CGMP Violation

October 1, 2018

Pharmaceutical distributor AmerisourceBergen Corporation will pay $625 million to the federal government and 43 states to settle claims that between 2001 and 2014 a pre-filled syringe program at one of its subsidiaries, Medical Initiatives, Inc., violated federal law.  Despite lacking the proper licensing and registration, MII opened FDA-approved sterile vials of oncology drugs, and in a non-sterile environment, pooled the medicine and transfered it into non-FDA approved pre-filled syringes which were then sold to oncology practices and physicians.  This practice allowed Amerisource to capture the "overfill" in the original FDA-approved sterile vials and produce a larger number of pre-filled syringes.  AmerisourceBergen also resolved claims that it provided unlawful kickbacks to physicians to induce them to purchase pre-filled syringes rather than vials.  The settlement resolved three qui tam actions initiated by whistleblowers Michael Mullen, Daniel Sypula, Kelly Hodge, and Omni Healthcare, Inc.; a payment of over $93 million will be made to relators. Previously, in September, 2017, AmerisourceBergen Specialty Group pleaded guilty to illegally distributing misbranded drugs and agreed to pay $260 million in criminal fines and forfeitures. USAO E.D.N.Y.;  NY

May 24, 2017

New York announced that 42 states and the District of Columbia have reached a $33 million settlement with Johnson & Johnson and Johnson & Johnson Consumer Inc., resolving allegations that the company’s subsidiary, McNeil-PPC, Inc., employed deceptive practices to market and promote numerous popular over-the-counter (“OTC”) drugs. In addition to reforming these practices, the corporation has agreed to pay New York State a total of $1.3 million. Between 2009 and 2011, McNeil-PPC, Inc.—then a wholly-owned subsidiary of Johnson & Johnson—manufactured and distributed OTC drugs that purported to comply with federally mandated current Good Manufacturing Practices (“cGMP”). However, an investigation conducted by the FDA and Attorneys General across the country revealed that a number of McNeil manufacturing facilities and the medications they produced did not meet the national cGMP standards. NY, NJ, TX, FL

January 12, 2017

Baxter International Inc. subsidiary Baxter Healthcare Corporation agreed to pay roughly $18 million to settle charges of violating the False Claims Act arising from the company's failure to follow current Good Manufacturing Practices when manufacturing sterile drug products in North Carolina. Baxter admitted that it distributed products in interstate commerce that were adulterated in violation of the Federal Food, Drug, and Cosmetic Act FDCA. It will pay a total of $16 million in monetary penalties and forfeiture. It will also pay roughly $2 million to resolve allegations it violated the False Claims Act by submitting false claims to the Department of Veterans Affairs based upon Baxter’s failure to follow cGMPs. The allegations originated in a whistleblower lawsuit under the qui tam provisions of the False Claims Act by Baxter employee Christopher Wall. He will receive a whistleblower award of roughly $432,000 from the proceeds of the government's False Claims Act recovery. DOJ

March 10, 2015

Johnson & Johnson subsidiary McNeil-PPC Inc. pleaded guilty to selling adulterated infants’ and children’s over-the-counter liquid medicines, including Infants’ and Children’s Tylenol Motrin.  As part of the criminal resolution, McNeil agreed to pay a criminal fine of $20 million and forfeit $5 million.  DOJ

February 3, 2015

Medical device maker Atrium Medical Corporation, Maquet Holding B.V. & Co. KG, Maquet Cardiovascular LLC, and Maquet Cardiopulmonary AG were permanently enjoined from distributing adulterated and misbranded medical devices. According to the government, Atrium — which manufactures medical devices for cardiovascular-related uses, including chest drains, surgical meshes, vascular grafts and stent systems — was not complying with the FDA’s current good manufacturing practice requirements for medical devices which are designed to ensure the devices are safe and effective and otherwise in compliance with the federal Food, Drug and Cosmetic Act. DOJ

January 16, 2015

A federal court in California issued an injunction shutting down Health One Pharmaceuticals Inc., a manufacturer of dietary supplements and unapproved new drugs. The firm and its president, Richard S. Yeh, agreed to shut down and resolve the lawsuit as part of a consent decree. The government alleged, among other things, the defendants failed to meet current good manufacturing practices for dietary supplements by failing to conduct appropriate testing and misbranding the supplements because their labels did not include all the information required by federal law. DOJ