Wyeth Pharmaceuticals Settles Off-label Marketing Allegations for $490.9 Million

Wyeth Pharmaceuticals Inc., (Wyeth) acquired by Pfizer Inc. in 2009, entered a $490.9 million settlement with the United States government that resolved criminal and civil liability arising from the off-label marketing of it immunosuppressive drug Rapamune.

Under the Federal Food, Drug and Cosmetic Act (FDCA), when a pharmaceutical company developes a product it must indicate the specific use of the product in its new drug approval application submitted to the U.S. Food and Drug Administration (FDA).  Once the FDA approves the product for the specific use, a company may not market the drug for any other uses, unless if recieves FDA approval for such new use. The FDA, in 1999, approved Wyeth’s Rapamune for the limited use in renal (kidney) transplant patients and required the drug’s label to include a warning against certain uses.

Under the government’s criminal information, it alleged that Wyeth trained its national Rapamune sales force to promote the drug for use with non-renal transplant patients. Or in other words to promote the use of Rapamune for uses other than its specific FDA approved use.  According to the information Wyeth also supplied its sales force with training materials regarding the off-label use of Rapamune and how to use such materials in presentations to transplant physicians.  Wyeth provided its sales force with financial incentives to target all transplant patients with the goal of increasing Rapamune sales. Sanford Coats, U.S. Attorney for the Western District of Oklahoma characterized Wyeth’s training of its sales forceon the off-label promotions of Rapamune as “a systemic, corporate effort to seek profit over safety.”

Wyeth pleaded guilty to the criminal information that charged it with a misbranding violation under the FDCA.  Wyeth was charged with a criminal fine and forfeiture of $233.5 million.  Wyeth concurrently settled civil allegations with the federal and state governments totalling $257.4 million.  The government under the civil settlement alleged that from 1998 through 2009, Wyeth promoted Rapamune for unapproved uses, some which were not medically accepted indications and, therefore, were not covered by Medicare, Medicaid and other federal health care programs.  The unapproved uses included promoting Rapamune for non-renal transplants, converting patients from other immunosuppressant drugs to Rapamune, and using Rapamune in combination with other immunosuppressive agents not included on Rapamune’s FDA approved label.  This conduct resulted in false claims being submitted to the federal and state health care programs.  Wyeth in settling these allegations will pay the federal government $230, 112, 596 and the state governments will recieve $27,287,404.

This civil settlement resovles two qui tam cases filed which included these allegations.  The first action was filed by former Rapamune sales representative Marlene Sandler, and pharmacist Scott Paris.  The second qui tam was filed by former Rapamune sales reprsentative Mark Campbell.  At the time of the Department of Justice’s announcement on July 30, 2013, the whistleblowers had not resovled the amount of their share of the total settlement.

 

Posted in False Claims, Federal False Claims Act, Healthcare Fraud, Off-Label Marketing, Qui Tam, Settlements, State False Claims ActsNo Comments


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