Pfizer Inc said it plans to pay $894 million to settle lawsuits alleging that its withdrawn Bextra painkiller and widely used Celebrex arthritis drug harmed U.S. patients and defrauded consumers. Pfizer said the money would be paid out under three separate tentative settlements — including one that resolves claims by 33 states and the District of Columbia primarily related to Bextra marketing practices.
“It’s good that Pfizer is settling the majority of these cases because these things tend to drag on for five to 10 years and take a lot of focus off running the company,” said Jon LeCroy, an analyst with Natixis Bleichroeder. LeCroy said Wall Street has closely followed the Bextra and Celebrex cases because Bextra was sold only briefly. Moreover, he said Celebrex has not been shown to have the same cardiovascular risks as Vioxx, a similar drug that Merck & Co Inc withdrew in 2004.
New York-based Pfizer said it has taken a pretax charge of $894 million in the third quarter for the proposed settlements, and that the funds should also be sufficient to cover personal injury cases that have not yet been resolved. The company, which still sells Celebrex, said it decided to settle to eliminate the legal distractions, although it admitted no wrongdoing.
“Putting all these matters behind Pfizer makes good sense from the company point of view and with respect to patients and doctors,” Amy Schulman, Pfizer’s general counsel, said in an interview.
The charge includes $745 million to resolve personal injury claims, $60 million to settle with the states over Bextra marketing practices and $89 million to resolve consumer fraud class-action cases that allege Bextra and Celebrex promotions caused financial harm.
Bextra and Celebrex belong to the same class of painkillers as Vioxx, which was withdrawn after being linked to heart attacks among long-time users. Merck has resolved claims from most of the thousands of U.S. patients who said they were harmed by its drug with a $4.85 billion settlement.
In 2005, the Food and Drug Administration asked Pfizer to withdraw Bextra from U.S. drugstores, citing a possible risk of causing heart problems and reports of a potentially fatal skin reaction called Stevens-Johnson syndrome in people taking the drug.
Pfizer’s Schulman declined to break down how much of the money being set aside would satisfy Bextra claims or Celebrex lawsuits.
But she said federal and state courts have ruled there is no reliable scientific evidence that Celebrex increases risk of heart attack and stroke.
At the time that Bextra was withdrawn, the FDA ordered that all prescription nonsteroidal anti-inflammatory drugs (NSAIDs), including Celebrex, carry a “black box” warning about potential increased risk of heart attacks, strokes and stomach problems.
The FDA also required that all over-the-counter NSAIDs, including naproxen and ibuprofen, include more information about those risks, as well as the risk of serious skin reactions. The label changes do not apply, however, to aspirin or acetaminophen — the active ingredient of Johnson & Johnson’s Tylenol painkiller.