WYETH,
PETITIONER v. DIANA LEVINE
SUPREME
COURT OF THE UNITED STATES
March
4, 2009, Decided
SYLLABUS
Petitioner
Wyeth manufactures the antinausea drug Phenergan. After a clinician
injected respondent
Levine with Phenergan by the "IV-push" method, whereby a drug is
injected directly into a patient's vein, the drug entered Levine's
artery, she
developed gangrene, and doctors amputated her forearm. Levine brought a
state-law damages action, alleging, inter alia, that Wyeth had
failed to
provide an adequate warning about the significant risks of
administering
Phenergan by the IV-push method. The
Held: Federal law
does not
pre-empt Levine's claim that Phenergan's label did not contain an
adequate
warning about the IV-push method of administration.
(a)
The argument that Levine's state-law claims are pre-empted because it
is
impossible for Wyeth to comply with both the state-law duties
underlying those
claims and its federal labeling duties is rejected. Although a
manufacturer
generally may change a drug label only after the FDA approves a
supplemental
application, the agency's "changes being effected" (CBE) regulation
permits certain preapproval labeling changes that add or strengthen a
warning
to improve drug safety. Pursuant to the CBE regulation, Wyeth could
have
unilaterally added a stronger warning about IV-push administration, and
there
is no evidence that the FDA would ultimately have rejected such a
labeling
change. Wyeth's cramped reading of the CBE regulation and its broad
assertion
that unilaterally changing the Phenergan label would have violated
federal law
governing unauthorized distribution and misbranding of drugs are based
on the
fundamental misunderstanding that the FDA, rather than the
manufacturer, bears
primary responsibility for drug labeling. It is a central premise of
the Food,
Drug, and Cosmetic Act (FDCA) and the FDA's regulations that the
manufacturer
bears responsibility for the content of its label at all times.
(b)
Wyeth's argument that requiring it to comply with a state-law duty to
provide a
stronger warning would interfere with Congress' purpose of entrusting
an expert
agency with drug labeling decisions is meritless because it relies on
an
untenable interpretation of congressional intent and an overbroad view
of an
agency's power to pre-empt state law. The history of the FDCA shows
that
Congress did not intend to pre-empt state-law failure-to-warn actions.
In
advancing the argument that the FDA must be presumed to have
established a
specific labeling standard that leaves no room for different state-law
judgments, Wyeth relies not on any statement by Congress but on the
preamble to
a 2006 FDA regulation declaring that state-law failure-to-warn claims
threaten
the FDA's statutorily prescribed role. Although an agency regulation
with the
force of law can pre-empt conflicting state requirements, this case
involves no
such regulation but merely an agency's assertion that state law is an
obstacle
to achieving its statutory objectives. Where, as here, Congress has not
authorized a federal agency to pre-empt state law directly, the weight
this
Court accords the agency's explanation of state law's impact on the
federal
scheme depends on its thoroughness, consistency, and persuasiveness.
Under this
standard, the FDA's 2006 preamble does not merit deference: It is
inherently
suspect in light of the FDA's failure to offer interested parties
notice or
opportunity for comment on the pre-emption question; it is at odds with
the available
evidence of Congress' purposes; and it reverses the FDA's own
longstanding
position that state law is a complementary form of drug regulation
without
providing a reasoned explanation.
JUDGES: STEVENS, J.,
delivered
the opinion of the Court, in which KENNEDY, SOUTER, GINSBURG, and
BREYER, JJ.,
joined. BREYER, J., filed a concurring opinion. THOMAS, J., filed an
opinion
concurring in the judgment. ALITO, J., filed a dissenting opinion, in
which
ROBERTS, C. J., and SCALIA, J., joined.
JUSTICE
STEVENS delivered the opinion of the Court.
Directly
injecting the drug Phenergan into a patient's vein creates a
significant risk
of catastrophic consequences. A
Wyeth
makes two separate pre-emption arguments: first, that it would have
been
impossible for it to comply with the state-law duty to modify
Phenergan's
labeling without violating federal law, and second, that recognition of
Levine's state tort action creates an unacceptable "obstacle to the
accomplishment and execution of the full purposes and objectives of
Congress,"
Hines v. Davidowitz, 312 U.S. 52, 67 (1941), because it
substitutes
a lay jury's decision about drug labeling for the expert judgment of
the FDA.
As a preface to our evaluation of these arguments, we identify two
factual
propositions decided during the trial court proceedings, emphasize two
legal
principles that guide our analysis, and review the history of the
controlling
federal statute.
