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Shire Inks $56.5M FCA Settlement Over Adderall Marketing in Goldberg Kohn Case

September 24, 2014
The London Times

Shire PLC agreed Wednesday to shell out $56.5 million to resolve allegations that it violated the False Claims Act through improper marketing and promotion of five drugs intended to treat both attention deficit hyperactive disorder and ulcerative colitis.  The settlement with the U.S. Department of Justice puts to rest claims raised by three Goldberg Kohn clients, as well as another whistleblower, that the company had made claims to prescribers about the uses and benefits of its drugs without proper supporting data.

The case exposed Shire's scheme of using sales representatives to comb through the patient files of child psychiatrists, determine the ones who might be eligible to switch to Shire's new ADHD drug, and then call Medicaid offices to get prior approval for a prescription.  The doctors who participated in the scheme and others who wrote lots of prescriptions for Shire ADHD medication received payments from Shire for riding along with Shire sales representatives on their sales call and for speaking to other doctors.  Shire was also accused of claiming that its ADHD medication Adderall XR would help to prevent certain issues linked to the condition including poor academic performance, criminal behavior, traffic accidents and sexually transmitted disease.

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