A class action lawsuit has been filed against Xanodyne Pharmaceuticals on behalf of people who took the recently recalled Darvocet painkiller, alleging that the drug maker failed to warn about the potential risk of serious and fatal heart problems.
The Darvocet class action lawsuit was filed by Linda Gallagher in U.S. district court in New Orleans, alleging that the medication caused her to suffer a heart attack. The suit seeks class action status on behalf of other similarly situated former users of Darvocet.
Last month, a Darvon and Darvocet recall was issued after the FDA determined that propoxyphene-based painkillers may increase the risk of potentially fatal heart rhythm abnormalities. The medications were also previously linked to a risk of overdose and suicide. All generic Darvocet and generic Darvon versions of propoxyphene were also recalled.
According to allegations raised in the complaint, Xanodyne Pharmaceuticals violated the Food, Drug and Cosmetic Act by creating a drug that could cause significant harm to users. The lawsuit also charges the company with failing to warn doctors and consumers about the potential side effects of Darvocet and Darvon.
Gallagher, the proposed lead plaintiff, claims to have suffered two heart attacks since being prescribed Darvocet in 2007, and blames her heart problems on the drug. The lawsuit is seeking compensatory damages, medical monitoring fees, court costs and attorney fees for everyone included in the class action.
Darvocet is a popular painkiller that combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol. Darvon was first introduced in 1957, with propoxyphene designed to relieve mild to moderate post-surgical pain. In recent years, Darvocet has grown to become one of the 25 most commonly prescribed medications, with more than 22 million people receiving the painkiller.
Various groups have been calling for a recall of Darvocet and Darvon for years, with the first petition for the FDA to ban the medications filed in 1978. The prominent consumer group Public Citizen has suggested that Darvon and Darvocet side effects likely resulted in between 1,000 and 2,000 additional deaths in the United States since the time the medication was banned in the U.K. in 2005.