Litigation Round-up

Settlements

Sanofi-Aventis reached a settlement in August 2013 with the Maryland Attorney General and other states for alleged violations of federal and state anti-kickback statutes related to its osteoarthritis drug Hyalgan.  The government alleged that Sanofi provided free Hyalgan units with knowledge that doctors could receive Medicaid reimbursement and/or were expected to buy additional quantities of the product.  The settlement also resolves allegations that Sanofi submitted inflated average sales price (ASP) information to the government, resulting in inflated Medicaid reimbursement for Hyalgan in certain states that use ASP to calculate reimbursement rates.

Dakota Laboratories entered into a consent decree of permanent injunction with the Department of Justice on August 26, 2013 that bans the company and its owner from committing violations of the Federal Food, Drug, and Cosmetic Act (FDCA).  The government alleges violations of Food and Drug Administration (FDA) current good manufacturing practices (cGMP) related to the manufacturing of sterile eye drops.  The company, which is not operating currently, received a FDA warning letter in March 2011. 

According to Bloomberg BNA, Pfizer has reached a settlement on September 9, 2013 with a whistleblower, Peter Rost, over 10 years after the original case was filed.  Rost, the former vice president of marketing for Pharmacia Corporation (now part of Pfizer), alleged that Pharmacia engaged in off-label marketing of the human growth hormone Genotropin and paid kickbacks to health care professionals.  After the government declined to intervene in Rost’s qui tam complaint in November 2005, a district court granted Pfizer’s motion to dismiss the complaint.  After subsequent litigation, Rost appealed a lower court’s dismissal of the amended complaint in October 2010.  This settlement resolves the appeal. 

Investigations

A lawsuit by the Louisiana Attorney General against Shire plc, Shire LLC and Shire U.S. Inc. (collectively, “Shire”) was removed to federal court in August 2013.  The government alleges that Shire sold and promoted the drugs Adderall, Adderall XR, Daytrana, Vyvanse, and Intuniv for uses not approved by the FDA, caused the submission of false claims to the government, and falsely reported the “best price” for certain products.

Posted by Sarah K. diFrancesca

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