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Matthew J. O'Connor

Partner

Washington +1 202 662 5469

Boston +1 617 603 8800

  • About
  • Representative Matters
  • Credentials
  • About

    Matthew O’Connor is co-chair of the Life Sciences Enforcement and Litigation Practice Group and a leading white collar defense and investigations lawyer representing pharmaceutical, biotechnology, and medical device companies.

    Recognized by Chambers USA as a nationally ranked lawyer for False Claims Act and Litigation matters and for White Collar Crime & Government Investigations in the District of Columbia, Matt has extensive experience representing life sciences companies and executives in federal and state civil and criminal investigations, congressional investigations, consumer protection actions, and other high-stakes litigation arising from government enforcement proceedings. He handles the full range of U.S. Department of Justice (DOJ) and state criminal enforcement proceedings, False Claims Act investigations, unfair and deceptive trade practices act investigations, and related litigations.

    Over the past 30 years, Matt has led the defense of some of the most significant life sciences enforcement matters, including investigations involving sales and marketing practices, FDA reporting and compliance, pharmaceutical and medical device safety, current good manufacturing practices (cGMP), charitable giving, reimbursement support programs, HIPAA compliance, pricing and price reporting, insurance fraud, and federal and state anti-kickback statute compliance.

    Matt has successfully secured civil and criminal declinations and other favorable resolutions for a broad range of pharmaceutical, biotechnology, and medical device companies. His experience includes matters involving allegations of off-label promotion, misleading safety claims, cGMP violations, and efforts to improperly influence formulary placement.

    In addition, Matt conducts complex internal investigations and advises life sciences companies on compliance programs, corporate governance, and regulatory requirements, including Corporate Integrity Agreements (CIAs).

    Areas of Expertise

  • Practices and Industries
  • Representative Matters

    Life Sciences Enforcement: DOJ, SEC, State AG, State Insurance Fraud

    • Represents numerous pharmaceutical, biotechnology, and medical device manufacturers in ongoing criminal, civil, and administrative investigations, including investigations of sales and marketing practices (e.g., off-label promotion, AKS), FDA reporting, device safety, reimbursement support, price reporting, good manufacturing practices, and insurance fraud.
    • Represents numerous life sciences, consumer products and food manufacturers in State AG investigations concerning potential unfair and deceptive trade practices in marketing activities.
    • Represented major consumer products manufacturer in a criminal and civil DOJ investigation concerning alleged FDCA violations related to surgical gowns, resulting in a deferred prosecution agreement (one-year term; no compliance monitor) and favorable False Claims Act resolution.
    • Represented major pharmaceutical manufacturer in obtaining declination in False Claims Act investigation concerning collaboration with electronic healthcare records (“EHR”) provider.
    • Represented major biopharmaceutical manufacturer in obtaining declination in False Claims Act investigation concerning Average Sales Price (“ASP”).
    • Represented pharmaceutical manufacturer in obtaining criminal and civil declination concerning investigation of marketing practices and product safety.
    • Represented major pharmaceutical manufacturer in settlement of False Claims Act matter alleging fraudulent FDA approval resulted in the submission of false claims.
    • Represented Vault Medical in DOJ False Claims Act investigation and resolution involving alleged improper billing to the Health Resources and Services Administration Uninsured Program for COVID‑19 testing.
    • Represented Bausch Health in favorable False Claims Act resolution ($100,000) concerning incentive compensation payments.
    • Represented major biotechnology company in obtaining declination in False Claims Act investigation alleging provision of replacement product constituted kickbacks.
    • Represented Advanced Bionics in civil and criminal DOJ investigation and civil resolution concerning testing standards in FDA submissions.
    • Represented Medisca, Inc. in favorable False Claims Act resolution concerning government price reporting related to Average Wholesale Price (“AWP”).
    • Represented major pharmaceutical manufacturer in obtaining declination in False Claims Act investigation concerning cGMP violations with respect to product handling and storage.
    • Represented device manufacturer in obtaining declination in DOJ investigation concerning alleged improper recall-related reimbursements.
    • Represented pharmaceutical manufacturer in obtaining declination in SEC investigation concerning potential FCPA violations.
    • Represented Avanir Pharmaceuticals in criminal (DPA) and civil resolution of federal and state investigations concerning the company’s sales and marketing practices.
    • Represented Olympus Medical Systems Corporation in misdemeanor resolution of federal investigation concerning medical device reporting under the Federal Food, Drug & Cosmetic Act.
    • Represented pharmaceutical manufacturer in obtaining civil and criminal declination in federal investigation concerning alleged payment of kickbacks to influence formulary position.
    • Represented Warner Chilcott Sales U.S. in criminal and civil resolution of federal and state investigation of allegations of improper conduct with respect to speaker programs, off-label promotion, prior authorizations and protected health information. Represented company in follow-on investigation and resolution with the California Department of Insurance.

