The first product-liability trial over Pfizer Inc.’s painkiller Celebrex has been set for June 6 in an Alabama state court. Rosie Ware, of Barbour County, Ala., is suing the New York drug maker, alleging that Celebrex caused her 2005 stroke.

Plaintiff attorneys in the Celebrex litigation face a substantial hurdle in proving the drug caused harm: It still is on the market. While Merck & Co.’s Vioxx and Pfizer’s Bextra, another painkiller in the class of Cox-2 inhibitors, were both withdrawn from the market amid safety concerns, Celebrex remains the only drug in the class still being sold.

In August, Pfizer put a “black-box” warning, or the strongest warning, on Celebrex, following a recommendation by the Food and Drug Administration. The label warns that the drug may increase the risk of cardiovascular events, including heart attack and stroke. The drug’s sales have been hurt by safety concerns, falling 48% last year to $1.73 billion.

Ms. Ware, who was 53 years old at the time of her alleged injury, is represented by Beasley, Allen, Crow, Methvin, Portis & Miles PC in Montgomery, Ala., the law firm that recently lost the first federal Vioxx trial. Attorney Jere Beasley said his client, a nonsmoker whose health was “very good” before her stroke, took Celebrex for back pain. Mr. Beasley says Ms. Ware was left disabled and unable to work after her stroke.

The attorney says he is undeterred by the fact that Celebrex has been deemed safe by regulatory agencies. “I don’t think that makes much difference,” he says. “The FDA is just an extension of the drug industry.”

A Pfizer spokesman said, “The FDA, [the European Medicines Agency] and other health authorities around the world have concluded that the benefits of Celebrex continue to outweigh its risks, and, as a result, Celebrex is the only Cox-2 inhibitor remaining on the market today.”

There are more than 200 federal cases over Celebrex and Bextra consolidated before Judge Charles R. Breyer of the U.S. District Court for the Northern District of California. Bextra was pulled from the market last April amid Food and Drug Administration concerns over its heart risks and other problems, and lawyers say suits filed over Bextra could be harder to defend than Celebrex cases.



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