VICTORIA CERVENY; CHARLES CERVENY; ALEXANDER CERVENY, Plaintiffs - Appellants,
AVENTIS, INC., Defendant-Appellee. PRODUCT LIABILITY ADVISORY COUNCIL, INC.; AMERICAN TORT REFORM ASSOCIATION; PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA; BIOTECHNOLOGY INNOVATION ORGANIZATION; CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; NATIONAL ASSOCIATION OF MANUFACTURERS, Amici Curiae.
from the United States District Court for the District of
Utah (D.C. No. 2:14-CV-00545-DB)
S. Davis (Christopher L. Schnieders, with him on the briefs),
Wagstaff & Cartmell, LLP, Kansas City, Missouri, for
A. Swan, Shook, Hardy & Bacon L.L.P., Kansas City,
Missouri (William F. Northrip, Shook, Hardy & Bacon,
L.L.P., Chicago, Illinois; Shawn McGarry, and Gary T. Wight,
Kipp and Christian, P.C., Salt Lake City, Utah, with him on
the brief), for Defendant-Appellee.
Comerford Todd, U.S. Chamber Litigation Center, Washington,
D.C., Linda E. Kelly and Leland P. Frost, Manufacturers'
Center for Legal Action, Washington, D.C., Jeffrey S.
Bucholtz and Sheldon Bradshaw, King & Spalding LLP,
Washington, D.C., and Andrew T. Bayman and Heather M. Howard,
King & Spalding LLP, Atlanta, Georgia, filed an amicus
curiae brief for Chamber of Commerce of the United States of
America, American Tort Reform Association, and National
Association of Manufacturers, on behalf of
Michael X. Imbroscio, Paul W. Schmidt, and Gregory L.
Halperin, Covington & Burling, Washington, D.C., filed an
amici curiae brief for Pharmaceutical Research and
Manufacturers of America and Biotechnology Innovation
Organization, on behalf of Defendant-Appellee.
F. Young, Jr., Product Liability Advisory Council, Inc.,
Reston, Virginia, Andrew E. Tauber, Mayer Brown LLP,
Washington, D.C., and Charles M. Woodworth, Mayer Brown LLP,
Chicago, Illinois, filed an amicus curiae brief for Product
Liability Advisory Council, Inc., on behalf of
BACHARACH, PHILLIPS, and McHUGH, Circuit Judges.
BACHARACH, Circuit Judge.
Alexander Cerveny was born over twenty years ago with birth
defects. Alexander and his parents attribute these
birth defects to Mrs. Cerveny's use of Clomid (a
fertility drug) in 1992, before she became pregnant with
Alexander. The Cervenys sued the manufacturer of Clomid
(Aventis, Inc.), asserting various tort claims under Utah
law: failure to warn under theories of strict liability and
negligence, breach of implied warranty, negligent
misrepresentation, and fraud.
district court granted summary judgment to Aventis based on
federal preemption, reasoning that the U.S. Food and Drug
Administration ("FDA") would not have approved the
drug warnings that the Cervenys allege are required under
Utah law. This reasoning led the district court to conclude
that Aventis could not have complied with both federal law
and Utah law. Based on this conclusion, the district court
granted summary judgment to Aventis on all of the
appeal, the Cervenys note that they "did not advocate
for a specific warning in laying out their failure-to-warn
claims." Appellants' Opening Br. at 9. Instead, the
Cervenys present two theories, pointing to two types of
warning labels that Aventis had allegedly failed to provide:
(1) a label that warned of risks to the fetus when a woman
takes Clomid before becoming pregnant and (2) a label that
unmistakably warned about harm to the fetus when Clomid is
taken during pregnancy.
both theories, the Cervenys point to a warning that the FDA
proposed in 1987, which stated that "Clomid may cause
fetal harm when administered to pregnant women."
