Healthy Skepticism Library item: 12418

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Pfizer Wins Key New York State Court Ruling on Celebrex
PharmaLive 2008 Jan 9
http://pharmalive.com/news/index.cfm?articleID=505072&categoryid=43

Full text:

Pfizer Inc announced today that a New York state court ruled in favor of the company on an important motion relating to litigation over Pfizer’s Celebrex medication. New York Supreme Court Justice Shirley W. Kornreich ruled that the plaintiffs suing Pfizer in New York failed to present reliable scientific evidence necessary to prove that Celebrex can cause heart attacks and strokes at 200 mg daily – the most commonly prescribed dosage of the Pfizer pain medication. In her decision, Justice Kornreich held that “ . . . with regard to Celebrex at 200mg/d(aily), the scientific evidence, whether for a heart attack or stroke, is just not there.”

The ruling follows a similar decision in November 2007 by the U.S. District Court of Northern California in the Celebrex multi-district federal litigation. In the federal court decision, the Court held there are “no randomized controlled trials or meta-analyses of such trials or meta-analyses of observational studies that find an association between Celebrex 200 mg/day and a risk of heart attack or stroke.”

Together, the two decisions render certain expert opinions inadmissible, which we believe could result in the dismissal of many Celebrex cases. The majority of the Celebrex cases are pending in the two courts that issued the decisions.

Most of the Celebrex lawsuits were filed after the U.S. Food and Drug Administration (FDA) held advisory committee hearings in 2005 on the cardiovascular risk of non-steroidal anti-inflammatory drugs (NSAIDS), including Celebrex. The FDA concluded that based on the available data, Celebrex’s benefits outweigh its risks for appropriate patients at approved doses. As a result, Celebrex has remained continuously on the market since it first became available to patients in 1999.

Although neither the New York nor federal district court ruling excludes – at this stage – all expert testimony concerning risk of heart attack or stroke in connection with plaintiffs who took more than 200 mg/daily of Celebrex in the ongoing litigation, Pfizer intends to challenge the admissibility of evidence that such higher doses might cause heart attacks or strokes in those specific cases.

“We are pleased with Justice Kornreich’s decision which, like the federal court decision, recognizes the lack of any credible evidence linking Celebrex, at its most common dosage form, with heart attacks or strokes,” said Pfizer General Counsel Allen Waxman. “We believe that these rulings will greatly limit the scope of this litigation, and we intend to continue to vigorously defend the cases against us.”