Cerveny, et al v. Aventi

Filing

[10463779] Affirmed in Part, Reversed in Part and Remanded; Terminated on the merits after oral hearing; Written, signed, published. Judges Bacharach (authoring judge), Phillips and McHugh. Mandate to issue. [16-4050]

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FILED
United States Court of Appeals
Tenth Circuit

PUBLISH

UNITED STATES COURT OF APPEALS
FOR THE TENTH CIRCUIT
_________________________________

May 2, 2017

Elisabeth A. Shumaker
Clerk of Court

VICTORIA CERVENY; CHARLES
CERVENY; ALEXANDER
CERVENY,
Plaintiffs - Appellants,
No. 16-4050
v.
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.
_________________________________
Appeal from the United States District Court
for the District of Utah
(D.C. No. 2:14-CV-00545-DB)
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Adam S. Davis (Christopher L. Schnieders, with him on the briefs),
Wagstaff & Cartmell, LLP, Kansas City, Missouri, for PlaintiffsAppellants.
Eric 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.
Kate 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 Defendant-Appellee.
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.
Hugh 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 Defendant-Appellee.
_________________________________
Before BACHARACH, PHILLIPS, and McHUGH, Circuit Judges.
_________________________________
BACHARACH, Circuit Judge.
_________________________________

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Mr. Alexander Cerveny was born over twenty years ago with birth
defects. 1 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. 2
The 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 Cervenys’ claims.
On 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

Alexander was born with a left elbow flexion deformity and only
three digits on his left hand.
2

The Cervenys also brought additional state-law tort claims that were
dismissed for failure to state a claim. See Fed. R. Civ. P. 12(b)(6). These
dismissals have not been appealed.
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(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.
For 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.
The 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.
The 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
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a warning. The district court failed to explain why claims involving
affirmative misrepresentations would have been preempted.
I.

Standard of Review
On the 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).
In 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 review.”).

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Preemption of the Failure-to-Warn Claims
Mrs. Cerveny had taken Clomid in September and October 1992,

before she became pregnant with Alexander. When Mrs. Cerveny took
Clomid, its label warned women 3 against use during pregnancy, stating that
Clomid had been shown to cause harm in fetuses for rats and rabbits.
The 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
proposed wording.
A.

FDA Approval Process and Clomid’s Regulatory History

The 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

3

The district court noted that a drug manufacturer bears a duty to
provide a warning to a patient’s prescribing physician. For convenience,
we omit reference to the prescribing physician in this opinion.
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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), (2), (5)(iv).
If the 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). 4
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

4

The text of the regulation in 1992 (when Mrs. Cerveny took the
Clomid) differs from today’s version. The 1992 regulation required the
applicant to notify the FDA of the change “at the time the applicant makes
any kind of [labeling] change.” 21 C.F.R. § 314.70(c) (1992). The current
version requires notification at least 30 days before distribution of the
drug. 21 C.F.R. § 314.70(c) (2016).

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between the drug and a serious hazard. 21 C.F.R. §§ 201.80(e),
314.70(c)(6)(iii).
Against 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:
CONTRAINDICATIONS
Pregnancy
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.
Appellants’ 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.
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In 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). 5 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.
Aventis 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:
PREGNANCY CATEGORY
Information for Patients.

X.

See

Contraindications

and

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.

5

Until recently, the FDA used a five-letter system to categorize the
risks of taking a drug or biological product during pregnancy. In 2015, the
FDA replaced the five-letter system with different labeling requirements.
See 21 C.F.R. § 201.80(f)(6) (2016).

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Appellants’ App’x vol. 3, at 596. Aventis eventually added a similar
warning, but only after Alexander had been born.
B.

Conflict Preemption and the Clear-Evidence Standard

There 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 Cir. 1998).
Aventis 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.
For 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,
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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.
The 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.
The 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,

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1269 (10th Cir. 2010). Thus, we must apply the “clear evidence” test set
forth in Levine. 6
The 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). 7
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.
The 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
6

The Cervenys question our prior application of Levine, but we are
bound by our published opinions. United States v. Spedalieri, 910 F.2d
707, 710 n.3 (10th Cir. 1990).
7

The parties debated the issue after oral argument in dual letters to the
Court regarding supplemental authority.
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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.
Nonetheless, 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.
C.

