The Department of Justice announced that it intervened and reached a settlement in the Endo Pharmaceuticals Inc. Qui Tam Whistleblower lawsuit.
The civil liability in the Endo Pharmaceuticals Qui Tam Whistleblower lawsuit involved Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration (FDA),
In the Endo Pharmaceuticals Qui Tam Whistleblower lawsuit, the government alleged in the lawsuit and stated that:
- that, from March 1999 through December 2007, Endo caused false claims to be submitted to federal health care programs, including Medicaid
- by promoting Lidoderm for unapproved uses, some of which were not medically accepted indications
- were not covered by the federal health care programs
- Of the $171.9 million Endo has agreed to pay to resolve these civil claims, Endo will pay $137.7 million to the federal government and $34.2 million to the states and the District of Columbia
- “Off-label marketing can undermine the doctor-patient relationship and adversely influence the clear and honest judgment of doctors that their patients rely on and trust,” said U.S. Attorney for the Eastern District of Pennsylvania Zane D. Memeger
- Also as part of the settlement, Endo Pharmaceuticals Inc. has agreed to enter into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General
- that requires Endo to implement measures designed to avoid or promptly detect conduct similar to that which gave rise to this resolution.
- Among other things, the CIA requires Endo to implement an internal risk assessment and mitigation program and requires numerous internal and external reviews of promotional and other practices
- The CIA also requires key executives and individual board members to sign certifications about compliance, and it requires the company to publicly report information about its financial arrangements with physicians
- The civil settlement resolves three lawsuits pending in federal court in the Eastern District of Pennsylvania under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery
- The actions were filed by Peggy Ryan, a former Lidoderm sales representative, Max Weathersby, another former Lidoderm sales representative and Gursheel S. Dhillon, a physician
- The private citizens in this action will receive a total of recovery (not yet determined) as their statutory share of the proceeds of this settlement.
Their action was filed under the qui tam provisions of the federal False Claims Act, which permits private citizens to bring lawsuits on behalf of the United States and receive a portion of the proceeds of a settlement or judgment awarded against a defendant.
For more information on Qui Tam Whistleblower lawsuits, click here.
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