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FDA Fraud

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

Posted  09/18/18
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...

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...

Supreme Court Considers Revisiting Key FCA Decision

Posted  04/17/18
Supreme CourtBy 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 False Claims Act (FCA) suit against pharmaceutical giant Gilead Sciences. The suit, which was brought by two former Gilead employees turned whistleblowers, alleges the company made false statements...

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...

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...

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....

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

June 26, 2015

Charlie Chi, the former president and CEO of OtisMed Corporation, was sentenced to two years in prison and to pay a $75,000 fine for intentionally distributing a medical device used in knee replacement surgery after its application for marketing clearance had been rejected by the Food and Drug Administration.  In September 2014, OtisMed, now a subsidiary of Stryker Corporation, was sentenced to a criminal fine of $34.4 million and ordered to pay $5.16 million in criminal forfeiture for this conduct.  In a related civil settlement, OtisMed agreed to pay approximately $41.2 million to resolve its civil liability for submitting false claims to the Medicare, TRICARE, Federal Employees Health Benefits and Medicaid programs.  DOJ