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His practice covers trade remedies, trade policy and negotiations, trade agreement enforcement, import compliance, supply chains, and government procurement. \u0026nbsp;He has particular experience in the steel, aluminum, automotive, agricultural, and energy industries.\u0026nbsp; He recently performed the functions of the Assistant Secretary for Enforcement and Compliance\u0026nbsp;at the U.S. Department of Commerce, International Trade Administration for over a year, serving as the decisionmaker for every AD/CVD duty imposed by the U.S.\u0026nbsp; He also was the Senior Policy Advisor for Supply Chains at the White House National Economic Council under President Joe Biden, where he played a central role in U.S. industrial strategy.\u0026nbsp;\u0026nbsp;Ryan has been regularly quoted and consulted by major media outlets, including Reuters, Bloomberg, the Washington Post, the New York Times, the Wall Street Journal, Barron\u0026rsquo;s, the Associated Press, AFP, the Detroit Free Press, Pitchbook, Agripulse, and Law360.\u0026nbsp; He has also made TV and radio appearances on the BBC, Street Signs Asia, and Bloomberg Radio.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePrior to his 4 years in political roles at Commerce and the White House, Ryan had a decade-long legal career in the federal government, serving as the Senior Counsel for Appellate And Supreme Court Litigation at the U.S. Department of Agriculture (\u0026ldquo;USDA\u0026rdquo;); as Assistant General Counsel at the Office of the USTR under the first Trump Administration, where he litigated several disputes before the WTO involving U.S. trade remedies and government subsidies and was a lead on agriculture trade policy. He also was a trial attorney in the Civil Division of the DOJ, where he represented Commerce as lead counsel in dozens of trade remedies cases before the U.S. Court of International Trade and the U.S. Court of Appeals for the Federal Circuit, and defended numerous agencies in government contracts and bid protest litigation before the U.S. Court of Federal Claims and Federal Circuit.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAdmitted in Washington, D.C. and New York.\u0026nbsp;\u003c/em\u003e\u003c/p\u003e","slug":"ryan-majerus","email":"rmajerus@kslaw.com","phone":null,"matters":["\u003cp\u003eAdvised\u003cstrong\u003e\u0026nbsp;manufacturing, technology, energy, consumer, and private equity clients\u003c/strong\u003e\u0026nbsp;on the U.S. Administration\u0026rsquo;s trade and tariff policies.\u003c/p\u003e","\u003cp\u003eAdvised clients on\u0026nbsp;\u003cstrong\u003egovernment procurement, construction, contractual, and M\u0026amp;A issues\u003c/strong\u003e\u0026nbsp;related to international trade, national security, and supply chain resiliency.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003emanufacturing clients\u003c/strong\u003e\u0026nbsp;on trade remedy investigations assessments and enforcement.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":3314}]},"expertise":[{"id":579,"guid":"579.smart_tags","index":0,"source":"smartTags"},{"id":106,"guid":"106.capabilities","index":1,"source":"capabilities"},{"id":124,"guid":"124.capabilities","index":2,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":3,"source":"capabilities"},{"id":118,"guid":"118.capabilities","index":4,"source":"capabilities"},{"id":1147,"guid":"1147.smart_tags","index":5,"source":"smartTags"},{"id":2,"guid":"2.capabilities","index":6,"source":"capabilities"},{"id":116,"guid":"116.capabilities","index":7,"source":"capabilities"},{"id":110,"guid":"110.capabilities","index":8,"source":"capabilities"},{"id":1330,"guid":"1330.smart_tags","index":9,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":10,"source":"smartTags"},{"id":1327,"guid":"1327.smart_tags","index":11,"source":"smartTags"},{"id":25,"guid":"25.capabilities","index":12,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":13,"source":"capabilities"},{"id":1689,"guid":"1689.smart_tags","index":14,"source":"smartTags"}],"is_active":true,"last_name":"Majerus","nick_name":"Ryan","clerkships":[{"name":"Law Clerk, Chief Judge McCalla, U.S. District Court for the Western District of Tennessee","years_held":"2010 - 2011"}],"first_name":"Ryan","title_rank":9999,"updated_by":202,"law_schools":[{"id":755,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"2010-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Recipient of the Department of Commerce gold medal for extraordinary efforts in the renegotiation of Section 232 agreements with the EU, UK, and Japan; and in the negotiation of new suspension agreements on a key agricultural product","detail":"Department of Commerce"},{"title":"Recipient of Harry S. Truman Scholarship","detail":"2006"}],"linked_in_url":"www.linkedin.com/in/ryan-majerus-bb114615","seodescription":"Ryan Majerus is a Partner in the International Trade Team of King \u0026 Spalding. Read more about him.","primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eRyan Majerus is a Partner in the International Trade Team of King \u0026amp; Spalding. His practice covers trade remedies, trade policy and negotiations, trade agreement enforcement, import compliance, supply chains, and government procurement. \u0026nbsp;He has particular experience in the steel, aluminum, automotive, agricultural, and energy industries.\u0026nbsp; He recently performed the functions of the Assistant Secretary for Enforcement and Compliance\u0026nbsp;at the U.S. Department of Commerce, International Trade Administration for over a year, serving as the decisionmaker for every AD/CVD duty imposed by the U.S.\u0026nbsp; He also was the Senior Policy Advisor for Supply Chains at the White House National Economic Council under President Joe Biden, where he played a central role in U.S. industrial strategy.\u0026nbsp;\u0026nbsp;Ryan has been regularly quoted and consulted by major media outlets, including Reuters, Bloomberg, the Washington Post, the New York Times, the Wall Street Journal, Barron\u0026rsquo;s, the Associated Press, AFP, the Detroit Free Press, Pitchbook, Agripulse, and Law360.\u0026nbsp; He has also made TV and radio appearances on the BBC, Street Signs Asia, and Bloomberg Radio.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePrior to his 4 years in political roles at Commerce and the White House, Ryan had a decade-long legal career in the federal government, serving as the Senior Counsel for Appellate And Supreme Court Litigation at the U.S. Department of Agriculture (\u0026ldquo;USDA\u0026rdquo;); as Assistant General Counsel at the Office of the USTR under the first Trump Administration, where he litigated several disputes before the WTO involving U.S. trade remedies and government subsidies and was a lead on agriculture trade policy. He also was a trial attorney in the Civil Division of the DOJ, where he represented Commerce as lead counsel in dozens of trade remedies cases before the U.S. Court of International Trade and the U.S. Court of Appeals for the Federal Circuit, and defended numerous agencies in government contracts and bid protest litigation before the U.S. Court of Federal Claims and Federal Circuit.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAdmitted in Washington, D.C. and New York.\u0026nbsp;\u003c/em\u003e\u003c/p\u003e","matters":["\u003cp\u003eAdvised\u003cstrong\u003e\u0026nbsp;manufacturing, technology, energy, consumer, and private equity clients\u003c/strong\u003e\u0026nbsp;on the U.S. Administration\u0026rsquo;s trade and tariff policies.\u003c/p\u003e","\u003cp\u003eAdvised clients on\u0026nbsp;\u003cstrong\u003egovernment procurement, construction, contractual, and M\u0026amp;A issues\u003c/strong\u003e\u0026nbsp;related to international trade, national security, and supply chain resiliency.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003emanufacturing clients\u003c/strong\u003e\u0026nbsp;on trade remedy investigations assessments and enforcement.\u003c/p\u003e"],"recognitions":[{"title":"Recipient of the Department of Commerce gold medal for extraordinary efforts in the renegotiation of Section 232 agreements with the EU, UK, and Japan; and in the negotiation of new suspension agreements on a key agricultural product","detail":"Department of Commerce"},{"title":"Recipient of Harry S. Truman Scholarship","detail":"2006"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12430}]},"capability_group_id":2},"created_at":"2025-12-05T05:02:15.000Z","updated_at":"2025-12-05T05:02:15.000Z","searchable_text":"Majerus{{ FIELD }}{:title=\u0026gt;\"Recipient of the Department of Commerce gold medal for extraordinary efforts in the renegotiation of Section 232 agreements with the EU, UK, and Japan; and in the negotiation of new suspension agreements on a key agricultural product\", :detail=\u0026gt;\"Department of Commerce\"}{{ FIELD }}{:title=\u0026gt;\"Recipient of Harry S. Truman Scholarship\", :detail=\u0026gt;\"2006\"}{{ FIELD }}Advised manufacturing, technology, energy, consumer, and private equity clients on the U.S. Administration’s trade and tariff policies.{{ FIELD }}Advised clients on government procurement, construction, contractual, and M\u0026amp;A issues related to international trade, national security, and supply chain resiliency.{{ FIELD }}Advised manufacturing clients on trade remedy investigations assessments and enforcement.{{ FIELD }}Ryan Majerus is a Partner in the International Trade Team of King \u0026amp; Spalding. His practice covers trade remedies, trade policy and negotiations, trade agreement enforcement, import compliance, supply chains, and government procurement.  He has particular experience in the steel, aluminum, automotive, agricultural, and energy industries.  He recently performed the functions of the Assistant Secretary for Enforcement and Compliance at the U.S. Department of Commerce, International Trade Administration for over a year, serving as the decisionmaker for every AD/CVD duty imposed by the U.S.  He also was the Senior Policy Advisor for Supply Chains at the White House National Economic Council under President Joe Biden, where he played a central role in U.S. industrial strategy.  Ryan has been regularly quoted and consulted by major media outlets, including Reuters, Bloomberg, the Washington Post, the New York Times, the Wall Street Journal, Barron’s, the Associated Press, AFP, the Detroit Free Press, Pitchbook, Agripulse, and Law360.  He has also made TV and radio appearances on the BBC, Street Signs Asia, and Bloomberg Radio.\nPrior to his 4 years in political roles at Commerce and the White House, Ryan had a decade-long legal career in the federal government, serving as the Senior Counsel for Appellate And Supreme Court Litigation at the U.S. Department of Agriculture (“USDA”); as Assistant General Counsel at the Office of the USTR under the first Trump Administration, where he litigated several disputes before the WTO involving U.S. trade remedies and government subsidies and was a lead on agriculture trade policy. He also was a trial attorney in the Civil Division of the DOJ, where he represented Commerce as lead counsel in dozens of trade remedies cases before the U.S. Court of International Trade and the U.S. Court of Appeals for the Federal Circuit, and defended numerous agencies in government contracts and bid protest litigation before the U.S. Court of Federal Claims and Federal Circuit.\nAdmitted in Washington, D.C. and New York.  Ryan Majerus lawyer Partner Recipient of the Department of Commerce gold medal for extraordinary efforts in the renegotiation of Section 232 agreements with the EU, UK, and Japan; and in the negotiation of new suspension agreements on a key agricultural product Department of Commerce Recipient of Harry S. Truman Scholarship 2006 Georgetown University  Georgetown University Georgetown University Law Center District of Columbia New York Washington International Trade Association Committee to Enforce the U.S. Trade Laws Editor-in-Chief of the Georgetown Journal of International Law Law Clerk, Chief Judge McCalla, U.S. District Court for the Western District of Tennessee Advised manufacturing, technology, energy, consumer, and private equity clients on the U.S. Administration’s trade and tariff policies. Advised clients on government procurement, construction, contractual, and M\u0026amp;A issues related to international trade, national security, and supply chain resiliency. Advised manufacturing clients on trade remedy investigations assessments and enforcement.","searchable_name":"Ryan Majerus","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":442384,"version":1,"owner_type":"Person","owner_id":966,"payload":{"bio":"\u003cp\u003eChris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\u003c/p\u003e\n\u003cp\u003eBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChris has been recognized by the\u0026nbsp;\u003cem\u003eBTI Consulting Group\u003c/em\u003e\u0026nbsp;as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by\u0026nbsp;\u003cem\u003eLMG Life Sciences.\u003c/em\u003e\u0026nbsp; She continues to be identified as one of\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;for FDA Law, and ranked as a life sciences practitioner by\u0026nbsp;\u003cem\u003eThe Legal 500\u003c/em\u003e.\u003c/p\u003e","slug":"christina-markus","email":"cmarkus@kslaw.com","phone":null,"matters":["\u003cp\u003eAdvised numerous pharmaceutical and device manufacturers and distributors on compliance with\u0026nbsp;\u003cstrong\u003estate laws\u003c/strong\u003e\u0026nbsp;governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.\u003c/p\u003e","\u003cp\u003eAdvised on range of clinical trial issues, including design, compliance and transparency disclosures.\u003c/p\u003e","\u003cp\u003eDeveloped responses to inspectional findings and import alerts, in close collaboration with technical experts.\u003c/p\u003e","\u003cp\u003eAdvised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003edozens of pharmaceutical and biological product companies\u003c/strong\u003e, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.\u003c/p\u003e","\u003cp\u003eDeveloped and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed\u0026nbsp;\u003cstrong\u003ebioequivalence standards, Hatch-Waxman 30-month stay provisions\u003c/strong\u003e, and other key regulatory topics.\u003c/p\u003e","\u003cp\u003ePerformed due diligence for\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eregulatory issues\u003c/strong\u003e\u0026nbsp;and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.\u003c/p\u003e","\u003cp\u003eEvaluated\u0026nbsp;\u003cstrong\u003eimpacts of the Drug Supply Chain Security Act (DSCSA)\u003c/strong\u003e\u0026nbsp;on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eproduct distributors\u003c/strong\u003e\u0026nbsp;against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.\u003c/p\u003e","\u003cp\u003eAdvised on the status and use of controlled substances\u0026nbsp;\u003cstrong\u003eand listed chemicals\u003c/strong\u003e, including:\u003c/p\u003e\n\u003cp\u003e- Administrative hearings concerning applicants for registration to import narcotic raw materials,\u003c/p\u003e\n\u003cp\u003e- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\u003c/p\u003e\n\u003cp\u003e- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\u003c/p\u003e\n\u003cp\u003e- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.smart_tags","index":1,"source":"smartTags"},{"id":107,"guid":"107.capabilities","index":2,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":3,"source":"smartTags"},{"id":105,"guid":"105.capabilities","index":4,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":5,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":6,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":7,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":8,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":9,"source":"capabilities"},{"id":33,"guid":"33.capabilities","index":10,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":11,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":12,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":13,"source":"capabilities"},{"id":764,"guid":"764.smart_tags","index":14,"source":"smartTags"}],"is_active":true,"last_name":"Markus","nick_name":"Chris","clerkships":[],"first_name":"Christina","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":"M.","name_suffix":"","recognitions":[{"title":"Client Service All-Star (unprompted survey of large company corporate counsel)","detail":"BTI Consulting, 2017"},{"title":"Who's Who Legal: Life Sciences","detail":"2017-2024"},{"title":"Leading Life Sciences Lawyer","detail":"LMG Life Sciences, 2012-2025"},{"title":"Best Lawyers in America - FDA Law","detail":"Best Lawyers/US News \u0026 World Report, 2015-2026"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eChris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\u003c/p\u003e\n\u003cp\u003eBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChris has been recognized by the\u0026nbsp;\u003cem\u003eBTI Consulting Group\u003c/em\u003e\u0026nbsp;as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by\u0026nbsp;\u003cem\u003eLMG Life Sciences.\u003c/em\u003e\u0026nbsp; She continues to be identified as one of\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;for FDA Law, and ranked as a life sciences practitioner by\u0026nbsp;\u003cem\u003eThe Legal 500\u003c/em\u003e.\u003c/p\u003e","matters":["\u003cp\u003eAdvised numerous pharmaceutical and device manufacturers and distributors on compliance with\u0026nbsp;\u003cstrong\u003estate laws\u003c/strong\u003e\u0026nbsp;governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.\u003c/p\u003e","\u003cp\u003eAdvised on range of clinical trial issues, including design, compliance and transparency disclosures.\u003c/p\u003e","\u003cp\u003eDeveloped responses to inspectional findings and import alerts, in close collaboration with technical experts.\u003c/p\u003e","\u003cp\u003eAdvised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003edozens of pharmaceutical and biological product companies\u003c/strong\u003e, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.\u003c/p\u003e","\u003cp\u003eDeveloped and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed\u0026nbsp;\u003cstrong\u003ebioequivalence standards, Hatch-Waxman 30-month stay provisions\u003c/strong\u003e, and other key regulatory topics.\u003c/p\u003e","\u003cp\u003ePerformed due diligence for\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eregulatory issues\u003c/strong\u003e\u0026nbsp;and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.\u003c/p\u003e","\u003cp\u003eEvaluated\u0026nbsp;\u003cstrong\u003eimpacts of the Drug Supply Chain Security Act (DSCSA)\u003c/strong\u003e\u0026nbsp;on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eproduct distributors\u003c/strong\u003e\u0026nbsp;against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.\u003c/p\u003e","\u003cp\u003eAdvised on the status and use of controlled substances\u0026nbsp;\u003cstrong\u003eand listed chemicals\u003c/strong\u003e, including:\u003c/p\u003e\n\u003cp\u003e- Administrative hearings concerning applicants for registration to import narcotic raw materials,\u003c/p\u003e\n\u003cp\u003e- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\u003c/p\u003e\n\u003cp\u003e- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\u003c/p\u003e\n\u003cp\u003e- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.\u003c/p\u003e"],"recognitions":[{"title":"Client Service All-Star (unprompted survey of large company corporate counsel)","detail":"BTI Consulting, 2017"},{"title":"Who's Who Legal: Life Sciences","detail":"2017-2024"},{"title":"Leading Life Sciences Lawyer","detail":"LMG Life Sciences, 2012-2025"},{"title":"Best Lawyers in America - FDA Law","detail":"Best Lawyers/US News \u0026 World Report, 2015-2026"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1035}]},"capability_group_id":2},"created_at":"2025-11-05T05:04:00.000Z","updated_at":"2025-11-05T05:04:00.000Z","searchable_text":"Markus{{ FIELD }}{:title=\u0026gt;\"Client Service All-Star (unprompted survey of large company corporate counsel)\", :detail=\u0026gt;\"BTI Consulting, 2017\"}{{ FIELD }}{:title=\u0026gt;\"Who's Who Legal: Life Sciences\", :detail=\u0026gt;\"2017-2024\"}{{ FIELD }}{:title=\u0026gt;\"Leading Life Sciences Lawyer\", :detail=\u0026gt;\"LMG Life Sciences, 2012-2025\"}{{ FIELD }}{:title=\u0026gt;\"Best Lawyers in America - FDA Law\", :detail=\u0026gt;\"Best Lawyers/US News \u0026amp; World Report, 2015-2026\"}{{ FIELD }}Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.{{ FIELD }}Advised on range of clinical trial issues, including design, compliance and transparency disclosures.{{ FIELD }}Developed responses to inspectional findings and import alerts, in close collaboration with technical experts.{{ FIELD }}Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.{{ FIELD }}Advised dozens of pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.{{ FIELD }}Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics.{{ FIELD }}Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.{{ FIELD }}Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.{{ FIELD }}Defended product distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.{{ FIELD }}Advised on the status and use of controlled substances and listed chemicals, including:\n- Administrative hearings concerning applicants for registration to import narcotic raw materials,\n- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\n- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\n- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.{{ FIELD }}Chris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.\nChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\nBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress. \nChris has been recognized by the BTI Consulting Group as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by LMG Life Sciences.  She continues to be identified as one of The Best Lawyers in America for FDA Law, and ranked as a life sciences practitioner by The Legal 500. Partner Client Service All-Star (unprompted survey of large company corporate counsel) BTI Consulting, 2017 Who's Who Legal: Life Sciences 2017-2024 Leading Life Sciences Lawyer LMG Life Sciences, 2012-2025 Best Lawyers in America - FDA Law Best Lawyers/US News \u0026amp; World Report, 2015-2026 College of William and Mary William \u0026amp; Mary Law School University of Virginia University of Virginia School of Law District of Columbia Virginia The District of Columbia Bar Virginia State Bar Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting. Advised on range of clinical trial issues, including design, compliance and transparency disclosures. Developed responses to inspectional findings and import alerts, in close collaboration with technical experts. Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples. Advised dozens of pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence. Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics. Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending. Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products. Defended product distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions. Advised on the status and use of controlled substances and listed chemicals, including:\n- Administrative hearings concerning applicants for registration to import narcotic raw materials,\n- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\n- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\n- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.","searchable_name":"Christina M. Markus (Chris)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":426421,"version":1,"owner_type":"Person","owner_id":3442,"payload":{"bio":"\u003cp\u003eWilliam McClintock is a partner in King \u0026amp; Spalding\u0026rsquo;s Washington, D.C. office and a member of the firm\u0026rsquo;s Special Matters and Government Investigations practice.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWilliam focuses his practice on government investigations, internal investigations, voluntary self-disclosures, and white collar criminal litigation. William advises clients on a range of white collar matters, including: the False Claims Act, the Anti-Kickback Statute, the Food Drug \u0026amp; Cosmetic Act, the Foreign Corrupt Practices Act, and whistleblower cases.\u003c/p\u003e\n\u003cp\u003eWilliam has experience representing companies and individuals in investigations conducted by federal and state authorities, including the Department of Justice, multiple United States Attorney\u0026rsquo;s offices, the Department of Health and Human Services Office of Inspector General, the Food and Drug Administration, the Environmental Protection Agency, the Securities and Exchange Commission, the Office of Comptroller of the Currency,\u0026nbsp;the Federal Election Commission,\u0026nbsp;and multiple investigative committees of the United States Congress.\u003c/p\u003e\n\u003cp\u003eWilliam previously served as a law clerk to the Honorable Richard J. Leon of the United States District Court for the District of Columbia.\u0026nbsp; William graduated summa cum laude from Notre Dame Law School, where he served as the Managing Articles Editor of the Notre Dame Law Review.