Drug maker, Sanofi, was just fined 40.6 million euros—$52.8 million—for attempting to reduce sales of the generic version of the blood thinner, Plavix (clopidogrel). Plavix, an anti-platelet medication approved in the United States in 1997, is prescribed to reduce risks of atherosclerotic events such as blood clot, stroke, and heart attack in patients with a history of these conditions.
The fine was levied by France’s competition regulator, according to Bloomberg News. Sanofi is that country’s largest drug maker. It seems that Sanofi “denigrated” generic Plavix versions to physicians and pharmacists, said the regulator. The Competition Authority was responding to a complaint made by Teva Pharmaceutical Industries Ltd., which is the world’s largest manufacturer of generic drugs.
Speaking to pharmacists and doctors, Sanofi’s sales force ensured doubt was cast on competing generic versions of Plavix in 2009 and 2010, warning that they could be held liable should patients suffer medical issues after taking the generics, according to the Bloomberg News report. Sanofi also persuaded physicians to indicate on prescriptions that the generic could not be substituted for the brand version and pharmacists to use Sanofi’s generic version should a generic be used, said the Competition Authority
Sanofi SA was recently being probed by federal officials over its disclosures to the U.S. Food & Drug Administration (FDA) about Plavix, which is co-marketed with Bristol-Myers Squibb Co. According to the filing Sanofi made to the U.S. Securities and Exchange Commission (SEC), the U.S. Department of Justice (DOJ) is probing Sanofi’s statements to the FDA concerning patient reports over Plavix, said Law360.
We previously wrote that recent research raised some doubts about the usefulness of Plavix in preventing a recurrent stroke. The study, previously published in The New England Journal of Medicine, found that the Plavix-aspirin combination is no better at preventing second strokes in people who’ve suffered a previous lacunar stroke, when compared to aspirin alone. The addition of Plavix to an aspirin regimen also increased the likelihood of serious gastrointestinal bleeding and death, according to the study.
Meanwhile, Plavix lawsuits continue to mount. In fact, we previously wrote that one Plavix lawsuit was filed on behalf of 64 Plavix patients who allege bleeding side effects. That group claims it suffered strokes and heart attacks after taking Plavix and alleges the drug can cause heart attacks, internal bleeding, strokes, blood disorders, or death. This is just one of a number of lawsuits filed over Plavix adverse reactions.
The national law firm Parker Waichman LLP, has filed a number of lawsuits on behalf of patients over Plavix injuries and allegations that the blood thinner caused adverse reactions such as multiple stomach bleeds, gastrointestinal hemorrhage, cerebral hemorrhage, and the blood condition TTP. Lawsuits claim that the drug makers knew Plavix increased risks of serious bleeding events, yet continued to sell the drug to protect their financial interests and that the drug makers made false and unsubstantiated claims when marketing Plavix by touting its superiority to aspirin in lowering the rate of blood clots, stroke, and heart attack.
The West Virginia attorney general brought a deceptive marketing lawsuit against Sanofi and Bristol-Myers late last year after the state was forced to overpay for an unnecessary drug. According to the allegations, the drug firms deceptively marketed Plavix as superior to aspirin for specific treatments and allegedly touted Plavix to physicians to justify its higher price, which cost about 100 times more than the price for aspirin, which drove profits, said Law360.
In addition to personal injury allegations, Plavix users have also filed lawsuits alleging False Claims Act violations; nine such suits were just consolidated in New Jersey federal court and 12 similar complaints are pending consolidation in California and Mississippi, Law360 explained.
Meanwhile, in 2010, the FDA added a black box warning to the Plavix label after it found that about three percent of the U.S. population is unable to properly metabolize the drug. The agency cited research that suggest that clopidogrel, which is sold as the brand Plavix, is less efficacious in some patients because of the way in which Plavix must be metabolized, according to Law360.