A settlement has been reached in a whistleblower class action lawsuit brought against Endo Health Solutions Inc and its subsidiary Endo Pharmaceuticals Inc who are accused of marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration (FDA).
Of the $171.9 million Endo has agreed to pay to resolve these civil claims, Endo will pay $137.7 million to the federal government and $34.2 million to the states and the District of Columbia. The share of the settlement that is awarded to the whistleblowers has not been determined.
The first lawsuit was filed in 2005. The sereis of cases alleged that Endo Pharmaceuticals Inc, between 2002 and 2006, introduced into interstate commerce Lidoderm that was misbranded under the Federal Food, Drug and Cosmetic Act (FDCA). During the period of 2002 to 2006, Lidoderm was approved by the FDA only for the relief of pain associated with post-herpetic neuralgia (PHN), a complication of shingles. The information alleges that, during the relevant time period, the Lidoderm distributed nationwide by Endo Pharmaceuticals Inc. was misbranded because its labeling lacked adequate directions for use in the treatment of non-PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome. These uses were intended by Endo Pharmaceuticals Inc. but never approved by the FDA. The information further alleges that certain Endo Pharmaceuticals Inc. sales managers provided instruction to certain sales representatives concerning how to expand sales conversations with doctors beyond PHN and encouraged promotion of Lidoderm in workers’ compensation clinics.
If you have a similar case please fill out the form below or email mail@whistleonfraud.com or call: 619 - 866 – 6157
OR
If you or someone you know experienced a similar situation or any other wrongdoing within a corporation you should contact mail@whistleonfraud.com or call: 619 - 866 – 6157
