N.Y. Judge Rules Evidence in Celebrex Case Unreliable

January 11, 2008

A New York court has ruled that plaintiffs suing Pfizer Inc. over its pain medication Celebrex do not have reliable scientific evidence to prove the drug can cause heart attacks and strokes at the 200-milligram dose, the company said Wednesday.

New York Supreme Court Justice Shirley W. Kornreich said, “The scientific evidence, whether for a heart attack or stroke, is just not there,” according to New York-based Pfizer.

The 200 milligram dose is the most commonly prescribe dose of the medication.

The ruling is similar to one in U.S. District Court in San Francisco, where Judge Charles R. Breyer ruled in November that lawyers for the more than 3,000 plaintiffs failed to produce “scientifically reliable evidence that Celebrex causes heart attacks or strokes when ingested at the 200 milligram a day dose.”

Pfizer said it believes the decisions together could result in the dismissal of many Celebrex cases, as the majority of the cases are pending in these two courts.

Pfizer intends to challenge the admissibility of evidence that doses higher than 200 milligrams a day might cause heart attacks or strokes. Neither the New York nor the federal district court ruling excludes all expert testimony concerning the risk of heart attack or stroke affiliated with those higher doses.

In 2005, the Food and Drug Administration reviewed the risks of drugs such as Celebrex and Vioxx, known as nonsteroidal anti-inflammatory drugs, and concluded they should include a label warning patients of increased risk of strokes and heart attacks. As a result, thousands of patients sued Pfizer and Vioxx-maker Merck & Co.

All the federal claims against Merck were consolidated in New Orleans; the claims against Pfizer were consolidated in San Francisco.

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