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Concentrating in complex criminal and civil litigation, Dan regularly represents life sciences companies, financial institutions, other highly-regulated companies, and their boards and senior executives in high-profile and sensitive investigations and litigation.\u0026nbsp; Dan has special experience in matters involving: life sciences criminal and civil investigations; Congressional investigations;\u0026nbsp;the False Claims Act; financial crimes, the Foreign Corrupt Practices Act (FCPA);\u0026nbsp; antitrust and market manipulation matters; the securities laws; whistleblower cases; and transnational tax investigations.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDan has special experience in cases involving allegations of off-label promotion and kickbacks in the life sciences industry and represented clients in the three largest Anti-Kickback Statute investigations ever resolved with DOJ.\u0026nbsp; Dan also has special experience in state attorney general investigations, and has personally negotiated quiet resolutions with all 50 state AG offices and the District of Columbia.\u0026nbsp; In addition, Dan has considerable experience defending clients in multi-jurisdictional investigations and litigation conducted cooperatively by United States, European, Middle Eastern, Asian and African authorities\u003c/p\u003e\n\u003cp\u003eThe Special Matters \u0026amp; Government Investigations group has been twice recognized by\u0026nbsp;\u003cem\u003eLaw 360\u003c/em\u003e\u0026nbsp;as the \u0026ldquo;White-Collar Group of the Year\u0026rdquo; and described as \u0026ldquo;the premier firm in this practice area\u0026rdquo; by the\u0026nbsp;\u003cem\u003eU.S. News \u0026amp; World Report/Best Lawyers\u0026rsquo;\u003c/em\u003e\u0026nbsp;\u0026ldquo;Best Law Firms\u0026rdquo; survey.\u003c/p\u003e\n\u003cp\u003eDan began his legal career as a law clerk to the Honorable Richard D. Bennett of the United States District Court for the District of Maryland. \u0026nbsp;He received his J.D. from Georgetown University Law Center, where he was an Editorial Board Member of the Tax Lawyer law journal, and his B.A. in economics from Yale University, where he was a Division I All New England Scholar Athlete lacrosse player.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDan holds Top Secret/SCI security clearances until their expiration.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eDan is a regular contributor to the American Bar Association's Criminal Litigation Section's Practice Points publication\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eThe US v. Vascular Solutions Acquittal: Three Lessons for Targets of Off-Label Promotion Enforcement\u003c/em\u003e, Washington Legal Foundation Legal Backgrounder (2016)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eRecent Trends in Health Care Enforcement and Compliance\u003c/em\u003e, Inside the Minds: Health Care Law Enforcement and Compliance (Apastore 2013)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eThe Future of Off-Label Promotion Enforcement in the Wake of Caronia \u0026mdash; Toward a First Amendment Safe Harbor\u003c/em\u003e, The Sedona Conference Journal, Volume 14 (2013)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eOff-Label Promotion: The Criminalization of Scientific Exchange\u003c/em\u003e, Pharma Magazine (UK) (2013)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eFDA as Arbiter of Truth? The First Amendment, Caronia, and the Future of Off-Label Promotion Enforcement\u003c/em\u003e, ABA White Collar Crime (2013)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eTenure Trap: Third Circuit Joins Sixth in Holding Tenure Buy-out Payments Subject to FICA Taxation in University of Pittsburgh v. United States\u003c/em\u003e, The Tax Lawyer, Volume 63 (2010)\u003c/li\u003e\n\u003c/ul\u003e","slug":"daniel-sale","email":"dsale@kslaw.com","phone":null,"matters":["\u003cp\u003eRepresenting\u0026nbsp;\u003cem\u003epro bono\u003c/em\u003e\u0026nbsp;a former Army Ranger convicted by court martial of murder in Iraq, resulting in a full Presidential pardon.\u003c/p\u003e","\u003cp\u003eRepresenting an individual in connection with the Special Counsel investigation conducted by Robert Mueller.\u003c/p\u003e","\u003cp\u003eRepresenting a global pharmaceutical company in an industry-wide investigation regarding donations to charitable patient assistance foundations.\u003c/p\u003e","\u003cp\u003eSecured a declination of all criminal and civil liability for a global medical device manufacturer in an investigation involving off-label promotion and fraud issues\u003c/p\u003e","\u003cp\u003eRepresented Vascular Solutions, Inc., a publicly traded medical device manufacturer that was indicted on federal criminal charges relating to off-label promotion and acquitted by a jury of all charges after a four week trial in February 2016.\u003c/p\u003e","\u003cp\u003eRepresenting several individual witnesses and targets in connection with domestic and international investigations of foreign exchange (FX) trading, resulting in no charges.\u003c/p\u003e","\u003cp\u003eRepresented leading pharmaceutical manufacturers into off-label promotion issues by the Department of Justice and multiple U.S. Attorneys\u0026rsquo; Offices, the FDA, the Department of Health and Human Services Office of Inspector General, and various state Attorneys General, as well as parallel federal False Claims Act\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;litigation.\u003c/p\u003e","\u003cp\u003eRepresented current and former CEOs, high-level executives, and other individuals in FCPA investigations related to events throughout Latin America, the Middle East, China, Mexico, and Eastern Europe.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":687,"guid":"687.smart_tags","index":1,"source":"smartTags"},{"id":2,"guid":"2.capabilities","index":2,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":3,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":4,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":5,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":6,"source":"capabilities"},{"id":780,"guid":"780.smart_tags","index":7,"source":"smartTags"},{"id":750,"guid":"750.smart_tags","index":8,"source":"smartTags"},{"id":20,"guid":"20.capabilities","index":9,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":10,"source":"smartTags"},{"id":5,"guid":"5.capabilities","index":11,"source":"capabilities"},{"id":11,"guid":"11.capabilities","index":12,"source":"capabilities"},{"id":6,"guid":"6.capabilities","index":13,"source":"capabilities"},{"id":7,"guid":"7.capabilities","index":14,"source":"capabilities"},{"id":1248,"guid":"1248.smart_tags","index":15,"source":"smartTags"}],"is_active":true,"last_name":"Sale","nick_name":"Daniel","clerkships":[{"name":"Law Clerk, Richard D. Bennett, U.S. District Court for the District of Maryland","years_held":"2010-2012"}],"first_name":"Daniel","title_rank":9999,"updated_by":202,"law_schools":[{"id":755,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"2010-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"C.","name_suffix":"","recognitions":null,"linked_in_url":"https://www.linkedin.com/in/daniel-sale-27063baa/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eDan Sale defends clients in high-stakes government and Congressional investigations, enforcement proceedings, and parallel civil litigation.\u0026nbsp; Concentrating in complex criminal and civil litigation, Dan regularly represents life sciences companies, financial institutions, other highly-regulated companies, and their boards and senior executives in high-profile and sensitive investigations and litigation.\u0026nbsp; Dan has special experience in matters involving: life sciences criminal and civil investigations; Congressional investigations;\u0026nbsp;the False Claims Act; financial crimes, the Foreign Corrupt Practices Act (FCPA);\u0026nbsp; antitrust and market manipulation matters; the securities laws; whistleblower cases; and transnational tax investigations.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDan has special experience in cases involving allegations of off-label promotion and kickbacks in the life sciences industry and represented clients in the three largest Anti-Kickback Statute investigations ever resolved with DOJ.\u0026nbsp; Dan also has special experience in state attorney general investigations, and has personally negotiated quiet resolutions with all 50 state AG offices and the District of Columbia.\u0026nbsp; In addition, Dan has considerable experience defending clients in multi-jurisdictional investigations and litigation conducted cooperatively by United States, European, Middle Eastern, Asian and African authorities\u003c/p\u003e\n\u003cp\u003eThe Special Matters \u0026amp; Government Investigations group has been twice recognized by\u0026nbsp;\u003cem\u003eLaw 360\u003c/em\u003e\u0026nbsp;as the \u0026ldquo;White-Collar Group of the Year\u0026rdquo; and described as \u0026ldquo;the premier firm in this practice area\u0026rdquo; by the\u0026nbsp;\u003cem\u003eU.S. News \u0026amp; World Report/Best Lawyers\u0026rsquo;\u003c/em\u003e\u0026nbsp;\u0026ldquo;Best Law Firms\u0026rdquo; survey.\u003c/p\u003e\n\u003cp\u003eDan began his legal career as a law clerk to the Honorable Richard D. Bennett of the United States District Court for the District of Maryland. \u0026nbsp;He received his J.D. from Georgetown University Law Center, where he was an Editorial Board Member of the Tax Lawyer law journal, and his B.A. in economics from Yale University, where he was a Division I All New England Scholar Athlete lacrosse player.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDan holds Top Secret/SCI security clearances until their expiration.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eDan is a regular contributor to the American Bar Association's Criminal Litigation Section's Practice Points publication\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eThe US v. Vascular Solutions Acquittal: Three Lessons for Targets of Off-Label Promotion Enforcement\u003c/em\u003e, Washington Legal Foundation Legal Backgrounder (2016)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eRecent Trends in Health Care Enforcement and Compliance\u003c/em\u003e, Inside the Minds: Health Care Law Enforcement and Compliance (Apastore 2013)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eThe Future of Off-Label Promotion Enforcement in the Wake of Caronia \u0026mdash; Toward a First Amendment Safe Harbor\u003c/em\u003e, The Sedona Conference Journal, Volume 14 (2013)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eOff-Label Promotion: The Criminalization of Scientific Exchange\u003c/em\u003e, Pharma Magazine (UK) (2013)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eFDA as Arbiter of Truth? The First Amendment, Caronia, and the Future of Off-Label Promotion Enforcement\u003c/em\u003e, ABA White Collar Crime (2013)\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eTenure Trap: Third Circuit Joins Sixth in Holding Tenure Buy-out Payments Subject to FICA Taxation in University of Pittsburgh v. United States\u003c/em\u003e, The Tax Lawyer, Volume 63 (2010)\u003c/li\u003e\n\u003c/ul\u003e","matters":["\u003cp\u003eRepresenting\u0026nbsp;\u003cem\u003epro bono\u003c/em\u003e\u0026nbsp;a former Army Ranger convicted by court martial of murder in Iraq, resulting in a full Presidential pardon.\u003c/p\u003e","\u003cp\u003eRepresenting an individual in connection with the Special Counsel investigation conducted by Robert Mueller.\u003c/p\u003e","\u003cp\u003eRepresenting a global pharmaceutical company in an industry-wide investigation regarding donations to charitable patient assistance foundations.\u003c/p\u003e","\u003cp\u003eSecured a declination of all criminal and civil liability for a global medical device manufacturer in an investigation involving off-label promotion and fraud issues\u003c/p\u003e","\u003cp\u003eRepresented Vascular Solutions, Inc., a publicly traded medical device manufacturer that was indicted on federal criminal charges relating to off-label promotion and acquitted by a jury of all charges after a four week trial in February 2016.\u003c/p\u003e","\u003cp\u003eRepresenting several individual witnesses and targets in connection with domestic and international investigations of foreign exchange (FX) trading, resulting in no charges.\u003c/p\u003e","\u003cp\u003eRepresented leading pharmaceutical manufacturers into off-label promotion issues by the Department of Justice and multiple U.S. Attorneys\u0026rsquo; Offices, the FDA, the Department of Health and Human Services Office of Inspector General, and various state Attorneys General, as well as parallel federal False Claims Act\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;litigation.\u003c/p\u003e","\u003cp\u003eRepresented current and former CEOs, high-level executives, and other individuals in FCPA investigations related to events throughout Latin America, the Middle East, China, Mexico, and Eastern Europe.\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12360}]},"capability_group_id":2},"created_at":"2025-05-26T04:52:35.000Z","updated_at":"2025-05-26T04:52:35.000Z","searchable_text":"Sale{{ FIELD }}Representing pro bono a former Army Ranger convicted by court martial of murder in Iraq, resulting in a full Presidential pardon.{{ FIELD }}Representing an individual in connection with the Special Counsel investigation conducted by Robert Mueller.{{ FIELD }}Representing a global pharmaceutical company in an industry-wide investigation regarding donations to charitable patient assistance foundations.{{ FIELD }}Secured a declination of all criminal and civil liability for a global medical device manufacturer in an investigation involving off-label promotion and fraud issues{{ FIELD }}Represented Vascular Solutions, Inc., a publicly traded medical device manufacturer that was indicted on federal criminal charges relating to off-label promotion and acquitted by a jury of all charges after a four week trial in February 2016.{{ FIELD }}Representing several individual witnesses and targets in connection with domestic and international investigations of foreign exchange (FX) trading, resulting in no charges.{{ FIELD }}Represented leading pharmaceutical manufacturers into off-label promotion issues by the Department of Justice and multiple U.S. Attorneys’ Offices, the FDA, the Department of Health and Human Services Office of Inspector General, and various state Attorneys General, as well as parallel federal False Claims Act qui tam litigation.{{ FIELD }}Represented current and former CEOs, high-level executives, and other individuals in FCPA investigations related to events throughout Latin America, the Middle East, China, Mexico, and Eastern Europe.{{ FIELD }}Dan Sale defends clients in high-stakes government and Congressional investigations, enforcement proceedings, and parallel civil litigation.  Concentrating in complex criminal and civil litigation, Dan regularly represents life sciences companies, financial institutions, other highly-regulated companies, and their boards and senior executives in high-profile and sensitive investigations and litigation.  Dan has special experience in matters involving: life sciences criminal and civil investigations; Congressional investigations; the False Claims Act; financial crimes, the Foreign Corrupt Practices Act (FCPA);  antitrust and market manipulation matters; the securities laws; whistleblower cases; and transnational tax investigations. \nDan has special experience in cases involving allegations of off-label promotion and kickbacks in the life sciences industry and represented clients in the three largest Anti-Kickback Statute investigations ever resolved with DOJ.  Dan also has special experience in state attorney general investigations, and has personally negotiated quiet resolutions with all 50 state AG offices and the District of Columbia.  In addition, Dan has considerable experience defending clients in multi-jurisdictional investigations and litigation conducted cooperatively by United States, European, Middle Eastern, Asian and African authorities\nThe Special Matters \u0026amp; Government Investigations group has been twice recognized by Law 360 as the “White-Collar Group of the Year” and described as “the premier firm in this practice area” by the U.S. News \u0026amp; World Report/Best Lawyers’ “Best Law Firms” survey.\nDan began his legal career as a law clerk to the Honorable Richard D. Bennett of the United States District Court for the District of Maryland.  He received his J.D. from Georgetown University Law Center, where he was an Editorial Board Member of the Tax Lawyer law journal, and his B.A. in economics from Yale University, where he was a Division I All New England Scholar Athlete lacrosse player. \nDan holds Top Secret/SCI security clearances until their expiration.\nPublications\n\nDan is a regular contributor to the American Bar Association's Criminal Litigation Section's Practice Points publication\nThe US v. Vascular Solutions Acquittal: Three Lessons for Targets of Off-Label Promotion Enforcement, Washington Legal Foundation Legal Backgrounder (2016)\nRecent Trends in Health Care Enforcement and Compliance, Inside the Minds: Health Care Law Enforcement and Compliance (Apastore 2013)\nThe Future of Off-Label Promotion Enforcement in the Wake of Caronia — Toward a First Amendment Safe Harbor, The Sedona Conference Journal, Volume 14 (2013)\nOff-Label Promotion: The Criminalization of Scientific Exchange, Pharma Magazine (UK) (2013)\nFDA as Arbiter of Truth? The First Amendment, Caronia, and the Future of Off-Label Promotion Enforcement, ABA White Collar Crime (2013)\nTenure Trap: Third Circuit Joins Sixth in Holding Tenure Buy-out Payments Subject to FICA Taxation in University of Pittsburgh v. United States, The Tax Lawyer, Volume 63 (2010)\n Partner Yale University Yale Law School Georgetown University Georgetown University Law Center U.S. Court of Appeals for the Fourth Circuit U.S. District Court for the District of Maryland District of Columbia Maryland Law Clerk, Richard D. Bennett, U.S. District Court for the District of Maryland Representing pro bono a former Army Ranger convicted by court martial of murder in Iraq, resulting in a full Presidential pardon. Representing an individual in connection with the Special Counsel investigation conducted by Robert Mueller. Representing a global pharmaceutical company in an industry-wide investigation regarding donations to charitable patient assistance foundations. Secured a declination of all criminal and civil liability for a global medical device manufacturer in an investigation involving off-label promotion and fraud issues Represented Vascular Solutions, Inc., a publicly traded medical device manufacturer that was indicted on federal criminal charges relating to off-label promotion and acquitted by a jury of all charges after a four week trial in February 2016. Representing several individual witnesses and targets in connection with domestic and international investigations of foreign exchange (FX) trading, resulting in no charges. Represented leading pharmaceutical manufacturers into off-label promotion issues by the Department of Justice and multiple U.S. Attorneys’ Offices, the FDA, the Department of Health and Human Services Office of Inspector General, and various state Attorneys General, as well as parallel federal False Claims Act qui tam litigation. Represented current and former CEOs, high-level executives, and other individuals in FCPA investigations related to events throughout Latin America, the Middle East, China, Mexico, and Eastern Europe.","searchable_name":"Daniel C. Sale","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":426539,"version":1,"owner_type":"Person","owner_id":4092,"payload":{"bio":"\u003cp\u003eKyle Sampson focuses on Food and Drug Administration regulatory, compliance and enforcement issues. As a partner in our FDA and Life Sciences practice, Kyle represents companies in the full range of regulatory and enforcement issues.\u003c/p\u003e\n\u003cp\u003e[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKyle advises food, drug, biologics, medical device, cosmetics and dietary supplement companies on FDA compliance, regulatory and enforcement matters. His practice also includes strategic advice and compliance counseling, enforcement, litigation and transactional matters.\u003c/p\u003e\n\u003cp\u003eKyle has engaged in extensive public service in every branch of the federal government. He served in the White House as Associate Counsel to the President; at the Department of Justice as a Special Assistant U.S. Attorney and as Counselor and Chief of Staff to two attorneys general; and in the U.S. Senate as Counsel to the Senate Judiciary Committee.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e","slug":"kyle-sampson","email":"ksampson@kslaw.com","phone":"+1 202 340 8202","matters":["\u003cp\u003eAssist \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical and medical device companies\u003c/strong\u003e in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving off-label promotion, anti-kickback violations, federal healthcare program reimbursement, and pricing and false claims actions.\u003c/p\u003e","\u003cp\u003eServe as counsel to \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical, biotechnology and medical device companies\u003c/strong\u003e in regulatory matters involving product development and commercialization.\u003c/p\u003e","\u003cp\u003eRepresent \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical and medical device manufacturers\u003c/strong\u003e in responding to FDA enforcement actions, including Form FDA-483 observations and Warning Letters.\u003c/p\u003e","\u003cp\u003eServe as compliance counsel for \u003cstrong data-redactor-tag=\"strong\"\u003ea\u003c/strong\u003e \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical company\u003c/strong\u003e subject to consent decree resulting from allegation that company provided false scientific data to FDA in regulatory submissions.\u003c/p\u003e","\u003cp\u003eRepresent \u003cstrong data-redactor-tag=\"strong\"\u003ea medical device manufacturer\u003c/strong\u003e in consent decree negotiations with FDA and Department of Justice.\u003c/p\u003e","\u003cp\u003eWith Monitor appointed by U.S. Attorney\u0026rsquo;s Office for the District of New Jersey under Deferred Prosecution Agreement (DPA), oversaw \u003cstrong data-redactor-tag=\"strong\"\u003eorthopedic device manufacturer\u003c/strong\u003e's compliance with federal Anti-Kickback Statute and other federal healthcare laws and its implementation of comprehensive compliance program.\u003c/p\u003e","\u003cp\u003eReview advertising and promotional materials and activities for prescription drugs, biologics and devices for \u003cstrong data-redactor-tag=\"strong\"\u003evarious clients.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eProvide advice to \u003cstrong data-redactor-tag=\"strong\"\u003emanufacturers\u003c/strong\u003e \u003cstrong data-redactor-tag=\"strong\"\u003eof controlled substances and listed chemicals\u003c/strong\u003e regarding compliance with the Controlled Substances Act and Drug Enforcement Administration regulations.\u003c/p\u003e","\u003cp\u003eRepresent \u003cstrong data-redactor-tag=\"strong\"\u003emanufacturers of drug, medical device, human food, animal feed and consumer products\u003c/strong\u003e in negotiations with the FDA over recalls of manufacturers\u0026rsquo; 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negotiations with the FDA over recalls of manufacturers\u0026rsquo; products, including proper classification of recall, assessment of health hazard, and development and implementation of recall strategy.\u003c/p\u003e","\u003cp\u003eRepresent \u003cstrong data-redactor-tag=\"strong\"\u003eforeign manufacturers and domestic importers\u003c/strong\u003e in responding to the FDA\u0026rsquo;s detention of imports and placement of firms on Import Alert, including negotiating firms\u0026rsquo; removal from Detention Without Physical Examination (DWPE).\u003c/p\u003e","\u003cp\u003eHelp \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical and medical device companies\u003c/strong\u003e respond to widespread counterfeiting of products and unlawful importation by Internet pharmacies and others in violation of the Federal Food, Drug, and Cosmetic Act and the Lanham Act.\u003c/p\u003e","\u003cul\u003e\n\u003cli\u003eProvided advice to two \u003cstrong 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}}{:title=\u0026gt;\"Attorney General’s Award for Outstanding Service to the Attorney General, the Department of Justice, and to America \", :detail=\u0026gt;\"U.S. Department of Justice, 2005\"}{{ FIELD }}Assist pharmaceutical and medical device companies in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving off-label promotion, anti-kickback violations, federal healthcare program reimbursement, and pricing and false claims actions.{{ FIELD }}Serve as counsel to pharmaceutical, biotechnology and medical device companies in regulatory matters involving product development and commercialization.{{ FIELD }}Represent pharmaceutical and medical device manufacturers in responding to FDA enforcement actions, including Form FDA-483 observations and Warning Letters.{{ FIELD }}Serve as compliance counsel for a pharmaceutical company subject to consent decree resulting from allegation that company provided false scientific data to FDA in regulatory submissions.{{ FIELD }}Represent a medical device manufacturer in consent decree negotiations with FDA and Department of Justice.{{ FIELD }}With Monitor appointed by U.S. Attorney’s Office for the District of New Jersey under Deferred Prosecution Agreement (DPA), oversaw orthopedic device manufacturer's compliance with federal Anti-Kickback Statute and other federal healthcare laws and its implementation of comprehensive compliance program.{{ FIELD }}Review advertising and promotional materials and activities for prescription drugs, biologics and devices for various clients.{{ FIELD }}Provide advice to manufacturers of controlled substances and listed chemicals regarding compliance with the Controlled Substances Act and Drug Enforcement Administration regulations.{{ FIELD }}Represent manufacturers of drug, medical device, human food, animal feed and consumer products in negotiations with the FDA over recalls of manufacturers’ products, including proper classification of recall, assessment of health hazard, and development and implementation of recall strategy.{{ FIELD }}Represent foreign manufacturers and domestic importers in responding to the FDA’s detention of imports and placement of firms on Import Alert, including negotiating firms’ removal from Detention Without Physical Examination (DWPE).{{ FIELD }}Help pharmaceutical and medical device companies respond to widespread counterfeiting of products and unlawful importation by Internet pharmacies and others in violation of the Federal Food, Drug, and Cosmetic Act and the Lanham Act.{{ FIELD }}\nProvided advice to two attorneys general on legal and policy issues, coordinated Justice Department positions in criminal prosecutions and civil litigation, and formulated and implemented policy initiatives and legislative proposals.\n{{ FIELD }}As Special Assistant U.S. Attorney, conducted trial and appellate litigation, including arguing three cases in the U.S. Courts of Appeals for the Fourth and Ninth Circuits.{{ FIELD }}Kyle Sampson focuses on Food and Drug Administration regulatory, compliance and enforcement issues. As a partner in our FDA and Life Sciences practice, Kyle represents companies in the full range of regulatory and enforcement issues.\n\nKyle advises food, drug, biologics, medical device, cosmetics and dietary supplement companies on FDA compliance, regulatory and enforcement matters. His practice also includes strategic advice and compliance counseling, enforcement, litigation and transactional matters.\nKyle has engaged in extensive public service in every branch of the federal government. He served in the White House as Associate Counsel to the President; at the Department of Justice as a Special Assistant U.S. Attorney and as Counselor and Chief of Staff to two attorneys general; and in the U.S. Senate as Counsel to the Senate Judiciary Committee.\n \n  Partner Attorney General’s Award for Outstanding Service to the Attorney General, the Department of Justice, and to America  U.S. Department of Justice, 2005 Brigham Young University J. Reuben Clark Law School University of Chicago University of Chicago Law School U.S. Court of Appeals for the Fourth 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 Utah District of Columbia Utah Law Clerk, Hon. Karen J. Williams, U.S. Court of Appeals for the Fourth Circuit Assist pharmaceutical and medical device companies in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving off-label promotion, anti-kickback violations, federal healthcare program reimbursement, and pricing and false claims actions. Serve as counsel to pharmaceutical, biotechnology and medical device companies in regulatory matters involving product development and commercialization. Represent pharmaceutical and medical device manufacturers in responding to FDA enforcement actions, including Form FDA-483 observations and Warning Letters. Serve as compliance counsel for a pharmaceutical company subject to consent decree resulting from allegation that company provided false scientific data to FDA in regulatory submissions. Represent a medical device manufacturer in consent decree negotiations with FDA and Department of Justice. With Monitor appointed by U.S. Attorney’s Office for the District of New Jersey under Deferred Prosecution Agreement (DPA), oversaw orthopedic device manufacturer's compliance with federal Anti-Kickback Statute and other federal healthcare laws and its implementation of comprehensive compliance program. Review advertising and promotional materials and activities for prescription drugs, biologics and devices for various clients. Provide advice to manufacturers of controlled substances and listed chemicals regarding compliance with the Controlled Substances Act and Drug Enforcement Administration regulations. Represent manufacturers of drug, medical device, human food, animal feed and consumer products in negotiations with the FDA over recalls of manufacturers’ products, including proper classification of recall, assessment of health hazard, and development and implementation of recall strategy. Represent foreign manufacturers and domestic importers in responding to the FDA’s detention of imports and placement of firms on Import Alert, including negotiating firms’ removal from Detention Without Physical Examination (DWPE). Help pharmaceutical and medical device companies respond to widespread counterfeiting of products and unlawful importation by Internet pharmacies and others in violation of the Federal Food, Drug, and Cosmetic Act and the Lanham Act. \nProvided advice to two attorneys general on legal and policy issues, coordinated Justice Department positions in criminal prosecutions and civil litigation, and formulated and implemented policy initiatives and legislative proposals.\n As Special Assistant U.S. Attorney, conducted trial and appellate litigation, including arguing three cases in the U.S. Courts of Appeals for the Fourth and Ninth Circuits.","searchable_name":"D. Kyle Sampson","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":442925,"version":1,"owner_type":"Person","owner_id":4147,"payload":{"bio":"\u003cp\u003eMark Sentenac is a Partner in King \u0026amp; Spalding\u0026rsquo;s Products Liability \u0026amp; Mass Torts group. His practice focuses on defending life sciences, technology, social media, automotive, tobacco, and mining companies in all phases of mass tort, product liability, and cutting-edge \u0026ldquo;tech tort\u0026rdquo; litigation across the country. Mark has extensive experience helping companies navigate increasingly risky and complex discovery issues in mass tort litigation. This includes serving as lead discovery counsel to TikTok in the \u003cem\u003eIn re Social Media Adolescent Addiction/Personal Injury Litigation\u003c/em\u003e, Boehringer Ingelheim in the nationwide\u003cem\u003e Zantac (Ranitidine) Products Liability Litigation\u003c/em\u003e, and General Motors in its California breach of warranty docket. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMark has also been at the forefront of advising companies on the potential product liability risks of implementing AI and routinely engaged by clients and industry groups\u0026mdash;including AdvaMed, the world\u0026rsquo;s largest medical device association\u0026mdash;to share his insights. He is a member of the firm\u0026rsquo;s AI/ML Tactical Operations team and leads the Product Liability \u0026amp; Mass Tort group\u0026rsquo;s technology and innovation initiatives seeking to achieve better results and drive efficiencies for clients and the firm through implementation of new technologies.\u003c/p\u003e\n\u003cp\u003eMark\u0026nbsp;is also widely published on cutting edge litigation issues of significance to\u0026nbsp;the life sciences industry, including\u0026nbsp;M\u003cem\u003eitigating Risks of Developing Drugs and Devices with AI\u003c/em\u003e, Law360 (Jul.\u0026nbsp;2023)\u0026mdash;named\u0026nbsp;by Law360 as\u0026nbsp;a Top Guest Article for 2023\u0026mdash;\u003cem\u003eMedical Device Makers Must Review Approach After California Case\u003c/em\u003e, Bloomberg Law (Jul. 2024),\u0026nbsp;\u003cem\u003eFDA\u0026rsquo;s Essure Order Affirms Role of Learned Intermediary\u003c/em\u003e, Law360 (Apr 2018),\u0026nbsp;and\u0026nbsp;\u003cem\u003eWill The Learned Intermediary Doctrine Survive A New Paradigm?\u003c/em\u003e, Law360 (Jan 2017).\u0026nbsp;\u0026nbsp;\u003c/p\u003e","slug":"mark-sentenac","email":"msentenac@kslaw.com","phone":null,"matters":["\u003cp\u003eMember of team serving as national coordinating and trial counsel in nationwide product liability litigation involving a leading pharmaceutical company\u0026rsquo;s antidepressant medication.\u0026nbsp; Mark\u0026rsquo;s experience includes trial preparation and briefing dispositive and pre-trial motions.\u0026nbsp;\u003c/p\u003e","\u003cp\u003eActed as national coordinating counsel for a multinational medical device manufacturer in claims related to its orthopedic products, including representing the manufacturer before the U.S. Judicial Panel on Multidistrict Litigation.\u0026nbsp;\u003c/p\u003e","\u003cp\u003eMember of team advising multinational pharmaceutical company on recall of popular consumer health product.\u003c/p\u003e","\u003cp\u003eMember of team serving as national trial counsel for medical device manufacturer in multidistrict litigation involving manufacturer\u0026rsquo;s surgical mesh products.\u0026nbsp; Mark\u0026rsquo;s experience included preparing manufacturer\u0026rsquo;s subject matter experts in device design for trial, taking percipient witness depositions throughout the country, briefing dispositive and pre-trial motions, and advising company during investigations by states\u0026rsquo; attorneys general.\u0026nbsp;\u003c/p\u003e","\u003cp\u003eMember of team representing manufacturer in nationwide litigation involving its complex implantable neurological medical devices.\u0026nbsp; Mark\u0026rsquo;s experience includes working with company\u0026rsquo;s subject matter experts on complex scientific fields, briefing complex issues of federal preemption, including successfully defending favorable result before the Fifth Circuit Court of Appeals, and coordinating large-scale electronic discovery.\u0026nbsp;\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":761,"guid":"761.smart_tags","index":0,"source":"smartTags"},{"id":17,"guid":"17.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":764,"guid":"764.smart_tags","index":3,"source":"smartTags"},{"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":1256,"guid":"1256.smart_tags","index":7,"source":"smartTags"},{"id":7,"guid":"7.capabilities","index":8,"source":"capabilities"},{"id":762,"guid":"762.smart_tags","index":9,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":10,"source":"smartTags"}],"is_active":true,"last_name":"Sentenac","nick_name":"Mark","clerkships":[],"first_name":"Mark","title_rank":9999,"updated_by":202,"law_schools":[{"id":2378,"meta":{"degree":"J.D.","honors":"Magna Cum Laude","is_law_school":"1","graduation_date":"2012-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":"www.linkedin.com/in/marksentenac","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eMark Sentenac is a Partner in King \u0026amp; Spalding\u0026rsquo;s Products Liability \u0026amp; Mass Torts group. His practice focuses on defending life sciences, technology, social media, automotive, tobacco, and mining companies in all phases of mass tort, product liability, and cutting-edge \u0026ldquo;tech tort\u0026rdquo; litigation across the country. Mark has extensive experience helping companies navigate increasingly risky and complex discovery issues in mass tort litigation. This includes serving as lead discovery counsel to TikTok in the \u003cem\u003eIn re Social Media Adolescent Addiction/Personal Injury Litigation\u003c/em\u003e, Boehringer Ingelheim in the nationwide\u003cem\u003e Zantac (Ranitidine) Products Liability Litigation\u003c/em\u003e, and General Motors in its California breach of warranty docket. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMark has also been at the forefront of advising companies on the potential product liability risks of implementing AI and routinely engaged by clients and industry groups\u0026mdash;including AdvaMed, the world\u0026rsquo;s largest medical device association\u0026mdash;to share his insights. He is a member of the firm\u0026rsquo;s AI/ML Tactical Operations team and leads the Product Liability \u0026amp; Mass Tort group\u0026rsquo;s technology and innovation initiatives seeking to achieve better results and drive efficiencies for clients and the firm through implementation of new technologies.\u003c/p\u003e\n\u003cp\u003eMark\u0026nbsp;is also widely published on cutting edge litigation issues of significance to\u0026nbsp;the life sciences industry, including\u0026nbsp;M\u003cem\u003eitigating Risks of Developing Drugs and Devices with AI\u003c/em\u003e, Law360 (Jul.\u0026nbsp;2023)\u0026mdash;named\u0026nbsp;by Law360 as\u0026nbsp;a Top Guest Article for 2023\u0026mdash;\u003cem\u003eMedical Device Makers Must Review Approach After California Case\u003c/em\u003e, Bloomberg Law (Jul. 2024),\u0026nbsp;\u003cem\u003eFDA\u0026rsquo;s Essure Order Affirms Role of Learned Intermediary\u003c/em\u003e, Law360 (Apr 2018),\u0026nbsp;and\u0026nbsp;\u003cem\u003eWill The Learned Intermediary Doctrine Survive A New Paradigm?\u003c/em\u003e, Law360 (Jan 2017).\u0026nbsp;\u0026nbsp;\u003c/p\u003e","matters":["\u003cp\u003eMember of team serving as national coordinating and trial counsel in nationwide product liability litigation involving a leading pharmaceutical company\u0026rsquo;s antidepressant medication.\u0026nbsp; Mark\u0026rsquo;s experience includes trial preparation and briefing dispositive and pre-trial motions.\u0026nbsp;\u003c/p\u003e","\u003cp\u003eActed as national coordinating counsel for a multinational medical device manufacturer in claims related to its orthopedic products, including representing the manufacturer before the U.S. Judicial Panel on Multidistrict Litigation.\u0026nbsp;\u003c/p\u003e","\u003cp\u003eMember of team advising multinational pharmaceutical company on recall of popular consumer health product.\u003c/p\u003e","\u003cp\u003eMember of team serving as national trial counsel for medical device manufacturer in multidistrict litigation involving manufacturer\u0026rsquo;s surgical mesh products.\u0026nbsp; Mark\u0026rsquo;s experience included preparing manufacturer\u0026rsquo;s subject matter experts in device design for trial, taking percipient witness depositions throughout the country, briefing dispositive and pre-trial motions, and advising company during investigations by states\u0026rsquo; attorneys general.\u0026nbsp;\u003c/p\u003e","\u003cp\u003eMember of team representing manufacturer in nationwide litigation involving its complex implantable neurological medical devices.\u0026nbsp; Mark\u0026rsquo;s experience includes working with company\u0026rsquo;s subject matter experts on complex scientific fields, briefing complex issues of federal preemption, including successfully defending favorable result before the Fifth Circuit Court of Appeals, and coordinating large-scale electronic discovery.