Pharmaceutical companies Endo Pharmaceuticals and Endo Health Solutions will have to pay $192.7 million to resolve criminal and civil charges related to their marketing policy for the product Lidoderm, under the terms of a settlement reached with the U.S. Department of Justice.
According to a statement from Endo, the Deferred Prosecution Agreement will last for two and a half years and the companies will also be part of a Corporate Integrity Agreement with the U.S. Department of Health and Human Services for a five-year period.
The charges against Endo related to the way Lidoderm — a topical patch used to relieve pain — had been marketed. The product was only approved by the regulator to be used to relieve pain associated with post-herpetic neuralgia but court documents revealed that between 1999 and 2007 Endo promoted it for other purposes as well, including for treatment of lower back problems and chronic pain, which resulted in False Claims Act charges being brought against the company. The case was initiated when whistleblowers from the company reported the breaches, reports said.
Endo's president and chief executive officer, Rajiv De Silva, stated that the company takes its responsibilities to patients and healthcare providers seriously and was pleased to resolve the matter with the U.S. Department of Justice. He added that Endo was implementing programs that would help the company comply with its legal agreements over the years to come.