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. We previously wrote that Plavix maker, Sanofi SA, was being probed by federal officials over its disclosures to the U.S. Food & Drug Administration (FDA) concerning the blood thinner.
These legal actions, a series of short complaints, are part of a coordinated multidistrict litigation (MDL) that alleges the blood thinner led to hemorrhage in patients, according to Law360. Specifically, plaintiffs nationwide allege having suffered from gastrointestinal hemorrhages and cerebral hemorrhages and other serious injuries after using Plavix. The lawsuits incorporate a master complaint filed June 2012 on behalf of patients who died or suffered serious Plavix injuries.
The master complaint, which was also filed on behalf of spouses, children, and ears, indicates that, “Each plaintiff maintains that the prescription drug Plavix is defective, dangerous to human health, unfit and unsuitable to be advertised, marketed and sold in the U.S., and lacked proper warnings of the dangers associated with its use,” according to Law360. The master complaint also accuses the drug makers of placing “profits over safety” by having sought expedited FDA clearance on just one clinical study and of being aware that Plavix does not offer increased benefits over aspirin, but marketed the drug as more effective than aspirin, according to Law360.
A variety of Plavix lawsuits have been filed nationwide and, this summer, more than three-dozen Plavix users and survivors filed lawsuits in Illinois court alleging that the drug makers, for years, encouraged doctors to overprescribe Plavix and disregarded clinical evidence finding that Plavix was no more effective than aspirin and other over-the-counter treatments, yet carried greater risks, according to Law360.
This February, U.S. Judicial Panel on MDL consolidated nine lawsuits in New Jersey. The lawsuits accuse the device makers of failing to warn of injury risks and violations of the False Claims Act, which concern alleged off-label marketing. The consolidated actions also include a qui tam lawsuit in Illinois over allegations that the drug makers engaged in a scheme to bogusly market the drug to physicians as better than other options. This led to a number of government health agencies paying for medications that they would not have had it not been for the scheme. The drug makers are also accused of swaying clinical trial data to falsely support these claims, Law360 reported.
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 suggests 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.
In August, consumer advocate, Public Citizen pressed the agency to also warn that patients implanted with stents may suffer fatal bleeds if they take Plavix for more than one year, according to Law360.
Daniel C. Burke and Michael S. Werner of the law firm, Parker Waichman LLP, represent the plaintiffs in this case.