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SUPREME COURT OF THE UNITED STATES
_________________
No. 17–290
_________________
MERCK SHARP & DOHME CORP., PETITIONER
v. DORIS ALBRECHT, et al.
on writ of certiorari to the united states
court of appeals for the third circuit
[May 20, 2019]
Justice Breyer delivered the opinion of the
Court.
When Congress enacted the Federal Food, Drug,
and Cosmetic Act, ch. 675, 52Stat. 1040, as amended, 21
U. S. C. §301
et seq., it charged the Food and
Drug Administration with ensuring that prescription drugs are “safe
for use under the conditions prescribed, recommended, or suggested”
in the drug’s “labeling.” §355(d). When the FDA exercises this
authority, it makes careful judgments about what warnings should
appear on a drug’s label for the safety of consumers.
For that reason, we have previously held that
“clear evidence” that the FDA would not have approved a change to
the drug’s label pre-empts a claim, grounded in state law, that a
drug manufacturer failed to warn consumers of the change-related
risks associated with using the drug. See
Wyeth v.
Levine,
555 U.S.
555, 571 (2009). We here determine that this question of
pre-emption is one for a judge to decide, not a jury. We also hold
that “clear evidence” is evidence that shows the court that the
drug manufacturer fully informed the FDA of the justifications for
the warning required by state law and that the FDA, in turn,
informed the drug manufacturer that the FDA would not approve a
change to the drug’s label to include that warning.
I
The central issue in this case concerns
federal pre-emption, which as relevant here, takes place when it is
“ ‘impossible for a private party to comply with both state
and federal requirements.’ ”
Mutual Pharmaceutical Co.
v.
Bartlett, 570 U.S. 472, 480 (2013). See also U. S.
Const., Art. VI, cl. 2. The state law that we consider is
state common law or state statutes that require drug manufacturers
to warn drug consumers of the risks associated with drugs. The
federal law that we consider is the statutory and regulatory scheme
through which the FDA regulates the information that appears on
brand-name prescription drug labels. The alleged conflict between
state and federal law in this case has to do with a drug that was
manufactured by petitioner Merck Sharp & Dohme and was
administered to respondents without a warning of certain associated
risks.
A
The FDA regulates the safety information that
appears on the labels of prescription drugs that are marketed in
the United States. 21 U. S. C. §355(b)(1)(F); 21 CFR
§201.57(a) (2018). Although we commonly understand a drug’s “label”
to refer to the sticker affixed to a prescription bottle, in this
context the term refers more broadly to the written material that
is sent to the physician who prescribes the drug and the written
material that comes with the prescription bottle when the drug is
handed to the patient at the pharmacy. 21 U. S. C.
§321(m). These (often lengthy) package inserts contain detailed
information about the drug’s medical uses and health risks.
§355(b)(1)(F); 21 CFR §201.57(a).
FDA regulations set out requirements for the
content, the format, and the order of the safety information on the
drug label. §201.57(c). Those regulations require drug labels to
include, among other things: (1) prominent “boxed” warnings
about risks that may lead to death or serious injury;
(2) contraindications describing any situation in which the
drug should not be used because the risk of use outweighs any
therapeutic benefit; (3) warnings and precautions about other
potential safety hazards; and (4) any adverse reactions for
which there is some basis to believe a causal relationship exists
between the drug and the occurrence of the adverse event.
Ibid.
As those requirements make clear, the category
in which a particular risk appears on a drug label is an indicator
of the likelihood and severity of the risk. The hierarchy of label
information is designed to “prevent overwarning” so that less
important information does not “overshadow” more important
information. 73 Fed. Reg. 49605–49606 (2008). It is also designed
to exclude “[e]xaggeration of risk, or inclusion of speculative or
hypothetical risks,” that “could discourage appropriate use of a
beneficial drug.”
Id., at 2851.