\u003c/p\u003e","slug":"william-mcclintock","email":"wmcclintock@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":4,"guid":"4.aofs","index":0,"source":"aofs"},{"id":6,"guid":"6.aofs","index":1,"source":"aofs"},{"id":780,"guid":"780.smart_tags","index":2,"source":"smartTags"},{"id":11,"guid":"11.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":5,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":6,"source":"smartTags"},{"id":973,"guid":"973.smart_tags","index":7,"source":"smartTags"},{"id":984,"guid":"984.smart_tags","index":8,"source":"smartTags"},{"id":113,"guid":"113.capabilities","index":9,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":10,"source":"smartTags"}],"is_active":true,"last_name":"McClintock","nick_name":"William","clerkships":[{"name":"Law Clerk, Hon. Richard J. Leon, U.S. District Court for the District of Columbia","years_held":"2016 - 2017"}],"first_name":"William","title_rank":9999,"updated_by":176,"law_schools":[{"id":2278,"meta":{"degree":"J.D.","honors":"summa cum laude","is_law_school":1,"graduation_date":"2014-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"S.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eWilliam McClintock is a partner in King \u0026amp; Spalding\u0026rsquo;s Washington, D.C. office and a member of the firm\u0026rsquo;s Special Matters and Government Investigations practice.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWilliam focuses his practice on government investigations, internal investigations, voluntary self-disclosures, and white collar criminal litigation. William advises clients on a range of white collar matters, including: the False Claims Act, the Anti-Kickback Statute, the Food Drug \u0026amp; Cosmetic Act, the Foreign Corrupt Practices Act, and whistleblower cases.\u003c/p\u003e\n\u003cp\u003eWilliam has experience representing companies and individuals in investigations conducted by federal and state authorities, including the Department of Justice, multiple United States Attorney\u0026rsquo;s offices, the Department of Health and Human Services Office of Inspector General, the Food and Drug Administration, the Environmental Protection Agency, the Securities and Exchange Commission, the Office of Comptroller of the Currency,\u0026nbsp;the Federal Election Commission,\u0026nbsp;and multiple investigative committees of the United States Congress.\u003c/p\u003e\n\u003cp\u003eWilliam previously served as a law clerk to the Honorable Richard J. Leon of the United States District Court for the District of Columbia.\u0026nbsp; William graduated summa cum laude from Notre Dame Law School, where he served as the Managing Articles Editor of the Notre Dame Law Review.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":6011}]},"capability_group_id":2},"created_at":"2025-05-26T04:52:49.000Z","updated_at":"2025-05-26T04:52:49.000Z","searchable_text":"McClintock{{ FIELD }}William McClintock is a partner in King \u0026amp; Spalding’s Washington, D.C. office and a member of the firm’s Special Matters and Government Investigations practice.\nWilliam focuses his practice on government investigations, internal investigations, voluntary self-disclosures, and white collar criminal litigation. William advises clients on a range of white collar matters, including: the False Claims Act, the Anti-Kickback Statute, the Food Drug \u0026amp; Cosmetic Act, the Foreign Corrupt Practices Act, and whistleblower cases.\nWilliam has experience representing companies and individuals in investigations conducted by federal and state authorities, including the Department of Justice, multiple United States Attorney’s offices, the Department of Health and Human Services Office of Inspector General, the Food and Drug Administration, the Environmental Protection Agency, the Securities and Exchange Commission, the Office of Comptroller of the Currency, the Federal Election Commission, and multiple investigative committees of the United States Congress.\nWilliam previously served as a law clerk to the Honorable Richard J. Leon of the United States District Court for the District of Columbia.  William graduated summa cum laude from Notre Dame Law School, where he served as the Managing Articles Editor of the Notre Dame Law Review. Partner Furman University  University of Notre Dame Notre Dame Law School District of Columbia Georgia Law Clerk, Hon. Richard J. Leon, U.S. District Court for the District of Columbia","searchable_name":"William S. McClintock","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":176,"capability_group_featured":null,"home_page_featured":null},{"id":444450,"version":1,"owner_type":"Person","owner_id":2728,"payload":{"bio":"\u003cp\u003eAmelia Medina represents\u0026nbsp;corporations, nonprofit organizations,\u0026nbsp;and board committees in major\u0026nbsp;investigations and disputes with government authorities.\u0026nbsp; A\u0026nbsp;partner in\u0026nbsp;King \u0026amp; Spalding's \u003cem\u003eChambers\u003c/em\u003e Band 1-ranked practice in Corporate Crime \u0026amp; Investigations, Amelia also specializes in litigation\u0026nbsp;involving\u0026nbsp;civil fraud,\u0026nbsp;national security, the\u0026nbsp;False Claims Act and \u003cem\u003equi tam \u003c/em\u003ewhistleblowers. Executives in regulated industries -- especially\u0026nbsp;life sciences, healthcare,\u0026nbsp;defense, technology, financial services, artificial intelligence, and government contracting --\u0026nbsp;turn to Amelia for her current insights about\u0026nbsp;domestic and\u0026nbsp;international law enforcement trends.\u003c/p\u003e\n\u003cp\u003ePrior to rejoining King \u0026amp; Spalding, Amelia served as Deputy Chief of Staff to the Director of the FBI, and as Senior Counsel to the U.S. Deputy Attorney General (DAG) at the Department of Justice.\u0026nbsp;\u0026nbsp;She also served as a federal criminal prosecutor\u0026nbsp;in the Financial Crimes \u0026amp; Public Corruption Unit of the U.S. Attorney\u0026rsquo;s Office for the Eastern District of Virginia.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAt the FBI, Amelia advised the Director and FBI leadership on all aspects of\u0026nbsp;investigations regarding complex financial fraud, healthcare fraud, procurement fraud and collusion,\u0026nbsp;trade sanctions and export controls,\u0026nbsp;cyber and security-related critical incidents, official corruption, counterintelligence, and issues before the National Security Council.\u0026nbsp; Amelia also prepared and advised\u0026nbsp;the FBI Director during numerous congressional hearings, including\u0026nbsp;at\u0026nbsp;\u0026ldquo;members only\u0026rdquo; classified briefings to the full U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Senior Counsel in the Office of the Deputy Attorney General from 2017-2018, Amelia managed a department-wide portfolio of corporate enforcement priorities, compliance initiatives, and\u0026nbsp;case-specific issues arising across Main Justice divisions and U.S. Attorneys\u0026rsquo; Offices, as well as multi-agency efforts with SEC, CFTC,\u0026nbsp;DHS, HHS, FDA,\u0026nbsp;and various agency Offices of Inspector General.\u0026nbsp; Amelia served as the first Chair of the Corporate Enforcement \u0026amp; Accountability Working Group, a leadership committee responsible for guiding the DOJ\u0026rsquo;s strategy and policies to combat corporate criminal and civil fraud nationwide. She played an integral part in the development and implementation of the Foreign Corrupt Practices Act Corporate Enforcement Policy and served as the principal staff counselor to the DAG on approvals of corporate compliance monitorships.\u003c/p\u003e\n\u003cp\u003eIn private practice, Amelia is experienced in steering responses to oversight requests by\u0026nbsp;congressional committees in the U.S. House and Senate. She also\u0026nbsp;prepares business leaders to give testimony at televised hearings before federal\u0026nbsp;and state legislative bodies.\u003c/p\u003e\n\u003cp\u003eAmelia\u0026nbsp;is a member of the invitation-only Edward Bennett Williams Inn of Court for\u0026nbsp;white collar practitioners in Washington, D.C. She serves on the boards of the Atlanta Police Foundation and The Goizueta Foundation.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAmelia\u0026nbsp;graduated Phi Beta Kappa from Princeton University, with a degree from the School of Public \u0026amp; International Affairs.\u0026nbsp; She holds a J.D. from Yale Law School and was a member of The Yale Law Journal.\u003c/p\u003e","slug":"amelia-medina","email":"amedina@kslaw.com","phone":"+1 202 900 0822","matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":1,"source":"smartTags"},{"id":110,"guid":"110.capabilities","index":2,"source":"capabilities"},{"id":687,"guid":"687.smart_tags","index":3,"source":"smartTags"},{"id":20,"guid":"20.capabilities","index":4,"source":"capabilities"},{"id":5,"guid":"5.smart_tags","index":5,"source":"smartTags"},{"id":118,"guid":"118.capabilities","index":6,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":7,"source":"capabilities"},{"id":1147,"guid":"1147.smart_tags","index":8,"source":"smartTags"},{"id":81,"guid":"81.capabilities","index":9,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":10,"source":"capabilities"},{"id":106,"guid":"106.capabilities","index":11,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":12,"source":"capabilities"},{"id":132,"guid":"132.capabilities","index":13,"source":"capabilities"},{"id":1199,"guid":"1199.smart_tags","index":14,"source":"smartTags"},{"id":1327,"guid":"1327.smart_tags","index":15,"source":"smartTags"},{"id":1248,"guid":"1248.smart_tags","index":16,"source":"smartTags"},{"id":1715,"guid":"1715.smart_tags","index":17,"source":"smartTags"}],"is_active":true,"last_name":"Medina","nick_name":"Amelia","clerkships":[{"name":"Law Clerk, Jose A. Cabranes, U.S. Court of Appeals for the Second Circuit","years_held":"2010-2011"},{"name":"Law Clerk, Michael M. Baylson, U.S. District Court for the Eastern District of Pennsylvania","years_held":"2011-2012"}],"first_name":"Amelia","title_rank":9999,"updated_by":202,"law_schools":[{"id":2605,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"2010-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"R.","name_suffix":"","recognitions":[{"title":"Selected for the White Collar Crime Editorial Advisory Board","detail":"Law360, 2024"},{"title":"Recommended nationally for Government: State Attorneys General","detail":"Legal 500, 2024"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eAmelia Medina represents\u0026nbsp;corporations, nonprofit organizations,\u0026nbsp;and board committees in major\u0026nbsp;investigations and disputes with government authorities.\u0026nbsp; A\u0026nbsp;partner in\u0026nbsp;King \u0026amp; Spalding's \u003cem\u003eChambers\u003c/em\u003e Band 1-ranked practice in Corporate Crime \u0026amp; Investigations, Amelia also specializes in litigation\u0026nbsp;involving\u0026nbsp;civil fraud,\u0026nbsp;national security, the\u0026nbsp;False Claims Act and \u003cem\u003equi tam \u003c/em\u003ewhistleblowers. Executives in regulated industries -- especially\u0026nbsp;life sciences, healthcare,\u0026nbsp;defense, technology, financial services, artificial intelligence, and government contracting --\u0026nbsp;turn to Amelia for her current insights about\u0026nbsp;domestic and\u0026nbsp;international law enforcement trends.\u003c/p\u003e\n\u003cp\u003ePrior to rejoining King \u0026amp; Spalding, Amelia served as Deputy Chief of Staff to the Director of the FBI, and as Senior Counsel to the U.S. Deputy Attorney General (DAG) at the Department of Justice.\u0026nbsp;\u0026nbsp;She also served as a federal criminal prosecutor\u0026nbsp;in the Financial Crimes \u0026amp; Public Corruption Unit of the U.S. Attorney\u0026rsquo;s Office for the Eastern District of Virginia.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eAt the FBI, Amelia advised the Director and FBI leadership on all aspects of\u0026nbsp;investigations regarding complex financial fraud, healthcare fraud, procurement fraud and collusion,\u0026nbsp;trade sanctions and export controls,\u0026nbsp;cyber and security-related critical incidents, official corruption, counterintelligence, and issues before the National Security Council.\u0026nbsp; Amelia also prepared and advised\u0026nbsp;the FBI Director during numerous congressional hearings, including\u0026nbsp;at\u0026nbsp;\u0026ldquo;members only\u0026rdquo; classified briefings to the full U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Senior Counsel in the Office of the Deputy Attorney General from 2017-2018, Amelia managed a department-wide portfolio of corporate enforcement priorities, compliance initiatives, and\u0026nbsp;case-specific issues arising across Main Justice divisions and U.S. Attorneys\u0026rsquo; Offices, as well as multi-agency efforts with SEC, CFTC,\u0026nbsp;DHS, HHS, FDA,\u0026nbsp;and various agency Offices of Inspector General.\u0026nbsp; Amelia served as the first Chair of the Corporate Enforcement \u0026amp; Accountability Working Group, a leadership committee responsible for guiding the DOJ\u0026rsquo;s strategy and policies to combat corporate criminal and civil fraud nationwide. She played an integral part in the development and implementation of the Foreign Corrupt Practices Act Corporate Enforcement Policy and served as the principal staff counselor to the DAG on approvals of corporate compliance monitorships.\u003c/p\u003e\n\u003cp\u003eIn private practice, Amelia is experienced in steering responses to oversight requests by\u0026nbsp;congressional committees in the U.S. House and Senate. She also\u0026nbsp;prepares business leaders to give testimony at televised hearings before federal\u0026nbsp;and state legislative bodies.\u003c/p\u003e\n\u003cp\u003eAmelia\u0026nbsp;is a member of the invitation-only Edward Bennett Williams Inn of Court for\u0026nbsp;white collar practitioners in Washington, D.C. She serves on the boards of the Atlanta Police Foundation and The Goizueta Foundation.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAmelia\u0026nbsp;graduated Phi Beta Kappa from Princeton University, with a degree from the School of Public \u0026amp; International Affairs.\u0026nbsp; She holds a J.D. from Yale Law School and was a member of The Yale Law Journal.\u003c/p\u003e","recognitions":[{"title":"Selected for the White Collar Crime Editorial Advisory Board","detail":"Law360, 2024"},{"title":"Recommended nationally for Government: State Attorneys General","detail":"Legal 500, 2024"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12849}]},"capability_group_id":2},"created_at":"2025-12-18T22:13:05.000Z","updated_at":"2025-12-18T22:13:05.000Z","searchable_text":"Medina{{ FIELD }}{:title=\u0026gt;\"Selected for the White Collar Crime Editorial Advisory Board\", :detail=\u0026gt;\"Law360, 2024\"}{{ FIELD }}{:title=\u0026gt;\"Recommended nationally for Government: State Attorneys General\", :detail=\u0026gt;\"Legal 500, 2024\"}{{ FIELD }}Amelia Medina represents corporations, nonprofit organizations, and board committees in major investigations and disputes with government authorities.  A partner in King \u0026amp; Spalding's Chambers Band 1-ranked practice in Corporate Crime \u0026amp; Investigations, Amelia also specializes in litigation involving civil fraud, national security, the False Claims Act and qui tam whistleblowers. Executives in regulated industries -- especially life sciences, healthcare, defense, technology, financial services, artificial intelligence, and government contracting -- turn to Amelia for her current insights about domestic and international law enforcement trends.\nPrior to rejoining King \u0026amp; Spalding, Amelia served as Deputy Chief of Staff to the Director of the FBI, and as Senior Counsel to the U.S. Deputy Attorney General (DAG) at the Department of Justice.  She also served as a federal criminal prosecutor in the Financial Crimes \u0026amp; Public Corruption Unit of the U.S. Attorney’s Office for the Eastern District of Virginia. \nAt the FBI, Amelia advised the Director and FBI leadership on all aspects of investigations regarding complex financial fraud, healthcare fraud, procurement fraud and collusion, trade sanctions and export controls, cyber and security-related critical incidents, official corruption, counterintelligence, and issues before the National Security Council.  Amelia also prepared and advised the FBI Director during numerous congressional hearings, including at “members only” classified briefings to the full U.S. Congress. \nAs Senior Counsel in the Office of the Deputy Attorney General from 2017-2018, Amelia managed a department-wide portfolio of corporate enforcement priorities, compliance initiatives, and case-specific issues arising across Main Justice divisions and U.S. Attorneys’ Offices, as well as multi-agency efforts with SEC, CFTC, DHS, HHS, FDA, and various agency Offices of Inspector General.  Amelia served as the first Chair of the Corporate Enforcement \u0026amp; Accountability Working Group, a leadership committee responsible for guiding the DOJ’s strategy and policies to combat corporate criminal and civil fraud nationwide. She played an integral part in the development and implementation of the Foreign Corrupt Practices Act Corporate Enforcement Policy and served as the principal staff counselor to the DAG on approvals of corporate compliance monitorships.\nIn private practice, Amelia is experienced in steering responses to oversight requests by congressional committees in the U.S. House and Senate. She also prepares business leaders to give testimony at televised hearings before federal and state legislative bodies.\nAmelia is a member of the invitation-only Edward Bennett Williams Inn of Court for white collar practitioners in Washington, D.C. She serves on the boards of the Atlanta Police Foundation and The Goizueta Foundation.  \nAmelia graduated Phi Beta Kappa from Princeton University, with a degree from the School of Public \u0026amp; International Affairs.  She holds a J.D. from Yale Law School and was a member of The Yale Law Journal. Partner Selected for the White Collar Crime Editorial Advisory Board Law360, 2024 Recommended nationally for Government: State Attorneys General Legal 500, 2024 Princeton University  Yale University Yale Law School U.S. Court of Appeals for the Second Circuit U.S. District Court for the Northern District of Georgia District of Columbia Georgia Court of Appeals of Georgia Supreme Court of Georgia Hispanic National Bar Association Board of Directors, The Goizueta Foundation (2019-Present) Board of Directors, Latin American Association (2015-2017) Law Clerk, Jose A. Cabranes, U.S. Court of Appeals for the Second Circuit Law Clerk, Michael M. Baylson, U.S. District Court for the Eastern District of Pennsylvania","searchable_name":"Amelia R. Medina","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":445049,"version":1,"owner_type":"Person","owner_id":1416,"payload":{"bio":"\u003cp\u003eBrian Meiners focuses his practice on government antitrust investigations that include criminal and civil matters, merger investigations, and civil litigation. A Partner in our Antitrust practice, Brian represents clients in some of their most complex matters, including global cartel investigations and transactions requiring regulatory approval in multiple jurisdictions. In addition, Brian routinely counsels clients on strategic antitrust issues arising from competitor collaborations, marketing, pricing, distribution practices, and trade association participation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBrian was named a \u0026ldquo;Future Leader\u0026rdquo; in antitrust law by\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003cem\u003eGlobal Competition Review\u003c/em\u003e\u0026nbsp;in the 2024, 2023, and 2022\u0026nbsp;publications of Competition Law \u0026ndash; Future Leaders.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eBrian appears regularly before the U.S. Department of Justice Antitrust Division and the Federal Trade Commission, and he coordinates with foreign counsel in dealing with competition authorities in jurisdictions around the globe.\u003c/p\u003e\n\u003cp\u003eHe is a member of the Cartel \u0026amp; Criminal Practice Committee, State Enforcement Committee,\u0026nbsp;and the Mergers \u0026amp; Acquisitions Committee of the American Bar Association, Section of Antitrust Law.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecent Presentations and Publications\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePanelist, \u0026ldquo;Criminal Antitrust Update: DOJ Announces New Policy Regarding Corporate Compliance Programs,\u0026rdquo; \u003cem\u003eABA Section of Antitrust Law, Cartel and Criminal Practice Committee\u003c/em\u003e (July 2019)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCo-author and editor of the Criminal Enforcement chapter of ABA Section of Antitrust Law, Antitrust Law Developments (8th ed.) (April 2017)\u003c/p\u003e\n\u003cp\u003eCo-author and editor of the Criminal Enforcement chapter of ABA Section of Antitrust Law, 2015 Annual Review of Antitrust Law Developments (March 2016)\u003c/p\u003e\n\u003cp\u003ePanelist, \u0026ldquo;Criminal Antitrust Update,\u0026rdquo; \u003cem\u003eABA Section of Antitrust Law, Cartel and Criminal Practice Committee\u003c/em\u003e (November 2014)\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;McWane Dismissal May Impact Future FTC Cases,\u0026rdquo; \u003cem\u003eCompetition Law360\u003c/em\u003e (February 2014)\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;Antitrust Bid-Rigging at Natural Gas Auctions,\u0026rdquo; \u003cem\u003eCompetition Law360\u003c/em\u003e (April 2012)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;Key Takeaways From US v. AU Optronics,\u0026rdquo; \u003cem\u003eCompetition Law360\u003c/em\u003e (March 2012)\u003c/p\u003e\n\u003cp\u003ePanelist, \u0026ldquo;Dawn Raids, Criminalization of Cartels and Beyond: Are You Ready?\u0026rdquo; King \u0026amp; Spalding and SAI Law \u0026amp; Economics Client Forum (Mexico City, Mexico, November 2011)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMemberships\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCartel \u0026amp; Criminal Practice Committee, Antitrust Section, American Bar Association\u003c/p\u003e\n\u003cp\u003eState Enforcement Committee, Antitrust Section, American Bar Association\u003c/p\u003e\n\u003cp\u003eMergers \u0026amp; Acquisitions Committee, Antitrust Section, American Bar Association\u003c/p\u003e\n\u003cp\u003eAmerican Health Lawyers Association\u003c/p\u003e","slug":"brian-meiners","email":"bmeiners@kslaw.com","phone":null,"matters":["\u003cp\u003e\u003cstrong\u003eCartel Investigations and Criminal Litigation Experience:\u0026nbsp;\u003cbr /\u003e\u003cbr /\u003e\u003c/strong\u003eRepresenting a senior executive of an international capacitors manufacturer as lead counsel in connection with a multi-jurisdictional cartel investigation and related civil proceedings.\u003c/p\u003e","\u003cp\u003eRepresenting senior executives of multiple international auto parts manufacturers in connection with a multi-jurisdictional cartel investigation in that industry.\u003c/p\u003e","\u003cp\u003eRepresented the chief executive officer of an international TFT-LCD manufacturer in connection with a multi-jurisdictional cartel investigation and related civil proceedings.\u003c/p\u003e","\u003cp\u003eRepresented a senior sales and marketing executive of an international freight consolidator in connection with a multi-jurisdictional cartel investigation and Foreign Corrupt Practices Act investigation. \u0026nbsp;\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eCivil Antitrust Litigation:\u003cem\u003e\u0026nbsp;\u003cbr /\u003e\u003cbr /\u003e\u003c/em\u003e\u003c/strong\u003eObtained dismissal for a leading national pharmaceutical company in multi-district class action antitrust litigation in In re Generic Pharmaceuticals Pricing Antitrust Litigation.\u003c/p\u003e","\u003cp\u003eObtained dismissal in class action antitrust litigation for the United States Postal Service in\u0026nbsp;\u003cem\u003eTOG, Inc. v. United States Postal Service\u003c/em\u003e.\u003c/p\u003e","\u003cp\u003eObtained dismissal for RLI Insurance Company in multi-district class action antitrust litigation in\u0026nbsp;\u003cem\u003eIn re Insurance Brokers Antitrust Litigation\u003c/em\u003e.\u003c/p\u003e","\u003cp\u003eSuccessfully defended Trelleborg AB in an international arbitration involving antitrust and fraud claims arising from a stock purchase agreement.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eEnergy:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresented\u0026nbsp;Transocean Ltd. in connection with its $2.7 billion acquisition of Ocean Rig UDW, Inc. in the offshore oil and gas drilling sector and successfully obtained\u0026nbsp;antitrust clearances in\u0026nbsp;several jurisdictions around the world.\u0026nbsp;\u003c/p\u003e","\u003cp\u003eSuccessfully defended Mirant Corporation in a DOJ Second Request investigation of its merger with RRI Energy, creating one of the largest independent power producers in the United States.\u003c/p\u003e","\u003cp\u003eSuccessfully defended Varel International Energy Services, Inc. in an investigation by the DOJ Antitrust Division and several foreign competition agencies in connection with its acquisition by Sandvik AB.