    • Represented biopharmaceutical manufacturer in obtaining criminal and civil declination of investigation concerning alleged cGMP violations.
    • Represented Salix Pharmaceuticals, Inc. in civil settlement of federal and state investigation of allegations concerning speaker programs.
    • Represented pharmaceutical manufacturer in resolution of investigation by California Department of Insurance concerning arrangement with a specialty pharmacy.
    • Represented pharmaceutical and biopharmaceuticals manufacturer in obtaining civil declinations in separate federal and state investigations concerning AMP price reporting and bona fide service fees.
    • Represented OSI Pharmaceutical LLC in civil settlement concerning allegations of improper promotional claims for an oncology therapy.
    • Represented pharmaceutical manufacturer in obtaining criminal and civil declination of investigation concerning alleged cGMP violations.
    • Represented pharmacy chain in obtaining civil declination in federal investigation of alleged retention of overpayments under the False Claims Act.
    • Represented pharmaceutical manufacturer in obtaining criminal and civil declination in federal investigation concerning alleged off-label promotion and improper safety claims.
    • Represented AstraZeneca in civil settlement of federal and state investigation concerning allegations of improper discounting practices to influence formulary placement.
    • Represented biopharmaceutical manufacturer in obtaining civil declination in federal investigation concerning price reporting and bona fide service fees.
    • Represented GlaxoSmithKline in criminal and civil resolution of three investigations concerning sales, marketing, pricing, and FDA reporting practices involving the company’s major products.
    • Represented company in related consumer protection investigation and settlement.
    • Represented GlaxoSmithKline in criminal and civil resolution of investigation concerning manufacturing practices at the company’s former manufacturing facility in Puerto Rico. Represented company in related consumer protection investigation and settlement.

    Administrative Enforcement: HHS/OIG

    • Represents numerous life sciences companies in negotiations with HHS/OIG concerning the exercise of its administrative remedies.
    • Represented multinational pharmaceutical company in negotiation of Corporate Integrity Agreement concerning contributions to independent charitable foundations.
    • Represented Novartis Pharmaceuticals Corporation in negotiation of Corporate Integrity Agreement Addendum concerning specialty pharmacies.

    Life Sciences Litigation (False Claims Act & RICO)

    • Represented Warner Chilcott in successful motion to dismiss civil RICO claims asserted on behalf of Medicare Advantage plans and HMOs alleging unlawful prescriptions induced by bribes, false efficacy claims and prior authorization fraud. MSP Recovery Claims, Series LLC v. Warner Chilcott PLC, et al., Civ. No. 18-cv-10274-ADB, 2019 WL 1333269 (D. Mass. Mar. 22, 2019).
    • Represented Novartis Pharmaceutical Corporation in successful motion to dismiss federal and state false claims act action concerning alleged offer of discounts to influence formulary position. United States ex rel. Perri v. Novartis Pharmaceuticals Corp. et al., No. 15-06547, 2019 U.S. Dist. LEXIS 28594 (D.N.J. Feb. 21, 2019).
    • Represented Genentech, Inc. in successful motion to dismiss and appeal of federal and state false claims action concerning alleged failure to report adverse events. United States ex rel. Petratos v. Genentech, Inc., et al., 855 F.3d 481 (3d Cir. 2017).
    • Represented Genentech, Inc. in successful motion to dismiss and appeal of federal and state false claims act action concerning alleged improper promotional practices of asthma medication. United States ex rel. Kelly v. Novartis Pharmaceutical Corp. and Genentech, Inc., et al., 827 F.3d 5 (1st Cir. 2016).
    • Represented GlaxoSmithKline in successful summary judgment and appeal related to whistleblower’s claim of retaliatory discharge under the False Claims Act. United States ex rel. Hamrick v. GlaxoSmithKline LLC, 814 F.3d 10 (1st Cir. 2016).

    Congressional Investigations 

    • Represented pharmaceutical company in Senate Special Committee on Aging investigation concerning product price levels.
    • Represented device company in Senate Finance Committee investigation concerning consultant payments.
    • Represented device and pharmaceutical companies in Senate Special Committee on Aging investigations concerning sponsorship of independent medical education programs.

    Other Investigations 

    • Represented client in investigation by the Special Inspector General for the Troubled Asset Relief Program (SIG TARP) concerning potential mortgage work-out services fraud.
    • Represented financial institution in federal investigation concerning lending practices.
    • Represented building products manufacturer in internal investigation related to alleged accounting irregularities.

    Areas of Expertise

  • Credentials
    Education
    • Boston College Law School, J.D., 1995
        • magna cum laude
    • Fairfield University, B.A., 1992
        • cum laude
    Bar Admissions
    • District of Columbia
    • Massachusetts
    Accolades
    • Chambers USA, False Claims Act and Litigation: White-Collar Crime & Government Investigations (2022-2026)
    • Legal 500 US, M&A: Commercial Deals and Contracts (2016-2017) 
    • Legal 500 US, Healthcare: Life Sciences (2013, 2016)
    • Legal 500 US, Litigation: White Collar Criminal Defense (2012)

    Areas of Expertise

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