Prospective drug manufacturers work with the FDA
to develop an appropriate label when they apply for FDA approval of
a new drug. 21 U. S. C. §§355(a), 355(b), 355(d)(7); 21
CFR §314.125(b)(6). But FDA regulations also acknowledge that
information about drug safety may change over time, and that new
information may require changes to the drug label. §§314.80(c),
314.81(b)(2)(i). Drug manufacturers generally seek advance
permission from the FDA to make substantive changes to their drug
labels. However, an FDA regulation called the “changes being
effected” or “CBE” regulation permits drug manufacturers to change
a label without prior FDA approval if the change is designed to
“add or strengthen a . . . warning” where there is “newly
acquired information” about the “evidence of a causal association”
between the drug and a risk of harm. 21 CFR
§314.70(c)(6)(iii)(A).
B
Petitioner Merck Sharp & Dohme
manufactures Fosamax, a drug that treats and prevents osteoporosis
in postmenopausal women. App. 192;
In re Fosamax
(
Alendronate Sodium)
Products Liability Litigation,
852 F.3d 268, 271, 274–275 (CA3 2017). Fosamax belongs to a class
of drugs called “bisphosphonates.” Fosamax and other
bisphosphonates work by affecting the “bone remodeling process,”
that is, the process through which bones are continuously broken
down and built back up again. App. 102, 111. For some
postmenopausal women, the two parts of the bone remodeling process
fall out of sync; the body removes old bone cells faster than it
can replace them. That imbalance can lead to osteoporosis, a
disease that is characterized by low bone mass and an increased
risk of bone fractures. Fosamax (like other bisphosphonates) slows
the breakdown of old bone cells and thereby helps postmenopausal
women avoid osteoporotic fractures.
Id., at 102.
However, the mechanism through which Fosamax
decreases the risk of osteoporotic fractures may increase the risk
of a different type of fracture.
Id., at 400–444, 661–663.
That is because all bones—healthy and osteoporotic alike—sometimes
develop microscopic cracks that are not due to any trauma, but are
instead caused by the mechanical stress of everyday activity.
Id., at 102. Those so-called “stress fractures” ordinarily
heal on their own through the bone remodeling process. But, by
slowing the breakdown of old bone cells, Fosamax and other
bisphosphonates may cause stress fractures to progress to complete
breaks that cause great pain and require surgical intervention to
repair.
Id., at 106–109, 139, 144–145. When that rare type
of complete, low-energy fracture affects the thigh bone, it is
called an “atypical femoral fracture.”
Id., at 101.
The Fosamax label that the FDA approved in 1995
did not warn of the risk of atypical femoral fractures. 852
F. 3d, at 274–275. At that time, Merck’s scientists were aware
of at least a theoretical risk of those fractures. Indeed, as far
back as 1990 and 1991, when Fosamax was undergoing preapproval
clinical trials, Merck scientists expressed concern in internal
discussions that Fosamax could inhibit bone remodeling to such a
“ ‘profound’ ” degree that “inadequate repair may take
place” and “ ‘micro-fractures would not heal.’ ” App.
111–113. When Merck applied to the FDA for approval of Fosamax,
Merck brought those theoretical considerations to the FDA’s
attention. 852 F. 3d, at 274–275. But, perhaps because the
concerns were only theoretical, the FDA approved Fosamax’s label
without requiring any mention of this risk.
Ibid.
Evidence connecting Fosamax to atypical femoral
fractures developed after 1995. Merck began receiving adverse event
reports from the medical community indicating that long-term
Fosamax users were suffering atypical femoral fractures. App.
122–125. For example, Merck received a report from a doctor who
said that hospital staff had begun calling atypical femoral
fractures the “ ‘Fosamax Fracture’ ” because “ ‘100%
of patients in his practice who have experienced femoral fractures
(without being hit by a taxicab), were taking Fosamax
. . . for over 5 years. ’ ”
Id., at 126.
Merck performed a statistical analysis of Fosamax adverse event
reports, concluding that these reports revealed a statistically
significant incidence of femur fractures. 3 App. in No. 14–1900
(CA3), pp. A1272–A1273, A1443. And about the same time, Merck began
to see numerous scholarly articles and case studies documenting
possible connections between long-term Fosamax use and atypical
femoral fractures. App. 106–110, 116–122.
