic University of America Columbus School of Law Columbus School of Law, Catholic University of America Columbus School of Law, Catholic University of America District of Columbia","searchable_name":"Patrick J. Murphy (Pat)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":34,"capability_group_featured":null,"home_page_featured":null},{"id":442406,"version":1,"owner_type":"Person","owner_id":1253,"payload":{"bio":"\u003cp\u003eMegan Michelsen is a lawyer with King \u0026amp; Spalding\u0026rsquo;s Mass Tort and Toxic Tort practice. Her practice focuses mainly on the representation of clients in the pharmaceutical industry and other FDA-regulated clients. She has experience with large-scale, multidistrict litigations as well as individual product liability actions.\u003c/p\u003e","slug":"megan-michelsen","email":"mmichelsen@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":1,"guid":"1.capabilities","index":0,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":1,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":2,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":3,"source":"capabilities"},{"id":16,"guid":"16.capabilities","index":4,"source":"capabilities"},{"id":74,"guid":"74.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":1256,"guid":"1256.smart_tags","index":8,"source":"smartTags"},{"id":129,"guid":"129.capabilities","index":9,"source":"capabilities"}],"is_active":true,"last_name":"Michelsen","nick_name":"Megan","clerkships":[],"first_name":"Megan","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":"M.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":2,"translated_fields":{"en":{"bio":"\u003cp\u003eMegan Michelsen is a lawyer with King \u0026amp; Spalding\u0026rsquo;s Mass Tort and Toxic Tort practice. Her practice focuses mainly on the representation of clients in the pharmaceutical industry and other FDA-regulated clients. She has experience with large-scale, multidistrict litigations as well as individual product liability actions.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1062}]},"capability_group_id":3},"created_at":"2025-11-05T05:04:28.000Z","updated_at":"2025-11-05T05:04:28.000Z","searchable_text":"Michelsen{{ FIELD }}Megan Michelsen is a lawyer with King \u0026amp; Spalding’s Mass Tort and Toxic Tort practice. Her practice focuses mainly on the representation of clients in the pharmaceutical industry and other FDA-regulated clients. She has experience with large-scale, multidistrict litigations as well as individual product liability actions. Associate McDaniel College  University of Maryland  Georgia State Bar of Georgia","searchable_name":"Megan M. Michelsen","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":446334,"version":1,"owner_type":"Person","owner_id":6024,"payload":{"bio":"\u003cp\u003eBren Moreno counsels pharmaceutical, biotechnology, and medical device manufacturers on a range of regulatory and compliance issues that impact their sales, marketing, and pricing activities. She advises on federal and state transparency laws, such as the federal Physician Payments Sunshine Act (Open Payments) and state drug price transparency laws. She\u0026nbsp;provides counsel on these issues and others, such as state aggregate spend, gift ban, sales representative licensing, compliance program laws, and\u0026nbsp;related industry standards, to the Ad Hoc Sunshine and State Law Compliance Group, a coalition of life sciences manufacturers. Bren also regularly advises\u0026nbsp;on issues related to government price-setting efforts effectuated through the Inflation Reduction Act\u0026rsquo;s Medicare Drug Price Negotiation Program and state prescription drug affordability boards (PDABs). She also has experience with pharmaceutical government pricing and price reporting matters.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAfter studying Biology and Bioethics at the Ohio State University, Bren attended Saint Louis University School of Law, where she\u0026nbsp;served as\u0026nbsp;president of the Health Law Association and Notes \u0026amp; Comments Managing Editor of the Journal of Health Law \u0026amp; Policy.\u0026nbsp;\u003c/p\u003e","slug":"brenna-moreno","email":"bmoreno@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"}],"is_active":true,"last_name":"Moreno","nick_name":"Bren","clerkships":[],"first_name":"Brenna","title_rank":9999,"updated_by":202,"law_schools":[{"id":1732,"meta":{"degree":"J.D.","honors":"summa cum laude","is_law_school":"1","graduation_date":"2022-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":2,"translated_fields":{"en":{"bio":"\u003cp\u003eBren Moreno counsels pharmaceutical, biotechnology, and medical device manufacturers on a range of regulatory and compliance issues that impact their sales, marketing, and pricing activities. She advises on federal and state transparency laws, such as the federal Physician Payments Sunshine Act (Open Payments) and state drug price transparency laws. She\u0026nbsp;provides counsel on these issues and others, such as state aggregate spend, gift ban, sales representative licensing, compliance program laws, and\u0026nbsp;related industry standards, to the Ad Hoc Sunshine and State Law Compliance Group, a coalition of life sciences manufacturers. Bren also regularly advises\u0026nbsp;on issues related to government price-setting efforts effectuated through the Inflation Reduction Act\u0026rsquo;s Medicare Drug Price Negotiation Program and state prescription drug affordability boards (PDABs). She also has experience with pharmaceutical government pricing and price reporting matters.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAfter studying Biology and Bioethics at the Ohio State University, Bren attended Saint Louis University School of Law, where she\u0026nbsp;served as\u0026nbsp;president of the Health Law Association and Notes \u0026amp; Comments Managing Editor of the Journal of Health Law \u0026amp; Policy.