A woman from Tennessee has filed a lawsuit against the makers of Plavix alleging the blood thinner caused her to suffer three gastrointestinal hemorrhages. The lawsuit, which was filed by the national law firm of Parker Waichman LLP, alleges Bristol-Myers Squibb, Sanofi-Aventis and other Defendants engaged in unethical business practices with regards to marketing Plavix.
According to a statement issued by Parker Waichman LLP, Plavix was approved to prevent atherosclerotic events in high risk patients based on a single study comparing the medication to Aspirin, known as CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events). Allegedly, the Defendants touted Plavix as “super-aspirin” in order to protect their financial interests, in defiance of the U.S. Food and Drug Administration (FDA), which stated that Plavix should not replace Aspirin as a first-line therapy for preventing ischemic events. According to the lawsuit, Plavix has generated $42.8 billion in sales since its approval in 1997; the drug generated $7.1 billion in 2011 alone.
The Plaintiff named in the lawsuit, a woman from Decatur, Tennessee, began taking Plavix in April 2011. She subsequently suffered three gastrointestinal hemorrhages, most recently in September 2011. The lawsuit alleges that Plavix caused the multiple bleeding episodes and holds the Defendants responsible for making misleading statements about the safety of the medication.
As we’ve reported previously, Plavix has been linked to a number of dangerous side effects, including:
- Thrombotic thrombocytopenic purpura or TTP (A condition which is marked by small clots through the entire circulatory system)
- Gastrointestinal hemorrhages
- Cerebral hemorrhage
- Internal bleeding
- Bone marrow damage
- Heart attack
In 2005, the New England Journal of Medicine published a study comparing the effects of Plavix versus Aspirin and esomeprazole in patients who had ulcer bleeding. The study reported an 8.6 percent increased risk of recurrent bleeding in patients taking Plavix versus 0.7 percent among those taking aspirin and esomeprazole. That same year, the FDA ordered that the Plavix label be updated to include information about reports linking Plavix to TTP. According to the FDA, some reports of TTP in Plavix patients occurred after only a short exposure (less than two weeks).