A 31-year-old New York woman says Darvocet, one of two painkillers recalled by Xanodyne Pharmaceuticals last month, caused her to suffer a near-fatal heart arrhythmia. She is now suing the drug maker in federal court.
Darvocet is made with Propoxyphene and acetaminophen. Propoxyphene is an opiod painkiller that was already known to be highly addictive. In November, the US Food & Drug Administration (FDA) announced that Xanodyne Pharmaceuticals Inc. had agreed to pull the Darvocet, as well as Darvon (Propoxyphene alone) because of their association with heart rhythm problems. The agency said it was also asking the manufacturers of generic Propoxyphene-containing products to remove those products from the market.
According to the complaint, prior to using Darvocet the Plaintiff did not have a pre-existing cardiac history and had never suffered a cardiac arrhythmia. Shortly thereafter, she experienced a near fatal cardiac arrhythmia as a result of taking Darvocet. The plaintiff was forced to undergo painful electrocardioversion and numerous other invasive cardiac procedures including cardiac ablation. The lawsuit alleges that because of her use of Darvocet, the Plaintiff sustained severe, permanent and life threatening personal injuries, pain, suffering, emotional distress, lifelong fear of premature death and the need for continued lifelong cardiac monitoring, treatment and medications.
The complaint (Index No. 10-5737), which was filed in U.S. District Court for the Eastern District of New York and assigned to Judge Weinstein, accuses Xanodyne Pharmaceuticals of negligence and fraud in not acting sooner to recall the drug.
“This is a classic case of a company that put profits before safety and that point is made crystal clear in the Xanodyne website, which repeatedly highlights the company’s goal of maximizing its profits by taking shortcuts in research and product development,” Matthew J. McCauley, an attorney with Parker Waichman LLP, the national law firm that filed the suit on behalf of the Plaintiff. “In July 2009, they again delayed the removal of the Darvocet from the market, only to see it removed in November 2010 for the same concern the FDA expressed then.”
The New York Darvocet lawsuit alleges that up until the market withdrawal, Xanodyne continued to ignore the correlation between the use of Darvocet and the increased risk of developing potentially fatal heart arrhythmias, despite the wealth of scientific and medical evidence available.