Endo to pay $192.7M in Lidoderm off-label marketing

Posted: February 23, 2014

Malvern-based Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. have agreed to pay $192.7 million to resolve allegations of off-label marketing of the prescription pain patch Lidoderm for uses not approved by the Food and Drug Administration, the U.S. Justice Department said Friday.

Endo will pay $171.9 million to states and the federal government and $20.8 million in criminal forfeiture and fines.

Of the $171.9 million, $137.7 million will go to the federal government and $34.2 million to all states (except Texas, Louisiana, and Arizona) and the District of Columbia.

Pennsylvania's share will be $1.6 million, state Attorney General Kathleen Kane said.

The civil settlement resolved three lawsuits in federal court in the Eastern District of Pennsylvania under the qui tam, or whistle-blower, 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 whistle-blower actions were filed by Peggy Ryan and Max Weathersby, former Lidoderm sales representatives, and Gursheel S. Dhillon, a physician. The whistle-blowers' share of the settlement has not been determined, the government said.

"Pharmaceutical companies have a legal obligation to promote their drugs for only FDA-approved uses. This obligation takes precedence over the company's bottom line," said Zane David Memeger, U.S. attorney for the Eastern District of Pennsylvania.

The criminal case was handled by the U.S. Attorney's Office for the Northern District of New York and the Civil Division's Consumer Protection Branch.

In a criminal information filed Friday in the Northern District, the government alleged that between 2002 and 2006, Endo distributed Lidoderm for unapproved treatment of lower-back pain and chronic pain, diabetic neuropathy, and carpal tunnel syndrome. Lidoderm was approved only to relieve post-herpetic neuralgia pain, a complication of shingles.

The government alleged that between March 1999 and December 2007, Endo submitted false claims to federal health care programs, including Medicaid, by promoting Lidoderm for unapproved medical uses not covered by federal health-care programs.



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