September 26, 2014

DOJ Catch of the Week — Shire Pharmaceuticals

By the C|C Whistleblower Lawyer Team

This week’s Department of Justice “catch of the week” goes to Shire Pharmaceuticals LLC.  On Wednesday, the Wayne, Pennsylvania based drug maker 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.  See DOJ Press Release.

Specifically, the government alleged, between January 2004 and December 2007, Shire promoted ADHD drug Adderall XR for certain uses without clinical data and overstated the efficacy of the drug.  According to the government, Shire (i) improperly claimed Adderall XR was clinically superior to other ADHD drugs because it would “normalize” its recipients, rendering them indistinguishable from their non-ADHD peers; (ii) improperly claimed it would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease; and (iii) improperly promoted the drug for the treatment of conduct disorder without FDA approval.

The government further charged that, between February 2007 and September 2010, Shire sales representatives and other agents made false, misleading or unsupported statements about the efficacy and “abuseability” of ADHD drug Vyvanse, and that it would prevent car accidents, divorce, arrests and unemployment.  The government also claimed that from April 2006 to September 2010, Shire improperly marketed ADHD drug Daytrana, administered through a patch, as less abuseable than traditional, pill-based medications.  And lastly, the government alleged that between January 2006 and June 2010, Shire promoted colitis drugs Lialda and Pentasa for off-label uses not approved by the FDA and not covered by federal healthcare programs; namely, for the prevention of colorectal cancer.

The federal government will receive roughly $35.7 million of the settlement with state Medicaid programs receiving the balance.  The government’s allegations arose from two whistleblower lawsuit filed under the qui tam provisions of the False Claims Act.  One was filed by Dr. Gerardo Torres, a former Shire executive.  The other was filed by Anita Hsieh, Kara Harris and Ian Clark, former Shire sales representatives.  Dr. Torres will receive a whistleblower award of $5.9 million.

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