\u003c/p\u003e","\u003cp\u003eSuccessfully defended Weatherford International Ltd. in an investigation by the DOJ Antitrust Division and several foreign competition agencies in connection with the acquisition of its pipeline and specialty services business by Baker Hughes Incorporated.\u003c/p\u003e","\u003cp\u003eSuccessfully defended Edison Chouest Offshore in a DOJ Antitrust Division investigation of its acquisition of Bollinger Shipyards, Inc. in the petroleum offshore services industry.\u003c/p\u003e","\u003cp\u003eRepresented a global energy and petroleum company in an international arbitration involving antitrust and breach of contract claims related to LNG production and distribution.\u003c/p\u003e","\u003cp\u003eRepresented Haddington Ventures, L.L.C. in the acquisition of its gas storage assets.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eHealthcare/Life Sciences:\u003cem\u003e\u0026nbsp;\u003cbr /\u003e\u003cbr /\u003e\u003c/em\u003e\u003c/strong\u003eSuccessfully defended Piedmont Healthcare, Inc. in a FTC merger investigation of Piedmont\u0026rsquo;s acquisition of a rival hospital system.\u003c/p\u003e","\u003cp\u003eDefended a physician member network in a FTC price-fixing investigation.\u003c/p\u003e","\u003cp\u003eDefended a major pharmaceutical company in a jury trial in United States District Court for the District of Columbia involving antitrust claims arising from exclusive pharmaceutical supply agreements.\u003c/p\u003e","\u003cp\u003eRepresented a leading global branded pharmaceutical company in a DOJ criminal antitrust investigation of a proposed patent settlement with a generic drug company and the use of authorized generics.\u0026nbsp;\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eAntitrust Counseling:\u0026nbsp;\u003cbr /\u003e\u003cbr /\u003e\u003c/strong\u003eAdvises clients on antitrust issues arising from everyday business practices, including compliance and audits, competitor collaborations, exclusivity and foreclosure, resale price maintenance, refusals to deal, and tying/bundling issues.\u003c/p\u003e","\u003cp\u003eObtained HSR clearances for hundreds of transactions.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003ePro Bono Litigation Service:\u003cbr /\u003e\u003cbr /\u003e\u003c/strong\u003eServed as co-lead counsel in a federal habeas death penalty proceeding challenging a pro bono client's Virginia capital murder conviction . \u0026nbsp;The proceeding culminated in a multi-day evidentiary hearing in federal district court and received national media coverage due to allegations involving extensive drug dealing by Northern Virginia youths, an alleged murder plot, and the Commonwealth's most experienced prosecutors seeking the death penalty. \u0026nbsp;After federal appellate and district court habeas proceedings, the federal district court issued an opinion vacating our client\u0026rsquo;s conviction and death sentence, finding violations of fundamental constitutional obligations.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":102,"guid":"102.capabilities","index":0,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":3,"source":"capabilities"},{"id":32,"guid":"32.capabilities","index":4,"source":"capabilities"},{"id":1,"guid":"1.capabilities","index":5,"source":"capabilities"},{"id":133,"guid":"133.capabilities","index":6,"source":"capabilities"},{"id":1248,"guid":"1248.smart_tags","index":7,"source":"smartTags"},{"id":1434,"guid":"1434.smart_tags","index":8,"source":"smartTags"},{"id":129,"guid":"129.capabilities","index":9,"source":"capabilities"}],"is_active":true,"last_name":"Meiners","nick_name":"Brian","clerkships":[],"first_name":"Brian","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":"R.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eBrian Meiners focuses his practice on government antitrust investigations that include criminal and civil matters, merger investigations, and civil litigation. A Partner in our Antitrust practice, Brian represents clients in some of their most complex matters, including global cartel investigations and transactions requiring regulatory approval in multiple jurisdictions. In addition, Brian routinely counsels clients on strategic antitrust issues arising from competitor collaborations, marketing, pricing, distribution practices, and trade association participation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBrian was named a \u0026ldquo;Future Leader\u0026rdquo; in antitrust law by\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003cem\u003eGlobal Competition Review\u003c/em\u003e\u0026nbsp;in the 2024, 2023, and 2022\u0026nbsp;publications of Competition Law \u0026ndash; Future Leaders.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eBrian appears regularly before the U.S. Department of Justice Antitrust Division and the Federal Trade Commission, and he coordinates with foreign counsel in dealing with competition authorities in jurisdictions around the globe.\u003c/p\u003e\n\u003cp\u003eHe is a member of the Cartel \u0026amp; Criminal Practice Committee, State Enforcement Committee,\u0026nbsp;and the Mergers \u0026amp; Acquisitions Committee of the American Bar Association, Section of Antitrust Law.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecent Presentations and Publications\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePanelist, \u0026ldquo;Criminal Antitrust Update: DOJ Announces New Policy Regarding Corporate Compliance Programs,\u0026rdquo; \u003cem\u003eABA Section of Antitrust Law, Cartel and Criminal Practice Committee\u003c/em\u003e (July 2019)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCo-author and editor of the Criminal Enforcement chapter of ABA Section of Antitrust Law, Antitrust Law Developments (8th ed.) (April 2017)\u003c/p\u003e\n\u003cp\u003eCo-author and editor of the Criminal Enforcement chapter of ABA Section of Antitrust Law, 2015 Annual Review of Antitrust Law Developments (March 2016)\u003c/p\u003e\n\u003cp\u003ePanelist, \u0026ldquo;Criminal Antitrust Update,\u0026rdquo; \u003cem\u003eABA Section of Antitrust Law, Cartel and Criminal Practice Committee\u003c/em\u003e (November 2014)\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;McWane Dismissal May Impact Future FTC Cases,\u0026rdquo; \u003cem\u003eCompetition Law360\u003c/em\u003e (February 2014)\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;Antitrust Bid-Rigging at Natural Gas Auctions,\u0026rdquo; \u003cem\u003eCompetition Law360\u003c/em\u003e (April 2012)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;Key Takeaways From US v. AU Optronics,\u0026rdquo; \u003cem\u003eCompetition Law360\u003c/em\u003e (March 2012)\u003c/p\u003e\n\u003cp\u003ePanelist, \u0026ldquo;Dawn Raids, Criminalization of Cartels and Beyond: Are You Ready?\u0026rdquo; King \u0026amp; Spalding and SAI Law \u0026amp; Economics Client Forum (Mexico City, Mexico, November 2011)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMemberships\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCartel \u0026amp; Criminal Practice Committee, Antitrust Section, American Bar Association\u003c/p\u003e\n\u003cp\u003eState Enforcement Committee, Antitrust Section, American Bar Association\u003c/p\u003e\n\u003cp\u003eMergers \u0026amp; Acquisitions Committee, Antitrust Section, American Bar Association\u003c/p\u003e\n\u003cp\u003eAmerican Health Lawyers Association\u003c/p\u003e","matters":["\u003cp\u003e\u003cstrong\u003eCartel Investigations and Criminal Litigation Experience:\u0026nbsp;\u003cbr /\u003e\u003cbr /\u003e\u003c/strong\u003eRepresenting a senior executive of an international capacitors manufacturer as lead counsel in connection with a multi-jurisdictional cartel investigation and related civil proceedings.\u003c/p\u003e","\u003cp\u003eRepresenting senior executives of multiple international auto parts manufacturers in connection with a multi-jurisdictional cartel investigation in that industry.\u003c/p\u003e","\u003cp\u003eRepresented the chief executive officer of an international TFT-LCD manufacturer in connection with a multi-jurisdictional cartel investigation and related civil proceedings.\u003c/p\u003e","\u003cp\u003eRepresented a senior sales and marketing executive of an international freight consolidator in connection with a multi-jurisdictional cartel investigation and Foreign Corrupt Practices Act investigation. \u0026nbsp;\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eCivil Antitrust Litigation:\u003cem\u003e\u0026nbsp;\u003cbr /\u003e\u003cbr /\u003e\u003c/em\u003e\u003c/strong\u003eObtained dismissal for a leading national pharmaceutical company in multi-district class action antitrust litigation in In re Generic Pharmaceuticals Pricing Antitrust Litigation.\u003c/p\u003e","\u003cp\u003eObtained dismissal in class action antitrust litigation for the United States Postal Service in\u0026nbsp;\u003cem\u003eTOG, Inc. v. United States Postal Service\u003c/em\u003e.\u003c/p\u003e","\u003cp\u003eObtained dismissal for RLI Insurance Company in multi-district class action antitrust litigation in\u0026nbsp;\u003cem\u003eIn re Insurance Brokers Antitrust Litigation\u003c/em\u003e.\u003c/p\u003e","\u003cp\u003eSuccessfully defended Trelleborg AB in an international arbitration involving antitrust and fraud claims arising from a stock purchase agreement.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eEnergy:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresented\u0026nbsp;Transocean Ltd. in connection with its $2.7 billion acquisition of Ocean Rig UDW, Inc. in the offshore oil and gas drilling sector and successfully obtained\u0026nbsp;antitrust clearances in\u0026nbsp;several jurisdictions around the world.\u0026nbsp;\u003c/p\u003e","\u003cp\u003eSuccessfully defended Mirant Corporation in a DOJ Second Request investigation of its merger with RRI Energy, creating one of the largest independent power producers in the United States.\u003c/p\u003e","\u003cp\u003eSuccessfully defended Varel International Energy Services, Inc. in an investigation by the DOJ Antitrust Division and several foreign competition agencies in connection with its acquisition by Sandvik AB.\u003c/p\u003e","\u003cp\u003eSuccessfully defended Weatherford International Ltd. in an investigation by the DOJ Antitrust Division and several foreign competition agencies in connection with the acquisition of its pipeline and specialty services business by Baker Hughes Incorporated.\u003c/p\u003e","\u003cp\u003eSuccessfully defended Edison Chouest Offshore in a DOJ Antitrust Division investigation of its acquisition of Bollinger Shipyards, Inc. in the petroleum offshore services industry.\u003c/p\u003e","\u003cp\u003eRepresented a global energy and petroleum company in an international arbitration involving antitrust and breach of contract claims related to LNG production and distribution.\u003c/p\u003e","\u003cp\u003eRepresented Haddington Ventures, L.L.C. in the acquisition of its gas storage assets.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eHealthcare/Life Sciences:\u003cem\u003e\u0026nbsp;\u003cbr /\u003e\u003cbr /\u003e\u003c/em\u003e\u003c/strong\u003eSuccessfully defended Piedmont Healthcare, Inc. in a FTC merger investigation of Piedmont\u0026rsquo;s acquisition of a rival hospital system.\u003c/p\u003e","\u003cp\u003eDefended a physician member network in a FTC price-fixing investigation.\u003c/p\u003e","\u003cp\u003eDefended a major pharmaceutical company in a jury trial in United States District Court for the District of Columbia involving antitrust claims arising from exclusive pharmaceutical supply agreements.\u003c/p\u003e","\u003cp\u003eRepresented a leading global branded pharmaceutical company in a DOJ criminal antitrust investigation of a proposed patent settlement with a generic drug company and the use of authorized generics.\u0026nbsp;\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eAntitrust Counseling:\u0026nbsp;\u003cbr /\u003e\u003cbr /\u003e\u003c/strong\u003eAdvises clients on antitrust issues arising from everyday business practices, including compliance and audits, competitor collaborations, exclusivity and foreclosure, resale price maintenance, refusals to deal, and tying/bundling issues.\u003c/p\u003e","\u003cp\u003eObtained HSR clearances for hundreds of transactions.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003ePro Bono Litigation Service:\u003cbr /\u003e\u003cbr /\u003e\u003c/strong\u003eServed as co-lead counsel in a federal habeas death penalty proceeding challenging a pro bono client's Virginia capital murder conviction . \u0026nbsp;The proceeding culminated in a multi-day evidentiary hearing in federal district court and received national media coverage due to allegations involving extensive drug dealing by Northern Virginia youths, an alleged murder plot, and the Commonwealth's most experienced prosecutors seeking the death penalty. \u0026nbsp;After federal appellate and district court habeas proceedings, the federal district court issued an opinion vacating our client\u0026rsquo;s conviction and death sentence, finding violations of fundamental constitutional obligations.\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":5194}]},"capability_group_id":2},"created_at":"2026-01-14T21:34:16.000Z","updated_at":"2026-01-14T21:34:16.000Z","searchable_text":"Meiners{{ FIELD }}Cartel Investigations and Criminal Litigation Experience: Representing a senior executive of an international capacitors manufacturer as lead counsel in connection with a multi-jurisdictional cartel investigation and related civil proceedings.{{ FIELD }}Representing senior executives of multiple international auto parts manufacturers in connection with a multi-jurisdictional cartel investigation in that industry.{{ FIELD }}Represented the chief executive officer of an international TFT-LCD manufacturer in connection with a multi-jurisdictional cartel investigation and related civil proceedings.{{ FIELD }}Represented a senior sales and marketing executive of an international freight consolidator in connection with a multi-jurisdictional cartel investigation and Foreign Corrupt Practices Act investigation.  {{ FIELD }}Civil Antitrust Litigation: Obtained dismissal for a leading national pharmaceutical company in multi-district class action antitrust litigation in In re Generic Pharmaceuticals Pricing Antitrust Litigation.{{ FIELD }}Obtained dismissal in class action antitrust litigation for the United States Postal Service in TOG, Inc. v. United States Postal Service.{{ FIELD }}Obtained dismissal for RLI Insurance Company in multi-district class action antitrust litigation in In re Insurance Brokers Antitrust Litigation.{{ FIELD }}Successfully defended Trelleborg AB in an international arbitration involving antitrust and fraud claims arising from a stock purchase agreement.{{ FIELD }}Energy: \nRepresented Transocean Ltd. in connection with its $2.7 billion acquisition of Ocean Rig UDW, Inc. in the offshore oil and gas drilling sector and successfully obtained antitrust clearances in several jurisdictions around the world. {{ FIELD }}Successfully defended Mirant Corporation in a DOJ Second Request investigation of its merger with RRI Energy, creating one of the largest independent power producers in the United States.{{ FIELD }}Successfully defended Varel International Energy Services, Inc. in an investigation by the DOJ Antitrust Division and several foreign competition agencies in connection with its acquisition by Sandvik AB.{{ FIELD }}Successfully defended Weatherford International Ltd. in an investigation by the DOJ Antitrust Division and several foreign competition agencies in connection with the acquisition of its pipeline and specialty services business by Baker Hughes Incorporated.{{ FIELD }}Successfully defended Edison Chouest Offshore in a DOJ Antitrust Division investigation of its acquisition of Bollinger Shipyards, Inc. in the petroleum offshore services industry.{{ FIELD }}Represented a global energy and petroleum company in an international arbitration involving antitrust and breach of contract claims related to LNG production and distribution.{{ FIELD }}Represented Haddington Ventures, L.L.C. in the acquisition of its gas storage assets.{{ FIELD }}Healthcare/Life Sciences: Successfully defended Piedmont Healthcare, Inc. in a FTC merger investigation of Piedmont’s acquisition of a rival hospital system.{{ FIELD }}Defended a physician member network in a FTC price-fixing investigation.{{ FIELD }}Defended a major pharmaceutical company in a jury trial in United States District Court for the District of Columbia involving antitrust claims arising from exclusive pharmaceutical supply agreements.{{ FIELD }}Represented a leading global branded pharmaceutical company in a DOJ criminal antitrust investigation of a proposed patent settlement with a generic drug company and the use of authorized generics. {{ FIELD }}Antitrust Counseling: Advises clients on antitrust issues arising from everyday business practices, including compliance and audits, competitor collaborations, exclusivity and foreclosure, resale price maintenance, refusals to deal, and tying/bundling issues.{{ FIELD }}Obtained HSR clearances for hundreds of transactions.{{ FIELD }}Pro Bono Litigation Service:Served as co-lead counsel in a federal habeas death penalty proceeding challenging a pro bono client's Virginia capital murder conviction .  The proceeding culminated in a multi-day evidentiary hearing in federal district court and received national media coverage due to allegations involving extensive drug dealing by Northern Virginia youths, an alleged murder plot, and the Commonwealth's most experienced prosecutors seeking the death penalty.  After federal appellate and district court habeas proceedings, the federal district court issued an opinion vacating our client’s conviction and death sentence, finding violations of fundamental constitutional obligations.{{ FIELD }}Brian Meiners focuses his practice on government antitrust investigations that include criminal and civil matters, merger investigations, and civil litigation. A Partner in our Antitrust practice, Brian represents clients in some of their most complex matters, including global cartel investigations and transactions requiring regulatory approval in multiple jurisdictions. In addition, Brian routinely counsels clients on strategic antitrust issues arising from competitor collaborations, marketing, pricing, distribution practices, and trade association participation. \nBrian was named a “Future Leader” in antitrust law by Global Competition Review in the 2024, 2023, and 2022 publications of Competition Law – Future Leaders. \nBrian appears regularly before the U.S. Department of Justice Antitrust Division and the Federal Trade Commission, and he coordinates with foreign counsel in dealing with competition authorities in jurisdictions around the globe.\nHe is a member of the Cartel \u0026amp; Criminal Practice Committee, State Enforcement Committee, and the Mergers \u0026amp; Acquisitions Committee of the American Bar Association, Section of Antitrust Law.\nRecent Presentations and Publications\nPanelist, “Criminal Antitrust Update: DOJ Announces New Policy Regarding Corporate Compliance Programs,” ABA Section of Antitrust Law, Cartel and Criminal Practice Committee (July 2019) \nCo-author and editor of the Criminal Enforcement chapter of ABA Section of Antitrust Law, Antitrust Law Developments (8th ed.) (April 2017)\nCo-author and editor of the Criminal Enforcement chapter of ABA Section of Antitrust Law, 2015 Annual Review of Antitrust Law Developments (March 2016)\nPanelist, “Criminal Antitrust Update,” ABA Section of Antitrust Law, Cartel and Criminal Practice Committee (November 2014)\n“McWane Dismissal May Impact Future FTC Cases,” Competition Law360 (February 2014)\n“Antitrust Bid-Rigging at Natural Gas Auctions,” Competition Law360 (April 2012) \n“Key Takeaways From US v. AU Optronics,” Competition Law360 (March 2012)\nPanelist, “Dawn Raids, Criminalization of Cartels and Beyond: Are You Ready?” King \u0026amp; Spalding and SAI Law \u0026amp; Economics Client Forum (Mexico City, Mexico, November 2011)\nMemberships\nCartel \u0026amp; Criminal Practice Committee, Antitrust Section, American Bar Association\nState Enforcement Committee, Antitrust Section, American Bar Association\nMergers \u0026amp; Acquisitions Committee, Antitrust Section, American Bar Association\nAmerican Health Lawyers Association Partner Texas Christian University  St. Louis University  U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the D.C. Circuit U.S. District Court for the District of Colorado U.S. District Court for the District of Columbia District of Columbia Missouri Cartel Investigations and Criminal Litigation Experience: Representing a senior executive of an international capacitors manufacturer as lead counsel in connection with a multi-jurisdictional cartel investigation and related civil proceedings. Representing senior executives of multiple international auto parts manufacturers in connection with a multi-jurisdictional cartel investigation in that industry. Represented the chief executive officer of an international TFT-LCD manufacturer in connection with a multi-jurisdictional cartel investigation and related civil proceedings. Represented a senior sales and marketing executive of an international freight consolidator in connection with a multi-jurisdictional cartel investigation and Foreign Corrupt Practices Act investigation.   Civil Antitrust Litigation: Obtained dismissal for a leading national pharmaceutical company in multi-district class action antitrust litigation in In re Generic Pharmaceuticals Pricing Antitrust Litigation. Obtained dismissal in class action antitrust litigation for the United States Postal Service in TOG, Inc. v. United States Postal Service. Obtained dismissal for RLI Insurance Company in multi-district class action antitrust litigation in In re Insurance Brokers Antitrust Litigation. Successfully defended Trelleborg AB in an international arbitration involving antitrust and fraud claims arising from a stock purchase agreement. Energy: \nRepresented Transocean Ltd. in connection with its $2.7 billion acquisition of Ocean Rig UDW, Inc. in the offshore oil and gas drilling sector and successfully obtained antitrust clearances in several jurisdictions around the world.  Successfully defended Mirant Corporation in a DOJ Second Request investigation of its merger with RRI Energy, creating one of the largest independent power producers in the United States. Successfully defended Varel International Energy Services, Inc. in an investigation by the DOJ Antitrust Division and several foreign competition agencies in connection with its acquisition by Sandvik AB. Successfully defended Weatherford International Ltd. in an investigation by the DOJ Antitrust Division and several foreign competition agencies in connection with the acquisition of its pipeline and specialty services business by Baker Hughes Incorporated. Successfully defended Edison Chouest Offshore in a DOJ Antitrust Division investigation of its acquisition of Bollinger Shipyards, Inc. in the petroleum offshore services industry. Represented a global energy and petroleum company in an international arbitration involving antitrust and breach of contract claims related to LNG production and distribution. Represented Haddington Ventures, L.L.C. in the acquisition of its gas storage assets. Healthcare/Life Sciences: Successfully defended Piedmont Healthcare, Inc. in a FTC merger investigation of Piedmont’s acquisition of a rival hospital system. Defended a physician member network in a FTC price-fixing investigation. Defended a major pharmaceutical company in a jury trial in United States District Court for the District of Columbia involving antitrust claims arising from exclusive pharmaceutical supply agreements. Represented a leading global branded pharmaceutical company in a DOJ criminal antitrust investigation of a proposed patent settlement with a generic drug company and the use of authorized generics.  Antitrust Counseling: Advises clients on antitrust issues arising from everyday business practices, including compliance and audits, competitor collaborations, exclusivity and foreclosure, resale price maintenance, refusals to deal, and tying/bundling issues. Obtained HSR clearances for hundreds of transactions. Pro Bono Litigation Service:Served as co-lead counsel in a federal habeas death penalty proceeding challenging a pro bono client's Virginia capital murder conviction .  The proceeding culminated in a multi-day evidentiary hearing in federal district court and received national media coverage due to allegations involving extensive drug dealing by Northern Virginia youths, an alleged murder plot, and the Commonwealth's most experienced prosecutors seeking the death penalty.  After federal appellate and district court habeas proceedings, the federal district court issued an opinion vacating our client’s conviction and death sentence, finding violations of fundamental constitutional obligations.","searchable_name":"Brian R. Meiners","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":426536,"version":1,"owner_type":"Person","owner_id":4090,"payload":{"bio":"\u003cp\u003eGary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food\u0026nbsp;and Drug Administration and other federal and state agencies.