Increasing numbers of Darvocet lawsuits pile up in US courts and experts continue to compare the tremendous scope of the Darvocet litigation to the mess of litigation that followed the damage down by the popular diet pill Fen-phen.
There are obvious similarities between Darvocet and Fen-phen. Both were linked to serious heart problems resulting in their removal from the market. Fen-phen was pulled from the market in 1997. But prior to its being pulled…6 million Americans had already taken the diet pill. And thousands experienced the dangerous Fen-phen side effects: pulmonary hypertension and valvular heart disease.
Wyeth, the Fen-phen manufacturer, has paid out substantial monies in compensatory damages to thousands of plaintiffs totaling over $13 million.
Experts are indicating that the similarities between the two drugs will most likely reach to similar monetary compensation totals for Darvocet lawsuits as those seen in response to Fen-Phen cases.
Darvocet was a popular and accepted mild painkiller for more than 50 years prior to being recalled for dangerous side effects. In 2009 along the prescription was filled over 10 million times.
Darvocet side effects are serious. And they have been evident for a long time. For decades consumer advocacy groups have petitioned the FDA to remove the drug. These same groups estimate that the FDAs refusal to remove the drug from the market has resulted in approximately 1,000 to 2,000 American deaths in the last 5 years. They also predict that these deaths will be the source of a high number of Darvocet lawsuits in the future. The FDA repeatedly, study after study, concluded that the benefits of Darvocet as a pain killer outweighed the risks from potential side effects. They changed their conclusion to one where the risks outweighed the benefits in 2010.
Last November the FDA ordered that Xanodyne Pharmaceuticals (who purchased the Darvocet patent from AAI Pharmaceuticals in 2005) pull Darvocet from US pharmacy shelves. Xanodyne immediately pulled the drug without contesting the order.
But now that the lawsuits are piling up Xanodyne is definitely complaining and contesting the FDAs claims of risk outweighing benefit of Darvocet. They are currently fighting the efforts being made on behalf of plaintiffs to consolidate litigation into a central federal court. Xanodyne’s main complaint regarding litigation consolidation is that they are not the sole manufacturers of the drug; several companies actively made and sold generic forms of Darvocet.
In spite of the company’s objections to Multidistrict Litigation legal experts fully expect the Judicial Panel on Multidistrict Litigation to approve the centralization of Darvocet lawsuits. The panel is expected to make their decision in late March.
Legal experts also expect that once the Multidistrict Litigation is approved that Xanodyne will then raise new objections; specifically bringing up their doubt of the causative link between cardiac issues and Darvocet.
It has been brought to the attention of the public that Darvocet manufactures will most likely attempt to raise a “Daubert motion” during the upcoming trial. A “Daubert motion” is a motion to exclude certain testimony on the grounds that the “expert” testifying has an inadequate knowledge of the material being discussed. In the case of Darvocet the drug manufacturers will most likely attempt to claim that the chosen expert has an inadequate expertise of the chemical mechanism through which Darvocet damages the individual’s heart.
When Fen-phen was pulled from the market in 1997 several clinical studies had already linked it to both pulmonary hypertension and valvular disease. In the case of Darvocet…evidence is still mounting continuing to point towards a causal connection between Darvocet and heart problems even when the drug is taken as prescribed.
The FDA finally found evidence that was “conclusive” after half a century. Most experts feel it is very likely that the judge will find similar evidence concluding that the drug is a danger.