In 2008, Merck applied to the FDA for
preapproval to change Fosamax’s label to add language to both the
“Adverse Reaction[s]” and the “Precaution[s]” sections of the
label.
Id., at 670. In particular, Merck proposed adding a
reference to “ ‘low-energy femoral shaft fracture’ ” in
the Adverse Reactions section, and cross-referencing a longer
discussion in the Precautions section that focused on the risk of
stress fractures associated with Fosamax.
Id., at 728. The
FDA approved the addition to the Adverse Reactions section, but
rejected Merck’s proposal to warn of a risk of “stress fractures.”
Id., at 511–512. The FDA explained that Merck’s
“justification” for the proposed change to the Precautions section
was “inadequate,” because “[i]dentification of ‘stress fractures’
may not be clearly related to the atypical subtrochanteric
fractures that have been reported in the literature.”
Id.,
at 511. The FDA invited Merck to “resubmit” its application and to
“fully address all the deficiencies listed.”
Id., at 512;
see 21 CFR §314.110(b). But Merck instead withdrew its application
and decided to make the changes to the Adverse Reactions section
through the CBE process. App. 654–660. Merck made no changes to the
Precautions section at issue here.
Id., at 274.
A warning about “atypical femoral fractures” did
not appear on the Fosamax label until 2011, when the FDA ordered
that change based on its own analyses.
Id., at 246–252,
526–534. Merck was initially resistant to the change, proposing
revised language that, once again, referred to the risk of “stress
fractures.”
Id., at 629–634. But the FDA, once again,
rejected that language. And this time, the FDA explained that “the
term ‘stress fracture’ was considered and was not accepted”
because, “for most practitioners, the term ‘stress fracture’
represents a minor fracture and this would contradict the
seriousness of the atypical femoral fractures associated with
bisphosphonate use.”
Id., at 566. In January 2011, Merck and
the FDA ultimately agreed upon adding a three-paragraph discussion
of atypical femoral fractures to the Warnings and Precautions
section of the Fosamax label.
Id., at 223–224. The label now
refers to the fractures five times as “atypical” without using the
term “stress fracture.”
Ibid.
C
The respondents here are more than 500
individuals who took Fosamax and who suffered atypical femoral
fractures between 1999 and 2010. Brief for Respondents 7.
Respondents, invoking federal diversity jurisdiction, filed
separate actions seeking tort damages on the ground that, during
the relevant period, state law imposed upon Merck a legal duty to
warn them and their doctors about the risk of atypical femoral
fractures associated with using Fosamax.
Id., at 1. One
respondent, for example, filed a complaint alleging that she took
Fosamax for roughly 10 years and suffered an atypical femoral
fracture. One day in 2009, when the respondent was 70 years old,
she turned to unlock the front door of her house, heard a popping
sound, and suddenly felt her left leg give out beneath her. She
needed surgery, in which doctors repaired her leg with a rod and
screws. She explained she would not have used Fosamax for so many
years if she had known that she might suffer an atypical femoral
fracture as a result. See
id., at 18–19.
Merck, in defense, argued that respondents’
state-law failure-to-warn claims should be dismissed as pre-empted
by federal law. Both Merck and the FDA have long been aware that
Fosamax could theoretically increase the risk of atypical femoral
fractures. But for some period of time between 1995 (when the FDA
first approved a drug label for Fosamax) and 2010 (when the FDA
decided to require Merck to add a warning about atypical femoral
fractures to Fosamax’s label), both Merck and the FDA were unsure
whether the developing evidence of a causal link between Fosamax
and atypical femoral fractures was strong enough to require adding
a warning to the Fosamax drug label. Merck conceded that the FDA’s
CBE regulation would have permitted Merck to try to change the
label to add a warning before 2010, but Merck asserted that the FDA
would have rejected that attempt. In particular, Merck pointed to
the FDA’s rejection of Merck’s 2008 attempt to amend the Fosamax
label to warn of the risk of “stress fractures” associated with
Fosamax. On that basis, Merck claimed that federal law prevented
Merck from complying with any state-law duty to warn the
respondents of the risk of atypical femoral fractures associated
with Fosamax.
