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Charles Toutant
New Jersey Law Journal
12-22-2006

Plavix, a popular blood-thinning drug, is the target of multiple lawsuits by users and third-party payers, who charge that manufacturers Bristol-Myers Squibb and Sanofi-Aventis US marketed the drug in disregard of its potential health risks.

In five suits filed Monday in federal court in Trenton, N.J., and two filed in October, the plaintiffs claim that the manufacturers promoted Plavix and aspirin together as a regimen for the prevention of blood clots, when safety of that therapy was unknown.

The plaintiffs say the manufacturers "over-promoted" the drug and were twice ordered by the Food and Drug Administration to withdraw ads that made overly broad claims.

Plavix was the second most widely prescribed drug in the world in 2005, with U.S. sales of $5.9 billion, according to the pharmaceutical market research firm IMS of Fairfield, Conn.

A study published on April 20 in the New England Journal of Medicine said Plavix with aspirin was no more effective than aspirin alone, and was harmful in patients with multiple risk factors, such as high blood pressure or high cholesterol.

"Despite the growing body of scientific knowledge that the four-dollar Plavix pill was not much better than a four-cent-a-day aspirin, defendants kept promoting it to the public and physicians, using hyperbole and outright falsification in the process," the plaintiffs claim.

The suits also charge that Plavix caused serious and sometimes fatal injuries. Among the plaintiffs is Eloise LaBarr of Bonifay, Fla., whose husband Edward began taking Plavix with aspirin after bypass surgery with a stent placement to repair a blocked artery in November 2002. In December 2004, he collapsed after suffering a serious intracranial bleeding injury and remained on life support for two days before being pronounced dead, with a subdural hematoma and "Plavix therapy" listed as the causes on his death certificate, according to the suit.

Another plaintiff, Patricia Begley of Crystal Lake, Ill., claims she took Plavix and aspirin from December 2003 until January 2006 after a stent implantation. She stopped after being rushed to the hospital for internal bleeding, necessitating a blood transfusion, a week's stay in the hospital and another week in a nursing home, according to her suit.

The suits include counts of negligent misrepresentation, defective design and manufacturing, breach of implied warranty, failure to warn and violations of the New Jersey Product Liability Act, N.J.S.A. 2A:58C-1 et seq., and the New Jersey Consumer Fraud Act, N.J.S.A. 56.8-1 et seq. The plaintiffs seek compensatory and punitive damages.

One of the suits filed in October is a putative class action on behalf of third-party payers, such as HMOs.

The cases are assigned to U.S. District Judge Freda Wolfson. On Dec. 12, U.S. Magistrate Judge Tonianne Bongiovanni granted the defendants an extension until Jan. 9 to file answers to the October suits.

The suits are in New Jersey based on diversity jurisdiction. Bristol-Myers Squibb is headquartered in New York with back-office operations in Princeton. Sanofi-Aventis US is a Bridgewater, N.J.,-based subsidiary of a French drug maker. The two companies produce Plavix as a joint venture.

The suits are filed by the same law firms, Miller & Associates in Alexandria, Va., and Hersh & Hersh in San Francisco.

Mark Burton Jr., of Hersh & Hersh, says he knows of only one other Plavix suit to date but believes many more will be filed soon by his firm and others.

He notes that many of the plaintiffs are relatively young. "We actually have quite a few clients in their 40s and 50s. These aren't 70- and 80-year-olds that are being targeted," he says, adding that this will make causation of injuries easier to prove.

Michele DiMartino of Miller & Associates' Bala Cynwyd, Pa., office is local counsel.

Bristol-Myers Squibb's attorney of record, Michael Tanenbaum, of Sedgwick, Detert, Moran & Arnold in Newark, referred questions about the case to Bristol-Myers. Company spokesman Jeff Macdonald said there would be no comment, as did Marc Greene, spokesman for Sanofi-Aventis, also represented by Sedgwick Detert.