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Off-Label and Unapproved Use

This archive displays posts tagged as relevant to off-label marketing and prescribing of pharmaceuticals and medical devices. You may also be interested in our pages:

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August 6, 2014

New York Attorney General Eric T. Schneiderman announced he, along with 40 other state Attorneys General and the District of Columbia, reached a $35M settlement with Pfizer arising from alleged improper marketing and promotion of the immunosuppressive drug Rapamune. New York’s share of the settlement is over $1.7M. Pfizer, as parent of Wyeth Pharmaceuticals Inc., agreed to be bound by the judgment and to resolve allegations that Wyeth unlawfully promoted Rapamune. Attorney General Schneiderman’s office served on the Executive Committee of this multi-state investigation. NYAG

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

June 4, 2014

New York Attorney General Eric T. Schneiderman announced he, along with 43 other State Attorneys General and the District of Columbia, reached a $105M settlement with GlaxoSmithKline, LLC (GSK) arising from alleged improper marketing and promotion of the asthma drug Advair and the anti-depressant drugs Paxil and Wellbutrin. New York’s share of the settlement is over $4.1M. NYAG

April 16, 2014

Drug manufacturer Astellas Pharma US agreed to pay $7.3 million to resolve allegations it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use when the drug did not have FDA approval for such use.  The allegations were first raised in a qui tam lawsuit filed by Frank Smith, a former Astellas sales representative, under the whistleblower provisions of the False Claims Act.  He will receive a whistleblower award of $708,852.  DOJ

Stiff Amgen Fine Shows No Slowing Down in Government Prosecution of Off-Label Marketing

Posted  12/20/12
By Gordon Schnell It was only two weeks ago that the Second Circuit Court of Appeals came down with its groundbreaking decision in U.S. v. Caronia.  In a 2-to-1 ruling by a three-judge panel, the appeals court overturned the conviction of a drug company sales representative for promoting a prescription drug for uses not approved by the FDA.  The majority reasoned that banning such off-label marketing violated the...

The Fraud Behind the Fraud of Off-Label Drug Marketing

Posted  10/5/12
By Gordon Schnell It has been one of the most common means for drug companies to get around what can be the very rigorous and time-consuming process of securing FDA approval for selling drugs.  That is, taking drugs that the FDA has approved as safe and effective for one particular use and marketing them to the medical community and the public for an entirely different set of uses.  This so-called off-label...
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