\u0026nbsp; Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes.\u0026nbsp; In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management.\u0026nbsp; Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.\u003c/p\u003e\n\u003cp\u003ePreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\u003c/p\u003e\n\u003cp\u003eA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by\u0026nbsp;\u003cem\u003eSuper Lawyers Washington, DC\u003c/em\u003e.\u003c/p\u003e","slug":"gary-messplay","email":"gmessplay@kslaw.com","phone":"+1 703 973 7500","matters":["\u003cp\u003eDeveloped customized, comprehensive healthcare compliance programs for numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and medical device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eServed as outside general counsel to \u003cstrong data-redactor-tag=\"strong\"\u003especialty pharmaceutical companies and emerging drug and device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eLed significant multi-year investigation for \u003cstrong data-redactor-tag=\"strong\"\u003ea large pharmaceutical company\u003c/strong\u003e involving complex data integrity issues related to their bioanalytics laboratory.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.\u003c/p\u003e","\u003cp\u003eConducted a significant number of compliance investigations on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies,\u003c/strong\u003e including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.\u003c/p\u003e","\u003cp\u003eRepresented Board of Directors of \u003cstrong data-redactor-tag=\"strong\"\u003epublicly traded pharmaceutical company\u003c/strong\u003e in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e on all aspects of compliance with their corporate integrity agreements.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea specialty pharmaceutical company\u003c/strong\u003e in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to clinical trial regulatory and compliance issues.\u003c/p\u003e","\u003cp\u003eAssisted \u003cstrong 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companies\u003c/strong\u003e in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug, biotechnology, device, food and tobacco companies\u003c/strong\u003e on legislative matters including drafting and commenting on legislation.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":2,"guid":"2.capabilities","index":0,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":5,"source":"smartTags"},{"id":17,"guid":"17.capabilities","index":6,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":7,"source":"capabilities"},{"id":109,"guid":"109.capabilities","index":8,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":9,"source":"smartTags"}],"is_active":true,"last_name":"Messplay","nick_name":"Gary","clerkships":[],"first_name":"Gary","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"C.","name_suffix":"","recognitions":[{"title":"","detail":"Super Lawyers, 2014, 2015 \u0026 2016"}],"linked_in_url":"https://www.linkedin.com/in/gary-messplay-45599b61/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eGary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food\u0026nbsp;and Drug Administration and other federal and state agencies.\u0026nbsp; Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes.\u0026nbsp; In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management.\u0026nbsp; Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.\u003c/p\u003e\n\u003cp\u003ePreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\u003c/p\u003e\n\u003cp\u003eA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by\u0026nbsp;\u003cem\u003eSuper Lawyers Washington, DC\u003c/em\u003e.\u003c/p\u003e","matters":["\u003cp\u003eDeveloped customized, comprehensive healthcare compliance programs for numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and medical device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eServed as outside general counsel to \u003cstrong data-redactor-tag=\"strong\"\u003especialty pharmaceutical companies and emerging drug and device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eLed significant multi-year investigation for \u003cstrong data-redactor-tag=\"strong\"\u003ea large pharmaceutical company\u003c/strong\u003e involving complex data integrity issues related to their bioanalytics laboratory.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.\u003c/p\u003e","\u003cp\u003eConducted a significant number of compliance investigations on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies,\u003c/strong\u003e including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.\u003c/p\u003e","\u003cp\u003eRepresented Board of Directors of \u003cstrong data-redactor-tag=\"strong\"\u003epublicly traded pharmaceutical company\u003c/strong\u003e in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e on all aspects of compliance with their corporate integrity agreements.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea specialty pharmaceutical company\u003c/strong\u003e in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to clinical trial regulatory and compliance issues.\u003c/p\u003e","\u003cp\u003eAssisted \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e in developing and implementing specialty pharmacy programs.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with adverse FDA inspections, including responding to 483s and warning letters.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements.\u003c/p\u003e","\u003cp\u003eLed numerous regulatory and compliance due diligence teams in \u003cstrong data-redactor-tag=\"strong\"\u003edrug, device, tobacco and food transactions.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug, biotechnology, device, food and tobacco companies\u003c/strong\u003e on legislative matters including drafting and commenting on legislation.\u003c/p\u003e"],"recognitions":[{"title":"","detail":"Super Lawyers, 2014, 2015 \u0026 2016"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4357}]},"capability_group_id":2},"created_at":"2025-05-26T04:54:29.000Z","updated_at":"2025-05-26T04:54:29.000Z","searchable_text":"Messplay{{ FIELD }}{:title=\u0026gt;\"\", :detail=\u0026gt;\"Super Lawyers, 2014, 2015 \u0026amp; 2016\"}{{ FIELD }}Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies.{{ FIELD }}Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies.{{ FIELD }}Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory.{{ FIELD }}Advised numerous drug and device companies related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.{{ FIELD }}Conducted a significant number of compliance investigations on behalf of drug and device companies, including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.{{ FIELD }}Represented Board of Directors of publicly traded pharmaceutical company in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.{{ FIELD }}Advised drug and device companies on all aspects of compliance with their corporate integrity agreements.{{ FIELD }}Advised numerous pharmaceutical companies on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.{{ FIELD }}Successfully represented a specialty pharmaceutical company in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.{{ FIELD }}Represented drug and device companies in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.{{ FIELD }}Advised drug and device companies related to clinical trial regulatory and compliance issues.{{ FIELD }}Assisted pharmaceutical companies in developing and implementing specialty pharmacy programs.{{ FIELD }}Represented drug and device companies in connection with adverse FDA inspections, including responding to 483s and warning letters.{{ FIELD }}Represented drug and device companies in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements.{{ FIELD }}Led numerous regulatory and compliance due diligence teams in drug, device, tobacco and food transactions.{{ FIELD }}Represented drug and device companies in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.{{ FIELD }}Advised drug, biotechnology, device, food and tobacco companies on legislative matters including drafting and commenting on legislation.{{ FIELD }}Gary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.\nGary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food and Drug Administration and other federal and state agencies.  Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes.  In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management.  Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.\nPreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\nA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by Super Lawyers Washington, DC. Partner  Super Lawyers, 2014, 2015 \u0026amp; 2016 District of Columbia Indiana Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies. Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies. Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory. Advised numerous drug and device companies related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement. Conducted a significant number of compliance investigations on behalf of drug and device companies, including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling. Represented Board of Directors of publicly traded pharmaceutical company in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute. Advised drug and device companies on all aspects of compliance with their corporate integrity agreements. Advised numerous pharmaceutical companies on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues. Successfully represented a specialty pharmaceutical company in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication. Represented drug and device companies in connection with FDA, OCI, Department of Justice, SEC and congressional investigations. Advised drug and device companies related to clinical trial regulatory and compliance issues. Assisted pharmaceutical companies in developing and implementing specialty pharmacy programs. Represented drug and device companies in connection with adverse FDA inspections, including responding to 483s and warning letters. Represented drug and device companies in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements. Led numerous regulatory and compliance due diligence teams in drug, device, tobacco and food transactions. Represented drug and device companies in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation. Advised drug, biotechnology, device, food and tobacco companies on legislative matters including drafting and commenting on legislation.","searchable_name":"Gary C. Messplay","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":426822,"version":1,"owner_type":"Person","owner_id":5778,"payload":{"bio":"\u003cp\u003eAndrew Michaelson is an accomplished former prosecutor who has advised global financial institutions, Fortune 100 companies, hedge funds, and senior executives in high-stakes investigations and related civil litigation.\u0026nbsp; Andrew has secured declinations, favorable settlements, and litigation victories in a wide range of white-collar and securities-related matters.\u0026nbsp; He has deep experience in trading and markets and is co-head of the firm\u0026rsquo;s Fintech Working Group, with several notable representations concerning the development of digital asset and blockchain technology.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChambers USA has noted that Andrew is \u0026ldquo;increasingly recognized\u0026rdquo; for his work defending \u0026ldquo;companies and individuals alike\u0026rdquo; in white collar and government investigations in New York. According to Chambers, clients described Andrew as \u0026ldquo;incredibly smart and understated,\u0026rdquo; and \u0026ldquo;very, very knowledgeable on regulatory matters.\u0026rdquo; He has appeared on 60 Minutes to discuss insider trading, and his prior work as a federal prosecutor was profiled in the Wall Street Journal and The New Yorker.\u003c/p\u003e\n\u003cp\u003eAndrew previously served in government with the SEC, Division of Enforcement, and with the U.S. Attorney\u0026rsquo;s Office for the Southern District of New York, where he led the Galleon insider trading investigation and prosecuted numerous securities and wire fraud cases. He served as trial counsel in U.S. v. Rajaratnam, the high-profile criminal trial resulting in the conviction of Raj Rajaratnam. Andrew has spoken about the Galleon case and federal securities law enforcement at Harvard Law School and the NYU School of Law.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e","slug":"andrew-michaelson","email":"amichaelson@kslaw.com","phone":"+1 646 244 0663","matters":["\u003cp\u003e\u003cstrong\u003eDigital Assets / Cryptocurrencies\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting Ripple Labs in connection with class action litigation, in multiple federal courts across the country, concerning whether Ripple\u0026rsquo;s distributions of XRP constitute \u0026ldquo;investment contracts\u0026rdquo; subject to regulation under federal securities laws.\u003c/p\u003e","\u003cp\u003eAdvising major financial institution on application of federal banking laws and regulations to state-chartered banks and trust companies affiliated with cryptocurrency exchanges or otherwise focused on digital assets.\u003c/p\u003e","\u003cp\u003eRepresenting major hedge fund in connection with internal review of trading in digital assets, to ensure compliance with federal laws and regulation.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eSecurities/Commodities/Unfair Trade Practices\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting HSBC in investigations and civil litigation relating to issuance of subprime RMBS, obtaining favorable settlements of DOJ investigation under FIRREA and civil claims asserted by FHFA\u003c/p\u003e","\u003cp\u003eRepresenting HSBC in connection with a variety of regulatory investigations by the SEC and/or State AGs\u003c/p\u003e","\u003cp\u003eRepresenting BNP Paribas in connection with the successful recovery of nearly $150 million from an SEC Fair Fund distribution\u003c/p\u003e","\u003cp\u003eRepresenting a financial services company in connection with CFPB investigation relating to fee disclosures and data security\u003c/p\u003e","\u003cp\u003eRepresenting Barclays in investigations relating to ISDAFIX, obtaining favorable settlement with CFTC and civil plaintiffs\u003c/p\u003e","\u003cp\u003eRepresenting a major ride hailing company in connection with investigations by State AGs relating to representations to investors, resulting in no action\u003c/p\u003e","\u003cp\u003eRepresenting a substantial hedge fund (\u0026gt;$20 billion in AUM) and its CEO in connection with SEC insider trading investigation, resulting in no action\u003c/p\u003e","\u003cp\u003eRepresenting Barclays in connection with CFTC investigation into potential insider trading, resulting in no action\u003c/p\u003e","\u003cp\u003eRepresenting a public, Silicon Valley-based Fintech company in connection with investigation by a State Attorney General concerning app-based securities trading.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eCorruption/FCPA\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting NIKE in connection with DOJ investigation into corruption in NCAA basketball\u003c/p\u003e","\u003cp\u003eRepresenting a Fortune 100 company in connection with DOJ investigation relating to bribery in South America, Africa, Asia, Europe, the Middle East and the U.S.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eAntitrust\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting ValueAct in connection with an unprecedented antitrust litigation filed by the DOJ relating to Hart-Scott-Rodino\u0026rsquo;s \u0026ldquo;Investment-Only Exemption\u0026rdquo;\u003c/p\u003e","\u003cp\u003eRepresenting Target Corp. in connection with opt-out antitrust litigation relating to a price-fixing in packaged seafood industry\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eData Privacy\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting a Fortune 100, Silicon Valley-based technology company in connection with an internal inquiry relating to data privacy controls\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eIndividuals\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting president of public company in connection with SEC investigation into public representations regarding foreign operations\u003c/p\u003e","\u003cp\u003eRepresenting CEO in connection with SEC investigation into accounting of purchases and sales of data\u003c/p\u003e","\u003cp\u003eRepresenting executive in connection with SEC FCPA investigation involving Russia, Turkey and Brazil\u003c/p\u003e","\u003cp\u003eRepresenting CEO in connection with internal investigation by the Board of Directors\u003c/p\u003e","\u003cp\u003eRepresenting numerous traders in connection with SEC and internal investigations relating to FX trading, pre-release ADRs, and other matters\u003c/p\u003e","\u003cp\u003eRepresenting trader in connection with CFTC inquiry into potential insider trading\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":3470}]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":2,"source":"capabilities"},{"id":118,"guid":"118.capabilities","index":3,"source":"capabilities"},{"id":111,"guid":"111.capabilities","index":4,"source":"capabilities"},{"id":780,"guid":"780.smart_tags","index":5,"source":"smartTags"},{"id":766,"guid":"766.smart_tags","index":6,"source":"smartTags"},{"id":19,"guid":"19.capabilities","index":7,"source":"capabilities"},{"id":765,"guid":"765.smart_tags","index":8,"source":"smartTags"},{"id":1180,"guid":"1180.smart_tags","index":9,"source":"smartTags"},{"id":122,"guid":"122.capabilities","index":10,"source":"capabilities"},{"id":1188,"guid":"1188.smart_tags","index":11,"source":"smartTags"},{"id":123,"guid":"123.capabilities","index":12,"source":"capabilities"},{"id":1199,"guid":"1199.smart_tags","index":13,"source":"smartTags"},{"id":750,"guid":"750.smart_tags","index":14,"source":"smartTags"},{"id":750,"guid":"750.smart_tags","index":15,"source":"smartTags"},{"id":1243,"guid":"1243.smart_tags","index":16,"source":"smartTags"},{"id":1248,"guid":"1248.smart_tags","index":17,"source":"smartTags"},{"id":20,"guid":"20.capabilities","index":18,"source":"capabilities"}],"is_active":true,"last_name":"Michaelson","nick_name":"Andrew","clerkships":[{"name":"Law Clerk, Hon. Sarah S. Vance, U.S. District Court for the Eastern District of Louisiana","years_held":"2002 - 2003"}],"first_name":"Andrew","title_rank":9999,"updated_by":202,"law_schools":[{"id":824,"meta":{"degree":"J.D.","honors":"cum laude","is_law_school":1,"graduation_date":"2002-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Top Ranked Lawyer: White-Collar Crime \u0026 Government Investigations","detail":"Chambers USA, New York (2019-2022)"},{"title":"Named Up and Coming Practitioner","detail":"Chambers (2019)"},{"title":"Named New York-Metro Super Lawyer ","detail":"Super Lawyers (2013-2015, 2017-2019)"},{"title":"Named to 500 Leading Lawyers in America","detail":"Lawdragon"}],"linked_in_url":null,"seodescription":"Andrew Michaelson is a partner of our Special Matters \u0026 Government Investigations Practice Group. Read more about him.","primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eAndrew Michaelson is an accomplished former prosecutor who has advised global financial institutions, Fortune 100 companies, hedge funds, and senior executives in high-stakes investigations and related civil litigation.\u0026nbsp; Andrew has secured declinations, favorable settlements, and litigation victories in a wide range of white-collar and securities-related matters.\u0026nbsp; He has deep experience in trading and markets and is co-head of the firm\u0026rsquo;s Fintech Working Group, with several notable representations concerning the development of digital asset and blockchain technology.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChambers USA has noted that Andrew is \u0026ldquo;increasingly recognized\u0026rdquo; for his work defending \u0026ldquo;companies and individuals alike\u0026rdquo; in white collar and government investigations in New York. According to Chambers, clients described Andrew as \u0026ldquo;incredibly smart and understated,\u0026rdquo; and \u0026ldquo;very, very knowledgeable on regulatory matters.\u0026rdquo; He has appeared on 60 Minutes to discuss insider trading, and his prior work as a federal prosecutor was profiled in the Wall Street Journal and The New Yorker.\u003c/p\u003e\n\u003cp\u003eAndrew previously served in government with the SEC, Division of Enforcement, and with the U.S. Attorney\u0026rsquo;s Office for the Southern District of New York, where he led the Galleon insider trading investigation and prosecuted numerous securities and wire fraud cases. He served as trial counsel in U.S. v. Rajaratnam, the high-profile criminal trial resulting in the conviction of Raj Rajaratnam. Andrew has spoken about the Galleon case and federal securities law enforcement at Harvard Law School and the NYU School of Law.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e","matters":["\u003cp\u003e\u003cstrong\u003eDigital Assets / Cryptocurrencies\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting Ripple Labs in connection with class action litigation, in multiple federal courts across the country, concerning whether Ripple\u0026rsquo;s distributions of XRP constitute \u0026ldquo;investment contracts\u0026rdquo; subject to regulation under federal securities laws.\u003c/p\u003e","\u003cp\u003eAdvising major financial institution on application of federal banking laws and regulations to state-chartered banks and trust companies affiliated with cryptocurrency exchanges or otherwise focused on digital assets.\u003c/p\u003e","\u003cp\u003eRepresenting major hedge fund in connection with internal review of trading in digital assets, to ensure compliance with federal laws and regulation.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eSecurities/Commodities/Unfair Trade Practices\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting HSBC in investigations and civil litigation relating to issuance of subprime RMBS, obtaining favorable settlements of DOJ investigation under FIRREA and civil claims asserted by FHFA\u003c/p\u003e","\u003cp\u003eRepresenting HSBC in connection with a variety of regulatory investigations by the SEC and/or State AGs\u003c/p\u003e","\u003cp\u003eRepresenting BNP Paribas in connection with the successful recovery of nearly $150 million from an SEC Fair Fund distribution\u003c/p\u003e","\u003cp\u003eRepresenting a financial services company in connection with CFPB investigation relating to fee disclosures and data security\u003c/p\u003e","\u003cp\u003eRepresenting Barclays in investigations relating to ISDAFIX, obtaining favorable settlement with CFTC and civil plaintiffs\u003c/p\u003e","\u003cp\u003eRepresenting a major ride hailing company in connection with investigations by State AGs relating to representations to investors, resulting in no action\u003c/p\u003e","\u003cp\u003eRepresenting a substantial hedge fund (\u0026gt;$20 billion in AUM) and its CEO in connection with SEC insider trading investigation, resulting in no action\u003c/p\u003e","\u003cp\u003eRepresenting Barclays in connection with CFTC investigation into potential insider trading, resulting in no action\u003c/p\u003e","\u003cp\u003eRepresenting a public, Silicon Valley-based Fintech company in connection with investigation by a State Attorney General concerning app-based securities trading.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eCorruption/FCPA\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting NIKE in connection with DOJ investigation into corruption in NCAA basketball\u003c/p\u003e","\u003cp\u003eRepresenting a Fortune 100 company in connection with DOJ investigation relating to bribery in South America, Africa, Asia, Europe, the Middle East and the U.S.