Preemption of the Failure-to-Warm Claims: The Risks of
Pre-Pregnancy Use of Clomid

The 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.

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Aventis 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.
Aventis 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, 8 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 established by the FDA’s rejection of Mr. Mix’s
citizen petition. In the face of that clear evidence, we reject the Cervenys’
argument based on the FDA’s 1987 recommendation.
8

Mr. Mix is an attorney who was involved in litigation relating to
birth defects allegedly caused by Clomid. He has authored a book on the
subject. Terence Mix, The Price of Ovulation: The Truth About Fertility
Drugs and Birth Defects and a Solution to the Problem (2009).
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Aventis’s Argument Involving Clomid’s Regulatory History

Aventis argues that Clomid’s regulatory history provides clear
evidence that the FDA would have rejected the label changes desired by
the Cervenys. According to Aventis, the FDA has long approved of
Aventis’s labels and has never suggested that Aventis include warnings
regarding when Clomid is taken prior to pregnancy.
As Aventis points out, its label has continuously denied a link
between Clomid and fetal harm. See Appellants’ App’x vol. 2, at 443 (1994
label) (stating that “no causative evidence of a deleterious effect of
CLOMID therapy on the human fetus has been established”); id. at 528
(2013 label) (stating that the “[a]vailable human data do not suggest an
increased risk for congenital anomalies above the background population
risk when used as indicated”). In our view, however, Aventis’s regulatory
history alone does not constitute clear evidence that the FDA would have
rejected the warnings desired by the Cervenys.
Levine involved the drug Phenergan. Thus, it is helpful to compare
the regulatory histories of Phenergan (in Levine) and Clomid (in our case).
See Mason v. SmithKline Beecham Corp., 596 F.3d 387, 392 (7th Cir.
2010).

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The Levine majority described Phenergan’s regulatory history. 9 The
FDA initially approved Phenergan in 1955, decades before the Levine
plaintiff was injured. Wyeth v. Levine, 555 U.S. 555, 561 (2009). The drug
manufacturer, Wyeth, submitted supplemental new drug applications in
1973 and 1976, which the FDA approved after proposing label changes. Id.
A third supplemental application was submitted in 1981 in response to a
new FDA rule. Id. Then, Wyeth and the FDA spent seventeen years
intermittently corresponding about Phenergan’s label. Id. “The most
notable activity occurred in 1987, when the FDA suggested different [but
not stronger] warnings about the risk of arterial exposure, and in 1988,
when Wyeth submitted revised labeling incorporating the proposed
changes.” Id. at 561-62. The FDA never responded and ultimately
instructed Wyeth in 1996 to retain its current label, which omitted the 1987
proposed label change regarding arterial exposure. Id. at 562. Based on
this regulatory history, the Supreme Court concluded that the manufacturer

9

The Levine dissent paints a different picture of Phenergan’s
regulatory history, one in which the FDA carefully “considered and
reconsidered” whether IV-push administration of Phenergan is safe when
performed in accordance with Phenergan’s label. Wyeth v. Levine, 555 U.S.
555, 612-16 (2009) (Alito, J., dissenting). We follow the majority’s view
of the facts but also note that the majority would have rejected preemption
even under the dissent’s version of Phenergan’s regulatory history. Id. at
573 n.6 (majority opinion) (“[E]ven the dissent’s account does not support
the conclusion that the FDA would have prohibited Wyeth from adding a
stronger warning pursuant to the CBE regulation.”).
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had not presented clear evidence that the FDA would have disallowed a
stronger warning about the IV-push method. Id. at 573.
Clomid’s regulatory history is similar to Phenergan’s. Like
Phenergan, Clomid had appeared on the market for decades before Mrs.
Cerveny took Clomid. And Aventis has intermittently corresponded with
the FDA about Clomid’s labels.
Aventis argues that this case differs because Clomid’s FDA-approved
labels stated that there was no definitive evidence linking Clomid to birth
defects. But in Levine, the label suggested “extreme care” when someone
uses the IV-push method to administer Phenergan. Levine, 555 U.S. at 560
n.1. Thus, the regulatory history in Levine showed that the FDA had known
of the dangers of the IV-push method, but had not required a stronger
warning. This was not enough in Levine to trigger preemption.
Likewise, the FDA’s approval of Clomid’s labels suggests only that
the FDA knew about potential issues involving pre-pregnancy use of
Clomid—not that the FDA would have rejected a stronger warning if one
had been proposed. As a result, Clomid’s regulatory history alone does not
meet the clear-evidence standard.

