Overview: A woman has decided to sue the makers of Plavix after experiencing three episodes of gastrointestinal hemorrhaging while taking the blood-thinning drug. The lawsuit was filed by the national law firm of Parker Waichman LLP on July 26th in the Supreme Court of the State of New York, County of New York.
Product: Plavix (clopidogrel)
Manufacturer: Sanofi-Aventis, Bristol-Myers Squibb Co.
Side Effects & Complications
- Cerebral hemorrhage
- Thrombotic Thrombocytopenic Purpura (TTP)
- Gastrointestinal bleeding
- Internal bleeding
- Bone marrow damage
- Heart attack
Lawsuit Claims Plavix Caused Severe Bleeding
According to a press release by Parker Waichman, the woman had been taking Plavix since last April. By that September, she had experienced three gastrointestinal hemorrhages. The lawsuit alleges that Plavix caused the bleeding, which subsequently caused the Plaintiff to suffer severe and permanent injuries, physical impairment and disfigurement, physical pain and suffering, mental pain and suffering and loss of enjoyment of life.
The lawsuit accuses the Defendants, Bristol-Myers Squibb Company, Sanofi-Aventis U.S., L.L.C., Sanofi US Services Inc., and Sanofi-Synthelabo, Inc., of making false or misleading statements when marketing Plavix. Allegedly, the Defendants overstated the benefits of drug in comparing it Aspirin, touting it as a “super-aspirin”. The U.S. Food and Drug Administration (FDA) had previously warned against marketing Plavix in this manner.
Plavix v. Aspirin
Among other things, Plavix makers had insisted that it was safe for patients to take the drug in combination with Aspirin in what is known as “dual therapy”. According to a study in the New England Journal of Medicine, however, the combination is not more effective than taking Aspirin alone. Plavix was also thought to be easier on the stomach compared to Aspirin. But another study, also published in the New England Journal of Medicine, contradicts this claim as well. The study found that Plavix users had a significantly higher rate of ulcer bleeding compared to those taking Aspirin and a heartburn pill.
Plavix was approved in 1997 to treat blood clots, stroke and heart attack in patients who have a history of these conditions, or in those who were likely to develop them. Since it’s been on the market, the drug has generated $42.8 billion in worldwide sales. The patent on Plavix expired in May, allowing other companies to manufacture generic versions of the pricey medication. However, these less-expensive alternatives carry the same side effects and risks as brand-name Plavix. Furthermore, those who believe they are injured due to side effects cannot sue if they are taking the generic brand.