\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eAntitrust\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting ValueAct in connection with an unprecedented antitrust litigation filed by the DOJ relating to Hart-Scott-Rodino\u0026rsquo;s \u0026ldquo;Investment-Only Exemption\u0026rdquo;\u003c/p\u003e","\u003cp\u003eRepresenting Target Corp. in connection with opt-out antitrust litigation relating to a price-fixing in packaged seafood industry\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eData Privacy\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting a Fortune 100, Silicon Valley-based technology company in connection with an internal inquiry relating to data privacy controls\u003c/p\u003e","\u003cp\u003e\u003cstrong\u003eIndividuals\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRepresenting president of public company in connection with SEC investigation into public representations regarding foreign operations\u003c/p\u003e","\u003cp\u003eRepresenting CEO in connection with SEC investigation into accounting of purchases and sales of data\u003c/p\u003e","\u003cp\u003eRepresenting executive in connection with SEC FCPA investigation involving Russia, Turkey and Brazil\u003c/p\u003e","\u003cp\u003eRepresenting CEO in connection with internal investigation by the Board of Directors\u003c/p\u003e","\u003cp\u003eRepresenting numerous traders in connection with SEC and internal investigations relating to FX trading, pre-release ADRs, and other matters\u003c/p\u003e","\u003cp\u003eRepresenting trader in connection with CFTC inquiry into potential insider trading\u003c/p\u003e"],"recognitions":[{"title":"Top Ranked Lawyer: White-Collar Crime \u0026 Government Investigations","detail":"Chambers USA, New York (2019-2022)"},{"title":"Named Up and Coming Practitioner","detail":"Chambers (2019)"},{"title":"Named New York-Metro Super Lawyer ","detail":"Super Lawyers (2013-2015, 2017-2019)"},{"title":"Named to 500 Leading Lawyers in America","detail":"Lawdragon"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":8444}]},"capability_group_id":2},"created_at":"2025-05-26T04:57:11.000Z","updated_at":"2025-05-26T04:57:11.000Z","searchable_text":"Michaelson{{ FIELD }}{:title=\u0026gt;\"Top Ranked Lawyer: White-Collar Crime \u0026amp; Government Investigations\", :detail=\u0026gt;\"Chambers USA, New York (2019-2022)\"}{{ FIELD }}{:title=\u0026gt;\"Named Up and Coming Practitioner\", :detail=\u0026gt;\"Chambers (2019)\"}{{ FIELD }}{:title=\u0026gt;\"Named New York-Metro Super Lawyer \", :detail=\u0026gt;\"Super Lawyers (2013-2015, 2017-2019)\"}{{ FIELD }}{:title=\u0026gt;\"Named to 500 Leading Lawyers in America\", :detail=\u0026gt;\"Lawdragon\"}{{ FIELD }}Digital Assets / Cryptocurrencies\nRepresenting Ripple Labs in connection with class action litigation, in multiple federal courts across the country, concerning whether Ripple’s distributions of XRP constitute “investment contracts” subject to regulation under federal securities laws.{{ FIELD }}Advising major financial institution on application of federal banking laws and regulations to state-chartered banks and trust companies affiliated with cryptocurrency exchanges or otherwise focused on digital assets.{{ FIELD }}Representing major hedge fund in connection with internal review of trading in digital assets, to ensure compliance with federal laws and regulation.{{ FIELD }}Securities/Commodities/Unfair Trade Practices\nRepresenting HSBC in investigations and civil litigation relating to issuance of subprime RMBS, obtaining favorable settlements of DOJ investigation under FIRREA and civil claims asserted by FHFA{{ FIELD }}Representing HSBC in connection with a variety of regulatory investigations by the SEC and/or State AGs{{ FIELD }}Representing BNP Paribas in connection with the successful recovery of nearly $150 million from an SEC Fair Fund distribution{{ FIELD }}Representing a financial services company in connection with CFPB investigation relating to fee disclosures and data security{{ FIELD }}Representing Barclays in investigations relating to ISDAFIX, obtaining favorable settlement with CFTC and civil plaintiffs{{ FIELD }}Representing a major ride hailing company in connection with investigations by State AGs relating to representations to investors, resulting in no action{{ FIELD }}Representing a substantial hedge fund (\u0026gt;$20 billion in AUM) and its CEO in connection with SEC insider trading investigation, resulting in no action{{ FIELD }}Representing Barclays in connection with CFTC investigation into potential insider trading, resulting in no action{{ FIELD }}Representing a public, Silicon Valley-based Fintech company in connection with investigation by a State Attorney General concerning app-based securities trading.{{ FIELD }}Corruption/FCPA\nRepresenting NIKE in connection with DOJ investigation into corruption in NCAA basketball{{ FIELD }}Representing a Fortune 100 company in connection with DOJ investigation relating to bribery in South America, Africa, Asia, Europe, the Middle East and the U.S.{{ FIELD }}Antitrust\nRepresenting ValueAct in connection with an unprecedented antitrust litigation filed by the DOJ relating to Hart-Scott-Rodino’s “Investment-Only Exemption”{{ FIELD }}Representing Target Corp. in connection with opt-out antitrust litigation relating to a price-fixing in packaged seafood industry{{ FIELD }}Data Privacy\nRepresenting a Fortune 100, Silicon Valley-based technology company in connection with an internal inquiry relating to data privacy controls{{ FIELD }}Individuals\nRepresenting president of public company in connection with SEC investigation into public representations regarding foreign operations{{ FIELD }}Representing CEO in connection with SEC investigation into accounting of purchases and sales of data{{ FIELD }}Representing executive in connection with SEC FCPA investigation involving Russia, Turkey and Brazil{{ FIELD }}Representing CEO in connection with internal investigation by the Board of Directors{{ FIELD }}Representing numerous traders in connection with SEC and internal investigations relating to FX trading, pre-release ADRs, and other matters{{ FIELD }}Representing trader in connection with CFTC inquiry into potential insider trading{{ FIELD }}Andrew Michaelson is an accomplished former prosecutor who has advised global financial institutions, Fortune 100 companies, hedge funds, and senior executives in high-stakes investigations and related civil litigation.  Andrew has secured declinations, favorable settlements, and litigation victories in a wide range of white-collar and securities-related matters.  He has deep experience in trading and markets and is co-head of the firm’s Fintech Working Group, with several notable representations concerning the development of digital asset and blockchain technology. \nChambers USA has noted that Andrew is “increasingly recognized” for his work defending “companies and individuals alike” in white collar and government investigations in New York. According to Chambers, clients described Andrew as “incredibly smart and understated,” and “very, very knowledgeable on regulatory matters.” He has appeared on 60 Minutes to discuss insider trading, and his prior work as a federal prosecutor was profiled in the Wall Street Journal and The New Yorker.\nAndrew previously served in government with the SEC, Division of Enforcement, and with the U.S. Attorney’s Office for the Southern District of New York, where he led the Galleon insider trading investigation and prosecuted numerous securities and wire fraud cases. He served as trial counsel in U.S. v. Rajaratnam, the high-profile criminal trial resulting in the conviction of Raj Rajaratnam. Andrew has spoken about the Galleon case and federal securities law enforcement at Harvard Law School and the NYU School of Law.\n  Andrew Michaelson lawyer Partner Top Ranked Lawyer: White-Collar Crime \u0026amp; Government Investigations Chambers USA, New York (2019-2022) Named Up and Coming Practitioner Chambers (2019) Named New York-Metro Super Lawyer  Super Lawyers (2013-2015, 2017-2019) Named to 500 Leading Lawyers in America Lawdragon Princeton University  Harvard University Harvard Law School New York Law Clerk, Hon. Sarah S. Vance, U.S. District Court for the Eastern District of Louisiana Digital Assets / Cryptocurrencies\nRepresenting Ripple Labs in connection with class action litigation, in multiple federal courts across the country, concerning whether Ripple’s distributions of XRP constitute “investment contracts” subject to regulation under federal securities laws. Advising major financial institution on application of federal banking laws and regulations to state-chartered banks and trust companies affiliated with cryptocurrency exchanges or otherwise focused on digital assets. Representing major hedge fund in connection with internal review of trading in digital assets, to ensure compliance with federal laws and regulation. Securities/Commodities/Unfair Trade Practices\nRepresenting HSBC in investigations and civil litigation relating to issuance of subprime RMBS, obtaining favorable settlements of DOJ investigation under FIRREA and civil claims asserted by FHFA Representing HSBC in connection with a variety of regulatory investigations by the SEC and/or State AGs Representing BNP Paribas in connection with the successful recovery of nearly $150 million from an SEC Fair Fund distribution Representing a financial services company in connection with CFPB investigation relating to fee disclosures and data security Representing Barclays in investigations relating to ISDAFIX, obtaining favorable settlement with CFTC and civil plaintiffs Representing a major ride hailing company in connection with investigations by State AGs relating to representations to investors, resulting in no action Representing a substantial hedge fund (\u0026gt;$20 billion in AUM) and its CEO in connection with SEC insider trading investigation, resulting in no action Representing Barclays in connection with CFTC investigation into potential insider trading, resulting in no action Representing a public, Silicon Valley-based Fintech company in connection with investigation by a State Attorney General concerning app-based securities trading. Corruption/FCPA\nRepresenting NIKE in connection with DOJ investigation into corruption in NCAA basketball Representing a Fortune 100 company in connection with DOJ investigation relating to bribery in South America, Africa, Asia, Europe, the Middle East and the U.S. Antitrust\nRepresenting ValueAct in connection with an unprecedented antitrust litigation filed by the DOJ relating to Hart-Scott-Rodino’s “Investment-Only Exemption” Representing Target Corp. in connection with opt-out antitrust litigation relating to a price-fixing in packaged seafood industry Data Privacy\nRepresenting a Fortune 100, Silicon Valley-based technology company in connection with an internal inquiry relating to data privacy controls Individuals\nRepresenting president of public company in connection with SEC investigation into public representations regarding foreign operations Representing CEO in connection with SEC investigation into accounting of purchases and sales of data Representing executive in connection with SEC FCPA investigation involving Russia, Turkey and Brazil Representing CEO in connection with internal investigation by the Board of Directors Representing numerous traders in connection with SEC and internal investigations relating to FX trading, pre-release ADRs, and other matters Representing trader in connection with CFTC inquiry into potential insider trading","searchable_name":"Andrew Michaelson","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":442801,"version":1,"owner_type":"Person","owner_id":5630,"payload":{"bio":"\u003cp\u003eGenevi\u0026egrave;ve Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\u003c/p\u003e\n\u003cp\u003eRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Genevi\u0026egrave;ve assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve\u0026rsquo;s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\u003c/p\u003e\n\u003cp\u003eShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 2019, \u0026ldquo;Are the paediatric rewards adapted? \u0026ldquo;, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\u003c/li\u003e\n\u003cli\u003eMay 30, 2019, \u0026ldquo;The regulation of advanced therapy medicinal products\u0026rdquo;\u0026nbsp;\u003cem\u003eLexisNexis.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2017, \u0026ldquo;Pediatric Regulation \u0026ndash; A Better application for more efficient incentives,\u0026rdquo;\u0026nbsp;\u003cem\u003eThe European Files, Medicines of the Future.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eSeptember 2016, \u0026ldquo;Should Anthroposophic Medicinal Products Be Regulated in Europe?\u0026rdquo;\u0026nbsp;\u003cem\u003eJournal of European Health Law\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJune 8, 2016, \u0026ldquo;Demonstrating Significant Benefit For Orphan Medicines \u0026ndash; Is It Time For A Drastic Change?\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;EU Pediatric Rewards \u0026ndash; More Questions than Answers,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eFebruary 2016, \u0026ldquo;The Need For Clarification On Post-Market Requirements For Pediatric Medicines,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSeptember 9, 2019, \u0026ldquo;\u003cem\u003eSummary of Key EUCJ Decisions\u003c/em\u003e,\u0026rdquo; European Pharmaceutical Law Academy.\u003c/li\u003e\n\u003cli\u003eJune 5, 2019, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eSeptember 10, 2018, \u0026ldquo;ATMP Regulatory Framework\u003cem\u003e,\u0026rdquo;\u0026nbsp;\u003c/em\u003eEuropean Pharmaceutical Law Academy, Cambridge, UK.\u003c/li\u003e\n\u003cli\u003eJune 2018, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eMay 15, 2018, \u0026ldquo;International Labeling Regulatory Requirements,\u0026rdquo; co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\u003c/li\u003e\n\u003cli\u003eMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\u003c/li\u003e\n\u003cli\u003eMarch 2018, ATMPs \u0026ndash; Challenges and Promises, ERA, EU Pharmaceutical Law.\u003c/li\u003e\n\u003cli\u003eNovember 2017, Borderline issues, Congr\u0026egrave;s Parfums \u0026amp; Cosm\u0026eacute;tiques, Enjeux r\u0026eacute;glementaires, Chartres.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\u003c/li\u003e\n\u003cli\u003eJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\u003c/li\u003e\n\u003cli\u003eMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\u003c/li\u003e\n\u003cli\u003eNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Protection for Mature Product,\u0026rdquo; DIA, 28th Annual EuroMeeting, Hamburg.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Interactions between regulatory and intellectual property, product liability and data privacy,\u0026rdquo; DIA, 28th Annual EuroMeeting in Hamburg.\u003c/li\u003e\n\u003c/ul\u003e","slug":"genevieve-michaux","email":"gmichaux@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":1,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":5,"source":"capabilities"},{"id":780,"guid":"780.smart_tags","index":6,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":7,"source":"smartTags"},{"id":970,"guid":"970.smart_tags","index":8,"source":"smartTags"},{"id":112,"guid":"112.capabilities","index":9,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":10,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":11,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":12,"source":"smartTags"},{"id":128,"guid":"128.capabilities","index":13,"source":"capabilities"}],"is_active":true,"last_name":"Michaux","nick_name":"Geneviève","clerkships":[],"first_name":"Geneviève","title_rank":9999,"updated_by":101,"law_schools":[{"id":824,"meta":{"degree":"Law Degree","honors":null,"is_law_school":1,"graduation_date":"1996-01-01 00:00:00 UTC"},"order":0,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Ranked in the Regulatory Practice","detail":"Best Lawyers Belgium, 2022"},{"title":"Global Elite Thought Leaders EMEA","detail":"WWL Life Sciences Report, 2022"},{"title":"Who's Who Legal, Life Sciences","detail":"2011–2022"},{"title":"Excellent in Healthcare, pharmaceuticals \u0026 biotech","detail":"Leadersleague Décideurs Belgium Life Sciences guide, 2021"},{"title":"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology","detail":"2012"},{"title":"PLC Which Lawyer?, Life Sciences","detail":"Regulatory, EU, 2012"},{"title":"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study","detail":"1988"}],"linked_in_url":"https://www.linkedin.com/in/geneviève-michaux-165829/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eGenevi\u0026egrave;ve Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\u003c/p\u003e\n\u003cp\u003eRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Genevi\u0026egrave;ve assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve\u0026rsquo;s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\u003c/p\u003e\n\u003cp\u003eShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 2019, \u0026ldquo;Are the paediatric rewards adapted? \u0026ldquo;, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\u003c/li\u003e\n\u003cli\u003eMay 30, 2019, \u0026ldquo;The regulation of advanced therapy medicinal products\u0026rdquo;\u0026nbsp;\u003cem\u003eLexisNexis.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2017, \u0026ldquo;Pediatric Regulation \u0026ndash; A Better application for more efficient incentives,\u0026rdquo;\u0026nbsp;\u003cem\u003eThe European Files, Medicines of the Future.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eSeptember 2016, \u0026ldquo;Should Anthroposophic Medicinal Products Be Regulated in Europe?\u0026rdquo;\u0026nbsp;\u003cem\u003eJournal of European Health Law\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJune 8, 2016, \u0026ldquo;Demonstrating Significant Benefit For Orphan Medicines \u0026ndash; Is It Time For A Drastic Change?\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;EU Pediatric Rewards \u0026ndash; More Questions than Answers,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eFebruary 2016, \u0026ldquo;The Need For Clarification On Post-Market Requirements For Pediatric Medicines,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSeptember 9, 2019, \u0026ldquo;\u003cem\u003eSummary of Key EUCJ Decisions\u003c/em\u003e,\u0026rdquo; European Pharmaceutical Law Academy.\u003c/li\u003e\n\u003cli\u003eJune 5, 2019, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eSeptember 10, 2018, \u0026ldquo;ATMP Regulatory Framework\u003cem\u003e,\u0026rdquo;\u0026nbsp;\u003c/em\u003eEuropean Pharmaceutical Law Academy, Cambridge, UK.\u003c/li\u003e\n\u003cli\u003eJune 2018, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eMay 15, 2018, \u0026ldquo;International Labeling Regulatory Requirements,\u0026rdquo; co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\u003c/li\u003e\n\u003cli\u003eMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\u003c/li\u003e\n\u003cli\u003eMarch 2018, ATMPs \u0026ndash; Challenges and Promises, ERA, EU Pharmaceutical Law.\u003c/li\u003e\n\u003cli\u003eNovember 2017, Borderline issues, Congr\u0026egrave;s Parfums \u0026amp; Cosm\u0026eacute;tiques, Enjeux r\u0026eacute;glementaires, Chartres.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\u003c/li\u003e\n\u003cli\u003eJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\u003c/li\u003e\n\u003cli\u003eMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\u003c/li\u003e\n\u003cli\u003eNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Protection for Mature Product,\u0026rdquo; DIA, 28th Annual EuroMeeting, Hamburg.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Interactions between regulatory and intellectual property, product liability and data privacy,\u0026rdquo; DIA, 28th Annual EuroMeeting in Hamburg.\u003c/li\u003e\n\u003c/ul\u003e","recognitions":[{"title":"Ranked in the Regulatory Practice","detail":"Best Lawyers Belgium, 2022"},{"title":"Global Elite Thought Leaders EMEA","detail":"WWL Life Sciences Report, 2022"},{"title":"Who's Who Legal, Life Sciences","detail":"2011–2022"},{"title":"Excellent in Healthcare, pharmaceuticals \u0026 biotech","detail":"Leadersleague Décideurs Belgium Life Sciences guide, 2021"},{"title":"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology","detail":"2012"},{"title":"PLC Which Lawyer?, Life Sciences","detail":"Regulatory, EU, 2012"},{"title":"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study","detail":"1988"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":8884}]},"capability_group_id":2},"created_at":"2025-11-13T04:57:39.000Z","updated_at":"2025-11-13T04:57:39.000Z","searchable_text":"Michaux{{ FIELD }}{:title=\u0026gt;\"Ranked in the Regulatory Practice\", :detail=\u0026gt;\"Best Lawyers Belgium, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Global Elite Thought Leaders EMEA\", :detail=\u0026gt;\"WWL Life Sciences Report, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Who's Who Legal, Life Sciences\", :detail=\u0026gt;\"2011–2022\"}{{ FIELD }}{:title=\u0026gt;\"Excellent in Healthcare, pharmaceuticals \u0026amp; biotech\", :detail=\u0026gt;\"Leadersleague Décideurs Belgium Life Sciences guide, 2021\"}{{ FIELD }}{:title=\u0026gt;\"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology\", :detail=\u0026gt;\"2012\"}{{ FIELD }}{:title=\u0026gt;\"PLC Which Lawyer?, Life Sciences\", :detail=\u0026gt;\"Regulatory, EU, 2012\"}{{ FIELD }}{:title=\u0026gt;\"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study\", :detail=\u0026gt;\"1988\"}{{ FIELD }}Geneviève Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\nRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.\nGeneviève’s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\nShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\nGeneviève has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\nGeneviève is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\nPublications\n\nOctober 2019, “Are the paediatric rewards adapted? “, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\nMay 30, 2019, “The regulation of advanced therapy medicinal products” LexisNexis.\nApril 2017, “Pediatric Regulation – A Better application for more efficient incentives,” The European Files, Medicines of the Future.\nSeptember 2016, “Should Anthroposophic Medicinal Products Be Regulated in Europe?” Journal of European Health Law\nJune 8, 2016, “Demonstrating Significant Benefit For Orphan Medicines – Is It Time For A Drastic Change?” Scrip Regulatory Affairs.\nApril 2016, “EU Pediatric Rewards – More Questions than Answers,” Scrip Regulatory Affairs.\nFebruary 2016, “The Need For Clarification On Post-Market Requirements For Pediatric Medicines,” Scrip Regulatory Affairs.\n\nSpeaking Engagements\n\nSeptember 9, 2019, “Summary of Key EUCJ Decisions,” European Pharmaceutical Law Academy.\nJune 5, 2019, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.\nSeptember 10, 2018, “ATMP Regulatory Framework,” European Pharmaceutical Law Academy, Cambridge, UK.\nJune 2018, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.\nMay 15, 2018, “International Labeling Regulatory Requirements,” co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\nMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\nMarch 2018, ATMPs – Challenges and Promises, ERA, EU Pharmaceutical Law.\nNovember 2017, Borderline issues, Congrès Parfums \u0026amp; Cosmétiques, Enjeux réglementaires, Chartres.\nSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\nSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\nJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London. \nMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\nMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\nNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\nApril 2016, “Protection for Mature Product,” DIA, 28th Annual EuroMeeting, Hamburg.\nApril 2016, “Interactions between regulatory and intellectual property, product liability and data privacy,” DIA, 28th Annual EuroMeeting in Hamburg.\n Partner Ranked in the Regulatory Practice Best Lawyers Belgium, 2022 Global Elite Thought Leaders EMEA WWL Life Sciences Report, 2022 Who's Who Legal, Life Sciences 2011–2022 Excellent in Healthcare, pharmaceuticals \u0026amp; biotech Leadersleague Décideurs Belgium Life Sciences guide, 2021 Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology 2012 PLC Which Lawyer?, Life Sciences Regulatory, EU, 2012 de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study 1988 Harvard University Harvard Law School Universite Libre de Bruxelles, Belgium  Paris Brussels Member of the editorial board of SCRIP Regulatory Affairs Mediator with the Brussels Business Mediation Center Member of the DIA Advisory Committee for Europe Middle East Africa Foreign Correspondent Member of the National Academy of Pharmacy (France)","searchable_name":"Geneviève Michaux","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":430199,"version":1,"owner_type":"Person","owner_id":2057,"payload":{"bio":"\u003cp\u003ePatrick Montgomery represents global financial institutions and public companies in high-risk government and internal investigations and complex litigation. In particular, Patrick defends clients in the financial services, accounting, technology, and manufacturing sectors in white-collar criminal matters, SEC enforcement actions, and securities and shareholder litigation.\u0026nbsp;\u0026nbsp; He has extensive experience counseling clients facing investigations before the U.S. Department of Justice, Securities and Exchange Commission, State Attorneys General and other regulatory authorities.\u003c/p\u003e\n\u003cp\u003ePatrick also serves (pro bono) as General Counsel for the Ethics \u0026amp; Compliance Initiative, a non-profit organization committed to assisting public companies and other institutions in creating and sustaining high quality\u0026nbsp;ethics and compliance\u0026nbsp;programs throughout the world.\u003c/p\u003e\n\u003cp\u003eAdditionally, Patrick serves as the Deputy Co-head of King \u0026amp; Spalding's Financial Services industry team.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePatrick is recognized in\u0026nbsp;\u003cem\u003eLegal 500\u0026nbsp;\u003c/em\u003efor his work in Antitrust: Civil Litigation/Class Actions.\u003c/p\u003e\n\u003cp\u003eHe started his career as an associate at King \u0026amp; Spalding before practicing for eight years at another AmLaw 50 law firm.\u003c/p\u003e\n\u003cp\u003eAfter graduating from law school, Patrick clerked for the Honorable Jane R. Roth on the United States Court of Appeals for the Third Circuit.