$192.7 million settlement in an Off-label Marketing Fraud case brought by whistleblowers against a major pharmaceutical company under the qui tam provisions of the False Claims Act, was announced by the US DOJ on February 21, 2014. Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve both criminal and civil liability arising from their off-label marketing practices. Endo Pharmaceuticals Inc. has also agreed to implement and maintain a number of enhanced compliance measures.
The drug at issue in the case is Lidoderm, which was approved by the FDA for only the relief of pain associated with post-herpetic neuralgia (PHN), a complication of shingles. The False Claims Act complaint charges that during the period of 2002 to 2006, Endo Pharmaceuticals marketed Lidoderm for the treatment of non-PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome.
Off-label marketing cases are usually challenging cases to make because the relator has to first show that the FDA’s marketing rules were violated and then must show that in doing so the pharmaceutical company violated the False Clams Act. Typically, proof of something more the just off-label marketing is required to help such cases succeed for whistleblowers.
Read More: http://www.justice.gov/opa/pr/2014/February/14-civ-187.html
