Physician Weighs in on FDA Action That Prompted Darvocet Lawsuits

Physician Weighs in on FDA Action That Prompted Darvocet Lawsuits

A professor of neurology at Albany Medical College recently discussed the FDA action that led to the current wave of Darvon andDarvocet lawsuits.

Dr. Charles Argoff, the Director of the Comprehensive Pain Center at Albany Medical Center in Albany, New York, posted a video statement onMedscape.com about the FDA's decision to remove all products containing the pain killerpropoxyphene from the U.S. market. Best known as the prescription medications Darvon and Darvocet,propoxyphene was recalled by the FDA in November 2010 due to its ability to cause life-threatening cardiac side effects. Since then, Xanodyne Pharmaceuticals, Inc., maker of Darvon and Darvocet, has been slapped with numerous federal lawsuits by injured propoxyphene users and the family members of those who died after using the drug. In just over a month, a hearing is scheduled in San Diego, where the Judicial Panel on Multidistrict Litigation will consider whether toconsolidate all federal Darvon and Darvocet cases under a single federal judge for the purpose of facilitating pretrial litigation.

Argoff notes that the FDA removal of propoxyphene from the U.S. market was due to cardiac safety issues, but adds that, "For many years it has been known that propoxyphene-containing products, such as Darvocet do not provide any more pain relief than aminophen (short for acetaminophen, better known as Tylenol) or aspirin alone. It perplexed a number of us for many years that individuals were prescribed propoxyphene-containing products when these drugs didn't appear to provide any greater pain relief than more simple approaches."

Although the effectiveness of propoxyphene as a painkiller did not formally figure into the FDA's decision to recall the drug, studies dating back as far back as the 1970s suggest that less-potent, over-the-counter medications provide equal (not to mention safer) pain relief. The consumer advocacy group Public Citizen, inits 2006 petition to the FDA to ban all propoxyphene products, cites the drug's weak analgesic properties as a reason for its proposed withdrawal.

Propoxyphene's ineffectiveness as a painkiller, however, is notgrounds for legal action against Xanodyne Pharmaceuticals or another drugmaker. The basis of the lawsuits filed to date is manufacturers' failure to provide sufficient warning of the potentially deadly side effects of products such as Darvon and Darvocet. This charge, known as a marketing defect under product liability law, could result in a blameworthy entity being forced to pay compensationto injured propoxyphene users and/ortheir families when such cases eventually go to trial.

The time to file a Darvon/Darvocet lawsuit is limited, so you need to act quickly if you wish to recover thedamages caused to you or a loved one by propoxyphene. The Rottenstein Law Group, a firm with decades of experience in product liability law, is currently offering free evaluations of propoxyphene injury claims. RLG takes an uncommonly sympathetic approach to helping clients recover losses caused by no fault of their own.

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