\u003c/p\u003e","slug":"patrick-montgomery","email":"pmontgomery@kslaw.com","phone":null,"matters":["\u003cp\u003eRepresenting a leading defense contractor in connection with a False Claims Act investigation.\u003c/p\u003e","\u003cp\u003eRepresenting a global financial institution in connection with a grand jury subpoena.\u003c/p\u003e","\u003cp\u003eRepresenting a Big Four accounting firm in investigations and securities litigation resulting from the sudden closure of several banks for which the firm acted as external auditor.\u003c/p\u003e","\u003cp\u003e\u003cem\u003eGovernment \u0026amp; Internal Investigation Matters\u003c/em\u003e\u003c/p\u003e","\u003cp\u003eCounsel to financial institution in Massachusetts Attorney General investigation into certain practices related to collateralized loan obligations (CLO)\u003c/p\u003e","\u003cp\u003eCounsel to global financial institution in investigations being conducted by numerous domestic and foreign regulatory authorities involving the benchmark WM/Reuters currency exchange rate\u003c/p\u003e","\u003cp\u003eCounsel to public company in an SEC investigation into potential accounting and disclosure violations related to revenue recognition\u003c/p\u003e","\u003cp\u003eCounsel to leading accounting firm in an SEC investigation into potential accounting misconduct by one of its financial institution audit clients, and possible associated audit failures\u003c/p\u003e","\u003cp\u003eCounsel to public company in an SEC investigation into possible insider trading arising from a corporate takeover\u003c/p\u003e","\u003cp\u003eCounsel to global financial institution in NYSE investigation into certain trading practices\u003c/p\u003e","\u003cp\u003eCounsel to collateral manager of a leading fixed-income asset manager in an SEC investigation into sales practices relating to asset-backed and synthetic collateralized debt obligations (CDO) and associated credit default swaps\u003c/p\u003e","\u003cp\u003eCounsel to publicly-traded company's board of directors in connection with FCPA-related internal investigations and government enforcement actions involving the U.S. Department of Justice and the SEC\u003c/p\u003e","\u003cp\u003eCounsel to private equity firm and its senior executives in an SEC investigation into potential breach of fiduciary duty, self-dealing and related-party transactions\u003c/p\u003e","\u003cp\u003e\u003cem\u003eLitigation Matters\u003c/em\u003e\u003c/p\u003e","\u003cp\u003eDefeated class certification on behalf of global financial institution in action brought in the U.S. District Court for the Southern District of New York alleging the client delayed execution of e-Trading foreign exchange orders to take advantage of market movements in its favor\u003c/p\u003e","\u003cp\u003eRepresenting a global bank in connection with alleged fraudulent transfer claims in connection with the Bernard Madoff SIPA proceedings (S.D.N.Y.)\u003c/p\u003e","\u003cp\u003eSuccessfully resolved dispute on behalf of group of investors in Delaware Chancery Court against allegations of breaches of fiduciary duty of disclosure and loyalty in connection with all-cash acquisition\u003c/p\u003e","\u003cp\u003eCounsel to global financial institution in federal antitrust class actions alleging that foreign currency dealers conspired to manipulate the benchmark WM/Reuters currency exchange rate. Three of the putative class actions were dismissed and one was voluntarily discontinued after pre-motion conference\u003c/p\u003e","\u003cp\u003eRepresenting a global financial institution in connection with multiple putative class actions asserting antitrust, RICO, CEA and common law claims based on alleged manipulation of USD LIBOR, Yen LIBOR, the Singapore Interbank Offered Rate, and the Australian Bank Bill Swap Rate\u003c/p\u003e","\u003cp\u003eRepresented CEO of Fortune 10 company in securities class action, shareholder derivative litigation and Delaware Section 220 books and records action\u003c/p\u003e","\u003cp\u003eCounsel to newly public technology company and its officers and directors in defense of dozens of securities class actions and shareholder derivative lawsuits in courts around the country following one of the largest initial public offerings in history\u003c/p\u003e","\u003cp\u003eWon summary judgment on behalf of leading private equity firm in defense of putative class action alleging failure to provide sixty-day notice of a mass layoff under the Federal and New Jersey WARN Acts. Trial court order affirmed by the U.S. Court of Appeals for the Third Circuit\u003c/p\u003e","\u003cp\u003eDefense of automotive headlight manufacturer in suit claiming false advertising, fraud and misrepresentation in connection with promotional materials and packaging for certain headlight brands\u003c/p\u003e","\u003cp\u003eCounsel to global financial institution in New York state court proceeding alleging breach of contract and related claims arising from a real estate lending transaction\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":74,"guid":"74.capabilities","index":1,"source":"capabilities"},{"id":20,"guid":"20.capabilities","index":2,"source":"capabilities"},{"id":1,"guid":"1.capabilities","index":3,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":4,"source":"capabilities"},{"id":766,"guid":"766.smart_tags","index":5,"source":"smartTags"},{"id":780,"guid":"780.smart_tags","index":6,"source":"smartTags"},{"id":699,"guid":"699.smart_tags","index":7,"source":"smartTags"},{"id":19,"guid":"19.capabilities","index":8,"source":"capabilities"},{"id":3,"guid":"3.capabilities","index":9,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":10,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":11,"source":"smartTags"},{"id":1165,"guid":"1165.smart_tags","index":12,"source":"smartTags"},{"id":122,"guid":"122.capabilities","index":13,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":14,"source":"capabilities"},{"id":1188,"guid":"1188.smart_tags","index":15,"source":"smartTags"},{"id":1197,"guid":"1197.smart_tags","index":16,"source":"smartTags"},{"id":1199,"guid":"1199.smart_tags","index":17,"source":"smartTags"},{"id":128,"guid":"128.capabilities","index":18,"source":"capabilities"},{"id":1261,"guid":"1261.smart_tags","index":19,"source":"smartTags"},{"id":803,"guid":"803.smart_tags","index":20,"source":"smartTags"},{"id":1248,"guid":"1248.smart_tags","index":21,"source":"smartTags"},{"id":129,"guid":"129.capabilities","index":22,"source":"capabilities"}],"is_active":true,"last_name":"Montgomery","nick_name":"Patrick","clerkships":[{"name":"Law Clerk, Hon. Jane R. Roth, U.S. Court of Appeals for the Third Circuit","years_held":"2011 - 2011"}],"first_name":"Patrick","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Patrick is recognized for his work in Corporate investigations and white-collar criminal defense: advice to corporates","detail":"Legal 500 USA 2024"},{"title":"Patrick has also been recognized in Legal 500 for his work in Antitrust: Civil Litigation/Class Actions","detail":"Legal 500"}],"linked_in_url":"https://www.linkedin.com/in/patrick-montgomery-4928ab5/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003ePatrick Montgomery represents global financial institutions and public companies in high-risk government and internal investigations and complex litigation. In particular, Patrick defends clients in the financial services, accounting, technology, and manufacturing sectors in white-collar criminal matters, SEC enforcement actions, and securities and shareholder litigation.\u0026nbsp;\u0026nbsp; He has extensive experience counseling clients facing investigations before the U.S. Department of Justice, Securities and Exchange Commission, State Attorneys General and other regulatory authorities.\u003c/p\u003e\n\u003cp\u003ePatrick also serves (pro bono) as General Counsel for the Ethics \u0026amp; Compliance Initiative, a non-profit organization committed to assisting public companies and other institutions in creating and sustaining high quality\u0026nbsp;ethics and compliance\u0026nbsp;programs throughout the world.\u003c/p\u003e\n\u003cp\u003eAdditionally, Patrick serves as the Deputy Co-head of King \u0026amp; Spalding's Financial Services industry team.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePatrick is recognized in\u0026nbsp;\u003cem\u003eLegal 500\u0026nbsp;\u003c/em\u003efor his work in Antitrust: Civil Litigation/Class Actions.\u003c/p\u003e\n\u003cp\u003eHe started his career as an associate at King \u0026amp; Spalding before practicing for eight years at another AmLaw 50 law firm.\u003c/p\u003e\n\u003cp\u003eAfter graduating from law school, Patrick clerked for the Honorable Jane R. Roth on the United States Court of Appeals for the Third Circuit.\u003c/p\u003e","matters":["\u003cp\u003eRepresenting a leading defense contractor in connection with a False Claims Act investigation.\u003c/p\u003e","\u003cp\u003eRepresenting a global financial institution in connection with a grand jury subpoena.\u003c/p\u003e","\u003cp\u003eRepresenting a Big Four accounting firm in investigations and securities litigation resulting from the sudden closure of several banks for which the firm acted as external auditor.\u003c/p\u003e","\u003cp\u003e\u003cem\u003eGovernment \u0026amp; Internal Investigation Matters\u003c/em\u003e\u003c/p\u003e","\u003cp\u003eCounsel to financial institution in Massachusetts Attorney General investigation into certain practices related to collateralized loan obligations (CLO)\u003c/p\u003e","\u003cp\u003eCounsel to global financial institution in investigations being conducted by numerous domestic and foreign regulatory authorities involving the benchmark WM/Reuters currency exchange rate\u003c/p\u003e","\u003cp\u003eCounsel to public company in an SEC investigation into potential accounting and disclosure violations related to revenue recognition\u003c/p\u003e","\u003cp\u003eCounsel to leading accounting firm in an SEC investigation into potential accounting misconduct by one of its financial institution audit clients, and possible associated audit failures\u003c/p\u003e","\u003cp\u003eCounsel to public company in an SEC investigation into possible insider trading arising from a corporate takeover\u003c/p\u003e","\u003cp\u003eCounsel to global financial institution in NYSE investigation into certain trading practices\u003c/p\u003e","\u003cp\u003eCounsel to collateral manager of a leading fixed-income asset manager in an SEC investigation into sales practices relating to asset-backed and synthetic collateralized debt obligations (CDO) and associated credit default swaps\u003c/p\u003e","\u003cp\u003eCounsel to publicly-traded company's board of directors in connection with FCPA-related internal investigations and government enforcement actions involving the U.S. Department of Justice and the SEC\u003c/p\u003e","\u003cp\u003eCounsel to private equity firm and its senior executives in an SEC investigation into potential breach of fiduciary duty, self-dealing and related-party transactions\u003c/p\u003e","\u003cp\u003e\u003cem\u003eLitigation Matters\u003c/em\u003e\u003c/p\u003e","\u003cp\u003eDefeated class certification on behalf of global financial institution in action brought in the U.S. District Court for the Southern District of New York alleging the client delayed execution of e-Trading foreign exchange orders to take advantage of market movements in its favor\u003c/p\u003e","\u003cp\u003eRepresenting a global bank in connection with alleged fraudulent transfer claims in connection with the Bernard Madoff SIPA proceedings (S.D.N.Y.)\u003c/p\u003e","\u003cp\u003eSuccessfully resolved dispute on behalf of group of investors in Delaware Chancery Court against allegations of breaches of fiduciary duty of disclosure and loyalty in connection with all-cash acquisition\u003c/p\u003e","\u003cp\u003eCounsel to global financial institution in federal antitrust class actions alleging that foreign currency dealers conspired to manipulate the benchmark WM/Reuters currency exchange rate. Three of the putative class actions were dismissed and one was voluntarily discontinued after pre-motion conference\u003c/p\u003e","\u003cp\u003eRepresenting a global financial institution in connection with multiple putative class actions asserting antitrust, RICO, CEA and common law claims based on alleged manipulation of USD LIBOR, Yen LIBOR, the Singapore Interbank Offered Rate, and the Australian Bank Bill Swap Rate\u003c/p\u003e","\u003cp\u003eRepresented CEO of Fortune 10 company in securities class action, shareholder derivative litigation and Delaware Section 220 books and records action\u003c/p\u003e","\u003cp\u003eCounsel to newly public technology company and its officers and directors in defense of dozens of securities class actions and shareholder derivative lawsuits in courts around the country following one of the largest initial public offerings in history\u003c/p\u003e","\u003cp\u003eWon summary judgment on behalf of leading private equity firm in defense of putative class action alleging failure to provide sixty-day notice of a mass layoff under the Federal and New Jersey WARN Acts. Trial court order affirmed by the U.S. Court of Appeals for the Third Circuit\u003c/p\u003e","\u003cp\u003eDefense of automotive headlight manufacturer in suit claiming false advertising, fraud and misrepresentation in connection with promotional materials and packaging for certain headlight brands\u003c/p\u003e","\u003cp\u003eCounsel to global financial institution in New York state court proceeding alleging breach of contract and related claims arising from a real estate lending transaction\u003c/p\u003e"],"recognitions":[{"title":"Patrick is recognized for his work in Corporate investigations and white-collar criminal defense: advice to corporates","detail":"Legal 500 USA 2024"},{"title":"Patrick has also been recognized in Legal 500 for his work in Antitrust: Civil Litigation/Class Actions","detail":"Legal 500"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":6186}]},"capability_group_id":2},"created_at":"2025-06-12T20:54:22.000Z","updated_at":"2025-06-12T20:54:22.000Z","searchable_text":"Montgomery{{ FIELD }}{:title=\u0026gt;\"Patrick is recognized for his work in Corporate investigations and white-collar criminal defense: advice to corporates\", :detail=\u0026gt;\"Legal 500 USA 2024\"}{{ FIELD }}{:title=\u0026gt;\"Patrick has also been recognized in Legal 500 for his work in Antitrust: Civil Litigation/Class Actions\", :detail=\u0026gt;\"Legal 500\"}{{ FIELD }}Representing a leading defense contractor in connection with a False Claims Act investigation.{{ FIELD }}Representing a global financial institution in connection with a grand jury subpoena.{{ FIELD }}Representing a Big Four accounting firm in investigations and securities litigation resulting from the sudden closure of several banks for which the firm acted as external auditor.{{ FIELD }}Government \u0026amp; Internal Investigation Matters{{ FIELD }}Counsel to financial institution in Massachusetts Attorney General investigation into certain practices related to collateralized loan obligations (CLO){{ FIELD }}Counsel to global financial institution in investigations being conducted by numerous domestic and foreign regulatory authorities involving the benchmark WM/Reuters currency exchange rate{{ FIELD }}Counsel to public company in an SEC investigation into potential accounting and disclosure violations related to revenue recognition{{ FIELD }}Counsel to leading accounting firm in an SEC investigation into potential accounting misconduct by one of its financial institution audit clients, and possible associated audit failures{{ FIELD }}Counsel to public company in an SEC investigation into possible insider trading arising from a corporate takeover{{ FIELD }}Counsel to global financial institution in NYSE investigation into certain trading practices{{ FIELD }}Counsel to collateral manager of a leading fixed-income asset manager in an SEC investigation into sales practices relating to asset-backed and synthetic collateralized debt obligations (CDO) and associated credit default swaps{{ FIELD }}Counsel to publicly-traded company's board of directors in connection with FCPA-related internal investigations and government enforcement actions involving the U.S. Department of Justice and the SEC{{ FIELD }}Counsel to private equity firm and its senior executives in an SEC investigation into potential breach of fiduciary duty, self-dealing and related-party transactions{{ FIELD }}Litigation Matters{{ FIELD }}Defeated class certification on behalf of global financial institution in action brought in the U.S. District Court for the Southern District of New York alleging the client delayed execution of e-Trading foreign exchange orders to take advantage of market movements in its favor{{ FIELD }}Representing a global bank in connection with alleged fraudulent transfer claims in connection with the Bernard Madoff SIPA proceedings (S.D.N.Y.){{ FIELD }}Successfully resolved dispute on behalf of group of investors in Delaware Chancery Court against allegations of breaches of fiduciary duty of disclosure and loyalty in connection with all-cash acquisition{{ FIELD }}Counsel to global financial institution in federal antitrust class actions alleging that foreign currency dealers conspired to manipulate the benchmark WM/Reuters currency exchange rate. Three of the putative class actions were dismissed and one was voluntarily discontinued after pre-motion conference{{ FIELD }}Representing a global financial institution in connection with multiple putative class actions asserting antitrust, RICO, CEA and common law claims based on alleged manipulation of USD LIBOR, Yen LIBOR, the Singapore Interbank Offered Rate, and the Australian Bank Bill Swap Rate{{ FIELD }}Represented CEO of Fortune 10 company in securities class action, shareholder derivative litigation and Delaware Section 220 books and records action{{ FIELD }}Counsel to newly public technology company and its officers and directors in defense of dozens of securities class actions and shareholder derivative lawsuits in courts around the country following one of the largest initial public offerings in history{{ FIELD }}Won summary judgment on behalf of leading private equity firm in defense of putative class action alleging failure to provide sixty-day notice of a mass layoff under the Federal and New Jersey WARN Acts. Trial court order affirmed by the U.S. Court of Appeals for the Third Circuit{{ FIELD }}Defense of automotive headlight manufacturer in suit claiming false advertising, fraud and misrepresentation in connection with promotional materials and packaging for certain headlight brands{{ FIELD }}Counsel to global financial institution in New York state court proceeding alleging breach of contract and related claims arising from a real estate lending transaction{{ FIELD }}Patrick Montgomery represents global financial institutions and public companies in high-risk government and internal investigations and complex litigation. In particular, Patrick defends clients in the financial services, accounting, technology, and manufacturing sectors in white-collar criminal matters, SEC enforcement actions, and securities and shareholder litigation.   He has extensive experience counseling clients facing investigations before the U.S. Department of Justice, Securities and Exchange Commission, State Attorneys General and other regulatory authorities.\nPatrick also serves (pro bono) as General Counsel for the Ethics \u0026amp; Compliance Initiative, a non-profit organization committed to assisting public companies and other institutions in creating and sustaining high quality ethics and compliance programs throughout the world.\nAdditionally, Patrick serves as the Deputy Co-head of King \u0026amp; Spalding's Financial Services industry team.\nPatrick is recognized in Legal 500 for his work in Antitrust: Civil Litigation/Class Actions.\nHe started his career as an associate at King \u0026amp; Spalding before practicing for eight years at another AmLaw 50 law firm.\nAfter graduating from law school, Patrick clerked for the Honorable Jane R. Roth on the United States Court of Appeals for the Third Circuit. Partner Patrick is recognized for his work in Corporate investigations and white-collar criminal defense: advice to corporates Legal 500 USA 2024 Patrick has also been recognized in Legal 500 for his work in Antitrust: Civil Litigation/Class Actions Legal 500 College of the Holy Cross  Georgetown University Georgetown University Law Center U.S. Court of Appeals for the Third Circuit U.S. District Court for the Southern District of New York U.S. District Court for the Northern District of Georgia U.S. District Court for the District of Columbia District of Columbia Georgia Court of Appeals of Georgia Law Clerk, Hon. Jane R. Roth, U.S. Court of Appeals for the Third Circuit Representing a leading defense contractor in connection with a False Claims Act investigation. Representing a global financial institution in connection with a grand jury subpoena. Representing a Big Four accounting firm in investigations and securities litigation resulting from the sudden closure of several banks for which the firm acted as external auditor. Government \u0026amp; Internal Investigation Matters Counsel to financial institution in Massachusetts Attorney General investigation into certain practices related to collateralized loan obligations (CLO) Counsel to global financial institution in investigations being conducted by numerous domestic and foreign regulatory authorities involving the benchmark WM/Reuters currency exchange rate Counsel to public company in an SEC investigation into potential accounting and disclosure violations related to revenue recognition Counsel to leading accounting firm in an SEC investigation into potential accounting misconduct by one of its financial institution audit clients, and possible associated audit failures Counsel to public company in an SEC investigation into possible insider trading arising from a corporate takeover Counsel to global financial institution in NYSE investigation into certain trading practices Counsel to collateral manager of a leading fixed-income asset manager in an SEC investigation into sales practices relating to asset-backed and synthetic collateralized debt obligations (CDO) and associated credit default swaps Counsel to publicly-traded company's board of directors in connection with FCPA-related internal investigations and government enforcement actions involving the U.S. Department of Justice and the SEC Counsel to private equity firm and its senior executives in an SEC investigation into potential breach of fiduciary duty, self-dealing and related-party transactions Litigation Matters Defeated class certification on behalf of global financial institution in action brought in the U.S. District Court for the Southern District of New York alleging the client delayed execution of e-Trading foreign exchange orders to take advantage of market movements in its favor Representing a global bank in connection with alleged fraudulent transfer claims in connection with the Bernard Madoff SIPA proceedings (S.D.N.Y.) Successfully resolved dispute on behalf of group of investors in Delaware Chancery Court against allegations of breaches of fiduciary duty of disclosure and loyalty in connection with all-cash acquisition Counsel to global financial institution in federal antitrust class actions alleging that foreign currency dealers conspired to manipulate the benchmark WM/Reuters currency exchange rate. Three of the putative class actions were dismissed and one was voluntarily discontinued after pre-motion conference Representing a global financial institution in connection with multiple putative class actions asserting antitrust, RICO, CEA and common law claims based on alleged manipulation of USD LIBOR, Yen LIBOR, the Singapore Interbank Offered Rate, and the Australian Bank Bill Swap Rate Represented CEO of Fortune 10 company in securities class action, shareholder derivative litigation and Delaware Section 220 books and records action Counsel to newly public technology company and its officers and directors in defense of dozens of securities class actions and shareholder derivative lawsuits in courts around the country following one of the largest initial public offerings in history Won summary judgment on behalf of leading private equity firm in defense of putative class action alleging failure to provide sixty-day notice of a mass layoff under the Federal and New Jersey WARN Acts. Trial court order affirmed by the U.S. Court of Appeals for the Third Circuit Defense of automotive headlight manufacturer in suit claiming false advertising, fraud and misrepresentation in connection with promotional materials and packaging for certain headlight brands Counsel to global financial institution in New York state court proceeding alleging breach of contract and related claims arising from a real estate lending transaction","searchable_name":"Patrick Montgomery","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":424306,"version":1,"owner_type":"Person","owner_id":7087,"payload":{"bio":"\u003cp\u003eA partner on the Special Matters \u0026amp; Government Investigations team, Pat Murphy leverages over two decades of high-level in-house and public sector experience to provide strategic solutions for clients. He focuses on high profile corporate internal investigations, complex litigation, enforcement actions and compliance matters, particularly for clients in the pharmaceutical, medical device, and broader life sciences sectors. He is recognized as a trusted advisor to boards, senior executives and legal teams for his work in internal investigations, particularly the Anti-Kickback Statute, False Claims Act, the Foreign Corrupt Practices Act and global crisis management. Pat rejoined King \u0026amp; Spalding after serving in senior legal leadership roles at two major healthcare companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePat is a 20 year veteran of the General Electric legal department where he spent 5 years in the Corporate Litigation group and nearly 15 years as GE Healthcare\u0026rsquo;s Global Chief Litigation Counsel. He has an acute understanding of the challenges and cost pressures facing in-house legal departments. He has a strong background personally handling and managing all aspects of high-profile investigations, is a trusted advisor in the implementation of effective Compliance programs, and the efficient managing of litigation matters. He also has extensive experience directly interfacing with government enforcement authorities worldwide.