The District Court agreed with Merck’s
pre-emption argument and granted summary judgment to Merck,
In re Fosamax (
Alendronate Sodium):
Products
Liability Litigation, 2014 WL 1266994, *17 (D NJ, Mar. 22,
2017), but the Court of Appeals vacated and remanded, 852
F. 3d, at 302. The Court of Appeals concluded that its
pre-emption analysis was controlled by this Court’s decision in
Wyeth.
Ibid. The Court of Appeals understood that
case as making clear that a failure-to-warn claim grounded in state
law is pre-empted where there is “ ‘clear evidence that the
FDA would not have approved a change to the . . .
label.’ ”
Id., at 280 (quoting
Wyeth, 555
U. S., at 571). The Court of Appeals, however, suggested that
this statement had led to varying lower court applications and that
it would be helpful for this Court to “clarif[y] or buil[d] out the
doctrine.” 852 F. 3d, at 284.
In attempting to do so itself, the Court of
Appeals held that “the Supreme Court intended to announce a
standard of proof when it used the term ‘clear evidence’ in
Wyeth.”
Ibid. That is, the Court of Appeals believed
that “[t]he term ‘clear evidence’ . . . does not refer
directly to the
type of facts that a manufacturer must show,
or to the circumstances in which preemption will be appropriate.”
Id., at 285
. “Rather, it specifies how
difficult it will be for the manufacturer to convince the
factfinder that the FDA would have rejected a proposed label
change.”
Ibid. And in the Court of Appeals’ view, “for a
defendant to establish a preemption defense under
Wyeth, the
factfinder must conclude that it is highly probable that the FDA
would not have approved a change to the drug’s label.”
Id.,
at 286. Moreover and importantly, the Court of Appeals also held
that “whether the FDA would have rejected a proposed label change
is a question of fact that must be answered by a jury.”
Ibid.
Merck filed a petition for a writ of certiorari.
Merck’s petition asked the Court to decide whether Merck’s case and
others like it “must . . . go to a jury” to determine
whether the FDA, in effect, has disapproved a state-law-required
labeling change. In light of differences and uncertainties among
the courts of appeals and state supreme courts in respect to the
application of
Wyeth, we granted certiorari. See,
e.g.,
Mason v.
SmithKline Beecham Corp., 596 F.3d 387, 391
(CA7 2010) (“The Supreme Court . . . did not clarify what
constitutes ‘clear evidence’ ”);
Reckis v.
Johnson
& Johnson, 471 Mass. 272, 286, 28 N. E. 3d 445,
457 (2015) (“
Wyeth did not define ‘clear evidence’
. . . ” (some internal quotation marks omitted)).
II
We stated in
Wyeth v.
Levine
that state law failure-to-warn claims are pre-empted by the Federal
Food, Drug, and Cosmetic Act and related labeling regulations when
there is “clear evidence” that the FDA would not have approved the
warning that state law requires. 555 U. S., at 571. We here
decide that a judge, not the jury, must decide the pre-emption
question. And we elaborate
Wyeth’s requirements along the
way.
A
We begin by describing
Wyeth. In that
case, the plaintiff developed gangrene after a physician’s
assistant injected her with Phenergan, an antinausea drug. The
plaintiff brought a state-law failure-to-warn claim against Wyeth,
the drug’s manufacturer, for failing to provide an adequate warning
about the risks that accompany various methods of administering the
drug. In particular, the plaintiff claimed that directly injecting
Phenergan into a patient’s vein (the “IV-push” method of
administration) creates a significant risk of catastrophic
consequences. And those consequences could be avoided by
introducing the drug into a saline solution that slowly descends
into a patient’s vein (the “IV-drip” method of administration). A
jury concluded that Wyeth’s warning label was inadequate, and that
the label’s inadequacy caused the plaintiff’s injury. On appeal,
Wyeth argued that the plaintiff’s state-law failure-to-warn claims
were pre-empted because it was impossible for Wyeth to comply with
both state law duties and federal labeling obligations. The Vermont
Supreme Court rejected Wyeth’s pre-emption claim.
