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Our health care fraud attorneys have deep experience in medical fraud; we represent companies and individuals in the healthcare industry who face a number of concerns.

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The Complexities of AI in Health Care

Legal and Business Issues at the Intersection of Life Sciences and Artificial Intelligence

34th Annual National Institute on Health Care Fraud  Subtitle

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True Facts About False Claims: MoFo's FCA Newsletter (October 2024)

中国发布的《医药企业合规指引》预示了未来执法重点关注的领域

China’s Compliance Guidelines for Healthcare Companies Signal Areas of Future Enforcement

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DOJ’s Healthcare Probes of AI Tools Rooted in Purdue Pharma Case

Outing Companies That Avoid Charges a Dilemma for US Prosecutors

Christine Wong Named to the 2023 NACD Directorship 100

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Stacy Cline Amin Named Regulatory Attorney of the Year: FDA Pharmaceutical by LMG Life Sciences

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Demme Doufekias is a trial attorney whose practice focuses on matters involving complex government and internal investigations. As a member of the firm’s Investigations + White-Collar Defense practice, individuals and corporations seek Demme’s counsel through all phases of investigations and litigation, from proactive compliance counseling and due diligence through the simultaneous defense of criminal investigations, administrative proceedings, and civil litigation. She successfully defends clients in civil and criminal matters in federal and state trials.Demme’s global investigations practice encompasses a number of substantive areas, including the Foreign Corrupt Practices Act and other anticorruption regimes, anti-money laundering, and criminal antitrust and securities violations. She has represented clients in cross-border investigations, including FCPA investigations and the U.S. Department of Justice’s (DOJ) investigations of price-fixing in the auto parts and generic drug industries. She also counsels clients in creating global anti-corruption compliance programs and in due diligence matters related to healthcare and anti-corruption laws.Demme regularly represents pharmaceutical, biotechnology, and medical device companies and has extensive experience with healthcare investigations and regulatory matters. She defends companies and executives in federal investigations conducted by DOJ, the Department of Health and Human Services, and the Food and Drug Administration. Her experience includes counseling and defending clients in matters related to the Food, Drug, and Cosmetic Act; other federal health care laws; and transparency laws such as the federal Physician Payments Sunshine Act. When required, Demme has successfully defended her healthcare clients at trial, including, obtaining a complete defense victory on behalf of a former pharmaceutical sales executive charged with violations of the federal Anti-Kickback statute in a two-week jury trial in U.S. District Court for the District of Massachusetts (U.S. v. Bruens, et al).Demme was most recently named to Global Investigations Review’s “Women in Investigations” 2018 survey, which recognizes the top 100 leading female investigations specialists from around the world.In addition to her investigations and healthcare practices, Demme maintains a robust civil litigation practice. Her experience includes conducting investigations and litigating on behalf of creditors’ committees and other constituents in federal bankruptcy matters and representing clients in state and federal civil trials.Prior to law school, Demme worked in the White House Counsel’s Office during the Clinton administration, where she worked on various investigations by the Office of Independent Counsel, including Whitewater, campaign finance, presidential impeachment, and the activities of various Cabinet members. She is admitted to practice in Virginia and the District of Columbia.<h4>Representative Experience</h4><h5>Criminal Investigations and Matters</h5><ul><li>Represents Fortune 500 multinational pharmaceutical company in DOJ and SEC investigations of potential FCPA violations.</li><li>Represented numerous executives of Japanese auto parts manufacturers in connection with DOJ investigation of price-fixing in the auto parts industry.</li><li>Represented Fortune 500 technology company on various FCPA matters in multiple emerging markets.</li><li>Represented software creator in connection with grand jury investigation of WikiLeaks.</li><li>Represented global power company in connection with FERC investigation of gas-trading practices.</li><li>Represented the former chairman and chief executive officer of Kansas public utility in DOJ and IRS investigations, related shareholder litigation and arbitration proceedings, resulting in two criminal trials, with the first ending in a hung jury and the second in a conviction later reversed on appeal and subsequently dismissed.</li></ul><h5>Health Care Fraud And False Claims Act Matters</h5><ul><li>Represents executive of generic drug manufacturer in connection with DOJ price-fixing investigation.</li><li>Represented former compliance director and marketing director of global pharmaceutical company in criminal investigation of marketing and promotion of arthritis pain medication.</li><li>Represented former president of a global medical device company indicted as “responsible corporate officer” in criminal investigation concerning off-label promotion of prosthetic bone cement.</li><li>Represented former senior executive of a Fortune 500 health care and pharmaceutical company during investigation of company’s good manufacturing practices (GMP) and related product recall.</li><li>Represented executive of large regional retina practice in qui tam litigation concerning Medicare and Medicaid reimbursement violations.</li></ul><h5>Bankruptcy And Other Litigation Matters</h5><ul><li>Conducted investigations on behalf of the official committee of unsecured creditors in various bankruptcy matters in the coal industry, including Murray Energy, Westmoreland Coal Company, Patriot Coal Corporation, Peabody Energy, Inc., and Armstrong Energy, Inc.</li><li>Conducted investigation on behalf of the official committee of unsecured creditors for international telecom company Avaya Inc. and its affiliated debtors.</li><li>Conducted investigation, on behalf of Chapter 11 Trustee, into collapse of global financial broker MF Global and brought suit against former officers and directors for breaches of various duties.</li><li>Represented government contractor specializing in technologies for national security and aerospace programs in trade secrets litigation, including at trial in state court litigation and winning a partial defense verdict.</li><li>Obtained defense judgment for a national law firm in a $226 million state legal malpractice suit.</li></ul>