\u0026nbsp;\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1177}]},"capability_group_id":3},"created_at":"2025-11-17T17:02:33.000Z","updated_at":"2025-11-17T17:02:33.000Z","searchable_text":"Sentenac{{ FIELD }}Member of team serving as national coordinating and trial counsel in nationwide product liability litigation involving a leading pharmaceutical company’s antidepressant medication.  Mark’s experience includes trial preparation and briefing dispositive and pre-trial motions. {{ FIELD }}Acted as national coordinating counsel for a multinational medical device manufacturer in claims related to its orthopedic products, including representing the manufacturer before the U.S. Judicial Panel on Multidistrict Litigation. {{ FIELD }}Member of team advising multinational pharmaceutical company on recall of popular consumer health product.{{ FIELD }}Member of team serving as national trial counsel for medical device manufacturer in multidistrict litigation involving manufacturer’s surgical mesh products.  Mark’s experience included preparing manufacturer’s subject matter experts in device design for trial, taking percipient witness depositions throughout the country, briefing dispositive and pre-trial motions, and advising company during investigations by states’ attorneys general. {{ FIELD }}Member of team representing manufacturer in nationwide litigation involving its complex implantable neurological medical devices.  Mark’s experience includes working with company’s subject matter experts on complex scientific fields, briefing complex issues of federal preemption, including successfully defending favorable result before the Fifth Circuit Court of Appeals, and coordinating large-scale electronic discovery. {{ FIELD }}Mark Sentenac is a Partner in King \u0026amp; Spalding’s Products Liability \u0026amp; Mass Torts group. His practice focuses on defending life sciences, technology, social media, automotive, tobacco, and mining companies in all phases of mass tort, product liability, and cutting-edge “tech tort” litigation across the country. Mark has extensive experience helping companies navigate increasingly risky and complex discovery issues in mass tort litigation. This includes serving as lead discovery counsel to TikTok in the In re Social Media Adolescent Addiction/Personal Injury Litigation, Boehringer Ingelheim in the nationwide Zantac (Ranitidine) Products Liability Litigation, and General Motors in its California breach of warranty docket.  \nMark has also been at the forefront of advising companies on the potential product liability risks of implementing AI and routinely engaged by clients and industry groups—including AdvaMed, the world’s largest medical device association—to share his insights. He is a member of the firm’s AI/ML Tactical Operations team and leads the Product Liability \u0026amp; Mass Tort group’s technology and innovation initiatives seeking to achieve better results and drive efficiencies for clients and the firm through implementation of new technologies.\nMark is also widely published on cutting edge litigation issues of significance to the life sciences industry, including Mitigating Risks of Developing Drugs and Devices with AI, Law360 (Jul. 2023)—named by Law360 as a Top Guest Article for 2023—Medical Device Makers Must Review Approach After California Case, Bloomberg Law (Jul. 2024), FDA’s Essure Order Affirms Role of Learned Intermediary, Law360 (Apr 2018), and Will The Learned Intermediary Doctrine Survive A New Paradigm?, Law360 (Jan 2017).   Partner University of California-Santa Barbara  University of San Francisco University of San Francisco School of Law U.S. District Court for the Eastern District of California U.S. District Court for the Northern District of California U.S. District Court for the Southern District of California California Georgia Member of team serving as national coordinating and trial counsel in nationwide product liability litigation involving a leading pharmaceutical company’s antidepressant medication.  Mark’s experience includes trial preparation and briefing dispositive and pre-trial motions.  Acted as national coordinating counsel for a multinational medical device manufacturer in claims related to its orthopedic products, including representing the manufacturer before the U.S. Judicial Panel on Multidistrict Litigation.  Member of team advising multinational pharmaceutical company on recall of popular consumer health product. Member of team serving as national trial counsel for medical device manufacturer in multidistrict litigation involving manufacturer’s surgical mesh products.  Mark’s experience included preparing manufacturer’s subject matter experts in device design for trial, taking percipient witness depositions throughout the country, briefing dispositive and pre-trial motions, and advising company during investigations by states’ attorneys general.  Member of team representing manufacturer in nationwide litigation involving its complex implantable neurological medical devices.  Mark’s experience includes working with company’s subject matter experts on complex scientific fields, briefing complex issues of federal preemption, including successfully defending favorable result before the Fifth Circuit Court of Appeals, and coordinating large-scale electronic discovery. ","searchable_name":"Mark Sentenac","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":442375,"version":1,"owner_type":"Person","owner_id":923,"payload":{"bio":"\u003cp\u003eJohn Shakow\u0026nbsp;focuses on complex regulatory, commercial, investigation and litigation issues related to pharmaceutical government pricing and price reporting. A Chambers-ranked partner in our FDA and Life Sciences practice and co-chair of the firm's Life Sciences \u0026amp; Healthcare Industry Group, John represents pharmaceutical and biotechnology manufacturers in every facet of government drug payor program compliance and liability mitigation.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJohn has over 25 years'\u0026nbsp;experience in helping pharmaceutical and biotechnology clients resolve commercial and organizational challenges while maintaining the integrity of their price-reporting compliance efforts.\u003c/p\u003e\n\u003cp\u003eHe counsels clients on their rights and obligations under Medicaid, Medicare,340B, VA/FSS and related programs, and regularly assists them in interactions with the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, the Department of Health and Human Services Office of Inspector General, and the Veterans Administration.\u003c/p\u003e\n\u003cp\u003eJohn often conducts in-depth pricing assessments to develop and implement government price calculation and reporting policies, procedures, systems and methodologies. John has overseen\u0026nbsp;dozens of substantial\u0026nbsp;\u003cem\u003ebona fide\u003c/em\u003e\u0026nbsp;service fee analysis projects for large and small drug manufacturers. He is experienced in managing the coordination and integration of pricing methodologies in major pharmaceutical mergers.\u003c/p\u003e\n\u003cp\u003eJohn has significant pharmaceutical litigation and investigation experience. He regularly challenges government agencies' positions on drug pricing and reimbursement matters, and defends clients in federal and state investigations related to price reporting. John represents manufacturers in 340B, IRA, and Medicaid Drug Rebate Program litigation, and has counseled drug manufacturers before the House Energy \u0026amp; Commerce and Senate Finance committees in drug-pricing investigations and inquiries.\u003c/p\u003e","slug":"john-shakow","email":"jshakow@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[{"id":179}]},"expertise":[{"id":103,"guid":"103.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":2,"source":"capabilities"},{"id":2,"guid":"2.capabilities","index":3,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":4,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":5,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":6,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":7,"source":"smartTags"},{"id":133,"guid":"133.capabilities","index":8,"source":"capabilities"}],"is_active":true,"last_name":"Shakow","nick_name":"John","clerkships":[],"first_name":"John","title_rank":9999,"updated_by":35,"law_schools":[],"middle_name":"D.","name_suffix":"","recognitions":[{"title":"“John is extremely strong and extremely client-focused.”","detail":"CHAMBERS USA, 2022"},{"title":"“Top Ranked Lawyer,” Healthcare: Pharmaceutical/Medical Products Regulatory","detail":"CHAMBERS USA, 2021, 2022, 2023 and 2024"},{"title":"Recommended Key Lawyer: 2021, 2022, 2023","detail":"Legal 500"},{"title":"Shortlist for Regulatory Attorney of the Year: Pricing \u0026 Reimbursement, 2017-2023","detail":"LMG Life Sciences"},{"title":"2016 Lifetime Achievement Award","detail":"Institute for International Research's Medicaid Drug Rebate Program"},{"title":"Life Sciences Star: Pricing and Reimbursement, 2012 to 2018","detail":"Guide to Leading Life Sciences Firms and Attorneys in North America"}],"linked_in_url":"https://www.linkedin.com/in/JohnShakow/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJohn Shakow\u0026nbsp;focuses on complex regulatory, commercial, investigation and litigation issues related to pharmaceutical government pricing and price reporting. A Chambers-ranked partner in our FDA and Life Sciences practice and co-chair of the firm's Life Sciences \u0026amp; Healthcare Industry Group, John represents pharmaceutical and biotechnology manufacturers in every facet of government drug payor program compliance and liability mitigation.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJohn has over 25 years'\u0026nbsp;experience in helping pharmaceutical and biotechnology clients resolve commercial and organizational challenges while maintaining the integrity of their price-reporting compliance efforts.\u003c/p\u003e\n\u003cp\u003eHe counsels clients on their rights and obligations under Medicaid, Medicare,340B, VA/FSS and related programs, and regularly assists them in interactions with the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, the Department of Health and Human Services Office of Inspector General, and the Veterans Administration.\u003c/p\u003e\n\u003cp\u003eJohn often conducts in-depth pricing assessments to develop and implement government price calculation and reporting policies, procedures, systems and methodologies. John has overseen\u0026nbsp;dozens of substantial\u0026nbsp;\u003cem\u003ebona fide\u003c/em\u003e\u0026nbsp;service fee analysis projects for large and small drug manufacturers. He is experienced in managing the coordination and integration of pricing methodologies in major pharmaceutical mergers.\u003c/p\u003e\n\u003cp\u003eJohn has significant pharmaceutical litigation and investigation experience. He regularly challenges government agencies' positions on drug pricing and reimbursement matters, and defends clients in federal and state investigations related to price reporting. John represents manufacturers in 340B, IRA, and Medicaid Drug Rebate Program litigation, and has counseled drug manufacturers before the House Energy \u0026amp; Commerce and Senate Finance committees in drug-pricing investigations and inquiries.\u003c/p\u003e","recognitions":[{"title":"“John is extremely strong and extremely client-focused.”","detail":"CHAMBERS USA, 2022"},{"title":"“Top Ranked Lawyer,” Healthcare: Pharmaceutical/Medical Products Regulatory","detail":"CHAMBERS USA, 2021, 2022, 2023 and 2024"},{"title":"Recommended Key Lawyer: 2021, 2022, 2023","detail":"Legal 500"},{"title":"Shortlist for Regulatory Attorney of the Year: Pricing \u0026 Reimbursement, 2017-2023","detail":"LMG Life Sciences"},{"title":"2016 Lifetime Achievement Award","detail":"Institute for International Research's Medicaid Drug Rebate Program"},{"title":"Life Sciences Star: Pricing and Reimbursement, 2012 to 2018","detail":"Guide to Leading Life Sciences Firms and Attorneys in North America"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":11649}]},"capability_group_id":2},"created_at":"2025-11-05T05:03:46.000Z","updated_at":"2025-11-05T05:03:46.000Z","searchable_text":"Shakow{{ FIELD }}{:title=\u0026gt;\"“John is extremely strong and extremely client-focused.”\", :detail=\u0026gt;\"CHAMBERS USA, 2022\"}{{ FIELD }}{:title=\u0026gt;\"“Top Ranked Lawyer,” Healthcare: Pharmaceutical/Medical Products Regulatory\", :detail=\u0026gt;\"CHAMBERS USA, 2021, 2022, 2023 and 2024\"}{{ FIELD }}{:title=\u0026gt;\"Recommended Key Lawyer: 2021, 2022, 2023\", :detail=\u0026gt;\"Legal 500\"}{{ FIELD }}{:title=\u0026gt;\"Shortlist for Regulatory Attorney of the Year: Pricing \u0026amp; Reimbursement, 2017-2023\", :detail=\u0026gt;\"LMG Life Sciences\"}{{ FIELD }}{:title=\u0026gt;\"2016 Lifetime Achievement Award\", :detail=\u0026gt;\"Institute for International Research's Medicaid Drug Rebate Program\"}{{ FIELD }}{:title=\u0026gt;\"Life Sciences Star: Pricing and Reimbursement, 2012 to 2018\", :detail=\u0026gt;\"Guide to Leading Life Sciences Firms and Attorneys in North America\"}{{ FIELD }}John Shakow focuses on complex regulatory, commercial, investigation and litigation issues related to pharmaceutical government pricing and price reporting. A Chambers-ranked partner in our FDA and Life Sciences practice and co-chair of the firm's Life Sciences \u0026amp; Healthcare Industry Group, John represents pharmaceutical and biotechnology manufacturers in every facet of government drug payor program compliance and liability mitigation.\nJohn has over 25 years' experience in helping pharmaceutical and biotechnology clients resolve commercial and organizational challenges while maintaining the integrity of their price-reporting compliance efforts.\nHe counsels clients on their rights and obligations under Medicaid, Medicare,340B, VA/FSS and related programs, and regularly assists them in interactions with the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, the Department of Health and Human Services Office of Inspector General, and the Veterans Administration.\nJohn often conducts in-depth pricing assessments to develop and implement government price calculation and reporting policies, procedures, systems and methodologies. John has overseen dozens of substantial bona fide service fee analysis projects for large and small drug manufacturers. He is experienced in managing the coordination and integration of pricing methodologies in major pharmaceutical mergers.\nJohn has significant pharmaceutical litigation and investigation experience. He regularly challenges government agencies' positions on drug pricing and reimbursement matters, and defends clients in federal and state investigations related to price reporting. John represents manufacturers in 340B, IRA, and Medicaid Drug Rebate Program litigation, and has counseled drug manufacturers before the House Energy \u0026amp; Commerce and Senate Finance committees in drug-pricing investigations and inquiries. John D Shakow Partner “John is extremely strong and extremely client-focused.” CHAMBERS USA, 2022 “Top Ranked Lawyer,” Healthcare: Pharmaceutical/Medical Products Regulatory CHAMBERS USA, 2021, 2022, 2023 and 2024 Recommended Key Lawyer: 2021, 2022, 2023 Legal 500 Shortlist for Regulatory Attorney of the Year: Pricing \u0026amp; Reimbursement, 2017-2023 LMG Life Sciences 2016 Lifetime Achievement Award Institute for International Research's Medicaid Drug Rebate Program Life Sciences Star: Pricing and Reimbursement, 2012 to 2018 Guide to Leading Life Sciences Firms and Attorneys in North America Swarthmore College  University of Virginia University of Virginia School of Law U.S. Court of Appeals for the Ninth Circuit U.S. Court of Appeals for the D.C. Circuit U.S. District Court for the Eastern District of Virginia U.S. District Court for the Central District of Illinois U.S. District Court for the District of Columbia District of Columbia Virginia District of Columbia Bar State Bar of Virginia","searchable_name":"John D. Shakow","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":427262,"version":1,"owner_type":"Person","owner_id":6596,"payload":{"bio":"\u003cp\u003eJeff has 30 years\u0026rsquo; experience in US medical device law and regulation. \u0026nbsp;He counsels firms in regulatory strategy and filings, including presubmissions, clearances, approvals, breakthrough designations, and internal agency appeals.\u0026nbsp; He helps firms develop a sound regulatory strategy for bringing their medical devices through US FDA review, to draft the relevant submissions, and to respond to FDA\u0026rsquo;s requests for information and data.\u0026nbsp; When advising start-ups and mid-sized manufacturers, Jeffrey recognizes the business considerations involved in creating regulatory strategies and managing compliance.\u0026nbsp; His mission is to bring companies through the FDA process as efficiently and expeditiously as possible.\u0026nbsp; Jeffrey also counsels companies on post-market compliance, such as reporting to FDA, complying with the quality system regulation, labeling and advertising compliance, recalls, inspections, and warning letters, and he is an expert in FDA\u0026rsquo;s regulation of combination products (e.g., drug-device combinations).[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJeff is a national authority on FDA\u0026rsquo;s regulation of medical devices, combination products, and HCT/Ps.\u0026nbsp; He actively contributes to industry conversations on FDA regulation of medical devices. He has published hundreds of articles on various topics relating to FDA\u0026rsquo;s regulation of medical devices.\u003c/p\u003e\n\u003cp\u003eHe is a past member of the Editorial Advisory Board for both\u0026nbsp;\u003cem\u003eMDDI\u0026nbsp;\u003c/em\u003eand\u0026nbsp;\u003cem\u003eUpdate\u0026nbsp;\u003c/em\u003emagazines, co-editor of two textbooks,\u0026nbsp;\u003cem\u003ePromotion of Biomedical Products\u0026nbsp;\u003c/em\u003e(Food and Drug Law Institute, 2006) and\u0026nbsp;\u003cem\u003eCombination Products, How to Develop the Optimal Strategic Path for Approval\u0026nbsp;\u003c/em\u003e(FDA News 2005).\u0026nbsp; He has contributed chapters to several textbooks, including\u0026nbsp;\u003cem\u003eMedical Devices Law and Regulation Answer Book\u003c/em\u003e\u0026nbsp;(Practising Law Institute 2023 ed.).\u003c/p\u003e\n\u003cp\u003eJeff was a Lecturer and Fischell Literati teaching the University of Maryland\u0026rsquo;s Regulatory Law: Medical Devices course. He has served on the Medical Devices and Diagnostics Committee, Food and Drug Law Institute.\u003c/p\u003e","slug":"jeffrey-shapiro","email":"jshapiro@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"},{"id":103,"guid":"103.capabilities","index":2,"source":"capabilities"},{"id":112,"guid":"112.capabilities","index":3,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":4,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":5,"source":"smartTags"},{"id":826,"guid":"826.smart_tags","index":6,"source":"smartTags"}],"is_active":true,"last_name":"Shapiro","nick_name":"Jeffrey","clerkships":[],"first_name":"Jeffrey","title_rank":9999,"updated_by":35,"law_schools":[{"id":824,"meta":{"degree":"J.D.","honors":"cum laude","is_law_school":"1","graduation_date":"1986-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"K.","name_suffix":"","recognitions":[{"title":"Life Sciences Key Lawyer","detail":"The Legal 500 (2024)"},{"title":"Life Science Star","detail":"LMG Life Sciences, 2012 – 2023"},{"title":"DC Super Lawyer","detail":"Super Lawyers, 2014 – 2023"},{"title":"The International Who’s Who of Business Lawyers – Life Sciences","detail":"Who’s Who Legal, 2014 – 2023"},{"title":"Nominee for Regulatory Attorney of the Year","detail":"LMG Life Sciences, 2017"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJeff has 30 years\u0026rsquo; experience in US medical device law and regulation. \u0026nbsp;He counsels firms in regulatory strategy and filings, including presubmissions, clearances, approvals, breakthrough designations, and internal agency appeals.\u0026nbsp; He helps firms develop a sound regulatory strategy for bringing their medical devices through US FDA review, to draft the relevant submissions, and to respond to FDA\u0026rsquo;s requests for information and data.\u0026nbsp; When advising start-ups and mid-sized manufacturers, Jeffrey recognizes the business considerations involved in creating regulatory strategies and managing compliance.