By Karen Freifeld
NEW YORK, Feb 21 (Reuters) - Endo Health Solutions Inc will pay $193 million to resolve civil and criminal allegations of unlawful marketing of the pain treatment Lidoderm, the U.S. Justice Department and New York Attorney General Eric Schneiderman said Friday.
Endo was accused of illegally marketing Lidoderm for lower back pain or chronic pain. The U.S. Food and Drug Administration had only approved it for treatment of pain associated with shingles.
The Malvern, Pennsylvania-based company agreed to pay $173 million to U.S. state and federal authorities and about $20 million more in criminal penalties and forfeitures in a deferred prosecution agreement.
“Illegally marketing drugs off-label puts patient lives at risk,” Schneiderman said in a statement.
New York led a team of states in the investigation and subsequent settlement, the statement said.
Endo also agreed to settle its potential civil liability in connection with Lidoderm marketing. The civil settlement resolves three whistleblower lawsuits pending in federal court filed by two former Lidoderm sales representatives and a physician. The whistleblowers’ share of the settlement has not been determined.
“We are pleased to resolve this matter and are confident that we have robust programs in place to assist us in satisfying our legal and regulatory agreements,” Endo’s president and chief executive office, Rajiv De Silva, said in a statement.
As part of the settlement, Endo will enter a corporate integrity agreement with the Department of Health and Human Services Office of Inspector General, designed to avoid or detect similar lapses.