Overview: The national law firm of Parker Waichman LLP has filed another lawsuit against the makers of Plavix over a user’s traumatic injuries, allegedly caused by the medication. The suit, which was filed on July 26th in the Supreme Court of the State of New York, County of New York, named Bristol-Myers Squibb Company, Sanofi-Aventis U.S., L.L.S., Sanofi US Services Inc., and Sanofi-Synthelabo, Inc as Defendants. Plavix is a blood thinner that has been associated with an increased risk of bleeding events, such as gastrointestinal or cerebral hemorrhaging.
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 Alleges Bleeding in the Brain
The Plaintiff took Plavix from 2004 to 2011, according to press release by Parker Waichman. During their course of therapy, the Plaintiff suffered from an epidural hematoma/hemorrhage, allegedly due to the use of Plavix. An epidural hematoma is a life-threatening condition where blood builds up between the outermost layer covering the brain (dura) and the skull; it is a type of traumatic brain injury (TBI). The rapid hemorrhaging increases the pressure within the head (intracranial pressure), which can lead to permanent brain damage if left untreated.
The lawsuit claims that the Plaintiff suffered numerous adverse effects as a result of using Plavix, and is alleging severe and permanent injuries, physical impairment and disfigurement, pain and suffering, loss of enjoyment of life, and economic damages.
Marketing Claims: Plavix Compared to Aspirin
The lawsuit also discusses the Defendants’ marketing claims with regards to Aspirin. When Plavix was launched in 1997, its approval was based on the results of one study called CAPRIE, (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) comparing the effects of Aspirin versus Plavix on lowering the rate of heart attack and stroke. From this point on, the suit states, the Defendants touted Plavix as a superior form of Aspirin despite direct requests from the U.S. Food and Drug Administration (FDA).
Not only did their marketing strategy defy direct FDA orders, the suit also alleges that their claims have been disproved by substantial research. For example, in 2006 a study published in the New England Journal of Medicine (NEJM) found no significant difference between using Aspirin alone versus Aspirin plus Plavix when it comes to preventing atherosclerotic events.