Florida Shares in Shire False Claims Act Settlement By Tod Aronovitz | 10/09/14 | 0 Comment

The federal government, along with attorneys general in all 50 states, reached a $56.5 million settlement with Shire Pharmaceuticals to resolve civil allegations that the Pennsylvania-based company violated the False Claims Act through the improper marketing and promotion of several of its drugs, the Justice Department announced.

The allegations resolved in the settlement first arose in two separate qui tam lawsuits filed under the False Claims Act’s whistleblower provisions. Dr. Gerardo Torres, a former Shire executive, will receive $5.9 million as a result. The announcement did not disclose award information for Anita Hsieh, Kara Harris and Ian Clark, former Shire sales representatives who filed the second lawsuit.

Florida will receive more than $900,000 in the overall $20.5 million Medicaid portion of the settlement which resolved accusations that false claims were submitted to government health care programs. According to the office of Florida Attorney General Pam Bondi, this settlement represents “the first national settlement in which Medicaid managed care damages have been calculated and included as part of a recovery.”

The drugs at the center of the allegations were: ADHD medications Adderall XR, Vyvanse and Daytrana, as well as Pentasa and Lialda, approved for the treatment of mild to moderate active ulcerative colitis.

The allegations resolved by the $56.5 million settlement include:

    • The promotion of Adderall XR between January 2004 and December 2007 as clinically superior to other ADHD drugs claiming recipients would be indistinguishable from their non-ADHD peers despite a lack of clinical data to support that claim
    • The promotion of Adderall XR between January 2004 and December 2007 based on unsupported claims that it would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease
    • The promotion of Adderall XR between January 2004 and December 2007 for the treatment of conduct disorder without approval from the Food and Drug Administration (FDA)
    • False and misleading statements allegedly made between February 2007 and September 2010 by sales reps and other agents about the efficacy and “abuseability” of Vyvanse to state Medicaid formulary committees and individual physicians, even though there was no study that supported claims that Vyvanse was not abuseable as an amphetamine product
    • Unsupported claims made by sales reps between February 2007 and September 2010 that treatment with Vyvanse would prevent car accidents, divorce, arrests and unemployment
    • From April 2006 to September 2010, improper marketing of Daytrana, administered through a patch, as being less subject to abuse than traditional, pill-based medications
    • For part of 2006-2010, inappropriately called and drafted letters to state Medicaid authorities to assist physicians with the prior authorization process for prescriptions to induce these physicians to prescribe Daytrana and Vyvanse
    • Promoted Lialda and Pentasa for off-label uses not approved by the FDA and not covered by federal healthcare programs, including the off-label use of Lialda to prevent colorectal cancer and Pentasa for the treatment of Crohn’s disease

“Marketing efforts that influence a doctor’s independent judgment can undermine the doctor-patient relationship and short-change the patient,” said U.S. Attorney Zane David Memeger for the Eastern District of Pennsylvania. “Where children’s medication is concerned, it can interfere with a parent’s right to clear information regarding the risks to the safety and health of their child. Shire cooperated throughout this investigation and, in advance of this settlement, began to correct its marketing activities.”

Shire Pharmaceuticals also reached a corporate integrity agreement with the U.S. Department of Health and Human Services-Office of the Inspector General (HHS-OIG) to address the company’s future marketing efforts.

How to Report Miami Medicare Fraud

Healthcare professionals or medical billing employees who have knowledge of questionable Medicare billing practices can file a confidential legal claim under the False Claims Act. By acting as a “whistleblower” in what is known as a “qui tam” lawsuit, a private party may collect up to 30 percent of the amount recovered, depending on how the case is prosecuted.

ARONOVITZ LAW: Miami Whistleblower / Qui Tam Law Firm

The Miami Qui Tam law firm of ARONOVITZ LAW routinely works with whistleblowers to document Medicare fraud and other forms of fraud against the government. Contact Miami Whistleblower / Qui Tam lawyer Tod Aronovitz to discuss your case.