\u0026nbsp; His mission is to bring companies through the FDA process as efficiently and expeditiously as possible.\u0026nbsp; Jeffrey also counsels companies on post-market compliance, such as reporting to FDA, complying with the quality system regulation, labeling and advertising compliance, recalls, inspections, and warning letters, and he is an expert in FDA\u0026rsquo;s regulation of combination products (e.g., drug-device combinations).[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJeff is a national authority on FDA\u0026rsquo;s regulation of medical devices, combination products, and HCT/Ps.\u0026nbsp; He actively contributes to industry conversations on FDA regulation of medical devices. He has published hundreds of articles on various topics relating to FDA\u0026rsquo;s regulation of medical devices.\u003c/p\u003e\n\u003cp\u003eHe is a past member of the Editorial Advisory Board for both\u0026nbsp;\u003cem\u003eMDDI\u0026nbsp;\u003c/em\u003eand\u0026nbsp;\u003cem\u003eUpdate\u0026nbsp;\u003c/em\u003emagazines, co-editor of two textbooks,\u0026nbsp;\u003cem\u003ePromotion of Biomedical Products\u0026nbsp;\u003c/em\u003e(Food and Drug Law Institute, 2006) and\u0026nbsp;\u003cem\u003eCombination Products, How to Develop the Optimal Strategic Path for Approval\u0026nbsp;\u003c/em\u003e(FDA News 2005).\u0026nbsp; He has contributed chapters to several textbooks, including\u0026nbsp;\u003cem\u003eMedical Devices Law and Regulation Answer Book\u003c/em\u003e\u0026nbsp;(Practising Law Institute 2023 ed.).\u003c/p\u003e\n\u003cp\u003eJeff was a Lecturer and Fischell Literati teaching the University of Maryland\u0026rsquo;s Regulatory Law: Medical Devices course. He has served on the Medical Devices and Diagnostics Committee, Food and Drug Law Institute.\u003c/p\u003e","recognitions":[{"title":"Life Sciences Key Lawyer","detail":"The Legal 500 (2024)"},{"title":"Life Science Star","detail":"LMG Life Sciences, 2012 – 2023"},{"title":"DC Super Lawyer","detail":"Super Lawyers, 2014 – 2023"},{"title":"The International Who’s Who of Business Lawyers – Life Sciences","detail":"Who’s Who Legal, 2014 – 2023"},{"title":"Nominee for Regulatory Attorney of the Year","detail":"LMG Life Sciences, 2017"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":11031}]},"capability_group_id":2},"created_at":"2025-05-26T04:59:28.000Z","updated_at":"2025-05-26T04:59:28.000Z","searchable_text":"Shapiro{{ FIELD }}{:title=\u0026gt;\"Life Sciences Key Lawyer\", :detail=\u0026gt;\"The Legal 500 (2024)\"}{{ FIELD }}{:title=\u0026gt;\"Life Science Star\", :detail=\u0026gt;\"LMG Life Sciences, 2012 – 2023\"}{{ FIELD }}{:title=\u0026gt;\"DC Super Lawyer\", :detail=\u0026gt;\"Super Lawyers, 2014 – 2023\"}{{ FIELD }}{:title=\u0026gt;\"The International Who’s Who of Business Lawyers – Life Sciences\", :detail=\u0026gt;\"Who’s Who Legal, 2014 – 2023\"}{{ FIELD }}{:title=\u0026gt;\"Nominee for Regulatory Attorney of the Year\", :detail=\u0026gt;\"LMG Life Sciences, 2017\"}{{ FIELD }}Jeff has 30 years’ experience in US medical device law and regulation.  He counsels firms in regulatory strategy and filings, including presubmissions, clearances, approvals, breakthrough designations, and internal agency appeals.  He helps firms develop a sound regulatory strategy for bringing their medical devices through US FDA review, to draft the relevant submissions, and to respond to FDA’s requests for information and data.  When advising start-ups and mid-sized manufacturers, Jeffrey recognizes the business considerations involved in creating regulatory strategies and managing compliance.  His mission is to bring companies through the FDA process as efficiently and expeditiously as possible.  Jeffrey also counsels companies on post-market compliance, such as reporting to FDA, complying with the quality system regulation, labeling and advertising compliance, recalls, inspections, and warning letters, and he is an expert in FDA’s regulation of combination products (e.g., drug-device combinations).\nJeff is a national authority on FDA’s regulation of medical devices, combination products, and HCT/Ps.  He actively contributes to industry conversations on FDA regulation of medical devices. He has published hundreds of articles on various topics relating to FDA’s regulation of medical devices.\nHe is a past member of the Editorial Advisory Board for both MDDI and Update magazines, co-editor of two textbooks, Promotion of Biomedical Products (Food and Drug Law Institute, 2006) and Combination Products, How to Develop the Optimal Strategic Path for Approval (FDA News 2005).  He has contributed chapters to several textbooks, including Medical Devices Law and Regulation Answer Book (Practising Law Institute 2023 ed.).\nJeff was a Lecturer and Fischell Literati teaching the University of Maryland’s Regulatory Law: Medical Devices course. He has served on the Medical Devices and Diagnostics Committee, Food and Drug Law Institute. Partner Life Sciences Key Lawyer The Legal 500 (2024) Life Science Star LMG Life Sciences, 2012 – 2023 DC Super Lawyer Super Lawyers, 2014 – 2023 The International Who’s Who of Business Lawyers – Life Sciences Who’s Who Legal, 2014 – 2023 Nominee for Regulatory Attorney of the Year LMG Life Sciences, 2017 Brown University  Harvard University Harvard Law School District of Columbia","searchable_name":"Jeffrey K. Shapiro","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":427660,"version":1,"owner_type":"Person","owner_id":1257,"payload":{"bio":"\u003cp\u003eDrawing upon his deep experience with the legislative process, Tom's practice includes the development and execution of Legislative and Executive Branch strategies involving issues critical to domestic and foreign interests. His practice also includes advising corporations on complying with the vast array of laws that regulate the interaction of lobbyists with state and federal government officials.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAs group co-leader of our Government Advocacy \u0026amp; Public Policy practice, Tom is actively involved in numerous lobbying efforts on the most pressing issues in Washington, involving tax, health, energy, defense, aerospace and appropriations.\u003c/p\u003e\n\u003cp\u003eTom counsels clients on the full suite of political law issues. He advises clients on complying with federal and state laws that regulate and require the reporting of lobbyist activities, and counsels clients on the ethical considerations involved when corporate representatives and government officials interact. He provides guidance on federal and state election laws, and assists corporations with establishing and administering federal and state political action committees. Tom assists foreign entities in complying with the Foreign Agent Registration Act. And he assists tax-exempt organizations with understanding and complying with provisions of law that regulate lobbying and political activities.\u003c/p\u003e\n\u003cp\u003eBefore entering private practice, Tom served as Staff Director and General Counsel of the House Committee on Rules, as well as General Counsel to the U.S. House of Representatives.\u003c/p\u003e\n\u003cp\u003eTom was recognized as a leading government relations lawyer by\u0026nbsp;\u003cem\u003eLegal 500\u003c/em\u003e\u0026nbsp;in 2015 and 2016\u003cem\u003e.\u003c/em\u003e\u0026nbsp;He was also ranked by\u0026nbsp;\u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;in 2011\u0026ndash;2014, and by\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;in 2013.\u003c/p\u003e\n\u003cp\u003eTom is an adjunct professor at Florida State University College\u0026nbsp;Of Law where he teaches political law.\u003c/p\u003e","slug":"thomas-spulak","email":"tspulak@kslaw.com","phone":"+1 202 255 6942","matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":106,"guid":"106.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.capabilities","index":1,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":2,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":3,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":4,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":5,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":6,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":7,"source":"capabilities"},{"id":25,"guid":"25.capabilities","index":8,"source":"capabilities"},{"id":687,"guid":"687.smart_tags","index":9,"source":"smartTags"},{"id":984,"guid":"984.smart_tags","index":10,"source":"smartTags"},{"id":1097,"guid":"1097.smart_tags","index":11,"source":"smartTags"},{"id":110,"guid":"110.capabilities","index":12,"source":"capabilities"},{"id":111,"guid":"111.capabilities","index":13,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":14,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":15,"source":"smartTags"},{"id":750,"guid":"750.smart_tags","index":16,"source":"smartTags"},{"id":1157,"guid":"1157.smart_tags","index":17,"source":"smartTags"},{"id":122,"guid":"122.capabilities","index":18,"source":"capabilities"},{"id":124,"guid":"124.capabilities","index":19,"source":"capabilities"},{"id":125,"guid":"125.capabilities","index":20,"source":"capabilities"},{"id":128,"guid":"128.capabilities","index":21,"source":"capabilities"},{"id":1270,"guid":"1270.smart_tags","index":22,"source":"smartTags"},{"id":132,"guid":"132.capabilities","index":23,"source":"capabilities"}],"is_active":true,"last_name":"Spulak","nick_name":"Thomas","clerkships":[],"first_name":"Thomas","title_rank":9999,"updated_by":34,"law_schools":[],"middle_name":"J.","name_suffix":"","recognitions":[{"title":"“Top Ranked Lawyer,” Government Relations","detail":"Chambers USA, 2011–2014"},{"title":"\"He is very responsive and client-focused. Thomas is an expert on Congressional ethics laws and FEC compliance.\" ","detail":"CHAMBERS USA, 2022"},{"title":"Named to Best Lawyers in America for Government Relations","detail":"Best Lawyers in America, 2020"},{"title":"Leading Government Relations Lawyer ","detail":"Legal 500, 2015 and 2016"},{"title":"The Best Lawyers in America, 2013","detail":""}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eDrawing upon his deep experience with the legislative process, Tom's practice includes the development and execution of Legislative and Executive Branch strategies involving issues critical to domestic and foreign interests. His practice also includes advising corporations on complying with the vast array of laws that regulate the interaction of lobbyists with state and federal government officials.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAs group co-leader of our Government Advocacy \u0026amp; Public Policy practice, Tom is actively involved in numerous lobbying efforts on the most pressing issues in Washington, involving tax, health, energy, defense, aerospace and appropriations.\u003c/p\u003e\n\u003cp\u003eTom counsels clients on the full suite of political law issues. He advises clients on complying with federal and state laws that regulate and require the reporting of lobbyist activities, and counsels clients on the ethical considerations involved when corporate representatives and government officials interact. He provides guidance on federal and state election laws, and assists corporations with establishing and administering federal and state political action committees. Tom assists foreign entities in complying with the Foreign Agent Registration Act. And he assists tax-exempt organizations with understanding and complying with provisions of law that regulate lobbying and political activities.\u003c/p\u003e\n\u003cp\u003eBefore entering private practice, Tom served as Staff Director and General Counsel of the House Committee on Rules, as well as General Counsel to the U.S. House of Representatives.\u003c/p\u003e\n\u003cp\u003eTom was recognized as a leading government relations lawyer by\u0026nbsp;\u003cem\u003eLegal 500\u003c/em\u003e\u0026nbsp;in 2015 and 2016\u003cem\u003e.\u003c/em\u003e\u0026nbsp;He was also ranked by\u0026nbsp;\u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;in 2011\u0026ndash;2014, and by\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;in 2013.\u003c/p\u003e\n\u003cp\u003eTom is an adjunct professor at Florida State University College\u0026nbsp;Of Law where he teaches political law.\u003c/p\u003e","recognitions":[{"title":"“Top Ranked Lawyer,” Government Relations","detail":"Chambers USA, 2011–2014"},{"title":"\"He is very responsive and client-focused. Thomas is an expert on Congressional ethics laws and FEC compliance.\" ","detail":"CHAMBERS USA, 2022"},{"title":"Named to Best Lawyers in America for Government Relations","detail":"Best Lawyers in America, 2020"},{"title":"Leading Government Relations Lawyer ","detail":"Legal 500, 2015 and 2016"},{"title":"The Best Lawyers in America, 2013","detail":""}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9887}]},"capability_group_id":2},"created_at":"2025-05-26T05:03:23.000Z","updated_at":"2025-05-26T05:03:23.000Z","searchable_text":"Spulak{{ FIELD }}{:title=\u0026gt;\"“Top Ranked Lawyer,” Government Relations\", :detail=\u0026gt;\"Chambers USA, 2011–2014\"}{{ FIELD }}{:title=\u0026gt;\"\\\"He is very responsive and client-focused. Thomas is an expert on Congressional ethics laws and FEC compliance.\\\" \", :detail=\u0026gt;\"CHAMBERS USA, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Named to Best Lawyers in America for Government Relations\", :detail=\u0026gt;\"Best Lawyers in America, 2020\"}{{ FIELD }}{:title=\u0026gt;\"Leading Government Relations Lawyer \", :detail=\u0026gt;\"Legal 500, 2015 and 2016\"}{{ FIELD }}{:title=\u0026gt;\"The Best Lawyers in America, 2013\", :detail=\u0026gt;\"\"}{{ FIELD }}Drawing upon his deep experience with the legislative process, Tom's practice includes the development and execution of Legislative and Executive Branch strategies involving issues critical to domestic and foreign interests. His practice also includes advising corporations on complying with the vast array of laws that regulate the interaction of lobbyists with state and federal government officials.\nAs group co-leader of our Government Advocacy \u0026amp; Public Policy practice, Tom is actively involved in numerous lobbying efforts on the most pressing issues in Washington, involving tax, health, energy, defense, aerospace and appropriations.\nTom counsels clients on the full suite of political law issues. He advises clients on complying with federal and state laws that regulate and require the reporting of lobbyist activities, and counsels clients on the ethical considerations involved when corporate representatives and government officials interact. He provides guidance on federal and state election laws, and assists corporations with establishing and administering federal and state political action committees. Tom assists foreign entities in complying with the Foreign Agent Registration Act. And he assists tax-exempt organizations with understanding and complying with provisions of law that regulate lobbying and political activities.\nBefore entering private practice, Tom served as Staff Director and General Counsel of the House Committee on Rules, as well as General Counsel to the U.S. House of Representatives.\nTom was recognized as a leading government relations lawyer by Legal 500 in 2015 and 2016. He was also ranked by Chambers USA in 2011–2014, and by The Best Lawyers in America in 2013.\nTom is an adjunct professor at Florida State University College Of Law where he teaches political law. Partner “Top Ranked Lawyer,” Government Relations Chambers USA, 2011–2014 \"He is very responsive and client-focused. Thomas is an expert on Congressional ethics laws and FEC compliance.\"  CHAMBERS USA, 2022 Named to Best Lawyers in America for Government Relations Best Lawyers in America, 2020 Leading Government Relations Lawyer  Legal 500, 2015 and 2016 The Best Lawyers in America, 2013  University of Miami University of Miami School of Law Florida State University Florida State University College of Law District of Columbia Florida","searchable_name":"Thomas J. Spulak","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":426465,"version":1,"owner_type":"Person","owner_id":3700,"payload":{"bio":"\u003cp\u003eSmitha Stansbury specializes in conventional food and beverages, dietary supplements and personal care products regulated by the U.S. Food and Drug Administration. A partner in our FDA and Life Sciences practice, Smitha represents clients in regulatory matters at the federal and state levels, and conducts risks assessments and due diligence reviews of FDA-regulated companies involved in mergers, acquisitions and other corporate transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith particular expertise in food law, Smitha provides strategic regulatory counseling to clients on important issues relating to the development, promotion and sale of foods and dietary supplements, as well as cosmetics, drugs, medical devices and tobacco products. She also assists clients in responding to regulatory enforcement actions such as FDA warning letters, product seizures, recall requests and import detentions. In addition, she guides clients in conducting regulatory due diligence on corporate transactions and private equity investments.\u003c/p\u003e\n\u003cp\u003eSmitha has worked extensively with food and beverage manufacturers and distributors, food industry trade associations, equipment suppliers, retailers and restaurants on issues related to food safety, ingredients and product formulation, and food labeling and advertising. She regularly prepares and submits public comments, citizen petitions and other regulatory submissions to the FDA and other federal agencies on behalf of food industry clients, and also helps develop strategies for responding to legislative initiatives, agency rule-makings and guidance documents, and other actions that could materially affect the industry.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;and\u0026nbsp;\u003cem\u003eBest Lawyers USA\u003c/em\u003e\u0026nbsp;rank Smitha among the leading lawyers for FDA Regulatory Law. Smitha is a frequent author and speaker on food safety and labeling, FDA regulations and related topics.\u003c/p\u003e","slug":"smitha-stansbury","email":"sstansbury@kslaw.com","phone":null,"matters":["\u003cp\u003eRoutinely assist \u003cstrong data-redactor-tag=\"strong\"\u003eprivate equity firms\u003c/strong\u003e and others in conducting FDA regulatory due diligence of target food, beverage, dietary supplement, personal care product, pharmaceutical and medical device companies.\u003c/p\u003e","\u003cp\u003eRoutinely assist \u003cstrong data-redactor-tag=\"strong\"\u003eforeign and domestic food manufacturers and ingredient suppliers\u003c/strong\u003e with new food safety compliance requirements under the FDA Food Safety Modernization Act; also authored a leading book chapter and numerous articles on this groundbreaking legislation.\u003c/p\u003e","\u003cp\u003eDrafted influential comments to the FDA and USDA on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003emajor food industry trade associations\u003c/strong\u003e in response to various FDA or USDA proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, updates to the Nutrition Facts Panel and serving size regulations, menu and vending labeling, competitive foods sold in school, and the National List of Allowed and Prohibited Substances.\u003c/p\u003e","\u003cp\u003eCounseled \u003cstrong data-redactor-tag=\"strong\"\u003eglobal food manufacturers\u003c/strong\u003e on the FDA\u0026rsquo;s requirements for health claims, nutrient content claims, and structure-function claims, as well as FTC\u0026rsquo;s substantiation standards and expectations for claims made in food advertising.\u003c/p\u003e","\u003cp\u003eCounseled \u003cstrong data-redactor-tag=\"strong\"\u003eglobal food producers\u003c/strong\u003e on labeling and advertising considerations related to \u0026ldquo;natural,\u0026rdquo; \u0026ldquo;organic,\u0026rdquo; \"pure,\" \"clean\" and \u0026ldquo;GMO\u0026rdquo; claims.\u003c/p\u003e","\u003cp\u003eIn response to a major product recall, helped \u003cstrong data-redactor-tag=\"strong\"\u003eglobal food producer\u003c/strong\u003e implement significant corrective actions and coordinated recall response and dealings with FDA.