Will Pay $192.7M to End Criminal & Civil Claims

EndoLogoPharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced Feb. 21, 2014.   The resolution includes a deferred prosecution agreement and forfeiture totaling $20.8 million and civil false claims settlements with the federal government and the states and the District of Columbia totaling $171.9 million.   Endo Pharmaceuticals Inc. is a Delaware corporation headquartered in Malvern, Pa.

“FDA’s drug approval process is designed to ensure that companies market their products for uses that are proven to be safe and effective,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery.   “We will hold accountable those who circumvent that process in pursuit of financial gain.”  

Read the DOJ’s full press release about Endo Pharmaceuticals Lidoderm settlement.

Also read about a recent off-label ruling involving Medtronic. 

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