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Consideration of Mr. Mix’s Citizen Petition as Clear
Evidence

To meet the clear-evidence standard, Aventis also relies on the
FDA’s rejection of Mr. Mix’s citizen petition, 10 which had alleged risks
when taking Clomid prior to pregnancy.
a.

Mr. Mix’s Prior Claims to the FDA

In his citizen petition, Mr. Mix presented arguments virtually
identical to the Cervenys’. For example, Mr. Mix alleged that taking
Clomid prior to pregnancy risks fetal harm because (1) Clomid “has a long
half-life and is still biologically active well into the second month of
pregnancy when most organs are being formed . . . and can accumulate
with multiple courses of treatment” and (2) Clomid inhibits cholesterol,
which may endanger the developing fetus. Appellants’ App’x vol. 1, at
248-49. Accordingly, Mr. Mix urged stronger warnings to (1) “set[] forth
reasonable and effective warnings of the teratogenic risks” for Clomid, (2)
“order risk evaluation and mitigation strategies . . . in order to determine
whether the benefits of [Clomid] outweigh the risks,” and (3) order studies
to determine whether dietary supplements of cholesterol or a high

10

Under the FDA’s regulations, citizens may petition the FDA to
“issue, amend, or revoke a regulation or order, or to take or refrain from
taking any other form of administrative action.” 21 C.F.R. § 10.25(a).
Accordingly, any citizen may ask the FDA to change or strengthen drug
labels. See id. §§ 10.25, 10.30.
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cholesterol diet “can mitigate or eliminate the increased risk of birth
defects” from using Clomid. Id. at 248.
In 2009, the FDA denied Mr. Mix’s petition, stating that the FDA had
“reviewed the references submitted with the Petition,” “evaluated the
scientific merit of each reference . . . submitted,” and “independently
surveyed the literature regarding [Clomid].” Appellants’ App’x vol. 2, at
383. The FDA concluded that (1) “the scientific literature [did] not justify
ordering changes to the labeling that warn of such risks beyond those
presently included in labeling” and (2) there was “insufficient evidence” to
support Mr. Mix’s other requests. Id.
Mr. Mix sought reconsideration, which he twice supplemented with
more information. The FDA declined to reconsider, explaining that the
original denial had “appropriately applied the standards in the [Federal
Food, Drug, and Cosmetic Act] and FDA regulations regarding drug safety,
warnings, and potential safety hazards.” Id. at 422. The FDA added that the
new information was not enough to alter the outcome. Id.
Aventis argues that the denial of Mr. Mix’s petition constitutes clear
evidence that the FDA would not have approved a warning in 1992 about
the risks when taking Clomid prior to pregnancy. The Cervenys admit that
their failure-to-warn claims are based on the same theories and scientific
evidence presented in Mr. Mix’s citizen petition. Oral Arg. at 5:09-6:11.

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Nonetheless, the Cervenys present two challenges to Aventis’s
reliance on the FDA’s denial of Mr. Mix’s petition. First, the Cervenys
argue that the FDA affords greater deference to label changes proposed by
manufacturers than by citizens. Second, the Cervenys urge a bright-line
rule that the denial of a citizen petition, standing alone, can never
constitute clear evidence. We reject both arguments.
b.

