Shire Pharmaceuticals has agreed to pay the U.S. $56.5 million to settle two whistleblower lawsuits filed by former employees of the company who alleged the company illegally marketed several drugs for unapproved, off-label purposes and then billed Medicare, Medicaid, and other taxpayer-funded health care programs for them.
Dublin, Ireland-based Shire operates in the U.S. out of its facility in Wayne, Penn. The company makes and markets Adderall XR, Vyvanse, and Daytrana, which are approved for the treatment of attention deficit hyperactivity disorder (ADHD), and Pentasa and Lialda, which are approved for the treatment of mild to moderate ulcerative colitis.
The settlement resolves allegations that between January 2004 and December 2007, Shire promoted Adderall XR for uses not approved by the U.S. Food and Drug Administration (FDA), such as conduct disorder and other uses. The company also marketed the drug with unsupported claims that it would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents, and sexually transmitted disease. No clinical data exists to support those claims.
The settlement also settles allegations that, between February 2007 and September 2010, Shire sales representatives and other agents allegedly made false and misleading statements about the efficacy and “abuseability” of Vyvanse to state Medicaid formulary committees and to individual physicians.
The lawsuit also claimed that between April 2006 to September 2010, Shire representatives improperly marketed Daytrana, administered through a patch, as less abusable than traditional, pill-based medications.
The whistleblowers also alleged that between January 2006 and June 2010, Shire sales representatives also promoted Lialda and Pentasa for off-label uses not approved by the FDA and not covered by federal health care programs. One such claim the company made was that Lialda prevented the development colorectal cancer.
The allegations were brought against Shire in a lawsuit filed by Gerardo Torres, a former Shire executive, and in a separate lawsuit filed by former Shire sales representatives Anita Hsieh, Kara Harris, and Ian Clark. The plaintiffs filed the lawsuits under the False Claims Act’s whistleblower provisions, which permit private parties to sue for false claims on behalf of the government and to share in any recovery. The whistleblowers in this case will share a reward of $5.9 million.