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Pfizer Reaches Massive Settlement In Celebrex, Bextra Lawsuits
TRENTON, N.J. — Drug giant Pfizer Inc. has reached an $894 million deal to settle the bulk of the lawsuits over its withdrawn pain reliever Bextra, following the lead of rival Merck & Co., which is spending five times as much to settle Vioxx suits.
The Pfizer agreement also would end lawsuits over its popular Celebrex, the only one of the three _ all in the same class of anti-inflammatory drugs and all linked to elevated risk of heart attacks and strokes _ still on the market.
The world's biggest drugmaker said Friday it has agreements in principle to end up to 92 percent of personal injury lawsuits brought by people claiming Bextra and Celebrex caused heart attacks, strokes or other harm.
The settlement includes roughly 7,000 personal injury cases, mainly plaintiffs who took Bextra, said plaintiff attorney Perry Weitz. He represents nearly 2,000 claimants, about 10 percent of them relatives of people who died.
"It gives Pfizer closure and the claimants their money sooner, rather than later or never at all," Weitz said.
Pfizer hopes to finalize the settlement by year's end. It also hopes to include additional claimants in the settlement and will fight any remaining personal injury suits with court motions or at trial, General Counsel Amy Schulman told The Associated Press.
"I don't think either side has an interest in protracting this," Schulman said in an interview.
Weitz said plaintiff lawyers will "have issues" with Pfizer "if their claimants aren't paid before the end of the year."
Pfizer shares fell 6 cents to $16.91.
Schulman said the deal comes after two important court rulings _ one by a New York state judge overseeing many of the state-level personal injury cases and the other by a federal judge in San Francisco coordinating pretrial steps in federal lawsuits over the drugs.
"We teed up some pretrial motions for a court ruling on whether there was significantly reliable evidence that ... there was an increased risk of heart attack and stroke at the most common dose," 200 milligrams, Schulman said. Both judges ruled there was not enough evidence, weakening the plaintiffs' case, she said.
The proposed deal also would end suits by insurers and patients seeking to recover what they spent on Bextra and Celebrex, plus claims by state attorneys general that Pfizer improperly promoted Bextra.
Out of the total settlement, $745 million will go to settle personal injury cases, $89 million will cover consumer fraud cases over reimbursement for money spent on the two drugs, and $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia. Louisiana and Mississippi still have pending cases regarding Pfizer's marketing.
New York-based Pfizer will take a pretax charge of $894 million to its third-quarter earnings.
"This is as good a result as Pfizer can get" and still leaves them plenty of money for acquisitions and other business needs, said Erik Gordon, head of biomedical industry programs at Stevens Institute of Technology. He likened the crush of lawsuits to "having a thousand fleas attack a dog at the same time.
"At some point, you have to do something to try to get most of them off," Gordon said.
Pfizer withdrew Bextra from the market in 2005, a year after Merck withdrew Vioxx.
The Vioxx withdrawal triggered an avalanche of lawsuits against Merck and raised concerns about the safety of Celebrex and Bextra because they are in the same class, Cox-2 inhibitors. They were heavily advertised as superior to traditional nonsteroidal anti-inflammatory drugs, or NSAIDs, because they block an enzyme involved in promoting inflammation but _ unlike NSAIDs _ don't block an enzyme that protects the stomach from bleeding and other side effects.
Other NSAIDs, such as ibuprofen and naproxen, also have been linked to increased heart risks.
The Food and Drug Administration decided to leave Celebrex on the market, stating its benefits outweigh the risks for some patients _ as Pfizer stresses in recent ads for the drug.
Attorney Christopher Seeger, a member of the plaintiffs steering committee for the federal lawsuits, said he'll "have no problem recommending" the settlement to his roughly 400 clients.
"We're very satisfied with the deal," Seeger said.
Negotiations between plaintiffs lawyers and Pfizer started early this year and picked up in the late summer.
"Litigation can be distracting, and putting these matters behind us helps our shareholders and, most importantly, patients and doctors," Schulman said.
Weitz noted it took four or five years to get through trials for less than 20 cases in the massive Vioxx litigation.
Merck, based in Whitehouse Station, N.J., reached a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming Vioxx cause heart attacks, ischemic strokes or death. The claims administrator, at a court hearing Friday, said $103.6 million either has been sent or will be sent by next Wednesday to plaintiff lawyers, who deduct their fees and expenses and send the rest on to clients.
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LINDA A. JOHNSON | October 17, 2008 09:05 PM EST |
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