Demme Doufekias

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James Koukios is co-chair of Morrison Foerster’s Securities Litigation, Enforcement, and White Collar Defense Group and serves as co-head of the FCPA + Global Anti-Corruption Practice. James represents companies and individuals in high-stakes government enforcement actions and complex internal investigations. He has handled matters across a wide range of jurisdictions including Brazil, China, Greece, India, Russia, Venezuela, and Vietnam, among others. James draws on his experience as a federal prosecutor, when he tried over 20 federal jury cases and supervised hundreds of white collar investigations, to obtain the best results for his clients. He is consistently praised for his judgment and advocacy in complex investigations and enforcement actions. Chambers USA notes that he is “super experienced with excellent judgement regarding what the government is looking for and concerned about,“ while Chambers Global describes James as, “a forceful advocate when appearing before the government.”Before joining Morrison Foerster, James spent 10 years at the U.S. Department of Justice (DOJ), beginning as an Assistant United States Attorney in Miami and finishing as Senior Deputy Chief of the Criminal Division’s Fraud Section in Washington, D.C., where he supervised investigations, prosecutions, and resolutions in the Fraud Section’s FCPA, Health Care Fraud, and Market Integrity and Major Fraud Units. While at DOJ, James investigated and prosecuted health care fraud, procurement fraud, domestic and foreign corruption, money laundering, and export control offenses, working closely with state, federal, and foreign law enforcement officials, as well as the U.S. Securities and Exchange Commission (SEC), the U.S. Departments of Defense, State, and Commerce, and intelligence agencies.While at DOJ, James assisted in drafting the widely acclaimed DOJ and SEC joint publication A Resource Guide to the U.S. Foreign Corrupt Practices Act, which followed a series of consultations with business and compliance leaders. He was also a lead examiner for the Phase 2 examination of Russia’s compliance with the Anti-Bribery Convention of the Organisation for Economic Co-operation and Development (OECD).From 2010 to 2011, James served as Special Counsel to then-FBI Director Robert S. Mueller, III, advising the Director and other FBI executives on criminal policy issues, preparing FBI Executive Management for congressional testimony, representing the FBI at interagency meetings, and acting as a liaison between FBI and other DOJ components.James has been recognized as: a leading lawyer in FCPA (Nationwide and Global) by Chambers USA and Chambers Global; a recommended lawyer for corporate investigations and white collar defense by Legal 500; an “Expert” and a “Thought Leader” in investigations by Who’s Who Legal; and an “Attorney Who Matters” by the Ethisphere Institute for making an impact in the area of ethics and compliance. He also received the Assistant Attorney General’s Distinguished Service Award in recognition for his work on two landmark FCPA-related trials: United States v. Esquenazi and United States v. Duperval. James also served as a lead prosecutor in United States v. AEY Inc., a defense procurement fraud and export licensing case that served as the basis for the 2016 film War Dogs.James is a recognized thought leader on the latest legal trends and industry developments. Chambers Global notes that, “James has a keen ability to distill trends and enforcement down to their core. He is a crisp thinker and discerning with regards to the market.” He is the lead editor of our award-winning monthly newsletter, Top 10 International Anti-Corruption Developments, which succinctly summarizes important case and policy developments for busy in-house counsel, compliance professionals, and anti-corruption lawyers. James also served as an adjunct professor of trial advocacy at the Georgetown University Law Center for over 10 years and regularly guest lectures at leading law and business schools on investigations, white collar enforcement, and anti-corruption issues.<h4>Selected Significant Representations</h4><h5>FCPA and Global Anti-Corruption</h5><ul><li>Successful resolution of a transnational bribery investigation of a multinational pharmaceutical company, securing cooperation credit, avoiding the imposition of a corporate compliance monitor, and negotiating a deferred prosecution agreement with DOJ and an administrative resolution with the SEC.