Manufacturer-Submitted Label Changes Versus Citizen
Petitions

The Cervenys contend that when the FDA considers proposed label
changes, manufacturers are treated more favorably than others. According
to the Cervenys, this favoritism leads the FDA to accord greater deference
to changes proposed by manufacturers than to changes proposed in citizen
petitions. For this alleged favoritism, the Cervenys rely on expert
testimony and statistics.
The Cervenys’ contention is based on an understandable, but
mistaken, premise: that a manufacturer’s willingness to strengthen its
warning is something always to be encouraged. Many would agree with
that proposition, but the FDA doesn’t. Instead, the FDA views
overwarnings as problematic because they can render the warnings useless
and discourage use of beneficial medications. Supplemental Applications
Proposing Labeling Changes for Approved Drugs, Biologics, and Medical
Devices, 73 Fed. Reg. 2848, 2851 (proposed Jan. 16, 2008) (codified at 21
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C.F.R. pts. 314, 601, 814); Requirement on Content and Format of
Labeling for Human Prescription Drug and Biologic Products, 71 Fed. Reg.
3922, 3927, 3935 (Jan. 24, 2006); Content and Format for Labeling for
Human Prescription Drugs, 44 Fed. Reg. 37434, 37447 (June 26, 1979).
In addition, the FDA standard for revising a warning label does not
discriminate between proposals submitted by manufacturers and proposals
submitted by citizens. See 21 C.F.R. § 201.80(e) (“The labeling shall be
revised to include a warning as soon as there is reasonable evidence of an
association of a serious hazard with a drug; a causal relationship need not
have been proved.”). The Cervenys admit that the standard is the same
regardless of who proposes to revise the label. Appellants’ Opening Br. at
38. Indeed, in denying Mr. Mix’s citizen petition, the FDA stated nine
times that it was applying the “reasonable evidence” standard for label
changes. Appellants’ App’x vol. 2, at 387, 389-90, 392-94. This is the
same standard that would have applied if Aventis had proposed to
strengthen its warnings. See Part II(A), above.
The Cervenys suggest that the FDA disobeys its own regulations to
apply different standards depending on the source of the proposed change.
But we do not presume that the FDA deviates from regulatory
requirements. Yuk v. Ashcroft, 355 F.3d 1222, 1232 (10th Cir. 2004). Even
if the FDA rejects more citizen petitions than manufacturer requests, the
disparity would be easily explainable.
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One explanation is that proposals by manufacturers are more
informed and better supported than proposals in citizen petitions. See Brian
K. Chen et al., Petitioning the FDA to Improve Pharmaceutical, Device
and Public Health Safety by Ordinary Citizens: A Descriptive Analysis,
PLoS ONE, May 12, 2016, at 2, 6, http://journals.plos.org/
plosone/article/file?id=10.1371/journal.pone.0155259&type=printable
(finding that “the majority of petitions [filed by ‘ordinary’ citizens] are
denied because petitioners fail to present sufficient and/or convincing
evidence” and that “[f]or these denials, the FDA provided detailed, pointby-point rebuttals to the petitioner’s scientific basis for the requested
actions”).
Another explanation is that brand-name drug manufacturers often file
frivolous citizen petitions, asking the FDA to disallow a generic drug’s
entry into the market. Michael A. Carrier & Daryl Wander, Citizen
Petitions: An Empirical Study, 34 Cardozo L. Rev. 249, 260, 282 (2012).
An empirical study of citizen petitions over a 9-year period found that 68%
of citizen petitions had been filed by brand-name drug manufacturers. Id.
at 270. Of those petitions, 78% targeted generic drugs. Id. at 271. The
study’s authors hypothesized that citizen petitions are frequently denied
because they involve unsupported efforts to stall entry of generic
medications into the marketplace. Id. at 253, 279.

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Rejecting these explanations, the Cervenys hypothesize that the FDA
would be more receptive to a manufacturer’s request to strengthen a
warning than to a citizen’s effort to compel a stronger warning. But a
factual dispute cannot be based on speculation that the FDA would jettison
its legal requirements and rubber-stamp Aventis’s hypothetical proposal
notwithstanding the risk of overwarning.
* * *
Under the same standard for manufacturer-initiated changes, the FDA
rejected a citizen petition containing arguments virtually identical to the
Cervenys’. We will not assume that the FDA would have scuttled its own
regulatory standard if Aventis had requested the new warning. 11 Thus, we
reject the Cervenys’ challenge to Aventis’s reliance on Mr. Mix’s citizen
petition.

