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September 24, 2014

Shire Pharmaceuticals LLC agreed to pay $56.5 million to settle charges it violated the False Claims Act through improper marketing and promotion of several drugs used to treat attention deficit hyperactivity disorder (ADHD) and ulcerative colitis  Several former employees will receive a whistleblower award in an undisclosed amount. DOJ

Tagged in: FCA Federal, Off-Label and Unapproved Use, Pharma Fraud, Whistleblower Case, Whistleblower Rewards,

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

Tagged in: FCA State, Medicaid, Off-Label and Unapproved Use, Pharma Fraud,

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

Tagged in: Drug and DME Pricing, FCA Federal, FDA Fraud, Medical Devices and DME, Off-Label and Unapproved Use, Whistleblower Case, Whistleblower Rewards,

June 25, 2014

Ohio-based Omnicare Inc., the country’s largest provider of pharmaceuticals and pharmacy services to nursing homes, agreed to pay $124 million to settle government charges of offering improper financial incentives to skilled nursing facilities in return for their continued selection of Omnicare to supply drugs to their elderly Medicare and Medicaid patients. Donald Gale, former employee of Omnicare Inc., will receive a whistleblower award of roughly $17M from the settlement.  DOJ

Tagged in: Anti-Kickback and Stark, FCA Federal, Pharma Fraud, SNF, Whistleblower Case, Whistleblower Rewards,

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

Tagged in: Off-Label and Unapproved Use, Pharma Fraud,

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

Tagged in: FCA Federal, Off-Label and Unapproved Use, Pharma Fraud, Whistleblower Case, Whistleblower Rewards,

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