Id., at
563.
We too considered Wyeth’s pre-emption argument,
and we too rejected it. In rejecting Wyeth’s argument, we undertook
a careful review of the history of federal regulation of drugs and
drug labeling.
Id., at 566–568. In doing so, we “assum[ed]
that the historic police powers of the States were not to be
superseded by the Federal Act unless that was the clear and
manifest purpose of Congress.”
Id., at 565 (internal
quotation marks omitted). And we found nothing within that history
to indicate that the FDA’s power to approve or to disapprove
labeling changes, by itself, pre-empts state law.
Rather, we concluded that Congress enacted the
FDCA “to bolster consumer protection against harmful products;”
that Congress provided no “
federal remedy for consumers
harmed by unsafe or ineffective drugs”; that Congress was “awar[e]
of the prevalence of state tort litigation;” and that, whether
Congress’ general purpose was to protect consumers, to provide
safety-related incentives to manufacturers, or both, language,
history, and purpose all indicate that “Congress did not intend FDA
oversight to be the exclusive means of ensuring drug safety and
effectiveness.”
Id., at 574–575 (emphasis added). See also
id., at 574 (“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”).
We also observed that “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.”
Id., at 570–571. A drug manufacturer “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.”
Id.,
at 571. Thus, when the risks of a particular drug become apparent,
the manufacturer has “a duty to provide a warning that adequately
describe[s] that risk.”
Ibid. “Indeed,” we noted, “prior to
2007, the FDA lacked the authority to order manufacturers to revise
their labels.”
Ibid. And even when “Congress granted the FDA
this authority,” in the 2007 Amendments to the FDCA, Congress
simultaneously “reaffirmed the manufacturer’s obligations and
referred specifically to the CBE regulation, which both reflects
the manufacturer’s ultimate responsibility for its label and
provides a mechanism for adding safety information to the label
prior to FDA approval.”
Ibid.
In light of Congress’ reluctance to displace
state laws that would penalize drug manufacturers for failing to
warn consumers of the risks associated with their drugs, and
Congress’ insistence on requiring drug manufacturers to bear the
responsibility for the content of their drug labels, we were
unpersuaded by Wyeth’s pre-emption argument. In Wyeth’s case, we
concluded, “when the risk of gangrene from IV-push injection of
Phenergan became apparent, Wyeth had a duty” under state law “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.”
Ibid.
At the same time, and more directly relevant
here, we pointed out that “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.”
Ibid. We then said that, nonetheless, “
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.”
Ibid. (emphasis added).
We reviewed the record and concluded that “Wyeth
has offered no such evidence.”
Id., at 572. We said that
Wyeth’s evidence of pre-emption fell short for two reasons. First,
the record did not show that Wyeth “supplied the FDA with an
evaluation or analysis concerning the specific dangers” that would
have merited the warning.
Id., at 572–573. We could find “no
evidence in this record that either the FDA or the manufacturer
gave more than passing attention to the issue of IV-push versus
IV-drip administration”—the matter at issue in the case.
Id., at 572 (internal quotation marks omitted). Second, the
record did not show that Wyeth “attempted to give the kind of
warning required by [state law] but was prohibited from doing so by
the FDA.”
Ibid., and n. 5. The “FDA had not made an
affirmative decision to preserve” the warning as it was or “to
prohibit Wyeth from strengthening its warning.”
Id., at 572.
For those reasons, we could not “credit Wyeth’s contention that the
FDA would have prevented it from adding a stronger warning about
the IV-push method of intravenous administration.” And we could not
conclude that “it was impossible for Wyeth to comply with both
federal and state requirements.”
Id., at 573. We
acknowledged that meeting the standard we set forth would be
difficult, but, we said, “[i]mpossibility pre-emption is a
demanding defense.”
Ibid.
