Pfizer Gains Partial Win In Celebrex Suits

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gavel.jpgA federal judge ruled yesterday that plaintiffs didn’t present scientifically reliable evidence that Celebrex caused heart attacks or strokes when taken at a daily dose of 200 milligrams, and the drugmaker claims this is the most common dose. There are more than 3,000 lawsuits, but the ruling by US Districrt Court Judge Charles Breyer in San Francisco kept alive lawsuits involving the 400 milligram dose.

At the moment, however, the number of lawsuits that can proceed with the heart attack or stroke claims isn’t clear. Another issue - some patients on 200 milligrams may have taken the painkiller twice a day. “More of the cases on file are 400 so this somewhat cuts the inventory of cases, but still leaves intact the majority of the litigation,” one plaintiff lawyer, who asked not to be named, tells us.

“The Court finds that dose matters,” Breyer writes. “All of plaintiffs’ experts, with perhaps a single exception, agree that there is a dose effect with Celebrex; that is, that it is more toxic, and is therefore more likely to cause an adverse side effect, when taken at greater doses…After carefully considering the parties’ memoranda and evidence, and the testimony offered at the hearing, the Court concludes that plaintiffs have not presented scientifically reliable evidence that Celebrex causes heart attacks or strokes when ingested at the 200 milligram a day dose.”You can read the complete ruling here.

The ruling emanated from the multi-district litigation concerning Pfizer’s Celebrex, as well as Bextra, a newer Cox-2 painkiller that was pulled from the market two years ago due to cardiovascular concerns. However, the hearing was only for Celebrex, and Pfizer was trying to exclude testimony by several expert witnesses that the painkiller was harmful. And so the ruling is, in some respects, a win for Pfizer.

That’s because the drugmaker can now proclaim that Celebrex - which, of course, is still on the market - is safe enough, at least at the lower dosage that Pfizer claims is more commonly taken. Had Breyer decided there is a serious cardiovascular risk across the board, his ruling could resonate beyond the courtroom, dampening enthusiasm for the painkiller just as Pfizer accelerates an FDA-approved effort to advertise Celebrex once again. At that point, perhaps the entire litigation might have looked like it was worth settling.

“We are pleased with the decision of the federal court, which recognizes the lack of any credible evidence linking Celebrex, at its most common dosage form, with heart attacks or strokes,” Pfizer General Counsel Allen Waxman tells The Wall Street Journal.

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