11

This conclusion would remain the same regardless of whether the
“clear evidence” standard entails a question of law or a question of fact.
The Third Circuit’s Fosamax opinion noted that district courts considering
summary judgment should “compare the evidence presented with the
evidence in Wyeth [v. Levine], to determine whether it is more or less
compelling” and that a jury trial would only be necessary “in those cases
where the evidence presented is more compelling than that in Wyeth but no
‘smoking gun’ rejection letter from the FDA is available.” In re Fosamax
(Alendronate Sodium) Prods. Liab. Litig., 852 F.3d 268, 2017 WL
1075047, at *18 (3d Cir. Mar. 22, 2017)). No jury trial is needed here
because the multiple rejections of Mr. Mix’s citizen petition constitute
“smoking guns” that would foreclose any reasonable juror from finding
that the FDA would have approved warnings about the risks when Clomid
is taken prior to pregnancy.
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Bright-Line Rule

The Cervenys argue that the denial of a citizen petition, by itself,
cannot constitute clear evidence. For this argument, the Cervenys rely on
opinions by one federal appellate court, one state supreme court, and five
federal district courts. We reject the Cervenys’ argument.
The Cervenys rely partly on Mason v. SmithKline Beecham Corp.,
where the Seventh Circuit concluded that the FDA’s rejection of a citizen
petition on three separate occasions did not constitute clear evidence. 596
F.3d 387, 396 (7th Cir. 2010). But Mason is distinguishable in two ways.
First, the citizen petitions in Mason pertained to a drug (Prozac) that
was similar, but not identical, to the drug (Paxil) that had injured the
plaintiff. See id. at 395 (“[W]e give little weight to the administrative
history of Prozac when we are concerned with whether there is clear
evidence that the FDA would have rejected a labeling change in Paxil.”).
Second, unlike in the present case, the citizen petitions in Mason had
been rejected before the plaintiff’s injury. Id. The court considered this
temporal gap as “especially important” because the FDA’s analysis of
drugs “constantly evolves as new data emerges.” Id. Thus, when the injury
took place, the FDA might have permitted the labeling change despite the
FDA’s earlier rejection of the citizen petition.
The Seventh Circuit’s subsequent approach in Robinson v. McNeil
Consumer Healthcare crystallizes the significance of the difference
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between our facts and those in Mason. In Robinson, the Seventh Circuit
found preemption because the FDA had “refus[ed] to require” a warning
label “when [the FDA] had been asked to do so in the submission to which
the agency was responding.” 615 F.3d 861, 873 (7th Cir. 2010). The fact
that Robinson came to a different result than Mason suggests that the two
distinguishing characteristics in Mason drove the result there.
The Cervenys also rely on Reckis v. Johnson & Johnson, 28 N.E.3d
445 (Mass. 2015). There the Supreme Judicial Court of Massachusetts
concluded that the denial of a citizen petition constituted clear evidence
that the FDA would have rejected some of the plaintiff’s requested
warnings. 28 N.E.3d at 457-58 (“[T]he FDA’s explicit rejection of the
2005 citizen petition’s proposed inclusion . . . provides the necessary
‘clear evidence’ that the FDA would have rejected the addition of [that
same inclusion] . . . .”). But the court reached the opposite conclusion for
another warning by distinguishing the proposal in the citizen petition from
the newly proposed warning. Id. at 458-59. In discussing this distinction,
the court suggested a difference between label changes requested by a
manufacturer and changes requested by others. Id. at 459 (“[E]ven
assuming for sake of argument that we could predict the FDA would have
rejected a citizen petition proposal to add only this warning, that would not
answer whether the FDA would have rejected the warning had it been
sought by the defendants themselves.”).
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Reckis does not foreclose consideration of a citizen petition as clear
evidence. As noted, the court expressly concluded that rejection of the
citizen petition constituted clear evidence on some warnings. The Cervenys
point out that Reckis treats the “clear evidence” standard as fact-specific.
See id. at 457 (“Wyeth did not ‘define clear evidence,’ so ‘application of
the clear evidence standard is necessarily fact specific.’” (quoting Dobbs v.
Wyeth Pharm., 797 F. Supp. 2d 1264, 1270 (W.D. Okla. 2011))). That’s
true, but the facts here involve the FDA’s prior rejection of a virtually
identical allegation based on virtually identical evidence and an identical
legal standard.
The Cervenys also point to five district court opinions in arguing that
the FDA’s rejection of a citizen petition cannot constitute clear evidence.
These opinions have little persuasive value. Only one of the opinions
(Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.) unambiguously
supports the Cervenys’ argument that rejection of a citizen petition,
without more, can never constitute clear evidence. 808 F. Supp. 2d 1125,
1133 (D. Minn. 2011), rev’d in part on other grounds sub nom. In re
Levaquin Prods. Liab. Litig., 700 F.3d 1161 (8th Cir. 2012). Another
district court opinion (Forst v. Smithkline Beecham Corp.) arguably
supports the Cervenys’ argument, though this opinion involved the FDA’s
handling of a manufacturer’s voluntary labeling supplement. 639 F. Supp.
2d 948, 954 (E.D. Wis. 2009). Neither Schedin nor Forst is persuasive on
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our facts because the FDA here had rejected virtually identical arguments
about the need for stronger warnings about Clomid.
The remaining three district court opinions are distinguishable. In
two, the citizen petitions had been submitted and rejected years before the
plaintiffs suffered their respective injuries. See Koho v. Forest Labs., Inc.,
17 F. Supp. 3d 1109, 1117 (W.D. Wash. 2014) (“In light of the evolving
nature of the data regarding the effects of prescription drugs, the temporal
gap between the latest rejection of a citizen petition in 1997 and Ilich’s
death in 2002 is significant.”); Dorsett v. Sandoz, Inc., 699 F. Supp. 2d
1142, 1158-59 (C.D. Cal. 2010) (similar reasoning). In our case, the
sequence was opposite: The FDA denied Mr. Mix’s citizen petition after
obtaining scientific data for over 20 years after Mrs. Cerveny had taken the
Clomid.
In the third case, Hunt v. McNeil Consumer Healthcare, the court
held that rejection of a citizen petition did not constitute clear evidence
because (1) the rejection had occurred years before the plaintiff’s injury
and (2) the warnings proposed by the plaintiffs had gone “much further”
than the citizen petition. 6 F. Supp. 3d 694, 700-01 (E.D. La. 2014). These
factors are absent in our case.
In our view, there is no persuasive authority for a bright-line rule
that the denial of a citizen petition cannot constitute clear evidence under
Levine.
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* * *
We conclude that the rejection of a citizen petition may constitute
clear evidence that the FDA would have rejected a manufacturer-initiated
change to a drug label. Our case provides a perfect example. In rejecting
Mr. Mix’s citizen petition, the FDA analyzed claims and data virtually
identical to those submitted by the Cervenys. Under the standard that
would have applied to a change proposed by Aventis, the FDA concluded
that warnings were unjustified for risks in taking Clomid prior to
pregnancy. That conclusion controls here, and the FDA’s denial constitutes
clear evidence that the FDA would not have approved the Cervenys’
desired warning of the risks of taking Clomid prior to pregnancy.
3.