\u003c/p\u003e","\u003cp\u003eWorked with \u003cstrong data-redactor-tag=\"strong\"\u003ea large dietary supplement manufacturer\u0026rsquo;s management team\u003c/strong\u003e to develop and implement cGMP procedures and policies to assist with FDA compliance and avoid potential enforcement action.\u003c/p\u003e","\u003cp\u003ePublished, presented and advised clients on an array of issues involving FDA\u0026rsquo;s application of the new dietary ingredient, food additive and GRAS substance safety rubric.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":208}]},"expertise":[{"id":103,"guid":"103.capabilities","index":0,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":1,"source":"capabilities"},{"id":104,"guid":"104.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":4,"source":"capabilities"},{"id":32,"guid":"32.capabilities","index":5,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":6,"source":"capabilities"},{"id":33,"guid":"33.capabilities","index":7,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":8,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":9,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":10,"source":"capabilities"},{"id":1199,"guid":"1199.smart_tags","index":11,"source":"smartTags"},{"id":128,"guid":"128.capabilities","index":12,"source":"capabilities"}],"is_active":true,"last_name":"Stansbury","nick_name":"Smitha","clerkships":[],"first_name":"Smitha","title_rank":9999,"updated_by":101,"law_schools":[{"id":2410,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"2003-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"G.","name_suffix":"","recognitions":[{"title":"Top Ranked Lawyer, Food \u0026 Beverages: Regulatory \u0026 Litigation","detail":"Chambers USA, Nationwide (2019-2022)"},{"title":"Top ranked lawyer for \"Food and Beverages: Regulatory and Litigation\"","detail":"Chambers USA (Nationwide), 2022"},{"title":"Ranked among the Best Lawyers for FDA Law","detail":"Best Lawyers USA, 2023"},{"title":"\"highly responsive, knowledgeable and our first call when we have complex problems in the food manufacturing industry\" ","detail":"Chambers USA, Quoting Clients"},{"title":"\"If you have a question about an FDA regulated product, she is a terrific resource.\"","detail":"Chambers USA, Quoting Clients"},{"title":"\"She has been exemplary in her knowledge, skills and ability to provide resources.\"","detail":"Chambers USA"},{"title":"\"She is an expert at interpreting and applying technical FDA regulations to food and beverage supplement products.\"","detail":"Chambers USA"},{"title":"Frequently sought out by food manufacturers and industry groups for her deep knowledge of FDA regulation","detail":"Chambers USA"},{"title":"\"She is very responsive, very efficient and very creative in her approach to helping balance our regulatory needs.\"","detail":"Chambers USA"},{"title":"Clients value her for being \"very sharp and customer-oriented\" ","detail":"Chambers USA"},{"title":"\"She is very enjoyable to work with and provides pin-point accurate advice.\" ","detail":"Chambers USA"},{"title":"Smitha is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues.","detail":"Chambers USA"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eSmitha Stansbury specializes in conventional food and beverages, dietary supplements and personal care products regulated by the U.S. Food and Drug Administration. A partner in our FDA and Life Sciences practice, Smitha represents clients in regulatory matters at the federal and state levels, and conducts risks assessments and due diligence reviews of FDA-regulated companies involved in mergers, acquisitions and other corporate transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith particular expertise in food law, Smitha provides strategic regulatory counseling to clients on important issues relating to the development, promotion and sale of foods and dietary supplements, as well as cosmetics, drugs, medical devices and tobacco products. She also assists clients in responding to regulatory enforcement actions such as FDA warning letters, product seizures, recall requests and import detentions. In addition, she guides clients in conducting regulatory due diligence on corporate transactions and private equity investments.\u003c/p\u003e\n\u003cp\u003eSmitha has worked extensively with food and beverage manufacturers and distributors, food industry trade associations, equipment suppliers, retailers and restaurants on issues related to food safety, ingredients and product formulation, and food labeling and advertising. She regularly prepares and submits public comments, citizen petitions and other regulatory submissions to the FDA and other federal agencies on behalf of food industry clients, and also helps develop strategies for responding to legislative initiatives, agency rule-makings and guidance documents, and other actions that could materially affect the industry.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;and\u0026nbsp;\u003cem\u003eBest Lawyers USA\u003c/em\u003e\u0026nbsp;rank Smitha among the leading lawyers for FDA Regulatory Law. Smitha is a frequent author and speaker on food safety and labeling, FDA regulations and related topics.\u003c/p\u003e","matters":["\u003cp\u003eRoutinely assist \u003cstrong data-redactor-tag=\"strong\"\u003eprivate equity firms\u003c/strong\u003e and others in conducting FDA regulatory due diligence of target food, beverage, dietary supplement, personal care product, pharmaceutical and medical device companies.\u003c/p\u003e","\u003cp\u003eRoutinely assist \u003cstrong data-redactor-tag=\"strong\"\u003eforeign and domestic food manufacturers and ingredient suppliers\u003c/strong\u003e with new food safety compliance requirements under the FDA Food Safety Modernization Act; also authored a leading book chapter and numerous articles on this groundbreaking legislation.\u003c/p\u003e","\u003cp\u003eDrafted influential comments to the FDA and USDA on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003emajor food industry trade associations\u003c/strong\u003e in response to various FDA or USDA proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, updates to the Nutrition Facts Panel and serving size regulations, menu and vending labeling, competitive foods sold in school, and the National List of Allowed and Prohibited Substances.\u003c/p\u003e","\u003cp\u003eCounseled \u003cstrong data-redactor-tag=\"strong\"\u003eglobal food manufacturers\u003c/strong\u003e on the FDA\u0026rsquo;s requirements for health claims, nutrient content claims, and structure-function claims, as well as FTC\u0026rsquo;s substantiation standards and expectations for claims made in food advertising.\u003c/p\u003e","\u003cp\u003eCounseled \u003cstrong data-redactor-tag=\"strong\"\u003eglobal food producers\u003c/strong\u003e on labeling and advertising considerations related to \u0026ldquo;natural,\u0026rdquo; \u0026ldquo;organic,\u0026rdquo; \"pure,\" \"clean\" and \u0026ldquo;GMO\u0026rdquo; claims.\u003c/p\u003e","\u003cp\u003eIn response to a major product recall, helped \u003cstrong data-redactor-tag=\"strong\"\u003eglobal food producer\u003c/strong\u003e implement significant corrective actions and coordinated recall response and dealings with FDA.\u003c/p\u003e","\u003cp\u003eWorked with \u003cstrong data-redactor-tag=\"strong\"\u003ea large dietary supplement manufacturer\u0026rsquo;s management team\u003c/strong\u003e to develop and implement cGMP procedures and policies to assist with FDA compliance and avoid potential enforcement action.\u003c/p\u003e","\u003cp\u003ePublished, presented and advised clients on an array of issues involving FDA\u0026rsquo;s application of the new dietary ingredient, food additive and GRAS substance safety rubric.\u003c/p\u003e"],"recognitions":[{"title":"Top Ranked Lawyer, Food \u0026 Beverages: Regulatory \u0026 Litigation","detail":"Chambers USA, Nationwide (2019-2022)"},{"title":"Top ranked lawyer for \"Food and Beverages: Regulatory and Litigation\"","detail":"Chambers USA (Nationwide), 2022"},{"title":"Ranked among the Best Lawyers for FDA Law","detail":"Best Lawyers USA, 2023"},{"title":"\"highly responsive, knowledgeable and our first call when we have complex problems in the food manufacturing industry\" ","detail":"Chambers USA, Quoting Clients"},{"title":"\"If you have a question about an FDA regulated product, she is a terrific resource.\"","detail":"Chambers USA, Quoting Clients"},{"title":"\"She has been exemplary in her knowledge, skills and ability to provide resources.\"","detail":"Chambers USA"},{"title":"\"She is an expert at interpreting and applying technical FDA regulations to food and beverage supplement products.\"","detail":"Chambers USA"},{"title":"Frequently sought out by food manufacturers and industry groups for her deep knowledge of FDA regulation","detail":"Chambers USA"},{"title":"\"She is very responsive, very efficient and very creative in her approach to helping balance our regulatory needs.\"","detail":"Chambers USA"},{"title":"Clients value her for being \"very sharp and customer-oriented\" ","detail":"Chambers USA"},{"title":"\"She is very enjoyable to work with and provides pin-point accurate advice.\" ","detail":"Chambers USA"},{"title":"Smitha is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues.","detail":"Chambers USA"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1199}]},"capability_group_id":2},"created_at":"2025-05-26T04:53:29.000Z","updated_at":"2025-05-26T04:53:29.000Z","searchable_text":"Stansbury{{ FIELD }}{:title=\u0026gt;\"Top Ranked Lawyer, Food \u0026amp; Beverages: Regulatory \u0026amp; Litigation\", :detail=\u0026gt;\"Chambers USA, Nationwide (2019-2022)\"}{{ FIELD }}{:title=\u0026gt;\"Top ranked lawyer for \\\"Food and Beverages: Regulatory and Litigation\\\"\", :detail=\u0026gt;\"Chambers USA (Nationwide), 2022\"}{{ FIELD }}{:title=\u0026gt;\"Ranked among the Best Lawyers for FDA Law\", :detail=\u0026gt;\"Best Lawyers USA, 2023\"}{{ FIELD }}{:title=\u0026gt;\"\\\"highly responsive, knowledgeable and our first call when we have complex problems in the food manufacturing industry\\\" \", :detail=\u0026gt;\"Chambers USA, Quoting Clients\"}{{ FIELD }}{:title=\u0026gt;\"\\\"If you have a question about an FDA regulated product, she is a terrific resource.\\\"\", :detail=\u0026gt;\"Chambers USA, Quoting Clients\"}{{ FIELD }}{:title=\u0026gt;\"\\\"She has been exemplary in her knowledge, skills and ability to provide resources.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"\\\"She is an expert at interpreting and applying technical FDA regulations to food and beverage supplement products.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"Frequently sought out by food manufacturers and industry groups for her deep knowledge of FDA regulation\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"\\\"She is very responsive, very efficient and very creative in her approach to helping balance our regulatory needs.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"Clients value her for being \\\"very sharp and customer-oriented\\\" \", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"\\\"She is very enjoyable to work with and provides pin-point accurate advice.\\\" \", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"Smitha is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues.\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}Routinely assist private equity firms and others in conducting FDA regulatory due diligence of target food, beverage, dietary supplement, personal care product, pharmaceutical and medical device companies.{{ FIELD }}Routinely assist foreign and domestic food manufacturers and ingredient suppliers with new food safety compliance requirements under the FDA Food Safety Modernization Act; also authored a leading book chapter and numerous articles on this groundbreaking legislation.{{ FIELD }}Drafted influential comments to the FDA and USDA on behalf of major food industry trade associations in response to various FDA or USDA proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, updates to the Nutrition Facts Panel and serving size regulations, menu and vending labeling, competitive foods sold in school, and the National List of Allowed and Prohibited Substances.{{ FIELD }}Counseled global food manufacturers on the FDA’s requirements for health claims, nutrient content claims, and structure-function claims, as well as FTC’s substantiation standards and expectations for claims made in food advertising.{{ FIELD }}Counseled global food producers on labeling and advertising considerations related to “natural,” “organic,” \"pure,\" \"clean\" and “GMO” claims.{{ FIELD }}In response to a major product recall, helped global food producer implement significant corrective actions and coordinated recall response and dealings with FDA.{{ FIELD }}Worked with a large dietary supplement manufacturer’s management team to develop and implement cGMP procedures and policies to assist with FDA compliance and avoid potential enforcement action.{{ FIELD }}Published, presented and advised clients on an array of issues involving FDA’s application of the new dietary ingredient, food additive and GRAS substance safety rubric.{{ FIELD }}Smitha Stansbury specializes in conventional food and beverages, dietary supplements and personal care products regulated by the U.S. Food and Drug Administration. A partner in our FDA and Life Sciences practice, Smitha represents clients in regulatory matters at the federal and state levels, and conducts risks assessments and due diligence reviews of FDA-regulated companies involved in mergers, acquisitions and other corporate transactions.\nWith particular expertise in food law, Smitha provides strategic regulatory counseling to clients on important issues relating to the development, promotion and sale of foods and dietary supplements, as well as cosmetics, drugs, medical devices and tobacco products. She also assists clients in responding to regulatory enforcement actions such as FDA warning letters, product seizures, recall requests and import detentions. In addition, she guides clients in conducting regulatory due diligence on corporate transactions and private equity investments.\nSmitha has worked extensively with food and beverage manufacturers and distributors, food industry trade associations, equipment suppliers, retailers and restaurants on issues related to food safety, ingredients and product formulation, and food labeling and advertising. She regularly prepares and submits public comments, citizen petitions and other regulatory submissions to the FDA and other federal agencies on behalf of food industry clients, and also helps develop strategies for responding to legislative initiatives, agency rule-makings and guidance documents, and other actions that could materially affect the industry.\nChambers USA and Best Lawyers USA rank Smitha among the leading lawyers for FDA Regulatory Law. Smitha is a frequent author and speaker on food safety and labeling, FDA regulations and related topics. Smitha G Stansbury Partner Top Ranked Lawyer, Food \u0026amp; Beverages: Regulatory \u0026amp; Litigation Chambers USA, Nationwide (2019-2022) Top ranked lawyer for \"Food and Beverages: Regulatory and Litigation\" Chambers USA (Nationwide), 2022 Ranked among the Best Lawyers for FDA Law Best Lawyers USA, 2023 \"highly responsive, knowledgeable and our first call when we have complex problems in the food manufacturing industry\"  Chambers USA, Quoting Clients \"If you have a question about an FDA regulated product, she is a terrific resource.\" Chambers USA, Quoting Clients \"She has been exemplary in her knowledge, skills and ability to provide resources.\" Chambers USA \"She is an expert at interpreting and applying technical FDA regulations to food and beverage supplement products.\" Chambers USA Frequently sought out by food manufacturers and industry groups for her deep knowledge of FDA regulation Chambers USA \"She is very responsive, very efficient and very creative in her approach to helping balance our regulatory needs.\" Chambers USA Clients value her for being \"very sharp and customer-oriented\"  Chambers USA \"She is very enjoyable to work with and provides pin-point accurate advice.\"  Chambers USA Smitha is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues. Chambers USA University of Virginia University of Virginia School of Law University of Virginia University of Virginia School of Law District of Columbia Maryland Routinely assist private equity firms and others in conducting FDA regulatory due diligence of target food, beverage, dietary supplement, personal care product, pharmaceutical and medical device companies. Routinely assist foreign and domestic food manufacturers and ingredient suppliers with new food safety compliance requirements under the FDA Food Safety Modernization Act; also authored a leading book chapter and numerous articles on this groundbreaking legislation. Drafted influential comments to the FDA and USDA on behalf of major food industry trade associations in response to various FDA or USDA proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, updates to the Nutrition Facts Panel and serving size regulations, menu and vending labeling, competitive foods sold in school, and the National List of Allowed and Prohibited Substances. Counseled global food manufacturers on the FDA’s requirements for health claims, nutrient content claims, and structure-function claims, as well as FTC’s substantiation standards and expectations for claims made in food advertising. Counseled global food producers on labeling and advertising considerations related to “natural,” “organic,” \"pure,\" \"clean\" and “GMO” claims. In response to a major product recall, helped global food producer implement significant corrective actions and coordinated recall response and dealings with FDA. Worked with a large dietary supplement manufacturer’s management team to develop and implement cGMP procedures and policies to assist with FDA compliance and avoid potential enforcement action. Published, presented and advised clients on an array of issues involving FDA’s application of the new dietary ingredient, food additive and GRAS substance safety rubric.","searchable_name":"Smitha G. Stansbury","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":442854,"version":1,"owner_type":"Person","owner_id":6020,"payload":{"bio":"\u003cp\u003eCliff Stricklin, a longtime Texas and Colorado based trial lawyer,\u0026nbsp;guides companies and executives through critical situations where litigation is a possible result. He advises clients in commercial disputes and defends them against government inquiries and private allegations of wrongdoing. He is a trusted advisor to C-suite executives and board members. He performs independent investigations on behalf of corporations and boards on subjects that include auditing, accounting, corporate governance and control, sexual harassment, and fraud. Should litigation become necessary, Cliff is an accomplished trial lawyer who has successfully tried and won some of the nation\u0026rsquo;s largest, most complex cases, including those involving Enron and Qwest.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eCliff aggressively defends corporations and executives in serious matters involving commercial litigation, antitrust, the False Claims Act, securities fraud and regulation (including cryptocurrency issues), industrial accidents, healthcare fraud, and environmental claims. He provides sophisticated advice and counseling in government\u0026nbsp;investigations and parallel civil suits.\u0026nbsp; His industry experience includes healthcare, finance \u0026amp; banking, fintech \u0026amp; cryptocurrency, oil \u0026amp; gas, pipelines, regulated utilities, telecommunications, civil engineering, web-based retail, biotech, medical devices, food production, faith-based organizations, real estate investments, recreation \u0026amp; hospitality, sports \u0026amp; entertainment, higher education, and mining.\u003c/p\u003e\n\u003cp\u003eHis public service positions have\u0026nbsp;included the roles of First Assistant U.S. Attorney for the District of Colorado, Special Assistant U.S. Attorney with the Enron Task Force in Houston and Dallas, Texas, State District Judge in Dallas, Texas, and Assistant U.S. Attorney in Plano and Dallas, Texas.