The
trial court proceedings established that Levine's injury would not have
occurred if Phenergan's label had included an adequate warning about
the risks
of the IV-push method of administering the drug. In finding Wyeth
negligent as
well as strictly liable, the jury also determined that Levine's injury
was
foreseeable. That the inadequate label was both a but-for and proximate
cause
of Levine's injury is supported by the record and no longer challenged
by
Wyeth.
The
trial court proceedings further established that the critical defect in
Phenergan's label was the lack of an adequate warning about the risks
of
IV-push administration. Levine also offered evidence that the IV-push
method
should be contraindicated and that Phenergan should never be
administered
intravenously, even by the IV-drip method. The jury verdict established
only
that Phenergan's warning was insufficient. It did not mandate a
particular
replacement warning, nor did it require contraindicating IV-push
administration:
"There may have been any number of ways for [Wyeth] to strengthen the
Phenergan warning without completely eliminating IV-push
administration."
We therefore need not decide whether a state rule proscribing
intravenous
administration would be pre-empted. The narrower question presented is
whether
federal law pre-empts Levine's claim that Phenergan's label did not
contain an
adequate warning about using the IV-push method of administration.
Our
answer to that question must be guided by two cornerstones of our
pre-emption
jurisprudence. First, "the purpose of Congress is the ultimate
touchstone
in every pre-emption case." Medtronic,
Inc. v. Lohr,
518
Wyeth
first argues that Levine's state-law claims are pre-empted because it
is
impossible for it to comply with both the state-law duties underlying
those
claims and its federal labeling duties. The FDA's premarket approval of
a new
drug application includes the approval of the exact text in the
proposed label.
Generally speaking, a manufacturer may only change a drug label after
the FDA
approves a supplemental application. There is, however, an FDA
regulation that
permits a manufacturer to make certain changes to its label before
receiving
the agency's approval. Among other things, this "changes being
effected" (CBE) regulation provides that if a manufacturer is changing
a
label to "add or strengthen a contraindication, warning, precaution, or
adverse reaction" or to "add or strengthen an instruction about
dosage and administration that is intended to increase the safe use of
the drug
product," it may make the labeling change upon filing its supplemental
application
with the FDA; it need not wait for FDA approval.
Wyeth
argues that the CBE regulation is not implicated in this case because a
2008
amendment provides that a manufacturer may only change its label "to
reflect newly acquired information." Resting on this language, Wyeth
contends that it could have changed Phenergan's label only in response
to new
information that the FDA had not considered. And it maintains that
Levine has
not pointed to any such information concerning the risks of IV-push
administration. Thus, Wyeth insists, it was impossible for it to
discharge its
state-law obligation to provide a stronger warning about IV-push
administration
without violating federal law. Wyeth's argument misapprehends both the
federal
drug regulatory scheme and its burden in establishing a pre-emption
defense.
We
need not decide whether the 2008 CBE regulation is consistent with the
FDCA and
the previous version of the regulation because Wyeth could have revised
Phenergan's label even in accordance with the amended regulation. As
the FDA
explained in its notice of the final rule, "'newly acquired
information'" is not limited to new data, but also encompasses "new
analyses of previously submitted data." The rule accounts for the fact
that risk information accumulates over time and that the same data may
take on
a different meaning in light of subsequent developments: "[I]f the
sponsor
submits adverse event information to FDA, and then later conducts a new
analysis of data showing risks of a different type or of greater
severity or
frequency than did reports previously submitted to FDA, the sponsor
meets the
requirement for 'newly acquired information.'"
The
record is limited concerning what newly acquired information Wyeth had
or
should have had about the risks of IV-push administration of Phenergan
because
Wyeth did not argue before the trial court that such information was
required
for a CBE labeling change. Levine did, however, present evidence of at
least 20
incidents prior to her injury in which a Phenergan injection resulted
in
gangrene and an amputation. After the first such incident came to
Wyeth's
attention in 1967, it notified the FDA and worked with the agency to
change
Phenergan's label. In later years, as amputations continued to occur,
Wyeth could
have analyzed the accumulating data and added a stronger warning about
IV-push
administration of the drug.
Wyeth
argues that if it had unilaterally added such a warning, it would have
violated
federal law governing unauthorized distribution and misbranding. Its
argument
that a change in Phenergan's labeling would have subjected it to
liability for
unauthorized distribution rests on the assumption that this labeling
change
would have rendered Phenergan a new drug lacking an effective
application. But
strengthening the warning about IV-push administration would not have
made
Phenergan a new drug. Nor would this warning have rendered Phenergan
misbranded.
Wyeth's
cramped reading of the CBE regulation and its broad reading of the
FDCA's
misbranding and unauthorized distribution provisions are premised on a
more
fundamental misunderstanding. Wyeth suggests that the FDA, rather than
the
manufacturer, bears primary responsibility for drug labeling. Yet
through many
amendments to the FDCA and to FDA regulations, it has remained a
central
premise of federal drug regulation that the manufacturer bears
responsibility
for the content of its label at all times. It is charged both with
crafting an
adequate label and with ensuring that its warnings remain adequate as
long as
the drug is on the market.
Indeed,
prior to 2007, the FDA lacked the authority to order manufacturers to
revise
their labels. When Congress granted the FDA this authority, it
reaffirmed the manufacturer's
ultimate responsibility for its label. Thus, when the risk of gangrene
from
IV-push injection of Phenergan became apparent, Wyeth had a duty to
provide a
warning that adequately described that risk, and the CBE regulation
permitted
it to provide such a warning before receiving the FDA's approval.
Of
course, the FDA retains authority to reject labeling changes made
pursuant to
the CBE regulation in its review of the manufacturer's supplemental
application, just as it retains such authority in reviewing all
supplemental
applications. But absent clear evidence that the FDA would not have
approved a
change to Phenergan's label, we will not conclude that it was
impossible for
Wyeth to comply with both federal and state requirements. Wyeth has
offered no
such evidence. We accordingly cannot credit Wyeth's contention that the
FDA
would have prevented it from adding a stronger warning about the
IV-push method
of intravenous administration.
Impossibility
pre-emption is a demanding defense. On the record before us, Wyeth has
failed
to demonstrate that it was impossible for it to comply with both
federal and
state requirements. The CBE regulation permitted Wyeth to unilaterally
strengthen
its warning, and the mere fact that the FDA approved Phenergan's label
does not
establish that it would have prohibited such a change.
IV
Wyeth
also argues 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. Levine's tort claims,
it
maintains, are pre-empted because they interfere with "Congress's
purpose
to entrust an expert agency to make drug labeling decisions that strike
a balance
between competing objectives." We find no merit in this argument, which
relies
on an untenable interpretation of congressional intent and an overbroad
view of
an agency's power to pre-empt state law.
Wyeth
contends that the FDCA establishes both a floor and a ceiling for drug
regulation: Once the FDA has approved a drug's label, a state-law
verdict may
not deem the label inadequate, regardless of whether there is any
evidence that
the FDA has considered the stronger warning at issue. The most glaring
problem
with this argument is that all evidence of Congress' purposes is to the
contrary.
Building on its 1906 Act, Congress enacted the FDCA to
bolster consumer
protection against harmful products.
If
Congress thought state-law suits posed an obstacle to its objectives,
it surely
would have enacted an express pre-emption provision at some point
during the
FDCA's 70-year history. But despite its 1976 enactment of an express
pre-emption provision for medical devices, Congress has not enacted
such a
provision for prescription drugs. Its silence on the issue, coupled
with its certain
awareness of the prevalence of state tort litigation, is powerful
evidence that
Congress did not intend FDA oversight to be the exclusive means of
ensuring
drug safety and effectiveness. As Justice O'Connor explained in her
opinion for
a unanimous Court: "The case for federal pre-emption is particularly
weak
where Congress has indicated its awareness of the operation of state
law in a
field of federal interest, and has nonetheless decided to stand by both
concepts and to tolerate whatever tension there [is] between them." Bonito
Boats, Inc. v. Thunder Craft Boats, Inc., 489
In
short, Wyeth has not persuaded us that failure-to-warn claims like
Levine's
obstruct the federal regulation of drug labeling. Congress has
repeatedly
declined to pre-empt state law.
Although we recognize that some state-law claims might well frustrate
the
achievement of congressional objectives, this is not such a case.
V
We
conclude that it is not impossible for Wyeth to comply with its state
and
federal law obligations and that Levine's common-law claims do not
stand as an
obstacle to the accomplishment of Congress' purposes in the FDCA.
Accordingly,
the judgment of the Vermont Supreme Court is affirmed.
JUSTICE
THOMAS, concurring in the judgment.
I
agree with the Court that the fact that the Food and Drug
Administration (FDA)
approved the label for petitioner Wyeth's drug Phenergan does not
pre-empt the
state-law judgment before the Court. I write separately, however,
because I
cannot join the majority's implicit endorsement of far-reaching implied
pre-emption doctrines. In particular, I have become increasingly skeptical of
this Court's "purposes and objectives" pre-emption jurisprudence.
Under this approach, the Court routinely invalidates state laws based
on
perceived conflicts with broad federal policy objectives, legislative
history,
or generalized notions of congressional purposes that are not embodied
within
the text of federal law. Because implied pre-emption doctrines that
wander far
from the statutory text are inconsistent with the Constitution, I
concur only
in the judgment.