Appellants' App'x vol. 3, at 596. For their first
theory, the Cervenys argue that this proposed warning
demonstrates the FDA's willingness to approve warnings
for women taking Clomid prior to pregnancy. For their second
theory, the Cervenys argue that (1) the warning clearly
informed women of risks to the fetus if taken during
pregnancy and (2) Mrs. Cerveny would not have taken Clomid if
Aventis had used the FDA's proposed wording.
district court rejected the Cervenys' claims based on
preemption. The ruling was correct on the Cervenys' first
theory, for the undisputed evidence shows that the FDA would
not have approved a warning about taking Clomid before
pregnancy. But on the second theory, the district court did
not explain why a state claim based on the FDA's own
proposed language would be preempted by federal law.
district court also erred in failing to distinguish the
remaining claims (breach of implied warranty, negligent
misrepresentation, and fraud) from the failure-to-warn
claims. These claims are based at least partly on affirmative
misrepresentations rather than on a failure to provide a
warning. The district court failed to explain why claims
involving affirmative misrepresentations would have been
Standard of Review
award of summary judgment, we engage in de novo review,
drawing all reasonable inferences and resolving all factual
disputes in favor of the Cervenys. Birch v. Polaris
Indus., Inc., 812 F.3d 1238, 1251 (10th Cir. 2015).
Summary judgment was required if Aventis had shown that no
genuine issue existed on a material fact and that Aventis was
entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a).
determining whether Aventis had satisfied this burden, we
engage in de novo review of all the district court's
legal conclusions. Auraria Student Hous. at the Regency,
LLC v. Campus Vill. Apartments, LLC, 843 F.3d 1225, 1244
(10th Cir. 2016) ("[W]e review the district court's
conclusions of law de novo . . . ."). Thus, we
ordinarily consider preemption as a legal issue subject to de
novo review. See Mount Olivet Cemetery Ass'n v. Salt
Lake City, 164 F.3d 480, 486 (10th Cir. 1998) (stating
that we review preemption rulings de novo); see also GTE
Mobilnet of Ohio v. Johnson, 111 F.3d 469, 475 (6th Cir.
1997) ("Questions of federal preemption of state law
generally are considered questions of law subject to de novo
II. Preemption of the Failure-to-Warn Claims
Cerveny had taken Clomid in September and October 1992,
before she became pregnant with Alexander. When Mrs. Cerveny
took Clomid, its label warned women against use during
pregnancy, stating that Clomid had been shown to cause harm
in fetuses for rats and rabbits.
Cervenys contend that this warning was insufficient under
Utah law. As mentioned above, the Cervenys support their
failure-to-warn claims under two separate theories: (1)
Aventis should have warned women of the risks of taking
Clomid prior to pregnancy and (2) Aventis should have better
warned women of the risks to the fetus when Clomid is taken
during pregnancy. The district court correctly held that
federal law preempted the first theory, which involved a
failure to warn of risks prior to pregnancy. But the district
court failed to explain the applicability of preemption to
the second theory, which was based on the FDA's own
FDA Approval Process and Clomid's Regulatory
Federal Food, Drug, and Cosmetic Act has long required a
manufacturer to obtain approval from the FDA before the
manufacturer can introduce a new drug in the market. 21
U.S.C. § 355(a). For brand-name drugs, a manufacturer
must submit an application. Mut. Pharm. Co. v.
Bartlett, 133 S.Ct. 2466, 2470-71 (2013). The
application must include the proposed label, "full
reports of investigations which have been made to show
whether such drug is [safe and effective], "
comprehensive information of the drug's composition and
the "manufacture, processing, and packing of such drug,
" relevant nonclinical studies, and "any other data
or information relevant to an evaluation of the safety and
effectiveness of the drug product obtained or otherwise
received by the applicant from any source." 21 U.S.C.
