Endo Health Solutions & Endo Pharmaceuticals to Pay $192.7 Million in Qui Tam Case Alleging Off-Label Marketing Of Lidoderm Pain Treatment Patches
The Department of Justice announced last week that Endo Health Solutions and its subsidiary, Endo Pharmaceuticals, have agreed to pay $192.7 million to settle healthcare whistleblower allegations of off-label marketing of a pain treatment patch called Lidoderm. The lawsuit was brought under the qui tam provision of the False Claims Act, which allows private whistleblowers to bring claims in the name of the government for fraud of government-funded healthcare programs, such as Medicare and Medicaid. The Lidoderm pain patch was only approved to treat symptoms of Post Herpetic Neuralgia (PHN), a rare disease which is a complication of Shingles, although according to the lawsuit Endo Pharmaceuticals also marketed it for other uses.
Between 2002 and 2006, Lidoderm was approved by the FDA only for the use described above. However, during this time period, some Endo Pharmaceuticals sales managers allegedly provided instructions to sales representatives, outlining how to expand sales conversations with doctors beyond the treatment of PHN and into the treatment of non-PHN related symptoms, including lower back pain, diabetic neuropathy, and carpal tunnel syndrome.
In a deferred prosecution agreement to resolve that charge, Endo Pharmaceuticals admitted that it had intended Lidoderm to be used for the unapproved symptoms noted previously, and that it promoted the drug to health care providers for those symptoms. Under the terms of the agreement, Endo Pharmaceuticals will pay a total of $20.8 million in penalties. Endo Pharmaceuticals further agreed to implement and maintain a number of enhanced compliance measures, including making the results of certain clinical trials available to the public, and requiring an annual review and certification of its compliance efforts by its parent company, Endo Health Solutions.
The whistleblower lawsuit also alleges that Endo Pharmaceuticals caused false claims to be submitted to federal health care programs. By purportedly marketing Lidoderm to doctors for other ailments besides PHN, Endo Pharmaceuticals caused the providers to write prescriptions which were paid for by Medicare and Medicaid. From 1999 to 2007, the government paid hundreds of millions of dollars for Lidoderm prescriptions which were not for the drug’s intended use. 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.
The healthcare whistleblowers in this particular case were two Endo Pharmaceuticals sales persons, and one physician. The whistleblowers’ share of the settlement has yet to be determined. However, under the False Claims Act, qui tam whistleblowers generally are entitled to an award of between 15-25% where, as in this case, the government intervenes and settles the claims.
If you have information concerning a potential qui tam case involved healthcare fraud, do not hesitate to take action. You might be able to bring your own whistleblower lawsuit under the False Claims Act.