Suit against Plavix makers alleges profits over safety

A St. Clair County woman accuses two drug manufacturers of injuring patients by intentionally lying to doctors in order to make more money.

Hazel LeFlore and more than 30 other out-of-state complainants filed a lawsuit Oct. 17 in St. Clair County Circuit Court against Bristol-Myers Squibb Company, Sanofi-Aventis US LLC, Sanofi-Aventis US Inc. and Sanofi-Synthelabo Inc.

LeFlore and the other plaintiffs claim ingesting Plavix caused them or their relatives serious injuries or -- in some cases -- death. Bristol-Myers Squibb and the Sanofi companies co-developed the drug in April 1997 and gained approval by the FDA for distribution six months later, according to the complaint. LeFlore says the manufacturers rushed to obtain that approval, placing "emphasis on marketing and profit-making over patient safety."

Plavix was marketed directly to consumers and touted as a "super-aspirin" that would help a patient avoid a heart attack or stroke while being safer and easier on a person's stomach than aspirin, the petition says. LeFlore claims Bristol-Myers Squibb and Sanofi had proof that Plavix was not more effective than aspirin and that the "risk of suffering a heart attack, stroke, internal bleeding, blood disorder or death far outweigh any potential benefits."

The plaintiffs claim the drug manufactuers exaggerated the results of their own studies and made false statements in advertising and promotional materials in order to increase profits from Plavix sales. According to the complaint, Plavix was the sixth top selling drug in the US in 2005, with annual sales totalling more than $3.8 billion.

The FDA allegeldy warned the defendants multiple times to stop making inaccurate claims about the effectiveness of Plavix, its proper uses and the type of patients who would benefit from it. In addition to sharing misinformation about the drug, Bristol-Myers Squibb and Sanofi are accused of encouraging physicians to prescribe higher doses to overcome study data that showed the drug wasn't working in many of the patients. As a result, the plaintiffs say they could have been treated appropriately by a simple aspirin but were instead paying about $4 a day for Plavix.

Rather than helping patients avoid cardiovascular issues, according to the complaint, Plavix was actually proven to increase the risk of heart attack, stroke, bleeding and other serious side effects. LeFlore says the manufacturers failed to warn doctors to monitor patients for the associated risks.

LeFlore and the other plaintiffs contend the defendants knew of significant dangers posed by Plavix, yet led doctors to over-prescribe the drug. They accuse the companies of strict product liability, manufacturing defect, failure to warn and negligence. LeFlore says Bristol-Myers Squibb and Sanofi breached their duty to the medical community and, as a result, caused the plaintiffs to suffer severe and permanent injuries, physical impairment and disfigurement, pain, suffering loss of enjoyment of life. They cause the companies' actions "intentional, wanton, oppressive, malicious and reckless."

LeFlore and each of the complaintants are asking to be awarded to an undisclosed amount in actual and compensatory damages for medical costs, lost wages, pain and suffering and mental anguish.

Attorneys Christopher Cueto and Michael Gras, of Belleville, and Robert L. Salim, of Louisiana, are representing LeFlore.

St. Clair County Circuit Court Case No. 12-L-552