Needle and the Damage Done

The Supreme Court handed down its decision this month in the case of Wyeth v. Levine,
ruling that federal law did not bar plaintiff Diana Levine from suing
pharmaceutical maker Wyeth over allegedly insufficient drug safety
warnings, even though the warnings had been approved by the Food and
Drug Administration (FDA). This decision establishes the troubling
precedent that a sympathetic jury can now supersede the expert opinions
of the FDA on what qualifies as adequate safety labeling. Ultimately,
that means drug firms face higher costs and greater uncertainty. Both
are bad for patients.

Levine lost an arm to gangrene after
a physician’s assistant injected the Wyeth drug Phenergan in such a way
that it came into contact with oxygen-rich arterial blood. Although the
drug’s label explicitly warned that doing so poses a high risk of
tissue damage, Levine claimed that the label should have instructed
physicians not to use this intravenous "IV-push" method at all. A
Vermont jury agreed, and awarded Levine $7.4 million, which the court
reduced to $6.7 million.

On appeal, Wyeth could not challenge
the jury’s fact finding, but argued that the FDA’s extensive regulation
of drug labeling should preclude claims of negligent failure to warn.
The Supreme Court held, by a 6-3 majority, that federal law does not
preempt Levine’s claim.

According to Justice John Paul
Stevens’ majority opinion, "The history of the [Food, Drug, and
Cosmetics Act] shows that Congress did not intend to preempt state-law
failure-to-warn actions." Although true in a general sense, the Court
failed to recognize that this is not a typical failure-to-warn case. As
Justice Samuel Alito’s dissenting opinion notes, Levine conceded that,
in 1988, Wyeth proposed a label change that "if followed, would have
prevented the inadvertent administration of Phenergan into an artery,"
but the FDA rejected that language.

Nevertheless, Levine
alleged not only that the warning on Phenergan’s label wasn’t strong
enough, but that Phenergan was "not reasonably safe for intravenous
administration"—and that the label should have said so. That, however,
poses a question regarding FDA’s approval of the product for that use,
not Wyeth’s alleged negligence in drafting the label.

first approved Phenergan in 1955. And, as the risk of arterial
injection became apparent over the years, the agency approved several
changes to the drug’s label, which now contains six statements (two in
all capital letters and bold face type) warning doctors about the exact
nature of that risk.

The doctor and physician’s assistant who
treated Levine nevertheless administered a dose twice as high as
indicated, injected it into the inner crook of her arm where the risk
of accidental arterial injection is very high, and continued to push in
the syringe’s plunger despite Levine’s protestations of pain, each in
direct contravention of explicit label warnings. It was this negligent
administration that caused the massive tissue damage that led to the
amputation of her arm.

Levine settled a claim against the
physician’s assistant and the prescribing doctor, then turned her
sights on Wyeth. At trial, Levine’s attorney argued that, despite the
FDA’s approval of Phenergan’s label, the drug firm acted negligently by
failing to add even sterner warnings or changing the label to rule out
intravenous injection altogether. But doing the latter would have
overruled a FDA decision that permits IV-push injections when that
method could provide more benefits than the alternative.

Stevens’s majority opinion asserts that the FDA can’t keep track of all
safety issues that arise after a drug is approved and that the agency
never specifically made a determination regarding the safety of IV-push
administration. Consequently, Wyeth could have changed its label
without the FDA’s pre-approval upon receiving information regarding the
risk of arterial injection of Phenergan. But that assertion is plainly
wrong. The case record shows that the FDA repeatedly and intensively
investigated this exact question and determined that IV-push injection
provided important medical benefits.

Furthermore, there are
no allegations that Wyeth hid any information about the risks of IV
injection, nor has any new information regarding the risks arisen that
would call the FDA’s decision into question. So, the decision in Levine
is tantamount to letting a group of laymen overrule the FDA’s expert
opinion regarding safety. In his closing arguments at trial, Levine’s
attorney told the jury, "Thank God we don’t rely on the FDA to…make
the safe[ty] decision…The FDA doesn’t make the decision, you do."

majority of the Supreme Court agreed, concluding that FDA regulation
should be seen as a floor, but should not preempt stricter state tort
laws. That, however, conflicts with longstanding Court precedent
regarding implied pre-emption of state laws that conflict with federal
regulatory decisions. As Justice Alito’s dissent notes, "the ordinary
principles of conflict pre-emption turn solely on whether a State has
upset the regulatory balance struck by the federal agency." That is
exactly what has happened here.

The Supreme Court could have
and should have held in Wyeth’s favor with a narrowly tailored opinion
confined to the facts of this case. Doing so would not have insulated
wrongdoers from punishment, but would have recognized that Congress
gave FDA statutory authority over questions of safety and efficacy
because it believed a federal expert body could most effectively
balance the benefits and risks of new medicines. Empowering lay juries
to override those decisions means that fewer patients will benefit from
important medicines in the future. Not only is the majority’s decision
bad law, it’s very bad for patients.

Gregory Conko is a senior fellow with the Competitive Enterprise Institute in Washington, DC.