• 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 Astellas Pharma U.S. Inc. 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.