\u0026nbsp;\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9982}]},"capability_group_id":2},"created_at":"2026-03-02T21:59:52.000Z","updated_at":"2026-03-02T21:59:52.000Z","searchable_text":"Moreno{{ FIELD }}Bren Moreno counsels pharmaceutical, biotechnology, and medical device manufacturers on a range of regulatory and compliance issues that impact their sales, marketing, and pricing activities. She advises on federal and state transparency laws, such as the federal Physician Payments Sunshine Act (Open Payments) and state drug price transparency laws. She provides counsel on these issues and others, such as state aggregate spend, gift ban, sales representative licensing, compliance program laws, and related industry standards, to the Ad Hoc Sunshine and State Law Compliance Group, a coalition of life sciences manufacturers. Bren also regularly advises on issues related to government price-setting efforts effectuated through the Inflation Reduction Act’s Medicare Drug Price Negotiation Program and state prescription drug affordability boards (PDABs). She also has experience with pharmaceutical government pricing and price reporting matters.\nAfter studying Biology and Bioethics at the Ohio State University, Bren attended Saint Louis University School of Law, where she served as president of the Health Law Association and Notes \u0026amp; Comments Managing Editor of the Journal of Health Law \u0026amp; Policy.  Associate The Ohio State University Michael E. Moritz College of Law Saint Louis University Saint Louis University School of Law","searchable_name":"Brenna Moreno (Bren)","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":427255,"version":1,"owner_type":"Person","owner_id":6548,"payload":{"bio":"\u003cp\u003eMichael Mosher represents Fortune 100 and other large companies in a diverse range of complex matters, including toxic and environmental torts, products liability, and consumer litigation. He has experience in high-stakes litigation and his cases frequently include novel medical, scientific and legal issues. As part of his practice, Michael has drafted dispositive and discovery motions, assisted in developing litigation and trial strategy, spearheaded fact investigations, and helped secure both favorable settlements and dismissals.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMichael joined the firm after graduating from Loyola Law School. While in school, he externed for the Honorable R. Gary Klausner at the United States District Court for the Central District of California, as well as the Honorable Sheri Bluebond at the United States Bankruptcy Court for the Central District of California. Michael also served as a Senior Production Editor for the\u0026nbsp;\u003cem\u003eLoyola of Los Angeles Law Review\u003c/em\u003e.\u003c/p\u003e\n\u003cp\u003eIn his last semester, Michael competed in the Scott Moot Court Competition, where he wrote a U.S. Supreme Court brief and argued complex Second and Fourth Amendment issues. He won the award for Best Brief and was a finalist in the oral argument portion of the competition.\u003c/p\u003e","slug":"michael-mosher","email":"mmosher@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[{"id":3570}]},"expertise":[{"id":17,"guid":"17.capabilities","index":0,"source":"capabilities"},{"id":74,"guid":"74.capabilities","index":1,"source":"capabilities"},{"id":16,"guid":"16.capabilities","index":2,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":3,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":4,"source":"capabilities"}],"is_active":true,"last_name":"Mosher","nick_name":"Michael","clerkships":[],"first_name":"Michael","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":"Michael Mosher is an  associate of our Product Liability \u0026 Mass Torts Practice Group. Read more about him.","primary_title_id":2,"translated_fields":{"en":{"bio":"\u003cp\u003eMichael Mosher represents Fortune 100 and other large companies in a diverse range of complex matters, including toxic and environmental torts, products liability, and consumer litigation. He has experience in high-stakes litigation and his cases frequently include novel medical, scientific and legal issues. As part of his practice, Michael has drafted dispositive and discovery motions, assisted in developing litigation and trial strategy, spearheaded fact investigations, and helped secure both favorable settlements and dismissals.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMichael joined the firm after graduating from Loyola Law School. While in school, he externed for the Honorable R. Gary Klausner at the United States District Court for the Central District of California, as well as the Honorable Sheri Bluebond at the United States Bankruptcy Court for the Central District of California. Michael also served as a Senior Production Editor for the\u0026nbsp;\u003cem\u003eLoyola of Los Angeles Law Review\u003c/em\u003e.\u003c/p\u003e\n\u003cp\u003eIn his last semester, Michael competed in the Scott Moot Court Competition, where he wrote a U.S. Supreme Court brief and argued complex Second and Fourth Amendment issues. He won the award for Best Brief and was a finalist in the oral argument portion of the competition.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12420}]},"capability_group_id":3},"created_at":"2025-05-26T04:59:27.000Z","updated_at":"2025-05-26T04:59:27.000Z","searchable_text":"Mosher{{ FIELD }}Michael Mosher represents Fortune 100 and other large companies in a diverse range of complex matters, including toxic and environmental torts, products liability, and consumer litigation. He has experience in high-stakes litigation and his cases frequently include novel medical, scientific and legal issues. As part of his practice, Michael has drafted dispositive and discovery motions, assisted in developing litigation and trial strategy, spearheaded fact investigations, and helped secure both favorable settlements and dismissals. \nMichael joined the firm after graduating from Loyola Law School. While in school, he externed for the Honorable R. Gary Klausner at the United States District Court for the Central District of California, as well as the Honorable Sheri Bluebond at the United States Bankruptcy Court for the Central District of California. Michael also served as a Senior Production Editor for the Loyola of Los Angeles Law Review.\nIn his last semester, Michael competed in the Scott Moot Court Competition, where he wrote a U.S. Supreme Court brief and argued complex Second and Fourth Amendment issues. He won the award for Best Brief and was a finalist in the oral argument portion of the competition. Michael Mosher lawyer Associate Loyola Law School Loyola Law School Central District of California California","searchable_name":"Michael Mosher","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}]}}