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FDA Fraud

This archive displays posts tagged as relevant to fraud on the FDA. You may also be interested in our pages:

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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

What Would You Do? Disgrace and Conflicts in Medical Clinical Studies

Posted  09/18/18
By Jessica T. Moore
The fall and resignation of the renowned Chief Medical Officer and physician-in-chief of Memorial Sloan Kettering Cancer Center, researcher Dr. Jose Baselga, once again sound the alarm of questionable ethics, conflicts of interest, and integrity in clinical studies. Dr. Baselga is known as one of the world’s top cancer doctors, credited with new, life-saving therapies. Drug companies sponsor interested researchers (like Dr. Baselga) and related institutions (Sloan Kettering) to conduct...

AstraZeneca Settles Seroquel False Claims Action -- Again

Posted  08/9/18
AstraZeneca
On August 8, 2018, AstraZeneca agreed to pay $110 million to the state of Texas to settle allegations that it promoted two of its drugs without FDA approval resulting in health risks to children, adolescents, and other state hospital patients. This case was brought by two whistleblowers under the qui tam provisions of Texas’s Medicaid Fraud Prevention Act. The whistleblowers, two former AstraZeneca employees, among them a sales representative, first...

Supreme Court Considers Revisiting Key FCA Decision

Posted  04/17/18
By the C|C Whistleblower Lawyer Team Yesterday, the justices asked the Trump Administration’s Office of the Solicitor General’s views on a petition for certiorari in United States ex rel. Campie v. Gilead Scis., a

September 22, 2017

Aegerion Pharmaceuticals Inc., the Massachusetts-based subsidiary of Novelion Therapeutics Inc., agreed to plead guilty to charges relating to its prescription drug Juxtapid.  Specifically, Aegerion introduced Juxtapid into interstate commerce that was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy.  Aegerion agreed to pay more than $35 million to resolve criminal and civil liability arising out of violations of the False Claims Act and Federal Food, Drug, and Cosmetic Act.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Aegerion former employees Michele Clarke, Tricia Mullins, and Kristi Winge.  They will receive a whistleblower award of $4.7 million from the proceeds of the government's recovery. DOJ

September 5, 2017

Novo Nordisk Inc. agreed to pay $58.65 million to settle charges it violated the False Claims Act and Food, Drug, and Cosmetic Act by failing to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza.  The New Jersey based pharmaceutical manufacturer is a subsidiary of Denmark’s Novo Nordisk A/S.  At the time of Victoza’s FDA approval in 2010, the FDA required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug. Under the REMS, Novo Nordisk was required to disclose to physicians the potential risk. If it failed to comply with these disclosure requirements, including requirements to communicate accurate risk information, the drug would be considered misbranded under the law.  According to the government, Novo Nordisk failed to comply with the REMS requirements, providing information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant.  The allegations originated in several whistleblower lawsuits filed under the qui tam provisions of the False Claims Act. The whistleblowers who brought these actions will receive a yet-to-be-determined whistleblower award from the proceeds of the government’s recovery. Whistleblower Insider

Aegerion Pharmaceuticals Will Pay More Than $40 Million to Resolve Investigations Into Its Marketing and Sales Practices

Posted  09/25/17
Aegerion Pharmaceuticals will plead guilty to charges concerning its prescription drug, Juxtapid, the Department of Justice announced on Friday.  According to the Justice Department’s press release: Aegerion introduced Juxtapid into interstate commerce that was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy (REMS).  The resolution also includes a deferred prosecution agreement relating to criminal liability under the Health Insurance Portability and Accountability...

DOJ Catch of the Week -- Novo Nordisk Inc.

Posted  09/8/17
By the C|C Whistleblower Lawyer Team This week's Department of Justice "Catch of the Week" goes to Novo Nordisk Inc. On Tuesday, the company agreed to pay $58.65 million to settle charges it violated the False Claims Act and Food, Drug, and Cosmetic Act by failing to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza. The New Jersey based pharmaceutical manufacturer...

Ninth Circuit Finds Materiality in the Face of Continued Government Payment

Posted  07/14/17
By Rosie Dawn Griffin Earlier this month, the U.S. Court of Appeals for the Ninth Circuit revived United States ex rel. Campie v. Gilead Scis., a False Claims Act (FCA) suit against pharmaceutical giant Gilead Sciences and, in doing so, provided the qui tam bar with additional guidance on how the lower courts will interpret the Supreme Court’s emphasis on materiality in Universal Health Services, Inc. v. United States ex rel. Escobar. The suit, brought...

July 15, 2016

A Minnesota federal court entered a permanent injunction against Kwong Tung Foods Inc. (dba Canton Foods) to prevent the distribution of adulterated noodles and sprouts.  The government charged the company with violating the Food, Drug and Cosmetic Act by preparing and packaging the company's food products under insanitary conditions.  DOJ
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