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs a federal prosecutor, Cliff was one of the few attorneys to have won the two highest awards bestowed by the U.S. Department of Justice: the Attorney General\u0026rsquo;s Award for Exceptional Service for his work as a key member of the Enron Task Force, and the Attorney General\u0026rsquo;s Award for Distinguished Service for his work prosecuting the CEO of Qwest Communications for insider trading.\u003c/p\u003e\n\u003cp\u003eCliff\u0026rsquo;s courtroom experience also extends to the bench. During his distinguished term as a Texas state district judge in which he heard thousands of cases \u0026ndash; not a single case was overturned on appeal. Cliff also served as presiding judge in Dallas County, Texas, a position he used to implement a number of measures designed to bring openness and fairness to the justice system. \u003cem\u003eThe Dallas Morning News\u003c/em\u003e opined, \u0026ldquo;Mr. Stricklin totes impressive credentials. His work ethic, calm judicial temperament and judgment have earned him the respect of his robed colleagues \u0026hellip; Mr. Stricklin has performed admirably on the bench.\u0026rdquo;\u003c/p\u003e\n\u003cp\u003eAdditionally, Cliff created the White Collar Criminal Law program at the University of Colorado\u0026rsquo;s School of Law and served there as an adjunct professor for ten years. He also\u0026nbsp;taught trial advocacy at SMU Dedman School of Law in Dallas, Texas, and at the U.S. Department of Justice's National Advocacy Center in Columbia, South Carolina and Washington, D.C.\u0026nbsp;He is also Board Certified in Criminal Law by the Texas Board of Legal Specialization.\u003c/p\u003e","slug":"cliff-stricklin","email":"cstricklin@kslaw.com","phone":"+1 303 489 6679","matters":["\u003cp\u003eRepresented the former CFO of a technology company in a federal grand jury investigation led by the U.S. Department of Justice\u0026rsquo;s Antitrust Division into alleged non-solicitation and \u0026ldquo;no poach\u0026rdquo; agreements. After a six-month long investigation, the government declined to prosecute and closed the case.\u003c/p\u003e","\u003cp\u003eRepresented a U.S. Olympic athletic organization in a multi-year investigation by the U.S. Department of Justice that included response to wide-ranging grand jury subpoenas. The matter was concluded when the Department declined to pursue charges.\u003c/p\u003e","\u003cp\u003eLed the defense of a large food manufacturing company and its majority shareholders against claims of breach of fiduciary duty and oppression brought by the minority shareholders in a two-week jury trial. The plaintiffs' lawsuit sought to dissolve the company and $2 billion in damages. After a two-week trial a jury found for the company and the majority shareholders and the plaintiffs took nothing. The jury foreperson was later quoted as saying, \"[Stricklin's] closing was amazing. [The defense team] did a great job. To us at least, the closing really pieced together a lot of the evidence we had questions about or thoughts about.\"\u003c/p\u003e","\u003cp\u003eRepresented the former CEO of a Fortune 250 healthcare company against first of their kind federal antitrust criminal charges involving \"no poach\" agreements brought by the U.S. Department of Justice's Antitrust Division. After a two-week trial a jury found the client not guilty of all charges.\u003c/p\u003e","\u003cp\u003eRepresented two banking executives in a grand jury investigation involving theft of trade secrets and computer crimes. After a six month investigation, case was dismissed by prosecutors.\u003c/p\u003e","\u003cp\u003eRepresented a midstream pipeline company in relation to largest pipeline spill of its kind. After a seven year investigation by the U.S. Department of Justice's Environmental and Natural Resources Division, the Environmental Protection Agency, and the North Dakota Department of Environmental Quality, all claims were resolved with a Clean Water Act Misdemeanor and Failure to Report felony. The plea did not include any individuals or restitution, did not require a corporate monitor or debarment, and allowed the fine to be paid out over five years.\u003c/p\u003e","\u003cp\u003eLed the defense of a large food manufacturing company in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;action under the False Claims Act matter brought by an individual U.S. Department of Agriculture Inspector valued at over $1b. The matter resulted in the government declining to intervene and the U.S. District Court dismissing the Inspector's lawsuit with prejudice and awarding client costs.\u003c/p\u003e","\u003cp\u003eRepresented a Fortune 250 healthcare company in a False Claims Act lawsuit brought by a whistleblower. The matter resulted in the U.S. District Court dismissing the complaint based on motions, and the relator did not re-file.\u003c/p\u003e","\u003cp\u003eRepresented a Fortune 250 healthcare company in an investigation by the U.S. Attorney\u0026rsquo;s Office and U.S. Health and Human Services in an investigation relating to the Anti-Kickback Statute and Stark Law. The matter resulted in no action being taken.\u003c/p\u003e","\u003cp\u003eRepresented a CEO of a large, publicly-traded tech company in an independent board member investigation. The matter resulted in no action being taken.\u003c/p\u003e","\u003cp\u003eRepresented a Chief Accounting Officer of a large civil engineering firm in an U.S. Securities and Exchange Commission investigation into financial reporting issues. The matter resulted in a \u0026ldquo;no action\u0026rdquo; letter provided by SEC.\u003c/p\u003e","\u003cp\u003eRepresented a corporate owner in an insider trading investigation brought by the U.S. Securities and Exchange Commission and U.S. Department of Justice. The result of the matter was the entry of a \u0026ldquo;no admit or deny\u0026rdquo; administrative order and no charges were brought.\u003c/p\u003e","\u003cp\u003eRepresented a national telecom provider in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;matter under the False Claims Act matter alleging fraud into the Federal Government E-Rate program. The matter resulted in the federal government declining to intervene and the case being dismissed.\u003c/p\u003e","\u003cp\u003eRepresented a large regional not-for-profit hospital in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;matter under the False Claims Act alleging Medicare and Medicaid fraud. The investigation lasted 18 months, with the results being a minimal settlement with the state Attorney General\u0026rsquo;s office, and the federal government declining to intervene.\u003c/p\u003e","\u003cp\u003eRepresented a large civil engineering firm in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;matter under the False Claims Act matter and a civil and criminal investigation by the Department of Energy and the Department of Justice. The matter resulted in the relator being dismissed, and there was a civil settlement with the DOJ that included a non-prosecution agreement.\u003c/p\u003e","\u003cp\u003eRepresented a large engineering and infrastructure corporation in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;matter under the False Claims Act investigation by the U.S. Department of Justice and the U.S. Attorney's Office related to liquid petroleum gas installation issued during Hurricane Katrina recovery. The matter resulted in the government declining to intervene and the case being dismissed.\u003c/p\u003e","\u003cp\u003eRepresented a principal investor in a complicated investment plan investigated over a three-year period for securities fraud. The matter resulted in no charges being filed.\u003c/p\u003e","\u003cp\u003eRepresented a healthcare industry executive investigated for conspiracy to defraud the government and importation of unlicensed medical devices. The matter resulted in no jail time, no probation, a guilty plea to misprision and a $10k fine.\u003c/p\u003e","\u003cp\u003eLed the defense of Xcel Energy, Inc. and Public Service Company of Colorado against federal criminal charges arising out of an accident that killed five contractors at a hydroelectric power plant. The result of the matter after a five-week long trial involving complex OSHA regulations, was a jury returning not-guilty verdicts in favor of both companies.\u003c/p\u003e","\u003cp\u003eRepresented a large food production company in environmental litigation against the seller of property that failed to disclose the presence of asbestos. The result of the matter was a successful settlement for the client.\u003c/p\u003e","\u003cp\u003eRepresented Chemical \u0026amp; Metal Industries, Inc. in an appeal from a $3m fine and restitution award in the U.S. 5th Circuit Court of Appeals. The result of the matter was the restitution being vacated completely and the fine being reduced to $500k.\u003c/p\u003e","\u003cp\u003eRepresented an executive at a Fortune 500 healthcare company in a matter involving the Anti-Kickback Statute and the Stark Law. The matter resulted in no charges being brought.\u003c/p\u003e","\u003cp\u003eDefended a natural gas production and distribution company against a civil complaint filed by the Environmental Protection Agency. The result of the matter was a successful settlement for the client.\u003c/p\u003e","\u003cp\u003eDefended Eddie Bauer in an intellectual property case involving trademarked brand names. The matter resulted in a successful resolution for Eddie Bauer.\u003c/p\u003e","\u003cp\u003eRepresented a Nobel Prize winning scientist in an investigation by the U.S. Department of Commerce relating to climate change issues. The matter resulted in no charges being brought.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":1,"source":"capabilities"},{"id":20,"guid":"20.capabilities","index":2,"source":"capabilities"},{"id":1,"guid":"1.capabilities","index":3,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":4,"source":"smartTags"},{"id":766,"guid":"766.smart_tags","index":5,"source":"smartTags"},{"id":71,"guid":"71.capabilities","index":6,"source":"capabilities"},{"id":1168,"guid":"1168.smart_tags","index":7,"source":"smartTags"},{"id":21,"guid":"21.capabilities","index":8,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":9,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":10,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":11,"source":"capabilities"},{"id":118,"guid":"118.capabilities","index":12,"source":"capabilities"},{"id":765,"guid":"765.smart_tags","index":13,"source":"smartTags"},{"id":1199,"guid":"1199.smart_tags","index":14,"source":"smartTags"},{"id":1188,"guid":"1188.smart_tags","index":15,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":16,"source":"smartTags"},{"id":750,"guid":"750.smart_tags","index":17,"source":"smartTags"},{"id":129,"guid":"129.capabilities","index":18,"source":"capabilities"}],"is_active":true,"last_name":"Stricklin","nick_name":"Cliff","clerkships":[],"first_name":"Cliff","title_rank":9999,"updated_by":202,"law_schools":[{"id":2484,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"1991-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Lawyer of the Year","detail":"Colorado Law Week, 2024"},{"title":"Barrister’s Best White Collar Lawyer ","detail":"Colorado Law Week, October 2023"},{"title":"Litigator of the Week","detail":"The American Lawyer, December 2022"},{"title":"Band One, Litigation: White-Collar Crime \u0026 Government Investigations","detail":"Chambers USA, Colorado, 2012-Present"},{"title":"U.S. Attorney General’s Award for Exceptional Service","detail":"U.S. Department of Justice"},{"title":"U.S. Attorney General’s Award for Distinguished Service","detail":"U.S. Department of Justice"},{"title":"Colorado Super Lawyer ","detail":"Super Lawyers, 2011-Present"},{"title":"Named to “Alumni 150” as being one of the Baylor University’s 150 most remarkable graduates over the last 150 years","detail":"Baylor University"},{"title":"Best Overall Litigator","detail":"Law Week Colorado’s Best in Show, 2011"},{"title":"Winner of the PowerBook Legal Industry Leader Award","detail":"Denver Business Journal, 2007"},{"title":"Awarded the Federal Bureau of Investigation’s Director’s Award for Outstanding Criminal Investigation","detail":"FBI"}],"linked_in_url":"https://www.linkedin.com/in/cliff-stricklin-8603001a/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eCliff Stricklin, a longtime Texas and Colorado based trial lawyer,\u0026nbsp;guides companies and executives through critical situations where litigation is a possible result. He advises clients in commercial disputes and defends them against government inquiries and private allegations of wrongdoing. He is a trusted advisor to C-suite executives and board members. He performs independent investigations on behalf of corporations and boards on subjects that include auditing, accounting, corporate governance and control, sexual harassment, and fraud. Should litigation become necessary, Cliff is an accomplished trial lawyer who has successfully tried and won some of the nation\u0026rsquo;s largest, most complex cases, including those involving Enron and Qwest.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eCliff aggressively defends corporations and executives in serious matters involving commercial litigation, antitrust, the False Claims Act, securities fraud and regulation (including cryptocurrency issues), industrial accidents, healthcare fraud, and environmental claims. He provides sophisticated advice and counseling in government\u0026nbsp;investigations and parallel civil suits.\u0026nbsp; His industry experience includes healthcare, finance \u0026amp; banking, fintech \u0026amp; cryptocurrency, oil \u0026amp; gas, pipelines, regulated utilities, telecommunications, civil engineering, web-based retail, biotech, medical devices, food production, faith-based organizations, real estate investments, recreation \u0026amp; hospitality, sports \u0026amp; entertainment, higher education, and mining.\u003c/p\u003e\n\u003cp\u003eHis public service positions have\u0026nbsp;included the roles of First Assistant U.S. Attorney for the District of Colorado, Special Assistant U.S. Attorney with the Enron Task Force in Houston and Dallas, Texas, State District Judge in Dallas, Texas, and Assistant U.S. Attorney in Plano and Dallas, Texas.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs a federal prosecutor, Cliff was one of the few attorneys to have won the two highest awards bestowed by the U.S. Department of Justice: the Attorney General\u0026rsquo;s Award for Exceptional Service for his work as a key member of the Enron Task Force, and the Attorney General\u0026rsquo;s Award for Distinguished Service for his work prosecuting the CEO of Qwest Communications for insider trading.\u003c/p\u003e\n\u003cp\u003eCliff\u0026rsquo;s courtroom experience also extends to the bench. During his distinguished term as a Texas state district judge in which he heard thousands of cases \u0026ndash; not a single case was overturned on appeal. Cliff also served as presiding judge in Dallas County, Texas, a position he used to implement a number of measures designed to bring openness and fairness to the justice system. \u003cem\u003eThe Dallas Morning News\u003c/em\u003e opined, \u0026ldquo;Mr. Stricklin totes impressive credentials. His work ethic, calm judicial temperament and judgment have earned him the respect of his robed colleagues \u0026hellip; Mr. Stricklin has performed admirably on the bench.\u0026rdquo;\u003c/p\u003e\n\u003cp\u003eAdditionally, Cliff created the White Collar Criminal Law program at the University of Colorado\u0026rsquo;s School of Law and served there as an adjunct professor for ten years. He also\u0026nbsp;taught trial advocacy at SMU Dedman School of Law in Dallas, Texas, and at the U.S. Department of Justice's National Advocacy Center in Columbia, South Carolina and Washington, D.C.\u0026nbsp;He is also Board Certified in Criminal Law by the Texas Board of Legal Specialization.\u003c/p\u003e","matters":["\u003cp\u003eRepresented the former CFO of a technology company in a federal grand jury investigation led by the U.S. Department of Justice\u0026rsquo;s Antitrust Division into alleged non-solicitation and \u0026ldquo;no poach\u0026rdquo; agreements. After a six-month long investigation, the government declined to prosecute and closed the case.\u003c/p\u003e","\u003cp\u003eRepresented a U.S. Olympic athletic organization in a multi-year investigation by the U.S. Department of Justice that included response to wide-ranging grand jury subpoenas. The matter was concluded when the Department declined to pursue charges.\u003c/p\u003e","\u003cp\u003eLed the defense of a large food manufacturing company and its majority shareholders against claims of breach of fiduciary duty and oppression brought by the minority shareholders in a two-week jury trial. The plaintiffs' lawsuit sought to dissolve the company and $2 billion in damages. After a two-week trial a jury found for the company and the majority shareholders and the plaintiffs took nothing. The jury foreperson was later quoted as saying, \"[Stricklin's] closing was amazing. [The defense team] did a great job. To us at least, the closing really pieced together a lot of the evidence we had questions about or thoughts about.\"\u003c/p\u003e","\u003cp\u003eRepresented the former CEO of a Fortune 250 healthcare company against first of their kind federal antitrust criminal charges involving \"no poach\" agreements brought by the U.S. Department of Justice's Antitrust Division. After a two-week trial a jury found the client not guilty of all charges.\u003c/p\u003e","\u003cp\u003eRepresented two banking executives in a grand jury investigation involving theft of trade secrets and computer crimes. After a six month investigation, case was dismissed by prosecutors.\u003c/p\u003e","\u003cp\u003eRepresented a midstream pipeline company in relation to largest pipeline spill of its kind. After a seven year investigation by the U.S. Department of Justice's Environmental and Natural Resources Division, the Environmental Protection Agency, and the North Dakota Department of Environmental Quality, all claims were resolved with a Clean Water Act Misdemeanor and Failure to Report felony. The plea did not include any individuals or restitution, did not require a corporate monitor or debarment, and allowed the fine to be paid out over five years.\u003c/p\u003e","\u003cp\u003eLed the defense of a large food manufacturing company in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;action under the False Claims Act matter brought by an individual U.S. Department of Agriculture Inspector valued at over $1b. The matter resulted in the government declining to intervene and the U.S. District Court dismissing the Inspector's lawsuit with prejudice and awarding client costs.\u003c/p\u003e","\u003cp\u003eRepresented a Fortune 250 healthcare company in a False Claims Act lawsuit brought by a whistleblower. The matter resulted in the U.S. District Court dismissing the complaint based on motions, and the relator did not re-file.\u003c/p\u003e","\u003cp\u003eRepresented a Fortune 250 healthcare company in an investigation by the U.S. Attorney\u0026rsquo;s Office and U.S. Health and Human Services in an investigation relating to the Anti-Kickback Statute and Stark Law. The matter resulted in no action being taken.\u003c/p\u003e","\u003cp\u003eRepresented a CEO of a large, publicly-traded tech company in an independent board member investigation. The matter resulted in no action being taken.\u003c/p\u003e","\u003cp\u003eRepresented a Chief Accounting Officer of a large civil engineering firm in an U.S. Securities and Exchange Commission investigation into financial reporting issues. The matter resulted in a \u0026ldquo;no action\u0026rdquo; letter provided by SEC.\u003c/p\u003e","\u003cp\u003eRepresented a corporate owner in an insider trading investigation brought by the U.S. Securities and Exchange Commission and U.S. Department of Justice. The result of the matter was the entry of a \u0026ldquo;no admit or deny\u0026rdquo; administrative order and no charges were brought.\u003c/p\u003e","\u003cp\u003eRepresented a national telecom provider in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;matter under the False Claims Act matter alleging fraud into the Federal Government E-Rate program. The matter resulted in the federal government declining to intervene and the case being dismissed.