Pharmaceutical Company Pays $192.7 Million to Settle Off-Label Marketing Charges

Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) agreed to pay $192.7 million to resolve criminal and civil charges that they marketed unapproved uses of the prescription drug, Lidoderm. Under a deferred prosecution agreement, Endo admitted that they marketed Lidoderm for unapproved indications, and agreed to pay a total of $20.8 million in monetary penalties and forfeiture. Endo also agreed to implement and maintain enhanced compliance measures.

In a separate civil claim, the government alleged that, from March 1999 through December 2007, Endo submitted false claims to Medicaid and other federal health care programs by promoting unapproved uses of Lidoderm that were not covered by those programs. Endo agreed to pay $137.7 million to the federal government and $34.2 million to the states and the District of Columbia, as well as enter into a Corporate Integrity Agreement with the HHS OIG. The civil settlement originates from three whistleblower lawsuits filed by two former Lidoderm sales representatives and a physician. The whistleblowers’ share of the settlement has not been determined.

Read the entire press release, “Endo Pharmaceuticals and Endo Health Solutions to Pay $192.7 Million to Resolve Criminal and Civil Liability Relating to Marketing of Prescription Drug Lidoderm for Unapproved Uses”