B
The underlying question for this type of
impossibility pre-emption defense is whether federal law (including
appropriate FDA actions) prohibited the drug manufacturer from
adding any and all warnings to the drug label that would satisfy
state law. And, of course, in order to succeed with that defense
the manufacturer must show that the answer to this question is yes.
But in
Wyeth, we confronted that question in the context of
a particular set of circumstances. Accordingly, for purposes of
this case, we assume—but do not decide—that, as was true of the
warning at issue in
Wyeth, there is sufficient evidence to
find that Merck violated state law by failing to add a warning
about atypical femoral fractures to the Fosamax label. In a case
like
Wyeth, showing that federal law prohibited the drug
manufacturer from adding a warning that would satisfy state law
requires the drug manufacturer to show that it fully informed the
FDA of the justifications for the warning required by state law and
that the FDA, in turn, informed the drug manufacturer that the FDA
would not approve changing the drug’s label to include that
warning.
These conclusions flow from our precedents on
impossibility pre-emption and the statutory and regulatory scheme
that we reviewed in
Wyeth. See 555 U. S., at 578. In
particular, “it has long been settled that state laws that conflict
with federal law are without effect.”
Mutual Pharmaceutical
Co., 570 U. S., at 480. But as we have cautioned many
times before, the “possibility of impossibility [is] not enough.”
PLIVA, Inc. v.
Mensing,
564 U.S.
604, 625, n. 8 (2011) (internal quotation marks omitted).
Consequently, we have refused to find clear evidence of such
impossibility where the laws of one sovereign permit an activity
that the laws of the other sovereign restrict or even prohibit.
See,
e.g., Barnett Bank of Marion Cty., N. A. v.
Nelson,
517 U.S.
25, 31 (1996);
Michigan Canners & Freezers Assn.,
Inc. v.
Agricultural Marketing and Bargaining Bd.,
467 U.S.
461, 478, and n. 21 (1984).
And, as we explained in
Wyeth, 555
U. S., at 571–573, federal law—the FDA’s CBE
regulation—permits drug manufacturers to change a label to “reflect
newly acquired information” if the changes “add or strengthen a
. . . warning” for which there is “evidence of a causal
association,” without prior approval from the FDA. 21 CFR
§314.70(c)(6)(iii)(A). Of course, the FDA reviews CBE submissions
and can reject label changes even after the manufacturer has made
them. See §§314.70(c)(6), (7). And manufacturers cannot propose a
change that is not based on reasonable evidence.
§314.70(c)(6)(iii)(A). But in the interim, the CBE regulation
permits changes, so a drug manufacturer will not ordinarily be able
to show that there is an actual conflict between state and federal
law such that it was impossible to comply with both.
We do not further define
Wyeth’s use of
the words “clear evidence” in terms of evidentiary standards, such
as “preponderance of the evidence” or “clear and convincing
evidence” and so forth, because, as we shall discuss,
infra,
at 15–17
, courts should treat the critical question not as a
matter of fact for a jury but as a matter of law for the judge to
decide. And where that is so, the judge must simply ask himself or
herself whether the relevant federal and state laws “irreconcilably
conflic[t].”
Rice v.
Norman Williams Co.,
458 U.S.
654, 659 (1982); see
ibid. (“The existence of a
hypothetical or potential conflict is insufficient to warrant the
pre-emption of the state statute”).
We do note, however, that the only agency
actions that can determine the answer to the pre-emption question,
of course, are agency actions taken pursuant to the FDA’s
congressionally delegated authority. The Supremacy Clause grants
“supreme” status only to the “the
Laws of the United
States.” U. S. Const., Art. VI, cl. 2. And pre-emption takes
place “ ‘only when and if [the agency] is acting within the
scope of its congressionally delegated authority, . . .
for an agency literally has no power to act, let alone pre-empt the
validly enacted legislation of a sovereign State, unless and until
Congress confers power upon it.’ ”
New York v.