\u003c/p\u003e","\u003cp\u003eRepresented a large regional not-for-profit hospital in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;matter under the False Claims Act alleging Medicare and Medicaid fraud. The investigation lasted 18 months, with the results being a minimal settlement with the state Attorney General\u0026rsquo;s office, and the federal government declining to intervene.\u003c/p\u003e","\u003cp\u003eRepresented a large civil engineering firm in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;matter under the False Claims Act matter and a civil and criminal investigation by the Department of Energy and the Department of Justice. The matter resulted in the relator being dismissed, and there was a civil settlement with the DOJ that included a non-prosecution agreement.\u003c/p\u003e","\u003cp\u003eRepresented a large engineering and infrastructure corporation in a\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;matter under the False Claims Act investigation by the U.S. Department of Justice and the U.S. Attorney's Office related to liquid petroleum gas installation issued during Hurricane Katrina recovery. The matter resulted in the government declining to intervene and the case being dismissed.\u003c/p\u003e","\u003cp\u003eRepresented a principal investor in a complicated investment plan investigated over a three-year period for securities fraud. The matter resulted in no charges being filed.\u003c/p\u003e","\u003cp\u003eRepresented a healthcare industry executive investigated for conspiracy to defraud the government and importation of unlicensed medical devices. The matter resulted in no jail time, no probation, a guilty plea to misprision and a $10k fine.\u003c/p\u003e","\u003cp\u003eLed the defense of Xcel Energy, Inc. and Public Service Company of Colorado against federal criminal charges arising out of an accident that killed five contractors at a hydroelectric power plant. The result of the matter after a five-week long trial involving complex OSHA regulations, was a jury returning not-guilty verdicts in favor of both companies.\u003c/p\u003e","\u003cp\u003eRepresented a large food production company in environmental litigation against the seller of property that failed to disclose the presence of asbestos. The result of the matter was a successful settlement for the client.\u003c/p\u003e","\u003cp\u003eRepresented Chemical \u0026amp; Metal Industries, Inc. in an appeal from a $3m fine and restitution award in the U.S. 5th Circuit Court of Appeals. The result of the matter was the restitution being vacated completely and the fine being reduced to $500k.\u003c/p\u003e","\u003cp\u003eRepresented an executive at a Fortune 500 healthcare company in a matter involving the Anti-Kickback Statute and the Stark Law. The matter resulted in no charges being brought.\u003c/p\u003e","\u003cp\u003eDefended a natural gas production and distribution company against a civil complaint filed by the Environmental Protection Agency. The result of the matter was a successful settlement for the client.\u003c/p\u003e","\u003cp\u003eDefended Eddie Bauer in an intellectual property case involving trademarked brand names. The matter resulted in a successful resolution for Eddie Bauer.\u003c/p\u003e","\u003cp\u003eRepresented a Nobel Prize winning scientist in an investigation by the U.S. Department of Commerce relating to climate change issues. The matter resulted in no charges being brought.\u003c/p\u003e"],"recognitions":[{"title":"Lawyer of the Year","detail":"Colorado Law Week, 2024"},{"title":"Barrister’s Best White Collar Lawyer ","detail":"Colorado Law Week, October 2023"},{"title":"Litigator of the Week","detail":"The American Lawyer, December 2022"},{"title":"Band One, Litigation: White-Collar Crime \u0026 Government Investigations","detail":"Chambers USA, Colorado, 2012-Present"},{"title":"U.S. Attorney General’s Award for Exceptional Service","detail":"U.S. Department of Justice"},{"title":"U.S. Attorney General’s Award for Distinguished Service","detail":"U.S. Department of Justice"},{"title":"Colorado Super Lawyer ","detail":"Super Lawyers, 2011-Present"},{"title":"Named to “Alumni 150” as being one of the Baylor University’s 150 most remarkable graduates over the last 150 years","detail":"Baylor University"},{"title":"Best Overall Litigator","detail":"Law Week Colorado’s Best in Show, 2011"},{"title":"Winner of the PowerBook Legal Industry Leader Award","detail":"Denver Business Journal, 2007"},{"title":"Awarded the Federal Bureau of Investigation’s Director’s Award for Outstanding Criminal Investigation","detail":"FBI"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":8785}]},"capability_group_id":2},"created_at":"2025-11-13T04:58:47.000Z","updated_at":"2025-11-13T04:58:47.000Z","searchable_text":"Stricklin{{ FIELD }}{:title=\u0026gt;\"Lawyer of the Year\", :detail=\u0026gt;\"Colorado Law Week, 2024\"}{{ FIELD }}{:title=\u0026gt;\"Barrister’s Best White Collar Lawyer \", :detail=\u0026gt;\"Colorado Law Week, October 2023\"}{{ FIELD }}{:title=\u0026gt;\"Litigator of the Week\", :detail=\u0026gt;\"The American Lawyer, December 2022\"}{{ FIELD }}{:title=\u0026gt;\"Band One, Litigation: White-Collar Crime \u0026amp; Government Investigations\", :detail=\u0026gt;\"Chambers USA, Colorado, 2012-Present\"}{{ FIELD }}{:title=\u0026gt;\"U.S. Attorney General’s Award for Exceptional Service\", :detail=\u0026gt;\"U.S. Department of Justice\"}{{ FIELD }}{:title=\u0026gt;\"U.S. Attorney General’s Award for Distinguished Service\", :detail=\u0026gt;\"U.S. Department of Justice\"}{{ FIELD }}{:title=\u0026gt;\"Colorado Super Lawyer \", :detail=\u0026gt;\"Super Lawyers, 2011-Present\"}{{ FIELD }}{:title=\u0026gt;\"Named to “Alumni 150” as being one of the Baylor University’s 150 most remarkable graduates over the last 150 years\", :detail=\u0026gt;\"Baylor University\"}{{ FIELD }}{:title=\u0026gt;\"Best Overall Litigator\", :detail=\u0026gt;\"Law Week Colorado’s Best in Show, 2011\"}{{ FIELD }}{:title=\u0026gt;\"Winner of the PowerBook Legal Industry Leader Award\", :detail=\u0026gt;\"Denver Business Journal, 2007\"}{{ FIELD }}{:title=\u0026gt;\"Awarded the Federal Bureau of Investigation’s Director’s Award for Outstanding Criminal Investigation\", :detail=\u0026gt;\"FBI\"}{{ FIELD }}Represented the former CFO of a technology company in a federal grand jury investigation led by the U.S. Department of Justice’s Antitrust Division into alleged non-solicitation and “no poach” agreements. After a six-month long investigation, the government declined to prosecute and closed the case.{{ FIELD }}Represented a U.S. Olympic athletic organization in a multi-year investigation by the U.S. Department of Justice that included response to wide-ranging grand jury subpoenas. The matter was concluded when the Department declined to pursue charges.{{ FIELD }}Led the defense of a large food manufacturing company and its majority shareholders against claims of breach of fiduciary duty and oppression brought by the minority shareholders in a two-week jury trial. The plaintiffs' lawsuit sought to dissolve the company and $2 billion in damages. After a two-week trial a jury found for the company and the majority shareholders and the plaintiffs took nothing. The jury foreperson was later quoted as saying, \"[Stricklin's] closing was amazing. [The defense team] did a great job. To us at least, the closing really pieced together a lot of the evidence we had questions about or thoughts about.\"{{ FIELD }}Represented the former CEO of a Fortune 250 healthcare company against first of their kind federal antitrust criminal charges involving \"no poach\" agreements brought by the U.S. Department of Justice's Antitrust Division. After a two-week trial a jury found the client not guilty of all charges.{{ FIELD }}Represented two banking executives in a grand jury investigation involving theft of trade secrets and computer crimes. After a six month investigation, case was dismissed by prosecutors.{{ FIELD }}Represented a midstream pipeline company in relation to largest pipeline spill of its kind. After a seven year investigation by the U.S. Department of Justice's Environmental and Natural Resources Division, the Environmental Protection Agency, and the North Dakota Department of Environmental Quality, all claims were resolved with a Clean Water Act Misdemeanor and Failure to Report felony. The plea did not include any individuals or restitution, did not require a corporate monitor or debarment, and allowed the fine to be paid out over five years.{{ FIELD }}Led the defense of a large food manufacturing company in a qui tam action under the False Claims Act matter brought by an individual U.S. Department of Agriculture Inspector valued at over $1b. The matter resulted in the government declining to intervene and the U.S. District Court dismissing the Inspector's lawsuit with prejudice and awarding client costs.{{ FIELD }}Represented a Fortune 250 healthcare company in a False Claims Act lawsuit brought by a whistleblower. The matter resulted in the U.S. District Court dismissing the complaint based on motions, and the relator did not re-file.{{ FIELD }}Represented a Fortune 250 healthcare company in an investigation by the U.S. Attorney’s Office and U.S. Health and Human Services in an investigation relating to the Anti-Kickback Statute and Stark Law. The matter resulted in no action being taken.{{ FIELD }}Represented a CEO of a large, publicly-traded tech company in an independent board member investigation. The matter resulted in no action being taken.{{ FIELD }}Represented a Chief Accounting Officer of a large civil engineering firm in an U.S. Securities and Exchange Commission investigation into financial reporting issues. The matter resulted in a “no action” letter provided by SEC.{{ FIELD }}Represented a corporate owner in an insider trading investigation brought by the U.S. Securities and Exchange Commission and U.S. Department of Justice. The result of the matter was the entry of a “no admit or deny” administrative order and no charges were brought.{{ FIELD }}Represented a national telecom provider in a qui tam matter under the False Claims Act matter alleging fraud into the Federal Government E-Rate program. The matter resulted in the federal government declining to intervene and the case being dismissed.{{ FIELD }}Represented a large regional not-for-profit hospital in a qui tam matter under the False Claims Act alleging Medicare and Medicaid fraud. The investigation lasted 18 months, with the results being a minimal settlement with the state Attorney General’s office, and the federal government declining to intervene.{{ FIELD }}Represented a large civil engineering firm in a qui tam matter under the False Claims Act matter and a civil and criminal investigation by the Department of Energy and the Department of Justice. The matter resulted in the relator being dismissed, and there was a civil settlement with the DOJ that included a non-prosecution agreement.{{ FIELD }}Represented a large engineering and infrastructure corporation in a qui tam matter under the False Claims Act investigation by the U.S. Department of Justice and the U.S. Attorney's Office related to liquid petroleum gas installation issued during Hurricane Katrina recovery. The matter resulted in the government declining to intervene and the case being dismissed.{{ FIELD }}Represented a principal investor in a complicated investment plan investigated over a three-year period for securities fraud. The matter resulted in no charges being filed.{{ FIELD }}Represented a healthcare industry executive investigated for conspiracy to defraud the government and importation of unlicensed medical devices. The matter resulted in no jail time, no probation, a guilty plea to misprision and a $10k fine.{{ FIELD }}Led the defense of Xcel Energy, Inc. and Public Service Company of Colorado against federal criminal charges arising out of an accident that killed five contractors at a hydroelectric power plant. The result of the matter after a five-week long trial involving complex OSHA regulations, was a jury returning not-guilty verdicts in favor of both companies.{{ FIELD }}Represented a large food production company in environmental litigation against the seller of property that failed to disclose the presence of asbestos. The result of the matter was a successful settlement for the client.{{ FIELD }}Represented Chemical \u0026amp; Metal Industries, Inc. in an appeal from a $3m fine and restitution award in the U.S. 5th Circuit Court of Appeals. The result of the matter was the restitution being vacated completely and the fine being reduced to $500k.{{ FIELD }}Represented an executive at a Fortune 500 healthcare company in a matter involving the Anti-Kickback Statute and the Stark Law. The matter resulted in no charges being brought.{{ FIELD }}Defended a natural gas production and distribution company against a civil complaint filed by the Environmental Protection Agency. The result of the matter was a successful settlement for the client.{{ FIELD }}Defended Eddie Bauer in an intellectual property case involving trademarked brand names. The matter resulted in a successful resolution for Eddie Bauer.{{ FIELD }}Represented a Nobel Prize winning scientist in an investigation by the U.S. Department of Commerce relating to climate change issues. The matter resulted in no charges being brought.{{ FIELD }}Cliff Stricklin, a longtime Texas and Colorado based trial lawyer, guides companies and executives through critical situations where litigation is a possible result. He advises clients in commercial disputes and defends them against government inquiries and private allegations of wrongdoing. He is a trusted advisor to C-suite executives and board members. He performs independent investigations on behalf of corporations and boards on subjects that include auditing, accounting, corporate governance and control, sexual harassment, and fraud. Should litigation become necessary, Cliff is an accomplished trial lawyer who has successfully tried and won some of the nation’s largest, most complex cases, including those involving Enron and Qwest.\nCliff aggressively defends corporations and executives in serious matters involving commercial litigation, antitrust, the False Claims Act, securities fraud and regulation (including cryptocurrency issues), industrial accidents, healthcare fraud, and environmental claims. He provides sophisticated advice and counseling in government investigations and parallel civil suits.  His industry experience includes healthcare, finance \u0026amp; banking, fintech \u0026amp; cryptocurrency, oil \u0026amp; gas, pipelines, regulated utilities, telecommunications, civil engineering, web-based retail, biotech, medical devices, food production, faith-based organizations, real estate investments, recreation \u0026amp; hospitality, sports \u0026amp; entertainment, higher education, and mining.\nHis public service positions have included the roles of First Assistant U.S. Attorney for the District of Colorado, Special Assistant U.S. Attorney with the Enron Task Force in Houston and Dallas, Texas, State District Judge in Dallas, Texas, and Assistant U.S. Attorney in Plano and Dallas, Texas.  \nAs a federal prosecutor, Cliff was one of the few attorneys to have won the two highest awards bestowed by the U.S. Department of Justice: the Attorney General’s Award for Exceptional Service for his work as a key member of the Enron Task Force, and the Attorney General’s Award for Distinguished Service for his work prosecuting the CEO of Qwest Communications for insider trading.\nCliff’s courtroom experience also extends to the bench. During his distinguished term as a Texas state district judge in which he heard thousands of cases – not a single case was overturned on appeal. Cliff also served as presiding judge in Dallas County, Texas, a position he used to implement a number of measures designed to bring openness and fairness to the justice system. The Dallas Morning News opined, “Mr. Stricklin totes impressive credentials. His work ethic, calm judicial temperament and judgment have earned him the respect of his robed colleagues … Mr. Stricklin has performed admirably on the bench.”\nAdditionally, Cliff created the White Collar Criminal Law program at the University of Colorado’s School of Law and served there as an adjunct professor for ten years. He also taught trial advocacy at SMU Dedman School of Law in Dallas, Texas, and at the U.S. Department of Justice's National Advocacy Center in Columbia, South Carolina and Washington, D.C. He is also Board Certified in Criminal Law by the Texas Board of Legal Specialization. Partner Lawyer of the Year Colorado Law Week, 2024 Barrister’s Best White Collar Lawyer  Colorado Law Week, October 2023 Litigator of the Week The American Lawyer, December 2022 Band One, Litigation: White-Collar Crime \u0026amp; Government Investigations Chambers USA, Colorado, 2012-Present U.S. Attorney General’s Award for Exceptional Service U.S. Department of Justice U.S. Attorney General’s Award for Distinguished Service U.S. Department of Justice Colorado Super Lawyer  Super Lawyers, 2011-Present Named to “Alumni 150” as being one of the Baylor University’s 150 most remarkable graduates over the last 150 years Baylor University Best Overall Litigator Law Week Colorado’s Best in Show, 2011 Winner of the PowerBook Legal Industry Leader Award Denver Business Journal, 2007 Awarded the Federal Bureau of Investigation’s Director’s Award for Outstanding Criminal Investigation FBI Baylor University Baylor University School of Law Washington and Lee University Washington and Lee University School of Law Colorado Texas American Bar Association, Criminal Justice Section, Rocky Mountain Region White Collar Crime Committee Chair Colorado Bar Association, Securities Section Urban Peak, a Homeless Youth Prevention \u0026amp; Assistance Organization, Board Member The Blue Bench, a Sexual Assault Prevention, Care \u0026amp; Advocacy Organization, Board Member Represented the former CFO of a technology company in a federal grand jury investigation led by the U.S. Department of Justice’s Antitrust Division into alleged non-solicitation and “no poach” agreements. After a six-month long investigation, the government declined to prosecute and closed the case. Represented a U.S. Olympic athletic organization in a multi-year investigation by the U.S. Department of Justice that included response to wide-ranging grand jury subpoenas. The matter was concluded when the Department declined to pursue charges. Led the defense of a large food manufacturing company and its majority shareholders against claims of breach of fiduciary duty and oppression brought by the minority shareholders in a two-week jury trial. The plaintiffs' lawsuit sought to dissolve the company and $2 billion in damages. After a two-week trial a jury found for the company and the majority shareholders and the plaintiffs took nothing. The jury foreperson was later quoted as saying, \"[Stricklin's] closing was amazing. [The defense team] did a great job. To us at least, the closing really pieced together a lot of the evidence we had questions about or thoughts about.