§ 355(b)(1); 21 C.F.R. § 314.50(c)(2)(i), (d)(1),
FDA approves the application, the manufacturer generally is
restricted from changing the label without advance permission
from the FDA. 21 U.S.C. §§ 331(a), (c), 352; 21
C.F.R. § 314.70(a), (b). But an exception exists,
allowing a manufacturer under certain circumstances to change
the label before obtaining FDA approval. 21 C.F.R. §
314.70(c).But even when this exception applies, the
FDA will ultimately approve the label change only if it is
based on reasonable evidence of an association between the
drug and a serious hazard. 21 C.F.R. §§ 201.80(e),
this regulatory backdrop, we consider the FDA's
historical consideration of Clomid's labels. Clomid
entered the market in 1967 upon approval by the FDA. Since
1967, Clomid's labels have consistently warned about the
risk of fetal harm if the mother takes Clomid while she is
pregnant. For example, the 1967 warning stated:
Although no causative evidence of a deleterious effect of
Clomid . . . therapy on the human fetus has been seen, such
evidence in regard to the rat and the rabbit has been
presented . . . . Therefore, Clomid should not be
administered during pregnancy. To avoid inadvertent
Clomid administration during early pregnancy, the basal body
temperature should be recorded throughout all treatment
cycles, and the patient should be carefully observed to
determine whether ovulation occurs. If the basal body
temperature following Clomid is biphasic and is not followed
by menses, the patient should be examined carefully for the
presence of an ovarian cyst and should have a pregnancy test.
The next course of therapy should be delayed until the
correct diagnosis has been determined.
App'x vol. 3, at 590. This warning addressed the risk of
continuing to take Clomid after a woman has become pregnant,
noting that the woman may be unaware of her pregnancy. The
label was revised in both 1980 and 1991, but the revised
labels contained the same pregnancy warning. Id. at
579; Appellants' App'x vol. 1, at 239.
1986, the FDA ordered Aventis to add a "Pregnancy
Category X" designation to Clomid's label. This
designation would indicate that "the risk of the use of
the drug in a pregnant woman clearly outweighs any possible
benefit." 21 C.F.R. § 201.57(f)(6)(i)(e)
(1986). The FDA recommended this designation on
the ground that Clomid does not benefit pregnant women and
that any risk to pregnant women would be unjustified.
Appellants' App'x vol. 3, at 586.
resisted this change, and the FDA acknowledged a dilemma:
Aventis needed to warn about taking Clomid during pregnancy,
but no woman who was already pregnant would have any reason
to take Clomid. In light of this dilemma, the FDA suggested
in 1987 that Aventis change the label to add a clear warning
about the risk of fetal harm when Clomid is taken during
PREGNANCY CATEGORY X. See Contraindications and Information
CONTRAINDICATIONS: Clomid is contraindicated in pregnant
women. Clomid may cause fetal harm when administered to
pregnant women. Since there is a reasonable likelihood of the
patient becoming pregnant while receiving Clomid, the patient
should be apprised of the potential hazard to the fetus.
App'x vol. 3, at 596. Aventis eventually added a similar
warning, but only after Alexander had been born.
Conflict Preemption and the Clear-Evidence Standard
are three types of preemption: "(1) express preemption,
which occurs when the language of the federal statute reveals
an express congressional intent to preempt state law . . .;
(2) field preemption, which occurs when the federal scheme of
regulation is so pervasive that Congress must have intended
to leave no room for a State to supplement it; and (3)
conflict preemption, which occurs either when compliance with
both the federal and state laws is a physical impossibility,
or when the state law stands as an obstacle to the
accomplishment and execution of the full purposes and
objectives of Congress." Mount Olivet Cemetery
Ass'n v. Salt Lake City, 164 F.3d 480, 486 (10th
asserts a form of conflict preemption known as impossibility
preemption. Under impossibility preemption, state law is
preempted "when compliance with both the federal and
state laws is a physical impossibility." Id.
conflict preemption, the Supreme Court set forth the
governing framework in Wyeth v. Levine, 555 U.S. 555
(2009). In Levine, the plaintiff was severely
injured when she was administered an antinausea drug using
the "IV-push" method of injection, which resulted
in the drug accidentally entering her arteries.
Levine, 555 U.S. at 559. The plaintiff sued Wyeth,
the manufacturer of the drug, for failing to adequately warn
of the risks of the IV-push method. Id. at 560.
Wyeth responded that the failure-to-warn claim was preempted
because the desired warning would have been disallowed by the
FDA. Id. at 563.