The Cervenys’ Argument About the FDA’s Proposed
Warning in 1987 Regarding the Risks When Taking Clomid
Prior to Pregnancy

The Cervenys argue that Clomid’s regulatory history shows that the
FDA would have approved a warning about taking Clomid prior to
pregnancy. For this argument, the Cervenys point to the FDA’s 1987
proposal to add the following Pregnancy Category X warning to Clomid:
PREGNANCY CATEGORY
Information for Patients.

X.

See

Contraindications

and

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.
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Appellants’ App’x vol. 3, at 596. The FDA’s 1987 proposal does not
support the Cervenys’ argument for a warning of the risks when Clomid is
taken prior to pregnancy.
We presume that the FDA would have allowed Aventis to include a
proposed warning that the FDA itself had proposed. The problem, however,
is that the 1987 proposed warning addresses only the risk of taking Clomid
after a woman has become pregnant. For instance, the warning’s
“Pregnancy Category X” notation indicated to the user 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) (1987). And the warning itself
referred to the risk of fetal harm when Clomid is “administered to pregnant
women.” Appellants’ App’x vol. 3, at 596. Thus, the FDA’s 1987 proposal
does not suggest that the FDA would have approved a warning about taking
Clomid prior to pregnancy.
The Cervenys argue that the FDA’s 1987 proposal must refer to the
risks of pre-pregnancy Clomid use because women take Clomid only if
they are trying to become pregnant; no one would reasonably need to take
Clomid after pregnancy had begun. It is true that the 1987 warning is
directed to women who are trying to become pregnant. But the FDA was
addressing a risk for women who might take Clomid before realizing that
they had become pregnant. See Appellants’ App’x vol. 3, at 596 (1987
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proposed warning) (“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.”). Mrs. Cerveny is not in this group,
for she did not take Clomid after becoming pregnant.
The Cervenys also argue that we should examine the FDA’s 1987
proposal alongside other known evidence of the risks of taking Clomid
before becoming pregnant. But, as explained above, the FDA considered
such evidence when rejecting Mr. Mix’s citizen petition. 12 See Part

