Ruling is blow to plaintiffs in Celebrex case

Hundreds of patients who allege they or their loved ones suffered heart attacks and strokes after taking pain medication Celebrex might be dropped from a massive lawsuit against drug maker Pfizer Inc. in light of a federal judge’s ruling.

U.S. District Judge Charles R. Breyer of San Francisco said in his ruling Monday that lawyers for the more than 3,000 plaintiffs in the case failed to produce “scientifically reliable evidence that Celebrex causes heart attacks or strokes when ingested at the 200-milligram-a-day dose.” That’s the most commonly prescribed dosage, according to Pfizer.

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 New York, N.Y.-based 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.

Two experts hired by the plaintiffs, a cardiologist and a neurologist, formed their opinions about the dangers of Celebrex merely for the purpose of testifying, Breyer said, adding that the opinions also were based on bad science.

The cardiologist, Dr. Neil Doherty, has “no relevant research experience” and “bases his opinion on a study he fundamentally misunderstood,” Breyer said.

The neurologist, Dr. Marilyn Rymer, “ignores all the evidence that contradicts her litigation-created conclusion” and “relies on an unpublished, non-peer-reviewed study,” he said. “These unreliable opinions are not admissible to prove general causation” at the 200-milligram-a-day dosage.

It’s unclear just how many of the 3,000 plaintiffs suing Pfizer will be eliminated from the court action as a result of the judge’s decision, but it’s estimated that about 900 people were 200-milligram-a-day patients, plaintiffs’ lawyer Paul Sizemore said. But he added that because Celebrex is taken as needed for pain, it’s difficult to establish a precise number.

“What exactly is a 200-milligram case?” Sizemore said. “Someone who has rheumatoid arthritis may take 200 on a day when they’re not really hurting and 400 when they are.”

He said patients would be interviewed, their records would be reviewed and Sizemore and other plaintiffs’ lawyers would decide whether to appeal Breyer’s decision.