\" Represented the former CEO of a Fortune 250 healthcare company against first of their kind federal antitrust criminal charges involving \"no poach\" agreements brought by the U.S. Department of Justice's Antitrust Division. After a two-week trial a jury found the client not guilty of all charges. Represented two banking executives in a grand jury investigation involving theft of trade secrets and computer crimes. After a six month investigation, case was dismissed by prosecutors. Represented a midstream pipeline company in relation to largest pipeline spill of its kind. After a seven year investigation by the U.S. Department of Justice's Environmental and Natural Resources Division, the Environmental Protection Agency, and the North Dakota Department of Environmental Quality, all claims were resolved with a Clean Water Act Misdemeanor and Failure to Report felony. The plea did not include any individuals or restitution, did not require a corporate monitor or debarment, and allowed the fine to be paid out over five years. Led the defense of a large food manufacturing company in a qui tam action under the False Claims Act matter brought by an individual U.S. Department of Agriculture Inspector valued at over $1b. The matter resulted in the government declining to intervene and the U.S. District Court dismissing the Inspector's lawsuit with prejudice and awarding client costs. Represented a Fortune 250 healthcare company in a False Claims Act lawsuit brought by a whistleblower. The matter resulted in the U.S. District Court dismissing the complaint based on motions, and the relator did not re-file. Represented a Fortune 250 healthcare company in an investigation by the U.S. Attorney’s Office and U.S. Health and Human Services in an investigation relating to the Anti-Kickback Statute and Stark Law. The matter resulted in no action being taken. Represented a CEO of a large, publicly-traded tech company in an independent board member investigation. The matter resulted in no action being taken. Represented a Chief Accounting Officer of a large civil engineering firm in an U.S. Securities and Exchange Commission investigation into financial reporting issues. The matter resulted in a “no action” letter provided by SEC. Represented a corporate owner in an insider trading investigation brought by the U.S. Securities and Exchange Commission and U.S. Department of Justice. The result of the matter was the entry of a “no admit or deny” administrative order and no charges were brought. Represented a national telecom provider in a qui tam matter under the False Claims Act matter alleging fraud into the Federal Government E-Rate program. The matter resulted in the federal government declining to intervene and the case being dismissed. Represented a large regional not-for-profit hospital in a qui tam matter under the False Claims Act alleging Medicare and Medicaid fraud. The investigation lasted 18 months, with the results being a minimal settlement with the state Attorney General’s office, and the federal government declining to intervene. Represented a large civil engineering firm in a qui tam matter under the False Claims Act matter and a civil and criminal investigation by the Department of Energy and the Department of Justice. The matter resulted in the relator being dismissed, and there was a civil settlement with the DOJ that included a non-prosecution agreement. Represented a large engineering and infrastructure corporation in a qui tam matter under the False Claims Act investigation by the U.S. Department of Justice and the U.S. Attorney's Office related to liquid petroleum gas installation issued during Hurricane Katrina recovery. The matter resulted in the government declining to intervene and the case being dismissed. Represented a principal investor in a complicated investment plan investigated over a three-year period for securities fraud. The matter resulted in no charges being filed. Represented a healthcare industry executive investigated for conspiracy to defraud the government and importation of unlicensed medical devices. The matter resulted in no jail time, no probation, a guilty plea to misprision and a $10k fine. Led the defense of Xcel Energy, Inc. and Public Service Company of Colorado against federal criminal charges arising out of an accident that killed five contractors at a hydroelectric power plant. The result of the matter after a five-week long trial involving complex OSHA regulations, was a jury returning not-guilty verdicts in favor of both companies. Represented a large food production company in environmental litigation against the seller of property that failed to disclose the presence of asbestos. The result of the matter was a successful settlement for the client. Represented Chemical \u0026amp; Metal Industries, Inc. in an appeal from a $3m fine and restitution award in the U.S. 5th Circuit Court of Appeals. The result of the matter was the restitution being vacated completely and the fine being reduced to $500k. Represented an executive at a Fortune 500 healthcare company in a matter involving the Anti-Kickback Statute and the Stark Law. The matter resulted in no charges being brought. Defended a natural gas production and distribution company against a civil complaint filed by the Environmental Protection Agency. The result of the matter was a successful settlement for the client. Defended Eddie Bauer in an intellectual property case involving trademarked brand names. The matter resulted in a successful resolution for Eddie Bauer. Represented a Nobel Prize winning scientist in an investigation by the U.S. Department of Commerce relating to climate change issues. The matter resulted in no charges being brought.","searchable_name":"Cliff Stricklin","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":426892,"version":1,"owner_type":"Person","owner_id":5859,"payload":{"bio":"\u003cp\u003eGeorgios Symeonidis is an associate in King \u0026amp; Spalding\u0026rsquo;s life sciences practice and focuses on EU regulatory matters for companies in the pharmaceutical, medical devices, cosmetic and food sectors. In particular, he advices clients on clinical research, compliance, product classification, marketing authorization, patient/compassionate use programs, labelling and packaging requirements and advertising and promotion in the EU. Georgios regularly deals with the national competent authorities in the EU and the European Commission.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePrior to joining King \u0026amp; Spalding, Georgios worked in the life sciences practice of another international law firm in Athens and at the Medical Products Directorate of the European Commission's Directorate General for Health \u0026amp; Food Safety (DG SANTE). He was involved in the implementation of the EU Clinical Trials Regulation, the application of the EU Transparency Directive, the regulation of ATMPs and the Revision of the EU Legislation for Blood Tissue and Cell based medicinal products.\u003c/p\u003e\n\u003cp\u003eGeorgios holds an LL.M. from the College of Europe as well as a Master\u0026rsquo;s degree in EU Health Products Law from Strasbourg University. Prior to pursuing postgraduate studies, Georgios obtained a Bachelor's degree from University of Strasbourg and University of Leuven. He is fluent in French and English and he is a native Greek speaker.\u003c/p\u003e","slug":"george-symeonidis","email":"gsymeonidis@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"},{"id":103,"guid":"103.capabilities","index":2,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":3,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":4,"source":"smartTags"},{"id":1193,"guid":"1193.smart_tags","index":5,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":6,"source":"smartTags"}],"is_active":true,"last_name":"Symeonidis","nick_name":"Georgios","clerkships":[],"first_name":"Georgios","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":2,"translated_fields":{"en":{"bio":"\u003cp\u003eGeorgios Symeonidis is an associate in King \u0026amp; Spalding\u0026rsquo;s life sciences practice and focuses on EU regulatory matters for companies in the pharmaceutical, medical devices, cosmetic and food sectors. In particular, he advices clients on clinical research, compliance, product classification, marketing authorization, patient/compassionate use programs, labelling and packaging requirements and advertising and promotion in the EU. Georgios regularly deals with the national competent authorities in the EU and the European Commission.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePrior to joining King \u0026amp; Spalding, Georgios worked in the life sciences practice of another international law firm in Athens and at the Medical Products Directorate of the European Commission's Directorate General for Health \u0026amp; Food Safety (DG SANTE). He was involved in the implementation of the EU Clinical Trials Regulation, the application of the EU Transparency Directive, the regulation of ATMPs and the Revision of the EU Legislation for Blood Tissue and Cell based medicinal products.\u003c/p\u003e\n\u003cp\u003eGeorgios holds an LL.M. from the College of Europe as well as a Master\u0026rsquo;s degree in EU Health Products Law from Strasbourg University. Prior to pursuing postgraduate studies, Georgios obtained a Bachelor's degree from University of Strasbourg and University of Leuven. He is fluent in French and English and he is a native Greek speaker.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9691}]},"capability_group_id":2},"created_at":"2025-05-26T04:57:36.000Z","updated_at":"2025-05-26T04:57:36.000Z","searchable_text":"Symeonidis{{ FIELD }}Georgios Symeonidis is an associate in King \u0026amp; Spalding’s life sciences practice and focuses on EU regulatory matters for companies in the pharmaceutical, medical devices, cosmetic and food sectors. In particular, he advices clients on clinical research, compliance, product classification, marketing authorization, patient/compassionate use programs, labelling and packaging requirements and advertising and promotion in the EU. Georgios regularly deals with the national competent authorities in the EU and the European Commission.\nPrior to joining King \u0026amp; Spalding, Georgios worked in the life sciences practice of another international law firm in Athens and at the Medical Products Directorate of the European Commission's Directorate General for Health \u0026amp; Food Safety (DG SANTE). He was involved in the implementation of the EU Clinical Trials Regulation, the application of the EU Transparency Directive, the regulation of ATMPs and the Revision of the EU Legislation for Blood Tissue and Cell based medicinal products.\nGeorgios holds an LL.M. from the College of Europe as well as a Master’s degree in EU Health Products Law from Strasbourg University. Prior to pursuing postgraduate studies, Georgios obtained a Bachelor's degree from University of Strasbourg and University of Leuven. He is fluent in French and English and he is a native Greek speaker. Associate College of Europe  Catholic University of Leuven, Belgium  University of Strasbourg  Brussels Athens-Greece","searchable_name":"Georgios Symeonidis","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":427525,"version":1,"owner_type":"Person","owner_id":315,"payload":{"bio":"\u003cp\u003eEric Smedley joined King \u0026amp; Spalding in 2000 as an attorney with the Mass Tort and Toxic Tort and Environmental practice.\u0026nbsp; His practice focuses on managing large-scale document productions, including electronic discovery issues, with an emphasis on representing pharmaceutical clients in mass tort litigation. Eric is a senior member King \u0026amp; Spalding\u0026rsquo;s E-Discovery Center.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e","slug":"eric-smedley","email":"esmedley@kslaw.com","phone":null,"matters":["\u003cp\u003eSupervising a core team of Discovery Center attorneys and paralegals for document production, privilege log, deposition/trial testimony preparation and defensive needs activities in connection with King \u0026amp; Spalding's role as national discovery counsel in product liability and consumer fraud matters for a Fortune 50 pharmaceutical client.\u003c/p\u003e","\u003cp\u003eManaging large scale document collections (both hard copy and electronic) totaling over 900,000 documents (18,000,000 pages) in connection with product liability and consumer fraud litigation for a Fortune 50 pharmaceutical client.\u003c/p\u003e","\u003cp\u003eAssisting in formulating document processing specifications used by vendors in connection with electronic and hard copy document collections.\u003c/p\u003e","\u003cp\u003eManaging a document database platform vendor and other electronic processing vendors used in connection with on-going document collection and electronic document reviews for a Fortune 50 pharmaceutical client.\u003c/p\u003e","\u003cp\u003eMonitoring outsourced litigation support personnel for a pharmaceutical client in product liability and consumer fraud litigation.\u003c/p\u003e","\u003cul\u003e\n\u003cli\u003eSupervising an electronic production of over 33,000 documents requiring significant image redactions which was completed in 12 weeks.\u003c/li\u003e\n\u003c/ul\u003e","\u003cp\u003eFrom 2000-2004, being a member of a Discovery Team responsible for coordinating and drafting responses to discovery requests in tobacco products liability litigation in connection with King \u0026amp; Spalding's role as national discovery counsel for a tobacco products manufacturer.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eLitigation Technology Experience\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSupervising and training attorney review teams and collecting, reviewing and producing documents.\u0026nbsp; Due to Eric's involvement in these projects, he has experience coordinating and supervising the selection of vendors.\u0026nbsp; He also has experience creating project plans and developing protocols for objective coding, imaging, scanning and printing. 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Eric is a senior member King \u0026amp; Spalding\u0026rsquo;s E-Discovery Center.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e","matters":["\u003cp\u003eSupervising a core team of Discovery Center attorneys and paralegals for document production, privilege log, deposition/trial testimony preparation and defensive needs activities in connection with King \u0026amp; Spalding's role as national discovery counsel in product liability and consumer fraud matters for a Fortune 50 pharmaceutical client.\u003c/p\u003e","\u003cp\u003eManaging large scale document collections (both hard copy and electronic) totaling over 900,000 documents (18,000,000 pages) in connection with product liability and consumer fraud litigation for a Fortune 50 pharmaceutical client.\u003c/p\u003e","\u003cp\u003eAssisting in formulating document processing specifications used by vendors in connection with electronic and hard copy document collections.\u003c/p\u003e","\u003cp\u003eManaging a document database platform vendor and other electronic processing vendors used in connection with on-going document collection and electronic document reviews for a Fortune 50 pharmaceutical client.\u003c/p\u003e","\u003cp\u003eMonitoring outsourced litigation support personnel for a pharmaceutical client in product liability and consumer fraud litigation.\u003c/p\u003e","\u003cul\u003e\n\u003cli\u003eSupervising an electronic production of over 33,000 documents requiring significant image redactions which was completed in 12 weeks.\u003c/li\u003e\n\u003c/ul\u003e","\u003cp\u003eFrom 2000-2004, being a member of a Discovery Team responsible for coordinating and drafting responses to discovery requests in tobacco products liability litigation in connection with King \u0026amp; Spalding's role as national discovery counsel for a tobacco products manufacturer.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eLitigation Technology Experience\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSupervising and training attorney review teams and collecting, reviewing and producing documents.\u0026nbsp; Due to Eric's involvement in these projects, he has experience coordinating and supervising the selection of vendors.\u0026nbsp; He also has experience creating project plans and developing protocols for objective coding, imaging, scanning and printing. Eric has extensive knowledge and experience of document review and litigation support systems including Relativity, Ringtail, Summation iBlaze, Discovery Radar, Concordance, IPro, and Microsoft Access\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1184}]},"capability_group_id":3},"created_at":"2025-05-26T05:01:38.000Z","updated_at":"2025-05-26T05:01:38.000Z","searchable_text":"Smedley{{ FIELD }}Supervising a core team of Discovery Center attorneys and paralegals for document production, privilege log, deposition/trial testimony preparation and defensive needs activities in connection with King \u0026amp; Spalding's role as national discovery counsel in product liability and consumer fraud matters for a Fortune 50 pharmaceutical client.{{ FIELD }}Managing large scale document collections (both hard copy and electronic) totaling over 900,000 documents (18,000,000 pages) in connection with product liability and consumer fraud litigation for a Fortune 50 pharmaceutical client.{{ FIELD }}Assisting in formulating document processing specifications used by vendors in connection with electronic and hard copy document collections.{{ FIELD }}Managing a document database platform vendor and other electronic processing vendors used in connection with on-going document collection and electronic document reviews for a Fortune 50 pharmaceutical client.{{ FIELD }}Monitoring outsourced litigation support personnel for a pharmaceutical client in product liability and consumer fraud litigation.{{ FIELD }}\nSupervising an electronic production of over 33,000 documents requiring significant image redactions which was completed in 12 weeks.\n{{ FIELD }}From 2000-2004, being a member of a Discovery Team responsible for coordinating and drafting responses to discovery requests in tobacco products liability litigation in connection with King \u0026amp; Spalding's role as national discovery counsel for a tobacco products manufacturer.{{ FIELD }}Litigation Technology Experience\nSupervising and training attorney review teams and collecting, reviewing and producing documents.  Due to Eric's involvement in these projects, he has experience coordinating and supervising the selection of vendors.  He also has experience creating project plans and developing protocols for objective coding, imaging, scanning and printing. Eric has extensive knowledge and experience of document review and litigation support systems including Relativity, Ringtail, Summation iBlaze, Discovery Radar, Concordance, IPro, and Microsoft Access{{ FIELD }}Eric Smedley joined King \u0026amp; Spalding in 2000 as an attorney with the Mass Tort and Toxic Tort and Environmental practice.  His practice focuses on managing large-scale document productions, including electronic discovery issues, with an emphasis on representing pharmaceutical clients in mass tort litigation. Eric is a senior member King \u0026amp; Spalding’s E-Discovery Center.\n  Senior Attorney Catholic University of America Columbus School of Law Duquesne University Duquesne University School of Law Georgia Pennsylvania Supervising a core team of Discovery Center attorneys and paralegals for document production, privilege log, deposition/trial testimony preparation and defensive needs activities in connection with King \u0026amp; Spalding's role as national discovery counsel in product liability and consumer fraud matters for a Fortune 50 pharmaceutical client. Managing large scale document collections (both hard copy and electronic) totaling over 900,000 documents (18,000,000 pages) in connection with product liability and consumer fraud litigation for a Fortune 50 pharmaceutical client. Assisting in formulating document processing specifications used by vendors in connection with electronic and hard copy document collections. Managing a document database platform vendor and other electronic processing vendors used in connection with on-going document collection and electronic document reviews for a Fortune 50 pharmaceutical client. Monitoring outsourced litigation support personnel for a pharmaceutical client in product liability and consumer fraud litigation. \nSupervising an electronic production of over 33,000 documents requiring significant image redactions which was completed in 12 weeks.\n From 2000-2004, being a member of a Discovery Team responsible for coordinating and drafting responses to discovery requests in tobacco products liability litigation in connection with King \u0026amp; Spalding's role as national discovery counsel for a tobacco products manufacturer. Litigation Technology Experience\nSupervising and training attorney review teams and collecting, reviewing and producing documents.  Due to Eric's involvement in these projects, he has experience coordinating and supervising the selection of vendors.  He also has experience creating project plans and developing protocols for objective coding, imaging, scanning and printing. Eric has extensive knowledge and experience of document review and litigation support systems including Relativity, Ringtail, Summation iBlaze, Discovery Radar, Concordance, IPro, and Microsoft Access","searchable_name":"Eric V. Smedley","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}]}}