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 â 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."
For further information, visit www.pfizer.com.