</li><li>Successful representation of a multinational medical device company in conducting an internal investigation into allegations of bribery in Vietnam that led to a deferred prosecution agreement with DOJ.</li><li>Representation of an international consulting firm in extensive, government-facing international corruption and money laundering investigations involving China, India, and other jurisdictions.</li><li>Representation of a multinational automotive company in an internal investigation into allegations of bribery in its Latin America operations and antitrust violations and whistleblower retaliation in its U.S. operations.</li><li>Representation of a consumer retail company in an internal investigation into allegations of bribery in its Indonesian operations.</li><li>Representation of business executives in government-facing FCPA investigations involving Brazil, China, Venezuela, and other jurisdictions.</li><li>FCPA legal advice, anti-corruption counseling, transactional due diligence, and post-acquisition integration advice to multinational corporations in several industries, including defense, extractive, financial services, food, gaming, health care, and technology.</li><li>Review of a multinational company’s compliance management system in connection with the spin-off of a subsidiary and investigations by multiple enforcement agencies.</li></ul><h5>Consumer Protection and Product Safety</h5><ul><li>Successful representation of a multinational consumer electronics company in the first-ever corporate criminal resolution of an alleged Consumer Product Safety Act (CPSA) violation, securing cooperation credit, avoiding the imposition of a corporate compliance monitor, and negotiating a deferred prosecution agreement for the parent company with DOJ.</li><li>Representation of a multinational vehicle manufacturer in a criminal CPSA investigation being led by DOJ’s Consumer Protection Branch.</li><li>Representation of the CEO of a consumer electronics company in a criminal CPSA investigation being led by DOJ’s Consumer Protection Branch.</li><li>Representation of the Supervisory Board of a car manufacturer in an investigation by DOJ, the U.S. Environmental Protection Agency, the California Air Resources Board, SEC, various state Attorneys General, German Prosecutors and the German vehicle admissions agency into potential violations of environmental, capital markets, consumer protection, antitrust and criminal laws.</li></ul><h5>Other White Collar and Civil Fraud Defense Matters</h5><ul><li>Representation of a multinational technology company in responding to a subpoena issued by the U.S. House of Representatives’ Judiciary Committee related to an investigation into alleged suppression or restriction of conservative opinions through “content moderation” policies on social media platforms.</li><li>Successful representation of a multinational defense contractor in conducting an internal investigation that led to a declination from the State Department for potential International Trafficking in Arms Regulation (ITAR) violations without referral to DOJ.</li><li>Representation of a consumer retail company in a DOJ insider trading investigation.</li><li>Representation of a company and several of its employees in connection with the Special Counsel investigation into Russian interference in the 2016 Presidential election.</li><li>Representation of Anthony Ornato, a former senior career civil servant who served as White House Deputy Chief of Staff of Operations, in the January 6 Select Committee investigation and related government investigations.</li><li>Representation of two former high-level executives of a public company in internal and external investigations concerning allegations of fraud, misuse of company funds, record violations, and disclosure violations and in a derivative lawsuit in the Delaware Chancery Court regarding alleged violations of fiduciary duty, corporate waste, and unjust enrichment.</li><li>Representation of business executives in anti-money-laundering, criminal securities fraud, whistleblower retaliation, government procurement fraud, and other DOJ investigations.</li><li>Defended independent directors against breach-of-fiduciary-duty claims in federal bankruptcy court, successfully moving to dismiss all claims against the directors with prejudice.</li></ul>