\u003c/p\u003e\n\u003cp\u003ePat is a leading authority in the structuring, managing and implementing cost effective strategies around Independent Monitorships. Prior to rejoining K\u0026amp;S, Pat served as Global Chief Litigation Counsel to Fresenius Medical Care, the world\u0026rsquo;s largest renal care provider with operations in more than 100 countries. He led the Company through the resolution of a major FCPA matter, including managing the appointment of the DOJ and SEC required Monitorship. In addition, he drove the DOJ and SEC certification of Fresenius\u0026rsquo; effective Compliance program following the implementation of over 100 improvements.\u003c/p\u003e\n\u003cp\u003ePat\u0026rsquo;s public service includes roles as Chief Counsel to the Crime and Technology Unit of the U.S. Senate Judiciary Committee Majority Staff and Assistant General Counsel to the FBI. He was a principal drafter of the Economic Espionage Act and began his legal career as a Judge Advocate in the U.S. Marine Corps, attaining the rank of Major. He later served in the Pentagon as the liaison between the Secretary of Defense\u0026rsquo;s Office and the Solicitor General\u0026rsquo;s Office on terrorism related litigation.\u003c/p\u003e\n\u003cp\u003ePat is also an adjunct professor at Catholic University, where he developed a course on Global In-House Practice. Outside of work, Pat enjoys coaching football and rugby and competing in triathlons.\u003c/p\u003e","slug":"patrick-murphy","email":"pjmurphy@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":3,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":4,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"Murphy","nick_name":"Pat","clerkships":[],"first_name":"Patrick","title_rank":9999,"updated_by":34,"law_schools":[{"id":3010,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"1989-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"J.","name_suffix":"","recognitions":null,"linked_in_url":"https://www.linkedin.com/in/patrick-murphy-2451a99/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eA partner on the Special Matters \u0026amp; Government Investigations team, Pat Murphy leverages over two decades of high-level in-house and public sector experience to provide strategic solutions for clients. He focuses on high profile corporate internal investigations, complex litigation, enforcement actions and compliance matters, particularly for clients in the pharmaceutical, medical device, and broader life sciences sectors. He is recognized as a trusted advisor to boards, senior executives and legal teams for his work in internal investigations, particularly the Anti-Kickback Statute, False Claims Act, the Foreign Corrupt Practices Act and global crisis management. Pat rejoined King \u0026amp; Spalding after serving in senior legal leadership roles at two major healthcare companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePat is a 20 year veteran of the General Electric legal department where he spent 5 years in the Corporate Litigation group and nearly 15 years as GE Healthcare\u0026rsquo;s Global Chief Litigation Counsel. He has an acute understanding of the challenges and cost pressures facing in-house legal departments. He has a strong background personally handling and managing all aspects of high-profile investigations, is a trusted advisor in the implementation of effective Compliance programs, and the efficient managing of litigation matters. He also has extensive experience directly interfacing with government enforcement authorities worldwide.\u003c/p\u003e\n\u003cp\u003ePat is a leading authority in the structuring, managing and implementing cost effective strategies around Independent Monitorships. Prior to rejoining K\u0026amp;S, Pat served as Global Chief Litigation Counsel to Fresenius Medical Care, the world\u0026rsquo;s largest renal care provider with operations in more than 100 countries. He led the Company through the resolution of a major FCPA matter, including managing the appointment of the DOJ and SEC required Monitorship. In addition, he drove the DOJ and SEC certification of Fresenius\u0026rsquo; effective Compliance program following the implementation of over 100 improvements.\u003c/p\u003e\n\u003cp\u003ePat\u0026rsquo;s public service includes roles as Chief Counsel to the Crime and Technology Unit of the U.S. Senate Judiciary Committee Majority Staff and Assistant General Counsel to the FBI. He was a principal drafter of the Economic Espionage Act and began his legal career as a Judge Advocate in the U.S. Marine Corps, attaining the rank of Major. He later served in the Pentagon as the liaison between the Secretary of Defense\u0026rsquo;s Office and the Solicitor General\u0026rsquo;s Office on terrorism related litigation.\u003c/p\u003e\n\u003cp\u003ePat is also an adjunct professor at Catholic University, where he developed a course on Global In-House Practice. Outside of work, Pat enjoys coaching football and rugby and competing in triathlons.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12766}]},"capability_group_id":2},"created_at":"2025-05-16T22:02:33.000Z","updated_at":"2025-05-16T22:02:33.000Z","searchable_text":"Murphy{{ FIELD }}A partner on the Special Matters \u0026amp; Government Investigations team, Pat Murphy leverages over two decades of high-level in-house and public sector experience to provide strategic solutions for clients. He focuses on high profile corporate internal investigations, complex litigation, enforcement actions and compliance matters, particularly for clients in the pharmaceutical, medical device, and broader life sciences sectors. He is recognized as a trusted advisor to boards, senior executives and legal teams for his work in internal investigations, particularly the Anti-Kickback Statute, False Claims Act, the Foreign Corrupt Practices Act and global crisis management. Pat rejoined King \u0026amp; Spalding after serving in senior legal leadership roles at two major healthcare companies.\nPat is a 20 year veteran of the General Electric legal department where he spent 5 years in the Corporate Litigation group and nearly 15 years as GE Healthcare’s Global Chief Litigation Counsel. He has an acute understanding of the challenges and cost pressures facing in-house legal departments. He has a strong background personally handling and managing all aspects of high-profile investigations, is a trusted advisor in the implementation of effective Compliance programs, and the efficient managing of litigation matters. He also has extensive experience directly interfacing with government enforcement authorities worldwide.\nPat is a leading authority in the structuring, managing and implementing cost effective strategies around Independent Monitorships. Prior to rejoining K\u0026amp;S, Pat served as Global Chief Litigation Counsel to Fresenius Medical Care, the world’s largest renal care provider with operations in more than 100 countries. He led the Company through the resolution of a major FCPA matter, including managing the appointment of the DOJ and SEC required Monitorship. In addition, he drove the DOJ and SEC certification of Fresenius’ effective Compliance program following the implementation of over 100 improvements.\nPat’s public service includes roles as Chief Counsel to the Crime and Technology Unit of the U.S. Senate Judiciary Committee Majority Staff and Assistant General Counsel to the FBI. He was a principal drafter of the Economic Espionage Act and began his legal career as a Judge Advocate in the U.S. Marine Corps, attaining the rank of Major. He later served in the Pentagon as the liaison between the Secretary of Defense’s Office and the Solicitor General’s Office on terrorism related litigation.\nPat is also an adjunct professor at Catholic University, where he developed a course on Global In-House Practice. Outside of work, Pat enjoys coaching football and rugby and competing in triathlons. Partner Catholic University of America Columbus School of Law Columbus School of Law, Catholic University of America Columbus School of Law, Catholic University of America District of Columbia","searchable_name":"Patrick J. Murphy (Pat)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":34,"capability_group_featured":null,"home_page_featured":null},{"id":427720,"version":1,"owner_type":"Person","owner_id":180,"payload":{"bio":"\u003cp\u003ePaul Murphy focuses on white-collar criminal defense, investigations and litigation under the False Claims Act, corporate internal investigations, corporate governance and compliance, and national security matters.\u0026nbsp;\u0026nbsp; Paul recently rejoined the firm after serving as the FBI Chief of Staff.\u0026nbsp; Earlier in his career, he held several other leadership roles with the Department of Justice, including as the U. S. Attorney for the Southern District of Georgia.\u0026nbsp; A partner in our Special Matters and Government Investigations practice, Paul represents and advises corporations, boards of directors and board committees as well as executives and other individuals.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith more than 30 years of experience, Paul helps clients navigate their most challenging and sensitive legal situations.\u0026nbsp; Paul has represented numerous clients over the years facing potential exposure on multiple fronts, including federal criminal investigations accompanied by parallel civil, regulatory, or state investigations and related shareholder or other litigation.\u0026nbsp; Paul brings a strategic and integrated approach to these multifaceted legal risks, taking into account both the immediate and longer-term issues confronting the client.\u0026nbsp;\u0026nbsp;\u003cem\u003eChambers USA\u0026nbsp;\u003c/em\u003ehas described Paul as \u0026ldquo;a go-to person for difficult cases.\u0026rdquo;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePaul has represented a wide variety of clients facing high-profile government investigations.\u0026nbsp; He has deep experience with health care fraud investigations, having represented clients across the health care and life sciences sector:\u0026nbsp; hospital systems, pharmaceutical companies, medical device manufacturers, pharmacy providers, dialysis providers, home health care companies, skilled nursing facility chains, and health insurers.\u0026nbsp; Paul also has handled several criminal environmental investigations, including some of the most significant enforcement matters pursued by the Justice Department.\u0026nbsp; In addition, he is experienced with alleged immigration offenses, customs and trade-related violations, tax offenses, securities and bank fraud, violations of the Foreign Corrupt Practices Act (FCPA), and public corruption.\u003c/p\u003e\n\u003cp\u003ePaul also has served as independent counsel to public company boards and board committees, conducting investigations into accounting or disclosure-related allegations or other issues that may implicate senior management.\u0026nbsp; In these matters, as well as others, he routinely advises clients on prospective solutions, including compliance program enhancements or other preventative measures designed to minimize the likelihood of recurrence and the possibility of future enforcement actions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs the Chief of Staff at the Federal Bureau of Investigation, Paul was the primary advisor to FBI Director Christopher Wray and worked closely with him and the senior leadership of the Department of Justice on criminal, national security, and operational issues.\u0026nbsp; From 2001 to 2004, Paul served in several other Department of Justice positions.\u0026nbsp; He was the U.S. Attorney for the Southern District of Georgia, and before that, he worked in Washington, D.C. as Associate Deputy Attorney General and later Chief of Staff to then-Deputy Attorney General Larry Thompson.\u0026nbsp; While on the Deputy Attorney General\u0026rsquo;s staff, he oversaw the Department\u0026rsquo;s criminal and civil health care fraud enforcement program and was the principal policy liaison to the Department of Health and Human Services on enforcement matters.\u0026nbsp; Paul also previously served as an Assistant U.S. Attorney, receiving commendations for his work as a prosecutor from the Attorney General, the FBI, and other federal law enforcement agencies.\u003c/p\u003e\n\u003cp\u003eIn addition to\u0026nbsp;\u003cem\u003eChambers USA\u003c/em\u003e, Paul has been recognized as a leading white-collar criminal defense attorney by several other publications, including\u0026nbsp;\u003cem\u003eThe Best Lawyers in America and Who\u0026rsquo;s Who Legal:\u0026nbsp; Business Crime Defense\u003c/em\u003e.\u0026nbsp; He is a frequent speaker and author on topics related to government investigations and prosecutions.\u003c/p\u003e","slug":"paul-b-murphy","email":"pbmurphy@kslaw.com","phone":null,"matters":["\u003cp\u003eRepresented high-ranking elected state official in highly publicized public corruption investigation by U.S. Attorney\u0026rsquo;s Office and FBI.\u003c/p\u003e","\u003cp\u003eRepresented chief executive officer of aircraft services corporation in investigation by U.S. Attorney\u0026rsquo;s Office and EPA into alleged violations of the Clean Water Act and the Resource Conservation and Recovery Act.\u003c/p\u003e","\u003cp\u003eRepresented chief executive officer of global pharmaceutical and medical device company in investigation by U.S. Attorney\u0026rsquo;s Office, National Security Division of U.S. Department of Justice, and U.S. Department of Treasury\u0026rsquo;s Office of Foreign Asset Controls regarding alleged shipments into embargoed foreign countries.\u003c/p\u003e","\u003cp\u003eRepresented Medicare Administrative Contractor in civil investigation by U.S. Attorney\u0026rsquo;s Office, Civil Division of U.S. Department of Justice, HHS-OIG, and FBI stemming from multiple qui tam complaints focusing on a variety of issues, including the alleged failure to properly enroll Medicare providers.\u003c/p\u003e","\u003cp\u003eRepresented large multi-hospital health system in civil investigation by U.S. Attorney\u0026rsquo;s Office, HHS-OIG, and state Attorney General\u0026rsquo;s Office prompted by multiple qui tam complaints alleging inappropriate admission and outlier charging practices.\u003c/p\u003e","\u003cp\u003eRepresented publicly held chemical manufacturer in criminal investigation by U.S. Attorney\u0026rsquo;s Office, the Environmental Crimes Section at Department of Justice, and EPA into alleged violations of the Clean Water Act and the Resource Conservation and Recovery Act.\u003c/p\u003e","\u003cp\u003eRepresented academic medical center in criminal and civil investigations by U.S. Attorney\u0026rsquo;s Office, HHS-OIG, and FBI related to alleged anti-kickback statute and Stark violations.\u003c/p\u003e","\u003cp\u003eRepresented national nursing home chain in civil investigation by U.S. Attorney\u0026rsquo;s Office, HHS-OIG, FBI, and state Attorney General\u0026rsquo;s Office arising from qui tam complaint alleging various quality of care issues.\u003c/p\u003e","\u003cp\u003eRepresented large publicly held manufacturing company in internal investigation and self-disclosure of potential Bank Secrecy Act violations.\u003c/p\u003e","\u003cp\u003eRetained by publicly held dialysis provider to assume representation of company in reopened discovery phase of the largest non-intervened qui tam case under the False Claims Act related to alleged overbilling of intravenous drugs reimbursed by Medicare.\u003c/p\u003e","\u003cp\u003eRetained by board of directors of publicly held agricultural corporation to provide advice on all legal matters in the wake of highly publicized refinery explosion that spawned lengthy investigation by the OSHA, shareholder litigation, and multiple wrongful death and personal injury cases.\u003c/p\u003e","\u003cp\u003eRepresented publicly held home health care company in civil investigation conducted by U.S. Department of Justice\u0026rsquo;s Civil Division, eight U.S. Attorney\u0026rsquo;s Offices, HHS-OIG, and FBI stemming from multiple qui tam complaints related to patient eligibility and medically necessity.\u003c/p\u003e","\u003cp\u003eRepresented publicly held medical device manufacturer in civil and criminal investigations conducted by the U.S. Department of Justice\u0026rsquo;s Civil and Criminal Divisions, multiple U.S. Attorney\u0026rsquo;s Offices, VA-OIG, and FDA stemming from qui tam complaints alleging non-conforming product under the FDCA.\u003c/p\u003e","\u003cp\u003eRetained by audit committee of board of directors of publicly held biomedical company to conduct independent investigation into allegations related to improper revenue recognition practices and other accounting irregularities.\u003c/p\u003e","\u003cp\u003eRepresented Fortune 500 food, energy, and transportation company in criminal and civil investigations by U.S. Attorney\u0026rsquo;s Office, Immigration and Customs Enforcement, Department of Labor, HHS-OIG, and state Attorney General\u0026rsquo;s Office into alleged health care fraud and immigration worksite enforcement violations.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":237}]},"expertise":[{"id":11,"guid":"11.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":110,"guid":"110.capabilities","index":2,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":3,"source":"capabilities"},{"id":111,"guid":"111.capabilities","index":4,"source":"capabilities"},{"id":1188,"guid":"1188.smart_tags","index":5,"source":"smartTags"},{"id":952,"guid":"952.smart_tags","index":6,"source":"smartTags"},{"id":803,"guid":"803.smart_tags","index":7,"source":"smartTags"},{"id":1409,"guid":"1409.smart_tags","index":8,"source":"smartTags"}],"is_active":true,"last_name":"Murphy","nick_name":"Paul","clerkships":[],"first_name":"Paul","title_rank":9999,"updated_by":174,"law_schools":[],"middle_name":"B.","name_suffix":"","recognitions":[{"title":"Top Ranked Lawyer, Litigation: White-Collar Crime \u0026 Government Investigations","detail":"Chambers USA, Georgia, 2013-2022"},{"title":"Paul has outstanding technical strength and a wealth of experience","detail":"Chambers USA, 2022"},{"title":"Litigation: White Collar Crime \u0026 Government Investigations - Georgia - Band 1","detail":"Chambers USA, 2023"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003ePaul Murphy focuses on white-collar criminal defense, investigations and litigation under the False Claims Act, corporate internal investigations, corporate governance and compliance, and national security matters.\u0026nbsp;\u0026nbsp; Paul recently rejoined the firm after serving as the FBI Chief of Staff.\u0026nbsp; Earlier in his career, he held several other leadership roles with the Department of Justice, including as the U. S. Attorney for the Southern District of Georgia.\u0026nbsp; A partner in our Special Matters and Government Investigations practice, Paul represents and advises corporations, boards of directors and board committees as well as executives and other individuals.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith more than 30 years of experience, Paul helps clients navigate their most challenging and sensitive legal situations.\u0026nbsp; Paul has represented numerous clients over the years facing potential exposure on multiple fronts, including federal criminal investigations accompanied by parallel civil, regulatory, or state investigations and related shareholder or other litigation.\u0026nbsp; Paul brings a strategic and integrated approach to these multifaceted legal risks, taking into account both the immediate and longer-term issues confronting the client.\u0026nbsp;\u0026nbsp;\u003cem\u003eChambers USA\u0026nbsp;\u003c/em\u003ehas described Paul as \u0026ldquo;a go-to person for difficult cases.\u0026rdquo;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePaul has represented a wide variety of clients facing high-profile government investigations.\u0026nbsp; He has deep experience with health care fraud investigations, having represented clients across the health care and life sciences sector:\u0026nbsp; hospital systems, pharmaceutical companies, medical device manufacturers, pharmacy providers, dialysis providers, home health care companies, skilled nursing facility chains, and health insurers.\u0026nbsp; Paul also has handled several criminal environmental investigations, including some of the most significant enforcement matters pursued by the Justice Department.\u0026nbsp; In addition, he is experienced with alleged immigration offenses, customs and trade-related violations, tax offenses, securities and bank fraud, violations of the Foreign Corrupt Practices Act (FCPA), and public corruption.\u003c/p\u003e\n\u003cp\u003ePaul also has served as independent counsel to public company boards and board committees, conducting investigations into accounting or disclosure-related allegations or other issues that may implicate senior management.\u0026nbsp; In these matters, as well as others, he routinely advises clients on prospective solutions, including compliance program enhancements or other preventative measures designed to minimize the likelihood of recurrence and the possibility of future enforcement actions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs the Chief of Staff at the Federal Bureau of Investigation, Paul was the primary advisor to FBI Director Christopher Wray and worked closely with him and the senior leadership of the Department of Justice on criminal, national security, and operational issues.\u0026nbsp; From 2001 to 2004, Paul served in several other Department of Justice positions.\u0026nbsp; He was the U.S. Attorney for the Southern District of Georgia, and before that, he worked in Washington, D.C. as Associate Deputy Attorney General and later Chief of Staff to then-Deputy Attorney General Larry Thompson.\u0026nbsp; While on the Deputy Attorney General\u0026rsquo;s staff, he oversaw the Department\u0026rsquo;s criminal and civil health care fraud enforcement program and was the principal policy liaison to the Department of Health and Human Services on enforcement matters.\u0026nbsp; Paul also previously served as an Assistant U.S. Attorney, receiving commendations for his work as a prosecutor from the Attorney General, the FBI, and other federal law enforcement agencies.\u003c/p\u003e\n\u003cp\u003eIn addition to\u0026nbsp;\u003cem\u003eChambers USA\u003c/em\u003e, Paul has been recognized as a leading white-collar criminal defense attorney by several other publications, including\u0026nbsp;\u003cem\u003eThe Best Lawyers in America and Who\u0026rsquo;s Who Legal:\u0026nbsp; Business Crime Defense\u003c/em\u003e.\u0026nbsp; He is a frequent speaker and author on topics related to government investigations and prosecutions.\u003c/p\u003e","matters":["\u003cp\u003eRepresented high-ranking elected state official in highly publicized public corruption investigation by U.S. Attorney\u0026rsquo;s Office and FBI.\u003c/p\u003e","\u003cp\u003eRepresented chief executive officer of aircraft services corporation in investigation by U.S. Attorney\u0026rsquo;s Office and EPA into alleged violations of the Clean Water Act and the Resource Conservation and Recovery Act.\u003c/p\u003e","\u003cp\u003eRepresented chief executive officer of global pharmaceutical and medical device company in investigation by U.S. Attorney\u0026rsquo;s Office, National Security Division of U.S. Department of Justice, and U.S. Department of Treasury\u0026rsquo;s Office of Foreign Asset Controls regarding alleged shipments into embargoed foreign countries.\u003c/p\u003e","\u003cp\u003eRepresented Medicare Administrative Contractor in civil investigation by U.S. Attorney\u0026rsquo;s Office, Civil Division of U.S. Department of Justice, HHS-OIG, and FBI stemming from multiple qui tam complaints focusing on a variety of issues, including the alleged failure to properly enroll Medicare providers.\u003c/p\u003e","\u003cp\u003eRepresented large multi-hospital health system in civil investigation by U.S. Attorney\u0026rsquo;s Office, HHS-OIG, and state Attorney General\u0026rsquo;s Office prompted by multiple qui tam complaints alleging inappropriate admission and outlier charging practices.