On Friday, Bristol-Myers Squibb and Sanofi-Aventis were hit with over 40 complaints in New York state court as part of a coordinated litigation claiming that the blood-thinning drug Plavix causes hemorrhages in users.
The plaintiffs, from a number of states, say they suffered gastrointestinal hemorrhages, cerebral hemorrhages, and other severe injuries after taking Plavix (clopidogrel) to recover from strokes, stent placements, and other medical conditions, Law360 reports.
These new lawsuits incorporate a master complaint filed in June 2012 on behalf of Plavix users who died or suffered severe injuries after using the drug. The suit, also filed on behalf of spouses, children, and heirs, alleges that “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 the master complaint.
Bristol-Myers Squibb and Sanofi are accused of putting “profits over safety” in seeking expedited approval from the U.S. Food and Drug Administration (FDA) based on only one clinical study, according to Law360. According to the complaint, the companies knew that Plavix isn’t more effective than aspirin, but advertised it as more effective.
Numerous Plavix lawsuits have been filed across the country. In February, the U.S. Judicial Panel on Multidistrict Litigation consolidated nine suits accusing the companies of failing to warn of injury risks and violations of the False Claims Act in off-label marketing of Plavix, claiming the drug is superior to cheaper medicines, as a result of which some government health programs paid for prescriptions they wouldn’t have otherwise.
The companies are also accused of manipulating clinical trial data to falsely support claims Plavix is superior to cheaper drugs, in particular aspirin, in preventing stroke, heart attack and vascular death, according to Law360. Not only is aspirin considerably less expensive—about 4 cents a pill versus $4 a pill for Plavix—but aspirin also has a much lower risk of complications.