Pfizer reaches $894 million settlement to resolve Bextra litigation

Pfizer Inc announced today that it has reached agreements in principle to resolve substantially all of the personal injury cases, consumer fraud cases and state attorneys general claims involving its non-steroidal anti-inflammatory (NSAID) pain medication Bextra, which the drug maker voluntarily withdrew from the US market in 2005.

Additionally, following key court rulings in favor of Celebrex, claims regarding Celebrex, an effective pain treatment for millions of patients, will also be resolved as part of the settlement.

''We are pleased by the favourable rulings we have achieved in this litigation and believe that now is the right time to resolve these matters,'' said Amy W. Schulman, senior vice president and general counsel of Pfizer. ''Inevitably, litigation can be distracting and putting these matters behind us helps our shareholders and, most importantly, patients and doctors.''

''Pfizer stands by the safety and efficacy profile of Celebrex. It is one of the most rigorously- and continuously-studied drugs in the world, as evidenced by its approval and use in 111 countries during the past 10 years across several different pain indications,'' said Joseph M. Feczko, chief medical officer for Pfizer. "We believe that putting these matters substantially behind us should better enable physicians to consider Celebrex purely on the strength of its clinical data, and its ability to meet the diverse needs of patients in pain.''

Today's announcement follows favourable rulings in which federal and New York state court judges overseeing a majority of the personal injury cases ruled that the plaintiffs' lawyers failed to present reliable scientific evidence to prove Celebrex can cause heart attacks or strokes at its most commonly prescribed dose. These rulings would have likely limited the scope of these cases had the litigation continued. By settling these matters now, the parties are minimizing the future cost and disruption inevitably associated with litigation.

These rulings within the past year are consistent with the conclusion reached by the U.S. Food and Drug Administration (FDA) in 2005 that, based on the available data, the benefits of Celebrex outweigh its risks for appropriate patients at approved doses. The FDA requires that all prescription NSAIDs carry the same cardiovascular boxed warnings.