12

In responding to Mr. Mix’s citizen petition, the FDA specifically
addressed his argument that the shelf-life of Clomid could remain in a
woman’s system after she became pregnant:
Radioactive tracer studies presented in the original NDA
document that clomiphene has a half-life of about 5 days. Enclomiphene . . . and zu-clomiphene . . . are the racemic isomers
of clomiphene citrate [Clomid],. [sic] The long half-life of
clomiphene citrate is attributable to zu-clomiphene. Enclomiphene disappears rapidly from the circulation, whereas
zu-clomiphene is cleared slowly and may accumulate across
consecutive cycles of treatment. Zu-clomiphene has been found
in feces up to 6 weeks after administration. Accordingly, it is
possible that there is some fetal exposure to zu-clomiphene in
mothers who have been treated with clomiphene prior to
pregnancy. Zu-clomiphene, however, had little effect on sterol
metabolism in an animal model. Currently available clinical
data support our conclusion that the level of zu-clomiphene
present at the time of organogenesis is insufficient to cause
significant inhibition of cholesterol synthesis even after
multiple cycles of treatment.
Appellants’ App’x vol. 2, at 386-87 (footnote omitted).

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II(C)(2), above. Therefore, this evidence does not bolster the Cervenys’
argument regarding the proposed 1987 warning.
* * *
For the reasons above, we conclude that the FDA would not have
permitted Aventis to warn users about the risks of taking Clomid prior to
pregnancy.
D.

Preemption of the Failure-to-Warn Claims: The Potential
for Fetal Harm Caused by Taking Clomid During Pregnancy

The Cervenys argue not only that the FDA’s proposal in 1987
suggests the opportunity for Aventis to warn about risks prior to
pregnancy, but also that the injury could have been averted if Aventis had
used the same wording that the FDA had proposed in 1987, warning of the
risks of taking Clomid during pregnancy. The district court rejected this
argument, but did not say how the issue would have involved preemption.
Thus, a remand is necessary on this issue.
1.

The 1987 Warning and the Potential Harm to the Fetus if
Clomid Is Taken During Pregnancy

When Mrs. Cerveny took Clomid, the label did not directly say that
Clomid could harm the fetus if Clomid is taken during pregnancy.
Appellants’ App’x vol. 1, at 239 (“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.”). The
FDA’s 1987 proposal would have warned women more directly about
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potential harm to the fetus when Clomid is taken during pregnancy.
Appellants’ App’x vol. 3, at 596 (“Clomid may cause fetal harm when
administered to pregnant women.”).
The Cervenys assert that “Aventis should have added [the 1987]
warning that was expressly proposed by the FDA.” Appellants’ Opening
Br. at 41. Mrs. Cerveny insists that she would not have taken Clomid, even
pre-pregnancy, if Aventis had used the FDA’s proposed wording. Id. at
42. 13
13

In district court, the Cervenys also presented the same argument. See
Opp. to Defendant’s Mot. for Summary Judgment at 15-19, Appellants’
App’x vol. 2, at 486-490:


“[T]here is clear evidence that the FDA proposed a [warning]
in 1987 that would have warned of a ‘potential hazard to the
fetus.’” Id. at 15, Appellants’ App’x vol. 2, at 486.



“Not only are Plaintiffs advocating a warning different from
what was rejected in response to the citizen petition, Plaintiffs
are also proposing a warning that was expressly suggested by
the FDA . . . .” Id. at 17, Appellants’ App’x vol. 2, at 488.



“Mrs. Cerveny’s affidavit establishes a question of fact as to
whether the warning proposed by the FDA in 1987—describing
a ‘potential hazard to the fetus’—would have altered Mrs.
Cerveny’s decision to use Clomid.” Id. at 18, Appellants’
App’x vol. 2, at 489.



