Shire Pharmaceuticals Settles for $56.5 Million to Resolve False Claims Act Allegations Over ADHD Drugs

The Justice Department announced last week that pharmaceutical company Shire Pharmaceuticals LLC will pay $56.5 million to resolve civil allegations that it violated the False Claims Act as a result of its marketing and promotion of several products, including ADHD drugs Adderall XR and Vyvanse.  The allegations arose from a lawsuit filed by Dr. Gerardo Torres, a former Shire executive, and a separate lawsuit filed by Anita Hsieh, Kara Harris, and Ian Clark, former Shire sales representatives.  The lawsuits were filed under the False Claims Act’s whistleblower provisions, which permit private parties to sue on behalf of the government and share in any recovery. DOJ notes that Torres will receive $5.9 million.   The complaints alleged that between January 2004 and December 2007, Shire advertised that their ADHD medication could turn children into better students. “There is no evidence to support the claim that these drugs lead to improved grades in school,” argued Stephen Sheller, an attorney representing the whistleblower. Joseph Trautwin, another whistleblower attorney on the case stated that “another claim Shire made was saying their drug Vyvanse was non-abusable. That turned out not to be true. It turned out that kids could abuse the drugs, and were doing so.” The government contended that no study Shire conducted had concluded that Vyvanse was not abuseable, and, as an amphetamine product, the Vyvanse label included an FDA-mandated black ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs