NEJM amicus brief supports failure-to-warn claims against Wyeth Laboratories.
A group of current and former editors of
The New England Journal of Medicine, along with several well-known
NEJM contributors, recently filed an amicus brief in U.S. Supreme Court, 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 FDA 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. The 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, all the while continuing to market these drugs to an
unsuspecting public. In all cases, the companies allegedly manufactured
data, ghostwrote articles for medical journals and/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 were likely attributable to Trasylol between its release
in 1993 and its eventual withdrawal from the market in May 2008.
In
light of these examples and others, the 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.
This article was published in Acupuncture Today, The Acupuncture and Oriental Medicine News Source