A Tennessee woman has filed a product liability lawsuit in New York state court against Bristol-Myers Squibb and Sanofi-Aventis, alleging that she sufferd gastrointestinal bleeding from side effects of Plavix.
The complaint was filed in the Supreme Court of New York on July 26, indicating that the blockbuster blood thinning medication caused the plaintiff to suffer at least three gastrointestinal hemorrhages between starting Plavix treatment in April 2011 and September 2011.
According to allegations raised in the Plavix lawsuit, the woman was left with severe and permanent injuries as a result of the bleeding events, resulting in physical impairment, physical and mental pain and suffering, disfigurement and loss of enjoyment of life. She seeks compensatory damages for her injuries and for past, present and future medical expenses.
Plavix (clopidogrel) is a blood thinner prescribed for prevention of blood clots, generating annual sales of over $6 billion for Bristol Myers Squibb Co. and Sanofi-Aventis.
Allegations raised in the complaint are similar to a number of other lawsuits over Plavix that have been filed by individuals throughout the United States, indicating that the drug makers mislead consumers about the safety of their drug, and did not sufficiently research the medication or provide adequate warnings before putting it on the market.
The release of Plavix was based on just one clinical trial, which compared it to aspirin, the recently filed lawsuit claims. The plaintiff also alleges that the drug manufacturers defied an FDA requirement that Plavix not be marketed as a replacement for the use of aspirin as the first treatment for preventing ischemic events.
In other complaints filed in state and federal courts, plaintiffs allege that the expensive Plavix treatment may actually be no better than taking a four-cent-a-day aspirin for many patients, yet exposes users to a risk of serious side effects. In addition, the lawsuits claim the drug makers failed to adequately warn doctors and patients that Plavix may not be effective for certain groups of users.
In addition to gastrointestinal bleeding claims, the drug makers also face other Plavix injury lawsuits, including cases involving severe ulcers and a rare blood disorder known as TTP, or thrombotic thrombocytopenic purpora.
Late last year, the U.S. Judicial Panel on Multidistrict Litigation denied a request by Bristol-Myers Squibb and Sanofi-Aventis to centralize the federal Plavix litigation as part of an MDL, or multidistrict litigation, indicating that it would not provide any benefit to the parties. Most cases filed throughout the country have been brought in state courts.