Many are Comparing the Mounting Darvocet Lawsuits to the Well Remembered Tidal Wave of Fen-Phen Litigation

Darvocet lawsuits are starting to pile up in US courts and while more Darvocet plaintiffs file a suit experts are citing similarities between the potential scope of the Darvocet litigation and the well remembered tidal wave of Fen-Phen (the popular diet pill) litigation.

Similarities between Darvocet lawsuits and the Fen-phen lawsuits

The similarities are obvious between the two drugs: Fen-phen and Darvocet. Both drugs have been linked with serious heart problems before being pulled from the market. Fen-phen was pulled in 1997 after 6 million Americans had used the diet pill to obtain weight loss. Thousands of those 6 million suffered from major Fen-phen side effects including both pulmonary hypertension and valvular heart disease.
Compensatory damages paid out by Fen-phen manufacturers have been substantial…totaling over $13 million.
Some experts are of the belief that Darvocet lawsuit settlements will reach similar proportions.
As a popular and well accepted mild pain killer Darvocet was on the market for over 50 years before it was recalled. Prior to the drug’s recall Darvocet was taken by countless individuals. In the year 2009 alone over 10 million Darvocet prescriptions were filled by patients.
The side effects of Darvocet are quite serious. And more importantly…they have been in evidence for quite some time. Decades have passed during which consumer advocacy groups consistently petitioned for the FDA to order a recall of the drug that they insisted was dangerous to patients. It has been estimated that in the last 5 years alone Darvocet is probably responsible for 1,000 to 2,000 deaths. And it is predicted that this number will rise in coming years. Study after study was conducted after which the FDA concluded repeatedly that the benefits of Darvocet outweighed the risks…until 2010. In 2010 the FDA finally conceded that the risks were greater than the benefit and pulled the drug.
In November of 2010 the FDA announced the Xanodyne Pharmaceuticals should pull Darvocet from pharmacies. Xanodyne purchased the Darvocet patent in 2005 from AAI Pharmaceuticals. Xanodyne pulled the drug without any complaints.
But since then Xanodyne has started to complain…plenty. At the moment Xanodyne is complaining not only about the FDA’s decision to label Darvocet as more dangerous than beneficial. They are also complaining regarding the potential consolidation of the lawsuits for Multidistrict Litigation. Their main complaint against suit consolidation is that they were not the sole responsible manufacturer as there were several companies manufacturing generic forms of Darvocet.
While Xanodyne strongly objects to consolidation for Multidistrict Litigation, most experts expect it to be approved for centralization. The decision should be announced by the end of March 2011.
Once the Multidistrict Litigation is approved pharmaceutical litigation experts expect Xanodyne lawyers to raise new objections regarding the proposed causative link between the drug and the alleged cardiac related side effects.
Still others have suggested the Xanodyne lawyers are likely to try to raise what is referred to as a “Daubert motion” in which the expertise of the “expert” on the stand is called into question. It is predicted that the defense lawyers will attempt to claim that the expert on the stand does not have adequate experience with the chemical mechanism that is used by Darvocet to result in cardiac damage.
Fen-phen was pulled from the market in 1997 after numerous clinical studies linked the drug to valvular disease and pulmonary hypertension. Similar evidence is mounting against Darvocet as more heart problems are being linked to use of the mild painkiller.
It only took the FDA half a century to finally discover that the evidence was conclusive regarding Darvocet and its serious side effects leading to cardiac conditions…many experts believe that the judge will come to a similar conclusion.