A wrongful death lawsuit over Darvocet has been filed by the widow of a Tennessee man who died due to sudden heart problems that were allegedly caused by the recently recalled painkillers.
Cornelius Kellehar died on November 2, just days before the FDA issued a Darvon and Darvocet recall, according to a complaint filed by his wife, Mary Ann Kellehar, on January 13 in the U.S. District Court for the Western District of Tennessee against Xanodyne Pharmaceuticals.
Kellehar was prescribed Darvon and Darvocet on July 30, 2010, for pain management. He used the painkillers until he died due to sudden heart problems, according to the lawsuit.
The complaint alleges that the manufacturer, Xanodyne Pharmaceuticals, knew or should have known that Darvon and Darvocet side effects increase the risk of potentially fatal heart rhythm problems and failed to warn doctors and patients about potential health risks.
Darvon was first introduced in 1957, containing propoxyphene to relieve mild to moderate post-surgical pain. Before the recall, it was most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol.
Darvocet was one of the 25 most commonly prescribed medications, which has been prescribed to more than 22 million people. In 2009 alone, 10 million people received a prescription for some kind of propoxyphene-based drug.
A recall of Darvocet and Darvon was issued on November 19, after the FDA determined that propoxyphene-based painkillers may increase the risk of fatal heart rhythm abnormalities, including heart arrythmia.
Some say that there have been warning signs that Darvon and Darvocet caused heart problems and an increased risk of death for decades. In 1978, the FDA was petitioned to issue a Darvocet and Darvon recall. A second petition was filed in 2006, which included indication that the medication may cause heart rhythm abnormalities. In 2009, an FDA advisory panel also recommended that the drugs be recalled due to the risks of suicide, overdose and heart rhythm problems.
However, the FDA allowed the painkillers to remain on the market while the manufacturer conducted additional studies to review the impact of Darvon and Darvocet on the heart. After preliminary results from this study showed that Darvon and Darvocet cause cardiac rhythm abnormalities in otherwise healthy volunteers when used at the maximum approved dose, federal regulators determined that the risk of sudden heart death from Darvocet and Darvon outweighed any potential benefits provided by the drugs over other available painkillers.
Since the recall, a growing number of individuals throughout the United States have filed a Darvon lawsuit or Darvocet lawsuit against Xanodyne Pharmaceuticals as a result of sudden and sometimes fatal heart problems that were allegedly caused by the drugs.
Last month, a Motion was filed with the U.S. Judicial Panel on Multidistrict Litigation seeking to have the Darvon and Darvocet litigation centralized before one judge for pretrial proceedings as part of a multidistrict litigation, or MDL. Xanodyne Pharmaceuticals has opposed the consolidation, saying that the health issues of each plaintiff represent significant differences from one case to the other. The MDL Panel will likely hear oral arguments on the Motion in March.