Contact

Click here for a confidential contact or call:

1-212-350-2764

FDA Fraud

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

Page 2 of 3

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

Is The FDA Ready For Kim Kardashian And Mutant Head Lice?

Posted  08/31/15
(published on the Huffington Post blog) A pharmaceutical company was recently reprimanded by the FDA for its misleading marketing tactics on an unexpected forum—Kim Kardashian's Instagram feed.  The new mother's failure to address the full safety profile of morning sickness drug, Diclegis, prompted the FDA to issue a warning letter to the drug's manufacturer.  This sort of enforcement is representative of the...

Is the FDA Ready for Kim Kardashian and Mutant Head Lice?

Posted  08/28/15
Huffington Post (August 28, 2015). Click here to read the article.

Does the FDA Hide Evidence of Clinical Fraud?

Posted  02/13/15
By Marlene Koury The FDA protects the public health and assures all drugs are proven safe and effective by reputable scientific trials before they are licensed for sale.  Or do they?  An investigative reporting class at NYU found evidence showing when the FDA finds scientific fraud or misconduct, it does not notify the public, doctors, or the scientific community.  Rather, the FDA "has shown a pattern of burying...

DOJ Catch of the Week – Vascular Solutions

Posted  08/1/14
By the C|C Whistleblower Lawyer Team This week's Department of Justice "catch of the week" goes to Vascular Solutions Inc (VSI).  On Monday, the Minneapolis-based medical device maker agreed to pay $520,000 to resolve allegations that it violated the False Claims Act by marketing a product for sealing veins without FDA approval.  Specifically, the government charged that VSI marketed and sold its "Vari-Lase...

July 28, 2014

Vascular Solutions Inc (VSI), a Minneapolis-based medical device maker, agreed to pay $520,000 to resolve allegations that it violated the False Claims Act by marketing a product for sealing veins without FDA approval.  Specifically, the government charged that VSI marketed and sold its "Vari-Lase Short Kit" for treating perforator veins (which run deep in the leg muscle) even though the FDA approved the device only for treating surface (or superficial) veins.  DeSalle Bui, a former sales representative of VSI, will receive a whistleblower award in an undisclosed amount.  DOJ

Another Bad Report Card for the Beleaguered FDA

Posted  11/29/12
By Gordon Schnell The Food and Drug Administration (FDA) admittedly has a lot on its plate.  Tasked with regulating the country’s food and medicine supply, not to mention the ever-evolving array of medical devices and procedures, the FDA is the federal agency perhaps most responsible for ensuring our health and well-being.  If the agency does not perform up to task, a lot of people are affected.  So it is no...

Newsletter

Subscribe to receive email updates from the Constantine Cannon blogs

Sign up for: