A group of current and former editors of The New England Journal of Medicine, along with several well-known NEJM contributors, filed an amicus brief in the U.S.Supreme Court on Aug. 16, 2008, charging pharmaceutical companies with deliberately withholding relevant adverse-reaction data when their profits are at stake. The brief was filed in conjunction with the Wyeth v. Levine case, in which drug giant Wyeth Laboratories is appealing a Vermont Supreme Court decision awarding $6.8 million to Diana Levine, who had to have her arm amputated after improper administration of the Wyeth anti-nausea drug Phenargan.
Levine's lawsuit charges that the drug contained inadequate warnings and instructions for use. Wyeth, in turn, is claiming that the FDA's authority to approve drug labeling preempts state failure-to-warn litigation regarding prescription medication. In the summary of its argument supporting Levine, the amicus brief stated:
"The argument of Petitioner [Wyeth] and its amici ('Petitioner/Amici') that federal preemption of state law failure-to-warn claims involving prescription drugs will actually make the world a safer place is riddled with factual fallacies. First, contrary to Petitioner's/Amici's necessary premise, the FDA is in no position to ensure the safety of prescription drugs. Not only is the FDA seriously hampered in its ability to determine the risks of drugs before they are approved for sale, but it has proven inadequate to the task of addressing hazards that only become apparent after a drug has been widely marketed to an unsuspecting public. Post-approval dangers posed by drugs placed into the market are unfortunately quite common. However, the FDA's ability to either anticipate these risks or react expeditiously once they have been revealed has been limited by serious information-gathering constraints in both pre- and post-approval settings."
Part of the difficulty the FDA has in addressing drug risks, according to the brief, stems from the fact that it is forced to rely on the manufacturers themselves for outcome data upon which to base its decision to either approve or disapprove a drug. As one might expect, the big pharmaceutical manufacturers have a vested interest in not only getting their drugs approved, but also keeping them on the market for as long as possible.
The amicus brief went on to use the examples of three different drugs (Pondimin/Redux, Vioxx and Trasylol) in which the manufacturers allegedly withheld key information from the FDA and strongly argued against stricter label warnings while continuing to market these drugs to an unsuspecting public. In all cases, the companies allegedly manufactured data, ghostwrote articles for medical journals or withheld negative findings from the FDA.
The worst of these offenders in terms of estimated patient deaths was the anticoagulant Trasylol, marketed by Bayer. The drug was found to cause kidney failure. According to the amicus brief: "Between 1999 and 2005, Bayer generated over $935 million in revenue from sales of Trasylol with over $353 million in 2005. Bayer forecast that Trasylol would some day generate upwards of $600 million annually." Although exact numbers may never be released, an estimated 242,000 deaths may have been attributable to Trasylol between the time of its release in 1993 and its eventual withdrawal from the market in May 2008.
In light of these examples, the amicus brief argues strongly in favor of the FDA and the legal system working together to enhance consumer protection:
"Product liability lawsuits and the FDA have peacefully coexisted for seventy years for one simple reason: they have complementary, rather than conflicting, goals. The tort system complements the federal regulatory structure by providing a mechanism for compensating victims of hazardous drugs. Product liability litigation provides the FDA with key information unearthed in litigation that the agency can use to better protect the public from unsafe and inadequately labeled drugs. At the same time, the tort system and the FDA are similarly constrained.
"Whereas the FDA, as a regulatory body, weighs the risks against the benefits of a drug, in "failure-to-warn" litigation most state courts require a similar balancing between the cost of care owed to a patient versus the prospective harm."
The brief went on to conclude:
"[G]iven that pharmaceutical companies have been known to equate increased warnings with a loss of sales, they would have an incentive to delay warnings as long as possible. As has been shown, certain pharmaceutical companies have already proven themselves unwilling to prioritize safety over profits, even when faced with the threat of civil liability. It is chilling to imagine how such companies might conduct themselves if the threat of tort liability for dangerous drugs were eliminated entirely by virtue of federal preemption."
The full text of the amicus brief, along with all other briefs filed in the lawsuit, is available online at www.abanet.org/publiced/preview/briefs/nov08.shtml#wyeth.