“In a nutshell, the FDA’s 1987 proposed label change shows
that it was possible to warn about a potential hazard to the
fetus, and to alert women attempting to become pregnant that
they, too, should be concerned about this hazard. This fact
alone defeats preemption, because it establishes that it was
possible for Defendant to change the label to warn about a
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Inclusion in the Complaint

Aventis implies that the Cervenys did not present this theory in the
complaint. Appellee’s Resp. Br. at 48. We disagree. It is true that the
complaint focused primarily on Aventis’s failure to warn of the risks when
Clomid is taken prior to pregnancy. But in the complaint, the Cervenys
also alleged that Aventis had “failed to adequately warn . . . consumers . . .
of the known effects in Clomid that can lead to . . . birth defects [and]
fraudulently concealed these effects . . . . [by] represent[ing] . . . that ‘no
causative evidence of a deleterious effect of Clomid therapy on the human
fetus has been seen.’” First Amended Complaint at 12, ¶¶ 56-57,
Appellants’ App’x vol. 1, at 22; see also id. at 5, ¶ 21, Appellants’ App’x
vol. 1, at 15 (alleging that Aventis had failed to warn “of the dangers of
taking the fertility drug”). We conclude that the Cervenys adequately
presented this theory in the complaint.
3.

The Need for Remand

Aventis does not deny that it could have used the wording that the
FDA had proposed in 1987. Rather, Aventis points out that (1) the
proposed warning addresses the risks from taking Clomid during pregnancy
and (2) Mrs. Cerveny took Clomid prior to her pregnancy. Appellee’s Resp.
Br. at 48 (“A plaintiff cannot allege as a defect in a label a warning that
potential hazard to the fetus.” Id. at 19, Appellants’ App’x vol.
2, at 490 (citation omitted).
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would not have applied to them.”). Aventis acknowledges that this
contention focuses on a deficiency under Utah law rather than federal
preemption. See Defendant’s Mot. for Summary Judgment at 18,
Appellants’ App’x vol. 1, at 235 (arguing that the 1987 warning is
“irrelevant to the question of preemption” because the Cervenys’ claim
would fail under Utah law); see also Appellants’ Opening Br. at 42 (“[T]he
issue . . . is one of [Utah law], not an issue of impossibility
preemption.”). 14
But Aventis moved for summary judgment based solely on
preemption. For this reason, the Cervenys urged the district court to ignore
Aventis’s state-law argument. Opp. to Defendant’s Mot. for Summary
Judgment at 17, Appellants’ App’x vol. 2, at 488. But the district court
entertained Aventis’s state-law argument and relied on it, reasoning that it
“would be a nonsensical result if a plaintiff could avoid a preemption
defense by arguing that a drug label could have been strengthened in any
form, regardless of its relevance to the plaintiff’s case.” Appellants’ App’x
vol. 3, at 731.

14

Aventis also argues that adoption of the FDA’s 1987 warning “would
not have substantively altered the information that was contained on the
1992 Clomid label” because the drug was already “contraindicated for use
in pregnant women.” Appellee’s Resp. Br. at 47 n.10. Though rooted in
federal law, this argument does not support preemption.
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But the Cervenys’ failure-to-warn claims are based on Utah law. If
the FDA’s proposed warning would have been irrelevant under Utah law,
Aventis could have


moved for summary judgment under Utah law or



moved to strike the portions of the Cervenys’ complaint that
had raised this issue.

But Aventis did not make either kind of motion; instead, Aventis relied
solely on federal preemption.
The district court did not explain why the defect here fell within the
scope of Aventis’s summary judgment motion. To be sure, a preemption
analysis requires the reviewing court to consider state law. See PLIVA, Inc.
v. Mensing, 564 U.S. 604, 611 (2011) (“Pre-emption analysis requires us to
compare federal and state law. We therefore begin by identifying the
[applicable] state tort duties and federal labeling requirements . . . .”). But
“[i]n pre-emption cases, the question is whether state law is pre-empted by
a federal statute, or in some instances, a federal agency action.” POM
Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228, 2236 (2014). Here there
is no question that Aventis could have added the proposed warning; after
all, the warning had been proposed by the FDA. The Cervenys contend that
Mrs. