update Darvocet Lawsuits Illustrate Debate Over FDA Effectiveness

As the Darvon and Darvocet lawsuits against Xanodyne Pharmaceuticals unfold, they draw into focus the debate over how well United States public health is protected by its regulatory agencies. On the one hand, it was new powers given to the Food and Drug Administration (FDA) that allowed it to order Xanodyne (the company that sells and distributes Darvon and Darvocet) to conduct a postmarket evaluation of the safety of propoxyphene (the active ingredient in Darvon and Darvocet). Critics, however, maintain that the FDA is ineffectual and allowed propoxyphene, which has been responsible for thousands of deaths, to remain on the market far too long.

Prior to September 2007, the FDA had limited authority to monitor a drug’s safety after the agency initially approved it for sale. But a new bill signed into law by President Bush on September 27, 2007, granted the FDA the authority to order safety evaluations of a drug anytime after it goes to market. Exercising this power in 2009, the FDA made Xanodyne Pharmaceuticals conduct a study of propoxyphene’s cardiac safety. The study found that even when taken at prescribed doses by healthy patients, the drug could cause potentially fatal heart rhythm abnormalities, which led the FDA to conclude that the synthetic opiate’s risks outweighed its benefits and to order its complete market withdrawal.

While the new FDA powers that led to Darvon’s and Darvocet’s recall may appear to be a triumph for U.S. public safety, this view fails to take into account decades of FDA inaction on propoxyphene despite considerable evidence that the drug was extremely dangerous. Sidney Wolfe, who directs the health research group Public Citizen (which twice petitioned for a propoxyphene ban) calls the study ordered by the FDA in 2009 “a pitiful exercise” that resulted in propoxyphene’s remaining on the market even longer. “We had originally petitioned the FDA 32 years ago to ban (propoxyphene-based drugs),” said Wolfe, whose group has asked for a Congressional investigation into what it perceives as a belated ban of the substance.

Recently, the FDA was granted new powers to order mandatory food recalls, and legislation has been introduced that would give the agency authority to do the same with drugs. As for Xanodyne, the potential liability it faces from lawsuits is the biggest question mark for the company. There are past examples of companies failing due to the cost of settling claims, a fate that Xanodyne obviously hopes to escape. Currently, the Newport, Kentucky based pharmaceutical firm is fighting an attempt to centralize and consolidate the pretrial litigation of all federal propoxyphene lawsuits, which could be approved as early as March.

Until then, be sure to check back in with the Rottenstein Law Group for continuing updates on Darvon and Darvocet lawsuits and other news surrounding this landmark drug withdrawal. You may also wish to contact RLG if you are interested in filing an injury or wrongful death claim against Xanodyne or another entity that you believe is responsible for causing harm to you or a loved one. RLG’s lawyers have more than 25 years of experience in product liability law and know how to obtain the results our clients demand. To find out more, or to receive a complimentary case evaluation, fill out this form or call 1 (888) 976-8529.

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