FERC,
535 U.S.
1, 18 (2002) (some alterations omitted). Federal law permits
the FDA to communicate its disapproval of a warning by means of
notice-and-comment rulemaking setting forth labeling standards,
see,
e.g., 21 U. S. C. §355(d); 21 CFR §§201.57,
314.105; by formally rejecting a warning label that would have been
adequate under state law, see,
e.g., 21 CFR §§314.110(a),
314.125(b)(6); or with other agency action carrying the force of
law, cf.,
e.g., 21 U. S. C. §355(o)(4)(A). The
question of disapproval “method” is not now before us. And we make
only the obvious point that, whatever the means the FDA uses to
exercise its authority, those means must lie within the scope of
the authority Congress has lawfully delegated.
III
We turn now to what is the determinative
question before us: Is the question of agency disapproval primarily
one of fact, normally for juries to decide, or is it a question of
law, normally for a judge to decide without a jury?
The complexity of the preceding discussion of
the law helps to illustrate why we answer this question by
concluding that the question is a legal one for the judge, not a
jury. The question often involves the use of legal skills to
determine whether agency disapproval fits facts that are not in
dispute. Moreover, judges, rather than lay juries, are better
equipped to evaluate the nature and scope of an agency’s
determination. Judges are experienced in “[t]he construction of
written instruments,” such as those normally produced by a federal
agency to memorialize its considered judgments.
Markman v.
Westview Instruments, Inc.,
517 U.S.
370, 388 (1996). And judges are better suited than are juries
to understand and to interpret agency decisions in light of the
governing statutory and regulatory context. Cf. 5
U. S. C. §706 (specifying that a “reviewing court,” not a
jury, “shall . . . determine the meaning or applicability
of the terms of an agency action”); see also H. R. Rep. No. 1980,
79th Cong., 2d Sess., 44 (1946) (noting longstanding view that
“questions respecting the . . . terms of any agency
action” and its “application” are “questions of law”). To
understand the question as a legal question for judges makes sense
given the fact that judges are normally familiar with principles of
administrative law. Doing so should produce greater uniformity
among courts; and greater uniformity is normally a virtue when a
question requires a determination concerning the scope and effect
of federal agency action. Cf.
Markman, 517 U. S., at
390–391.
We understand that sometimes contested brute
facts will prove relevant to a court’s legal determination about
the meaning and effect of an agency decision. For example, if the
FDA rejected a drug manufacturer’s supplemental application to
change a drug label on the ground that the information supporting
the application was insufficient to warrant a labeling change, the
meaning and scope of that decision might depend on what information
the FDA had before it. Yet in litigation between a drug consumer
and a drug manufacturer (which will ordinarily lack an official
administrative record for an FDA decision), the litigants may
dispute whether the drug manufacturer submitted all material
information to the FDA.
But we consider these factual questions to be
subsumed within an already tightly circumscribed legal analysis.
And we do not believe that they warrant submission alone or
together with the larger pre-emption question to a jury. Rather, in
those contexts where we have determined that the question is “for
the judge and not the jury,” we have also held that “courts may
have to resolve subsidiary factual disputes” that are part and
parcel of the broader legal question.
Teva Pharmaceuticals USA,
Inc. v.
Sandoz, Inc., 574 U. S. ___, ___–___ (2015)
(slip op., at 6–7). And, as in contexts as diverse as the proper
construction of patent claims and the voluntariness of criminal
confessions, they create a question that “ ‘falls somewhere
between a pristine legal standard and a simple historical
fact.’ ”
Markman, 517 U. S., at 388 (quoting
Miller v.
Fenton,
474 U.S.
104, 114 (1985)). In those circum- stances, “ ‘the
fact/law distinction at times has turned on a determination that,
as a matter of the sound administration of justice, one judicial
actor is better positioned than another to decide the issue in
question.’ ”
Markman, 517 U. S., at 388 (quoting
Miller, 474 U. S., at 114). In this context, that
“better positioned” decisionmaker is the judge.
IV
Because the Court of Appeals treated the
pre-emption question as one of fact, not law, and because it did
not have an opportunity to consider fully the standards we have
described in Part II of our opinion, we vacate its judgment and
remand the case to that court for further proceedings consistent
with this opinion.
It is so ordered.