update Drug Companies, Not the FDA, Can Be Held Liable in a Darvocet Lawsuit

While it’s difficult to put a number on  how many people have been injured or killed by the pain reliever propoxyphene (known best as the prescription drugs Darvon and Darvocet), it is safe to say the figure is somewhere in the tens of thousands. According to the Drug Abuse Warning Network (DAWN), between 1981 and 1999, propoxyphene was responsible for more than 7,000 U.S. deaths between 1981 and 1999 alone. (This works out to nearly 400 deaths per year caused by the opiod painkiller.) The British Committee on the Safety of Medicines, just prior to issuing a ban of the drug in Britain, noted in January 2005 that the drug was responsible for 300-400 fatalities per year. And even though these figures were sufficient for British authorities to outlaw propoxyphene products, the United States Food and Drug Administration (FDA), waited until 2010 to request a withdrawal of Darvon and Darvocet (despite receiving more than 3,000 reports of propoxyphene problems, including suicide, addiction, and overdose), potentially costing the health and lives of thousands of more people. In the face of this inaction, one might wonder whether the FDA can be held responsible for the harm suffered by propoxyphene users and their families.

The argument can certainly be made that the FDA is feckless when it comes to ensuring consumer health, but even if this were true, an individual who is injured by a dangerous or defective drug cannot sue the FDA for failure to request a recall or otherwise take action on a product with questionable safety. This doesn’t mean, however, that an injured Darvon or Darvocet user or the family of a fatal overdose victim has no recourse. Ultimately, the responsibility of ensuring that a drug does not cause harm falls to the product’s manufacturer. When a drugmaker does not fulfill this obligation, it can be sued by an injured consumer and made to pay compensatory damages. This is the scenario now playing out in litigation pending against Darvon and Darvocet manufacturer Xanodyne Pharmaceuticals, Inc., in which injury victims and their lawyers are alleging that Xanodyne failed to warn of the sever cardiac side effects of Darvon and Darvocet.

The success of a plaintiff in a Darvocet lawsuit is likely to come down to establishing whether or not Xanodyne (or a manufacturer of a generic propoxyphene product) was aware, or at least should have been aware, of the drug’s ability to cause heart attack, stroke, arrhythmia, atrial fibrillation, and other potentially fatal heart problems and failed to warn about them. A number of salient events—including two petitions by the group Public Citizen to have propoxyphene banned and the withdrawal of the drug from British and European Union markets—suggest that Xanodyne and other manufacturers should have known about the pain reliever’s severe health risks. Xanodyne did actually conduct a study on propoxyphene’s effects on the heart, the results of which led to the FDA’s decision last November to recall the drug. But the company only performed the research at the request of the FDA, so it can’t claim that it was trying to proactively protect public health.

Until Darvon and Darvocet lawsuits go to trial, the fate of propoxyphene manufacturers and those injured by the dangerous drug cannot be known. But in light of the extensive scientific literature on propoxyphene’s toxicity, not to mention its ineffectiveness, thin margin of safety, and addictiveness, there is little reason to assume that the courts will side with drugmakers. By all indications they placed profits over safety and will be held accountable for disregarding public safety.

If you believe your coronary injury or the death of a loved one was caused by propoxyphene, you may wish to join the growing number of people taking action against Xanodyne and other manufacturers. To find out whether you have a case or not, let your claim be evaluated for free by a member of the Rottenstein Law Group. For more than 25 years, we have been helping clients recover the compensation they deserve from negligent corporations. For your complimentary Darvocet lawsuit evaluation, fill out this contact form or call 1 (888) 976-8529.

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