Supreme Court rejected Wyeth's preemption argument, but
the Court noted that the claim would have been preempted upon
"clear evidence" that the FDA would have rejected
the desired label change. Id. at 571 ("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."). The Court reasoned that Wyeth had
not (1) alleged an attempt to provide the kind of warning
allegedly required under state law or (2) supplied the FDA
with any analysis about the dangers from the IV-push method.
Id. at 572-73.
Cervenys emphasize that in Levine, the Supreme Court
held that the state tort claim was not preempted, downplaying
the discussion of the "clear evidence" standard as
dicta. But our court has relied on Levine in holding
that a state tort claim is preempted if a pharmaceutical
company presents clear evidence that the FDA would have
rejected an effort to strengthen the label's warnings.
Dobbs v. Wyeth Pharm., 606 F.3d 1269, 1269 (10th
Cir. 2010). Thus, we must apply the "clear
evidence" test set forth in
resulting issue is whether this test involves a question of
fact or law. On this issue, the Cervenys and Aventis debate
the potential impact of a recent Third Circuit opinion:
In re Fosamax (Alendronate Sodium) Prods. Liab.
Litig., 852 F.3d 268, 2017 WL 1075047 (3d Cir. Mar. 22,
2017).Fosamax interpreted the
"clear evidence" language from Wyeth to
refer to the "standard of proof" for the
manufacturer to "convince the factfinder that the FDA
would have rejected a proposed label change." In re
Fosamax, 2017 WL 1075047, at *11. As a result, the court
concluded that satisfaction of this standard involves a
question of fact: "A state-law failure-to-warn claim
will only be preempted if a jury concludes it is highly
probable that the FDA would not have approved a label
change." Id. at *18.
Cervenys did not argue in their briefing that the "clear
evidence" standard involves a question of fact, and
Aventis did not argue that the "clear evidence"
standard raises a question of law. Nonetheless, the Cervenys
insist that we should adopt the Third Circuit's approach
and deny summary judgment if "no reasonable juror could
conclude that it is anything less than highly probable that
the FDA would have rejected" the proposed label.
Id. at *19. We are reticent to take this approach,
for the parties' appeal briefs do not address this issue.
we may assume for the sake of argument that the Cervenys are
correct, for their characterization of the issue is
nondispositive because all of the material facts are
undisputed. In applying these undisputed facts, we consider
(1) whether Aventis presented clear evidence that the FDA
would have disapproved of the warnings suggested by the
Cervenys and (2) whether a reasonable juror could conclude
that the FDA would have approved those warnings.
Preemption of the Failure-to-Warm Claims: The Risks of
Pre-Pregnancy Use of Clomid
parties agree that Mrs. Cerveny took Clomid before she became
pregnant, but not afterward. The Cervenys contend that even
pre-pregnancy use of Clomid may harm the fetus because (1)
Clomid has a long half-life and can accumulate in the body
with multiple courses of treatment, remaining active in the
body after pregnancy, and (2) Clomid inhibits cholesterol,
which may harm the fetus's development. For both reasons,
the Cervenys allege in part that Aventis should have warned
women about the risks when taking Clomid prior to pregnancy.
argues that even if the Cervenys are correct, the FDA would
not have allowed addition of a warning in 1992 about the
risks when taking Clomid prior to pregnancy. Thus, Aventis
contends that it would have been impossible to comply with
both federal and Utah law. If Aventis is right, federal law
would preempt the Utah tort claims. We agree with Aventis
that the FDA would have prohibited Aventis from warning about
the risk when taking Clomid prior to pregnancy.
bears the burden to present clear evidence that the FDA would
not have approved the desired warning. See Emerson v.
Kan. City S. Ry. Co., 503 F.3d 1126, 1133-34 (10th Cir.
2007). To meet this burden, Aventis points to (1) the
FDA's history of approving Clomid for use by women before
becoming pregnant and (2) the FDA's rejection of a
citizen petition by Mr. Terence Mix,  which had alleged a risk of
fetal harm when Clomid is taken prior to pregnancy. In
response, the Cervenys rely on the FDA's recommendation
in 1987 for Aventis to warn of potential harm to the fetus.
We conclude that clear evidence is not established by
Clomid's regulatory history, but is ...