The Sheller whistleblower team announced a $58.9 milllion settlement with Shire Pharmaceuticals over off-label marketing of ADHD drugs Adderall and Vyvanse in September, 2014.

Court documents detailing the civil allegations and settlement were signed by Shire and unsealed by the Office of the United States Attorney for the Eastern District of Pennsylvania.

A Shire executive, the whistleblower in the case, contacted attorney Stephen Sheller who filed a qui tam complaint with the U.S. Attorney’s Office in 2008. The court settlement documents list the whistleblower’s allegations that Shire submitted fraudulent claims to government healthcare programs while engaging in off-label marketing attention-deficit hyperactivity disorder (ADHD) drugs Adderall XR, Vyvanse, and Daytrana for FDA unapproved uses in children. Government prosecutors said that Shire made unsubstantiated claims that Adderall XR and the other drugs would help prevent “certain issues linked to ADHD” including poor academic performance, car accidents, divorce, loss of employment, criminal behavior and arrest and sexually transmitted disease. (1)

Sheller, assisted by Sheller, P.C. attorneys including former assistant U.S. Attorney Joseph Trautwein, worked with the whistleblower to prepare the case, submit evidence and file the complaint under seal with the government according to court documents.

ADHD is a chronic condition in children and adults, according to the Mayo Clinic, marked by difficulty sustaining attention, hyperactivity and impulsive behavior that can affect the ability to function in everyday life. Experts at Mayo say that treatment will not cure the condition, but that it can help with the symptoms. The FDA cautions doctors and patients, however, on their approved labeling of Adderall and Vyvanse. Both have a “Black Box Warning,” with Adderall’s stating “Amphetamines have a high potential for abuse; prolonged use may lead to dependence. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse reactions.”  TheVyvanse label adds the statement “Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence.”

The settlement documents allege that Shire also claimed their drug Vyvanse was not “abuseable.” The Department of Justice in the court documents say Shire sales representatives “made false and misleading statements about the efficacy and ‘abuseability’ of Vyvanse” despite no supporting clinical data, to avoid requirements for prior authorization” for “abuseable” drugs as set by the government health program Medicaid.

The court documents indicate the government also found that pharmaceutical company employees “knowingly and improperly made phone calls and drafted letters to Medicaid to assist physicians” with prior authorization policies that “may only be requested by health care providers and their staff.” The documents continue with more details, that the Shire sales representatives “failed to disclose they worked for Shire” when contacting Medicaid to “induce the physicians to prescribe Vyvanse paid for by Medicaid.”

Further allegations by government prosecutors include that Shire marketed Lialda, an FDA approved drug for ulcerative colitis, as more effective than other medications and that the drug “would induce ‘complete remission’” of the condition despite a lack of clinical data to support such a claim. Shire’s Pentasa, another drug for disruptive digestive conditions, was, according to the court documents, promoted by the drug manufacturer as a treatment for Crohn’s disease and indeterminate colitis, which were not FDA approved uses of the drug.

The settlement was achieved through the coordinated efforts of the Sheller attorneys and the U.S. Department of Justice and U.S. Attorney’s Office for the Eastern District of Pennsylvania including Assistant U.S. Attorneys David Degnan and Paul Kaufman, and Natalie Priddy of the Department of Justice Civil Frauds Division.

The lawsuit is captioned United States ex rel. Torres et al. v. Shire Specialty Pharmaceuticals et al., No. 08-4795 (E.D. Pa.). The final settlement agreement is available on the U.S. Department of Justice website.

About Stephen A. Sheller and Sheller, P.C.

Sheller, P.C. represents plaintiffs injured by defective drugs, devices, and consumer products nationwide as well as whistleblowers reporting corporate and government fraud. Founded by Stephen A. Sheller and in practice since 1977, Sheller, P.C. has challenged some of the largest corporations in the United States, including pharmaceutical and medical device companies, auto, tobacco and others.

The firm’s off-label marketing and federal and state False Claims Act qui tam whistleblower cases have recovered more than $6.3 billion for the U.S. Government and taxpayers to date, including some of the largest in U.S. history.(Verdicts and settlements as listed below, 1,2,3,4,5,6)

Cases cited

(1) United States ex rel. Torres et al. v. Shire Specialty Pharmaceuticals et al., No. 08-4795 (E.D. Pa.)
(2) United States ex. rel. Starr, et al. v. Janssen Pharmaceutica Prods., L.P., No. 04-1529
(3) United States ex. rel. Rudolph, et al. v. Eli Lilly and Company, No. 03-943
(4) United States ex. rel. Rainero, et al. v. Pfizer, Inc., No. 07-11728
(5) United States ex. rel. Wetta, et al. v. AstraZeneca Corp., No. 04-0379
(6) United States ex rel. Gavin v. Sarasota Pain Associates, P.A. and Steven Y. Chun, M.D., 6:11-cv-583-T-23TBM (M.D. Fla. 2014)