James Koukios é co-líder do grupo de Contencioso de Valores Mobiliários e Defesa de Colarinho Branco e atua como co-líder global do grupo FCPA (Foreign Corrupt Practices Act) + Anticorrupção. James representa empresas e indivíduos em ações governamentais de alto risco e investigações internas complexas.James, um experiente advogado de litígios e ex-promotor federal, litigou mais de 20 casos federais de júri, inclusive sendo o principal promotor em dois julgamentos históricos relacionados à FCPA: Estados Unidos v. Esquenazi e Estados Unidos v. Duperval. James também atuou como promotor-chefe nocaso Estados Unidos v. AEY Inc., um caso de fraude de aquisição de defesa e licenciamento de exportação que serviu de base para o filme de 2016 chamado "Cães de Guerra".<h4>Casos Representativos</h4><ul><li>Representou empresas multinacionais de dispositivos médicos e farmacêuticos em investigações da FCPA perante o governo.</li><li>Representou empresas e organizações multinacionais em vários setores a conduzir investigações internas sobre possíveis violações de FCPA, ITAR, sobre informações privilegiadas, entre outras violações.</li><li>Representou uma empresa e vários de seus funcionários em investigações do Conselho Especial.</li><li>Representou uma empresa de produtos de consumo em uma investigação criminal de segurança de produtos perante o governo.</li><li>Forneceu consultoria jurídica sobre FCPA, consultoria anticorrupção, due diligence transacional e consultoria de integração pós-aquisição a empresas multinacionais em vários setores, incluindo defesa, extração, serviços financeiros, alimentos, assistência médica e tecnologia.</li><li>Representou indivíduos em casos de investigações anti-corrupção, lavagem de dinheiro, fraude criminal em valores mobiliários, retaliação de denunciantes, fraude de compras do governo, dentre outras.</li><li>Defendeu conselheiros independentes contra reclamações por quebra de obrigações fiduciárias no tribunal federal de falências.</li></ul>Antes de ingressar na Morrison Foerster, James trabalhou  por 10 anos no Departamento de Justiça dos Estados Unidos, começando sua carreira como Advogado Assistente dos Estados Unidos em Miami e encerrando seu mandato no Departamento de Justiça como Chefe Adjunto de Seção de Fraude da Divisão Criminal em Washington, DC, onde supervisionou investigações, processos e resoluções na Seção de Fraude em FCPA, Fraude em Assistência Médica, e em Valores Mobiliários e na Unidade de Fraude Financeira. Enquanto estava no Departamento de Justiça, James investigou e processou fraudes na área da saúde, fraude de compras, corrupção doméstica e estrangeira, lavagem de dinheiro e infrações de controle de exportação, trabalhando em estreita colaboração com autoridades estaduais, federais e estrangeiras, bem como a Comissão de Valores Mobiliários dos Estados Unidos (SEC); Departamentos de Defesa, Estado e Comércio dos Estados Unidos; e agências de inteligência. Ele ajudou na redação da amplamente divulgada publicação conjunta da SEC e do Departamento de Justiça, “Guia de Recursos da Lei de Práticas de Corrupção no Exterior dos Estados Unidos (“A Resource Guide to the U.S. Foreign Corrupt Practices Act”), que seguiu uma série de consultas com os líderes de negócios e conformidade. Ele também foi examinador principal da Fase 2 da avaliação de conformidade da da Rússia com a Convenção Anti-suborno da Organização para Cooperação e Desenvolvimento Econômico (OCDE).De 2010 a 2011, James atuou como consultor especial do então diretor do FBI Robert S. Mueller, III, assessorando o diretor e outros executivos do FBI em questões de política criminal, preparando a Diretoria Executiva do FBI para testemunhar perante o Congresso, representando o FBI em reuniões entre agências e atuando como uma ligação entre o FBI e outros componentes do Departamento de Justiça.James foi reconhecido como um dos principais advogados da FCPA, nacional e globalmente, pela Chambers USA e pela Chambers Global, "recomendado" para investigações corporativas e advocacia de colarinho branco pelo Legal 500, um "especialista" e um "líder de pensamento" nas investigações do Who is Who Legal e um "advogado que importa" pelo Instituto Ethisphere por ter um impacto na área de ética e conformidade. Ele também recebeu o Prêmio de Serviço Distinto do Procurador Geral em reconhecimento ao seu trabalho nos julgamentos de Esquenazi e Duperval durante seu período no Departamento de Justiça.James é professor adjunto de defesa de julgamento no Centro de Direito da Universidade de Georgetown e é regularmente convidado para palestras nas principais faculdades de administração e direito sobre investigações, fiscalização de colarinho branco e questões anticorrupção.

