Endo Health Solutions Lidoderm Settlement and Corporate Integrity Agreement, CME Obligations

Endo Health Solutions, Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $171.9 million to resolve civil allegations of marketing their adhesive pain patch Lidoderm for off-label uses. As part of the settlement, Endo will enter into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General.  The Department of Justice (DOJ) announcement states: "[F]rom March 1999 through December 2007, Endo caused false claims to be submitted to federal health care programs…by promoting Lidoderm for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by the federal health care programs." Endo has also agreed to pay $20.8 million to resolve criminal liability. In a deferred prosecution agreement to resolve the charge, Endo admitted to promoting Lidoderm to healthcare providers for unapproved indications. Interestingly, the government press release failed to mention any allegations of kickbacks or false statements at all. These "plus factors" have become staples of off-label settlement announcements. The DOJ announcement focused purely on the fact that Endo promoted its drug for uses not yet approved by the Food and Drug Administration (FDA). Lidoderm was FDA-approved for relief of pain associated with post-herpetic neuralgia ("PHA"), a condition that can affect individuals with a history of shingles. Endo admitted to promoting Lidoderm for lower back pai...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs