Toxic Tort/Appellate Alert
March 6, 2009
Author:
Nicholas Ranjan
nicholas.ranjan@klgates.com
+1.412.355.8618
Contacts:
Nicholas P. Vari
nick.vari@klgates.com
+1.412.355.8365
John P. Krill, Jr.
john.krill@klgates.com
+1.717.231.4505
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Regulatory Compliance May Not Be Enough:
U.S. Supreme Court Rejects Pharmaceutical
Maker s Argument That Compliance With
Federal Labeling Requirements Precluded
State Court Failure-To-Warn Claim
On March 4, 2009, the Supreme Court of the United States, in a 6-3 decision
authored by Justice Stevens, held that a pharmaceutical manufacturer s compliance
with federal labeling regulations does not preclude a state-court tort claim. See
Wyeth v. Levine, 555 U.S.__ (2009). The Court based its decision primarily on the
absence of express language indicating a congressional intent of preemption, as well
as the central premise of federal drug regulation that the manufacturer bears
responsibility for the content of its label at all times.
In Wyeth, Diana Levine filed suit in Vermont state court against drug manufacturer,
Wyeth, alleging that its drug, Phenergan (an antihistamine used to treat nausea), did
not contain sufficient warnings. Specifically, Levine contended that the drug s label
failed to instruct clinicians to use the IV-drip method of intravenous administration
instead of the higher risk IV-push method the latter of which was employed by
Levine s physician and resulted in her gangrene and loss of limb. Wyeth countered
by arguing that it could not provide such a warning, since federal law prescribed
what it could and could not put on its label. The trial court rejected Wyeth s
argument, and the jury awarded Levine approximately $7 million in damages.
Wyeth unsuccessfully pressed its preemption argument before the Vermont appellate
courts before obtaining a writ of certiorari from the Supreme Court on the question
of whether the FDA s drug labeling judgments preempt state law product liability
claims premised on the theory that different labeling judgments were necessary to
make drugs reasonably safe for use.
In the Supreme Court, Wyeth raised two conflict-preemption arguments. It first
raised an impossibility defense, arguing that Levine s state-law claims were
preempted because it was impossible for Wyeth to comply with both the state-law
duties underlying those claims and its federal labeling duties. That is, Wyeth
contended that under the FDA s regulations it could have changed Phenergan s label
only in response to new information that the FDA had not considered, and that
Levine did not point to any new information concerning the risks of IV-push
administration. The Court rejected this argument, finding Wyeth s reading of the
relevant regulation to be cramped and its concern with violating the misbranding
provisions of the FDCA overstated, and noted that Levine had, in fact, presented
evidence of at least 20 incidents prior to her injury in which a Phenergan injection
resulted in gangrene and an amputation. More broadly, the Court considered
Wyeth s argument to be premised on a misapprehension of the regulatory scheme
as the FDCA and FDA regulations place the responsibility for the content of a drug s
label with the manufacturer.
Toxic Tort/Appellate Alert
Wyeth next argued that requiring it to comply with a
state-law duty to provide a stronger warning about
IV-push administration would obstruct the purposes
and objectives of federal drug labeling regulation,
and would interfere with Congress s purpose to
entrust an expert agency to make drug labeling
decisions that strike a balance between competing
objectives. The Court, examining the statutory
framework of the FDCA, discovered nothing in the
FDCA that would suggest that state lawsuits may
hinder Congress s objectives. To the contrary, the
Court concluded that the absence of an express
preemption provision regarding prescription drugs
coupled with the statute s preemption provision for
medical devices was powerful evidence that
Congress did not intend FDA oversight to be the
exclusive means of ensuring drug safety and
effectiveness.
Wyeth, of course, represents a significant setback for
entities that relied upon federal regulatory
compliance as a defense to failure-to-warn claims.
However, product-liability defendants should
recognize that Wyeth likely will be limited to its
context. The Court repeatedly emphasized the
narrowness of the question involved. And the
Court s implied-preemption discussion centered
upon the unique FDA regulatory scheme. For
instance, the Court distinguished its decision in
Geier v. American Honda Motor Co., 529 U.S. 861
(2000), which involved compliance with automobile
safety regulations, as involving a quite different
regulatory scheme. The impact of the case-specific
nature of Wyeth and the statutory or regulatory
language upon the outcome may be illustrated by
comparing the lineup of the justices in Wyeth with
that in last term s decision in Estate of Riegel v.
Medtronic, Inc., 128 S. Ct. 999 (2008), in which the
Court found that state tort claims against
manufacturers of certain medical devices were
preempted by federal law. In Wyeth the majority
consisted of Justices Stevens, Kennedy, Souter,
Ginsburg, and Breyer, with Justice Thomas
concurring only in the result. In Medtronic the only
dissenter was Justice Ginsburg.
Notably, the Court in Wyeth did not curtail its
implied preemption purposes and objectives
jurisprudence, which involves an assessment of
Congress s purposes behind a statute and whether a
state law (or, in Wyeth, a state tort claim) would
undermine those purposes typically a useful
defense for product-liability defendants. This
implied-preemption doctrine has oftentimes been
criticized for being boundless and overbroad, and
Justice Thomas s lengthy concurrence in Wyeth
echoed such concerns, which the majority implicitly
rejected. Thus, at least outside of the precise
pharmaceutical-labeling context of Wyeth, productliability defendants should be able to continue to
raise an implied-preemption defense based on
compliance with federal regulation; the success of
the defense will be dependent upon the regulatory
scheme at issue.
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©2009 K&L Gates LLP. All Rights Reserved.
March 6, 2009
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