\u003c/p\u003e","\u003cp\u003eRepresented publicly held chemical manufacturer in criminal investigation by U.S. Attorney\u0026rsquo;s Office, the Environmental Crimes Section at Department of Justice, and EPA into alleged violations of the Clean Water Act and the Resource Conservation and Recovery Act.\u003c/p\u003e","\u003cp\u003eRepresented academic medical center in criminal and civil investigations by U.S. Attorney\u0026rsquo;s Office, HHS-OIG, and FBI related to alleged anti-kickback statute and Stark violations.\u003c/p\u003e","\u003cp\u003eRepresented national nursing home chain in civil investigation by U.S. Attorney\u0026rsquo;s Office, HHS-OIG, FBI, and state Attorney General\u0026rsquo;s Office arising from qui tam complaint alleging various quality of care issues.\u003c/p\u003e","\u003cp\u003eRepresented large publicly held manufacturing company in internal investigation and self-disclosure of potential Bank Secrecy Act violations.\u003c/p\u003e","\u003cp\u003eRetained by publicly held dialysis provider to assume representation of company in reopened discovery phase of the largest non-intervened qui tam case under the False Claims Act related to alleged overbilling of intravenous drugs reimbursed by Medicare.\u003c/p\u003e","\u003cp\u003eRetained by board of directors of publicly held agricultural corporation to provide advice on all legal matters in the wake of highly publicized refinery explosion that spawned lengthy investigation by the OSHA, shareholder litigation, and multiple wrongful death and personal injury cases.\u003c/p\u003e","\u003cp\u003eRepresented publicly held home health care company in civil investigation conducted by U.S. Department of Justice\u0026rsquo;s Civil Division, eight U.S. Attorney\u0026rsquo;s Offices, HHS-OIG, and FBI stemming from multiple qui tam complaints related to patient eligibility and medically necessity.\u003c/p\u003e","\u003cp\u003eRepresented publicly held medical device manufacturer in civil and criminal investigations conducted by the U.S. Department of Justice\u0026rsquo;s Civil and Criminal Divisions, multiple U.S. Attorney\u0026rsquo;s Offices, VA-OIG, and FDA stemming from qui tam complaints alleging non-conforming product under the FDCA.\u003c/p\u003e","\u003cp\u003eRetained by audit committee of board of directors of publicly held biomedical company to conduct independent investigation into allegations related to improper revenue recognition practices and other accounting irregularities.\u003c/p\u003e","\u003cp\u003eRepresented Fortune 500 food, energy, and transportation company in criminal and civil investigations by U.S. Attorney\u0026rsquo;s Office, Immigration and Customs Enforcement, Department of Labor, HHS-OIG, and state Attorney General\u0026rsquo;s Office into alleged health care fraud and immigration worksite enforcement violations.\u003c/p\u003e"],"recognitions":[{"title":"Top Ranked Lawyer, Litigation: White-Collar Crime \u0026 Government Investigations","detail":"Chambers USA, Georgia, 2013-2022"},{"title":"Paul has outstanding technical strength and a wealth of experience","detail":"Chambers USA, 2022"},{"title":"Litigation: White Collar Crime \u0026 Government Investigations - Georgia - Band 1","detail":"Chambers USA, 2023"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4510},{"id":4510}]},"capability_group_id":2},"created_at":"2025-05-26T05:04:12.000Z","updated_at":"2025-05-26T05:04:12.000Z","searchable_text":"Murphy{{ FIELD }}{:title=\u0026gt;\"Top Ranked Lawyer, Litigation: White-Collar Crime \u0026amp; Government Investigations\", :detail=\u0026gt;\"Chambers USA, Georgia, 2013-2022\"}{{ FIELD }}{:title=\u0026gt;\"Paul has outstanding technical strength and a wealth of experience\", :detail=\u0026gt;\"Chambers USA, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Litigation: White Collar Crime \u0026amp; Government Investigations - Georgia - Band 1\", :detail=\u0026gt;\"Chambers USA, 2023\"}{{ FIELD }}Represented high-ranking elected state official in highly publicized public corruption investigation by U.S. Attorney’s Office and FBI.{{ FIELD }}Represented chief executive officer of aircraft services corporation in investigation by U.S. Attorney’s Office and EPA into alleged violations of the Clean Water Act and the Resource Conservation and Recovery Act.{{ FIELD }}Represented chief executive officer of global pharmaceutical and medical device company in investigation by U.S. Attorney’s Office, National Security Division of U.S. Department of Justice, and U.S. Department of Treasury’s Office of Foreign Asset Controls regarding alleged shipments into embargoed foreign countries.{{ FIELD }}Represented Medicare Administrative Contractor in civil investigation by U.S. Attorney’s Office, Civil Division of U.S. Department of Justice, HHS-OIG, and FBI stemming from multiple qui tam complaints focusing on a variety of issues, including the alleged failure to properly enroll Medicare providers.{{ FIELD }}Represented large multi-hospital health system in civil investigation by U.S. Attorney’s Office, HHS-OIG, and state Attorney General’s Office prompted by multiple qui tam complaints alleging inappropriate admission and outlier charging practices.{{ FIELD }}Represented publicly held chemical manufacturer in criminal investigation by U.S. Attorney’s Office, the Environmental Crimes Section at Department of Justice, and EPA into alleged violations of the Clean Water Act and the Resource Conservation and Recovery Act.{{ FIELD }}Represented academic medical center in criminal and civil investigations by U.S. Attorney’s Office, HHS-OIG, and FBI related to alleged anti-kickback statute and Stark violations.{{ FIELD }}Represented national nursing home chain in civil investigation by U.S. Attorney’s Office, HHS-OIG, FBI, and state Attorney General’s Office arising from qui tam complaint alleging various quality of care issues.{{ FIELD }}Represented large publicly held manufacturing company in internal investigation and self-disclosure of potential Bank Secrecy Act violations.{{ FIELD }}Retained by publicly held dialysis provider to assume representation of company in reopened discovery phase of the largest non-intervened qui tam case under the False Claims Act related to alleged overbilling of intravenous drugs reimbursed by Medicare.{{ FIELD }}Retained by board of directors of publicly held agricultural corporation to provide advice on all legal matters in the wake of highly publicized refinery explosion that spawned lengthy investigation by the OSHA, shareholder litigation, and multiple wrongful death and personal injury cases.{{ FIELD }}Represented publicly held home health care company in civil investigation conducted by U.S. Department of Justice’s Civil Division, eight U.S. Attorney’s Offices, HHS-OIG, and FBI stemming from multiple qui tam complaints related to patient eligibility and medically necessity.{{ FIELD }}Represented publicly held medical device manufacturer in civil and criminal investigations conducted by the U.S. Department of Justice’s Civil and Criminal Divisions, multiple U.S. Attorney’s Offices, VA-OIG, and FDA stemming from qui tam complaints alleging non-conforming product under the FDCA.{{ FIELD }}Retained by audit committee of board of directors of publicly held biomedical company to conduct independent investigation into allegations related to improper revenue recognition practices and other accounting irregularities.{{ FIELD }}Represented Fortune 500 food, energy, and transportation company in criminal and civil investigations by U.S. Attorney’s Office, Immigration and Customs Enforcement, Department of Labor, HHS-OIG, and state Attorney General’s Office into alleged health care fraud and immigration worksite enforcement violations.{{ FIELD }}Paul Murphy focuses on white-collar criminal defense, investigations and litigation under the False Claims Act, corporate internal investigations, corporate governance and compliance, and national security matters.   Paul recently rejoined the firm after serving as the FBI Chief of Staff.  Earlier in his career, he held several other leadership roles with the Department of Justice, including as the U. S. Attorney for the Southern District of Georgia.  A partner in our Special Matters and Government Investigations practice, Paul represents and advises corporations, boards of directors and board committees as well as executives and other individuals.\nWith more than 30 years of experience, Paul helps clients navigate their most challenging and sensitive legal situations.  Paul has represented numerous clients over the years facing potential exposure on multiple fronts, including federal criminal investigations accompanied by parallel civil, regulatory, or state investigations and related shareholder or other litigation.  Paul brings a strategic and integrated approach to these multifaceted legal risks, taking into account both the immediate and longer-term issues confronting the client.  Chambers USA has described Paul as “a go-to person for difficult cases.” \nPaul has represented a wide variety of clients facing high-profile government investigations.  He has deep experience with health care fraud investigations, having represented clients across the health care and life sciences sector:  hospital systems, pharmaceutical companies, medical device manufacturers, pharmacy providers, dialysis providers, home health care companies, skilled nursing facility chains, and health insurers.  Paul also has handled several criminal environmental investigations, including some of the most significant enforcement matters pursued by the Justice Department.  In addition, he is experienced with alleged immigration offenses, customs and trade-related violations, tax offenses, securities and bank fraud, violations of the Foreign Corrupt Practices Act (FCPA), and public corruption.\nPaul also has served as independent counsel to public company boards and board committees, conducting investigations into accounting or disclosure-related allegations or other issues that may implicate senior management.  In these matters, as well as others, he routinely advises clients on prospective solutions, including compliance program enhancements or other preventative measures designed to minimize the likelihood of recurrence and the possibility of future enforcement actions. \nAs the Chief of Staff at the Federal Bureau of Investigation, Paul was the primary advisor to FBI Director Christopher Wray and worked closely with him and the senior leadership of the Department of Justice on criminal, national security, and operational issues.  From 2001 to 2004, Paul served in several other Department of Justice positions.  He was the U.S. Attorney for the Southern District of Georgia, and before that, he worked in Washington, D.C. as Associate Deputy Attorney General and later Chief of Staff to then-Deputy Attorney General Larry Thompson.  While on the Deputy Attorney General’s staff, he oversaw the Department’s criminal and civil health care fraud enforcement program and was the principal policy liaison to the Department of Health and Human Services on enforcement matters.  Paul also previously served as an Assistant U.S. Attorney, receiving commendations for his work as a prosecutor from the Attorney General, the FBI, and other federal law enforcement agencies.\nIn addition to Chambers USA, Paul has been recognized as a leading white-collar criminal defense attorney by several other publications, including The Best Lawyers in America and Who’s Who Legal:  Business Crime Defense.  He is a frequent speaker and author on topics related to government investigations and prosecutions. Paul B Murphy Partner Top Ranked Lawyer, Litigation: White-Collar Crime \u0026amp; Government Investigations Chambers USA, Georgia, 2013-2022 Paul has outstanding technical strength and a wealth of experience Chambers USA, 2022 Litigation: White Collar Crime \u0026amp; Government Investigations - Georgia - Band 1 Chambers USA, 2023 Vanderbilt University Vanderbilt University School of Law University of Georgia University of Georgia School of Law District of Columbia Georgia Represented high-ranking elected state official in highly publicized public corruption investigation by U.S. Attorney’s Office and FBI. Represented chief executive officer of aircraft services corporation in investigation by U.S. Attorney’s Office and EPA into alleged violations of the Clean Water Act and the Resource Conservation and Recovery Act. Represented chief executive officer of global pharmaceutical and medical device company in investigation by U.S. Attorney’s Office, National Security Division of U.S. Department of Justice, and U.S. Department of Treasury’s Office of Foreign Asset Controls regarding alleged shipments into embargoed foreign countries. Represented Medicare Administrative Contractor in civil investigation by U.S. Attorney’s Office, Civil Division of U.S. Department of Justice, HHS-OIG, and FBI stemming from multiple qui tam complaints focusing on a variety of issues, including the alleged failure to properly enroll Medicare providers. Represented large multi-hospital health system in civil investigation by U.S. Attorney’s Office, HHS-OIG, and state Attorney General’s Office prompted by multiple qui tam complaints alleging inappropriate admission and outlier charging practices. Represented publicly held chemical manufacturer in criminal investigation by U.S. Attorney’s Office, the Environmental Crimes Section at Department of Justice, and EPA into alleged violations of the Clean Water Act and the Resource Conservation and Recovery Act. Represented academic medical center in criminal and civil investigations by U.S. Attorney’s Office, HHS-OIG, and FBI related to alleged anti-kickback statute and Stark violations. Represented national nursing home chain in civil investigation by U.S. Attorney’s Office, HHS-OIG, FBI, and state Attorney General’s Office arising from qui tam complaint alleging various quality of care issues. Represented large publicly held manufacturing company in internal investigation and self-disclosure of potential Bank Secrecy Act violations. Retained by publicly held dialysis provider to assume representation of company in reopened discovery phase of the largest non-intervened qui tam case under the False Claims Act related to alleged overbilling of intravenous drugs reimbursed by Medicare. Retained by board of directors of publicly held agricultural corporation to provide advice on all legal matters in the wake of highly publicized refinery explosion that spawned lengthy investigation by the OSHA, shareholder litigation, and multiple wrongful death and personal injury cases. Represented publicly held home health care company in civil investigation conducted by U.S. Department of Justice’s Civil Division, eight U.S. Attorney’s Offices, HHS-OIG, and FBI stemming from multiple qui tam complaints related to patient eligibility and medically necessity. Represented publicly held medical device manufacturer in civil and criminal investigations conducted by the U.S. Department of Justice’s Civil and Criminal Divisions, multiple U.S. Attorney’s Offices, VA-OIG, and FDA stemming from qui tam complaints alleging non-conforming product under the FDCA. Retained by audit committee of board of directors of publicly held biomedical company to conduct independent investigation into allegations related to improper revenue recognition practices and other accounting irregularities. Represented Fortune 500 food, energy, and transportation company in criminal and civil investigations by U.S. Attorney’s Office, Immigration and Customs Enforcement, Department of Labor, HHS-OIG, and state Attorney General’s Office into alleged health care fraud and immigration worksite enforcement violations.","searchable_name":"Paul B. Murphy","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":174,"capability_group_featured":null,"home_page_featured":null},{"id":436472,"version":1,"owner_type":"Person","owner_id":5085,"payload":{"bio":"\u003cp\u003eHamid Mamdouh is a Senior Counsel at King \u0026amp; Spalding LLP and former Director of the Trade in Services and Investment Division of the WTO. Prior to that he was a Senior Counsellor in the Services Division and was the Secretary of the WTO Council for Trade in Services since the establishment of the WTO in 1995.\u0026nbsp; During that time, he was also responsible for legal affairs in the area of Trade in Services.\u0026nbsp; During the Uruguay Round negotiations his responsibilities included legal matters relating to the negotiation and the drafting of the General Agreement on Trade in Services (GATS). His previous positions in the GATT include:\u0026nbsp; Assistant to the Deputy Director-General of the GATT and legal advisor on GATT dispute settlement.\u0026nbsp; Prior to that he was a trade negotiator with the diplomatic service of Egypt.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDeep knowledge of, and long experience in trade policy formulation and implementation, including development-related policy challenges and responses.\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eExtensive legal expertise based on long career in public international law (trade law) and international trade negotiations.\u003cbr /\u003e \u0026nbsp;\u003c/li\u003e\n\u003cli\u003eProfound experience in trade negotiations both as a negotiator, as well as a senior international official, providing guidance to inter-governmental trade negotiations in the WTO.\u003cbr /\u003e \u0026nbsp;\u003c/li\u003e\n\u003cli\u003eExtensive experience with the implementation of the WTO General Agreement on Trade in Services (GATS) and its related instruments, including:\u003cbr /\u003e \u0026nbsp;\u003cbr /\u003e Providing advice to dispute panels relating to Trade in Services.\u003cbr /\u003e Providing advice to member governments of the WTO, developed as well as developing countries regarding their treaty obligations.\u003cbr /\u003e Delivering technical assistance to developing countries at governmental, non-government and academic levels.\u003cbr /\u003e Outreach to the private sector and civil society, in countries members of the WTO, on issues relating to the interface between domestic services regulation and treaty obligations under the GATS.\u003cbr /\u003e Frequently solicited for advice and guidance to governments of developed and developing countries on legal and policy matters relating to WTO negotiations.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n\u003cli\u003eProven track record of outreach at senior levels in governments and private sector, including guidance on key negotiating issues.\u003cbr /\u003e \u0026nbsp;\u003c/li\u003e\n\u003cli\u003eHigh degree of credibility with both developing and developed country governments.\u003cbr /\u003e \u0026nbsp;\u003c/li\u003e\n\u003cli\u003eEgyptian/Swiss national - Arabic mother-tongue, excellent English and fluent French.\u003c/li\u003e\n\u003c/ul\u003e","slug":"abdelhamid-mamdouh","email":"hmamdouh@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":25,"guid":"25.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":579,"guid":"579.smart_tags","index":2,"source":"smartTags"}],"is_active":true,"last_name":"Mamdouh","nick_name":"Hamid","clerkships":[],"first_name":"Abdelhamid","title_rank":9999,"updated_by":34,"law_schools":[{"id":2962,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"1974-01-01 00:00:00 UTC"},"order":0,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":77,"translated_fields":{"en":{"bio":"\u003cp\u003eHamid Mamdouh is a Senior Counsel at King \u0026amp; Spalding LLP and former Director of the Trade in Services and Investment Division of the WTO. Prior to that he was a Senior Counsellor in the Services Division and was the Secretary of the WTO Council for Trade in Services since the establishment of the WTO in 1995.\u0026nbsp; During that time, he was also responsible for legal affairs in the area of Trade in Services.\u0026nbsp; During the Uruguay Round negotiations his responsibilities included legal matters relating to the negotiation and the drafting of the General Agreement on Trade in Services (GATS). His previous positions in the GATT include:\u0026nbsp; Assistant to the Deputy Director-General of the GATT and legal advisor on GATT dispute settlement.\u0026nbsp; Prior to that he was a trade negotiator with the diplomatic service of Egypt.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDeep knowledge of, and long experience in trade policy formulation and implementation, including development-related policy challenges and responses.\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eExtensive legal expertise based on long career in public international law (trade law) and international trade negotiations.\u003cbr /\u003e \u0026nbsp;\u003c/li\u003e\n\u003cli\u003eProfound experience in trade negotiations both as a negotiator, as well as a senior international official, providing guidance to inter-governmental trade negotiations in the WTO.\u003cbr /\u003e \u0026nbsp;\u003c/li\u003e\n\u003cli\u003eExtensive experience with the implementation of the WTO General Agreement on Trade in Services (GATS) and its related instruments, including:\u003cbr /\u003e \u0026nbsp;\u003cbr /\u003e Providing advice to dispute panels relating to Trade in Services.\u003cbr /\u003e Providing advice to member governments of the WTO, developed as well as developing countries regarding their treaty obligations.\u003cbr /\u003e Delivering technical assistance to developing countries at governmental, non-government and academic levels.\u003cbr /\u003e Outreach to the private sector and civil society, in countries members of the WTO, on issues relating to the interface between domestic services regulation and treaty obligations under the GATS.\u003cbr /\u003e Frequently solicited for advice and guidance to governments of developed and developing countries on legal and policy matters relating to WTO negotiations.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n\u003cli\u003eProven track record of outreach at senior levels in governments and private sector, including guidance on key negotiating issues.\u003cbr /\u003e \u0026nbsp;\u003c/li\u003e\n\u003cli\u003eHigh degree of credibility with both developing and developed country governments.\u003cbr /\u003e \u0026nbsp;\u003c/li\u003e\n\u003cli\u003eEgyptian/Swiss national - Arabic mother-tongue, excellent English and fluent French.\u003c/li\u003e\n\u003c/ul\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":5697}]},"capability_group_id":2},"created_at":"2025-09-02T04:55:22.000Z","updated_at":"2025-09-02T04:55:22.000Z","searchable_text":"Mamdouh{{ FIELD }}Hamid Mamdouh is a Senior Counsel at King \u0026amp; Spalding LLP and former Director of the Trade in Services and Investment Division of the WTO. Prior to that he was a Senior Counsellor in the Services Division and was the Secretary of the WTO Council for Trade in Services since the establishment of the WTO in 1995.  During that time, he was also responsible for legal affairs in the area of Trade in Services.  During the Uruguay Round negotiations his responsibilities included legal matters relating to the negotiation and the drafting of the General Agreement on Trade in Services (GATS). His previous positions in the GATT include:  Assistant to the Deputy Director-General of the GATT and legal advisor on GATT dispute settlement.  Prior to that he was a trade negotiator with the diplomatic service of Egypt.\nDeep knowledge of, and long experience in trade policy formulation and implementation, including development-related policy challenges and responses.\n\nExtensive legal expertise based on long career in public international law (trade law) and international trade negotiations.  \nProfound experience in trade negotiations both as a negotiator, as well as a senior international official, providing guidance to inter-governmental trade negotiations in the WTO.  \nExtensive experience with the implementation of the WTO General Agreement on Trade in Services (GATS) and its related instruments, including:   Providing advice to dispute panels relating to Trade in Services. Providing advice to member governments of the WTO, developed as well as developing countries regarding their treaty obligations. Delivering technical assistance to developing countries at governmental, non-government and academic levels. Outreach to the private sector and civil society, in countries members of the WTO, on issues relating to the interface between domestic services regulation and treaty obligations under the GATS. Frequently solicited for advice and guidance to governments of developed and developing countries on legal and policy matters relating to WTO negotiations.\n\n\nProven track record of outreach at senior levels in governments and private sector, including guidance on key negotiating issues.  \nHigh degree of credibility with both developing and developed country governments.  \nEgyptian/Swiss national - Arabic mother-tongue, excellent English and fluent French.\n Senior Counsel Cairo University Cairo University, Law School Egyptian Bar Association – Appellate Egyptian Bar Association - Appellate (Reg # 604236)","searchable_name":"Abdelhamid Mamdouh (Hamid)","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}]}}