“Failing to adhere to the safety and marketing standards put in place by the FDA can cause enormous risk to patients,” says Christopher Paulos, an attorney with the Levin, Papantonio law firm who practices in the areas of product liability, bad drug and False Claims Act litigation. “But time after time companies continue to put their own gains, their profits, before the safety and well-being of patients and consumers.”
Last Friday, the Department of Justice announced that the pharmaceutical health companies Endo Pharmaceuticals and Endo Health Solutions would pay $192.7 million in order to resolve both criminal and civil charges over the companies’ marketing of Lidoderm.
Lidoderm is a topical patch used to relieve pain. Once applied it will cause numbing or loss of feeling in the area of the body to which it is applied. The product is often used with surgery and in treatment of emergency heart rhythm problems. The product was only approved by the FDA for the relief of post-herpetic neuralgia (PHN).
A large portion of the settlement is responding to False Claims Act charges. In court documents, the government alleged that from March 1999 through 2007 Endo promoted Lidoderm for off-label uses. The propagation of Lidoderm for unapproved uses caused federal health care programs to pay false claims.
“The safety and efficacy of drugs must be shown by science, not sales pitches, “said U.S. Attorney for the Northern District of New York Richard S. Hartunian. “Drugs marketed for intended uses not approved by the FDA are misbranded because their labeling lacks adequate directions for those uses.”
“Endo clearly put their profits first with Lidoderm,” Mr. Paulos added. “That misalignment of priorities could have put patients’ health at risk.”
The lawsuit was originally filed under the qui tam or whistleblower provision of the False Claims Act. The False Claims Act allows individuals to file suit against an entity that is alleged to have submitted false claims for payment to the government. Peggy Ryan, a former sales representative, Max Weathersby, a former sales representative, and Gursheel S. Dillion, a doctor, filed the whistleblower lawsuit against Endo. Their respective shares of the settlement have not yet been determined.
“Whistleblowers are a vital part of the ongoing efforts to combat corruption and stop the theft of taxpayer funds,” said Paulos. “For their efforts, it is important that they are compensated and protected.”