James Koukios es copresidente del grupo de Litigios de Valores, Aplicación de la Ley y Defensa de Cuello Blanco de la firma y se desempeña como codirector global del grupo de FCPA (Foreign Corrupt Practices Act) + Anticorrupción de la firma. James representa a empresas e individuos en acciones gubernamentales de alto riesgo e investigaciones internas complejas.James, un abogado con experiencia litigando y ex fiscal federal, ha litigado más de 20 casos de jurado federal, incluyendo ser el fiscal principal en dos juicios históricos relacionados con la FCPA: Estados Unidos v. Esquenazi y Estados Unidos v. Duperval. James también se desempeñó como fiscal principal en Estados Unidos v. AEY Inc., un caso de fraude de adquisición de defensa y licencias de exportación que sirvió de base para la película de 2016 llamada “War Dogs”.<h4>Experiencia Representativa</h4><ul><li>Representó a compañías multinacionales de dispositivos médicos y farmacéuticos en investigaciones de la FCPA ante el gobierno.</li><li>Asistió a compañías y organizaciones multinacionales en varios sectores llevando a cabo investigaciones internas sobre posibles FCPA, ITAR, abuso de información privilegiada y otras violaciones.</li><li>Representó a una empresa y a varios de sus empleados en relación con las investigaciones sobre delitos de investigación del Consejo Especial.</li><li>Representó a una compañía de productos de consumo en una investigación criminal de seguridad de productos del gobierno.</li><li>Brindó asesoramiento legal de FCPA, asesoramiento anticorrupción, diligencia debida transaccional y asesoramiento de integración posterior a la adquisición a corporaciones multinacionales en varias industrias, incluyendo defensa, extracción, servicios financieros, alimentos, atención médica y tecnología.</li><li>Representó a personas en anticorrupción, anti-lavado de dinero, fraude de valores criminales, represalias de denunciantes, fraude de compras gubernamentales y otras investigaciones.</li><li>Defendió a directores independientes contra demandas por incumplimiento de obligaciones fiduciarias en un tribunal federal de quiebras.</li></ul>Antes de unirse a Morrison Foerster, James trabajó 10 años en el Departamento de Justicia de los Estados Unidos, comenzando su carrera como Asistente del Fiscal de los Estados Unidos en Miami y terminando su mandato en el Departamento de Justicia como Subjefe Principal de la Sección de Fraude de la División Criminal en Washington, D.C., donde supervisó investigaciones, enjuiciamientos y resoluciones en la FCPA de la Sección de Fraude, Fraude de Atención Médica y Unidades de Valores y Fraude Financiero. Mientras estuvo en el Departamento de Justicia, James investigó y procesó el fraude a la atención médica, el fraude de adquisiciones, la corrupción nacional y extranjera, el lavado de dinero y los delitos de control de exportaciones, trabajando en estrecha colaboración con los funcionarios estatales, federales y extranjeros encargados de hacer cumplir la ley, así como con la Comisión de Bolsa y Valores de EE. UU. (SEC); Departamentos de Defensa, Estado y Comercio de los Estados Unidos; y agencias de inteligencia. Asistió en la redacción de la publicación conjunta del Departamento de Justicia y la SEC, ampliamente aclamada, “Guía de recursos de la Ley de prácticas corruptas en el extranjero de EE. UU.” (“A Resource Guide to the U.S. Foreign Corrupt Practices Act”), que siguió a una serie de consultas con líderes empresariales y de cumplimiento. También fue un examinador principal para el examen de Fase 2 del cumplimiento de Rusia con la Convención Antisoborno de la Organización para la Cooperación y el Desarrollo Económico (OCDE).De 2010 a 2011, James se desempeñó como Asesor Especial del entonces Director del FBI Robert S. Mueller, III, asesorando al Director y a otros ejecutivos del FBI sobre cuestiones de política criminal, preparando a la Dirección Ejecutiva del FBI para el testimonio ante el Congreso, representando al FBI en las reuniones interinstitucionales, y actuando como enlace entre el FBI y otros componentes del Departamento de Justicia.James ha sido reconocido como abogado líder en FCPA tanto nacionalmente como globalmente por Chambers USA y Chambers Global, "recomendado" para investigaciones corporativas y defensa de cuello blanco por Legal 500, un "experto" y un "líder de pensamiento" en investigaciones de Who's Who Legal, y un "Abogado que importa" por Ethisphere Institute por tener un impacto en el área de ética y cumplimiento. También recibió el Premio al Servicio Distinguido del Fiscal General Adjunto en reconocimiento por su trabajo en los juicios de Esquenazi y Duperval durante su tiempo en el Departamento de Justicia.James es profesor adjunto de defensa de juicios en el Centro de Leyes de la Universidad de Georgetown y regularmente es invitado a conferencias en las principales escuelas de derecho y de negocios sobre investigaciones, aplicación de cuello blanco y temas anticorrupción.

James M. Koukios

When Your Life Sciences Are on the Line: Life Sciences and Food + Agriculture

AI in Health Care: Case Law and Enforcement Trends

When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

Above Board: Regulatory and Enforcement Trends in the Life Sciences and Healthcare Industries

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