The financial fall-out from Pfizer’s withdrawal of its COX-2 pain reliever, Bextra (valdecoxib), from the market at the request of the US Food and Drug Administration last week is likely to be huge, and not just in lost sales.
Lawsuits are already flying across the USA that could hit the drugs behemoth very hard following the FDA’s decision to suspend Bextra amid fears that it could cause a potentially life-threatening skin condition, known as Stevens-Johnson syndrome, which usually begins as a blistering of the lips and can spread to the rest of the body [[08/04/05a]]. The drug had sales of $1.3 billion last year.
However, the lawsuits that are being planned are not purely based on product liability, but also include consumer fraud as the result of the so-called false advertising of Bextra and Pfizer’s other COX-2 drug, Celebrex (celecoxib), and the withholding of information regarding the drugs’ alleged safety risks.
It is unclear how many suits have been filed against Pfizer concerning its COX-2 inhibitors, but the situation resembles the problems being faced by Merck & Co, which recently said that, as of the end of January, it had been named in 850 lawsuits concerning its withdrawn COX-2 drug, Vioxx (rofecoxib), and it expects many more [[14/03/05c]].
Andy Birchfield, lead Bextra litigation attorney at US law firm Beasley Allen, is spearheading the review of over 1,000 cases, having already filed 58 of them against Pfizer, and said: “It is apparent that without the courts, the American people would have little hope when it comes to the regulation of the drug industry.”
So what now for Pfizer? One possibility is that it follows Merck’s example and seeks to transfer all pending product liability lawsuits surrounding Vioxx into one consolidated litigation [[17/02/05e]], though this has caused some problems with the firm’s insurers [[14/03/05c]].
Pfizer’s annual report, filed in February, acknowledged that it is the subject of government investigations and numerous lawsuits, and although it claimed to have “substantial defences,” the firm warned that potential judgments or settlements “could have a material adverse effect.” How adverse will soon become clearer.