By Karen Freifeld
NEW YORK Feb 21 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
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
"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
"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.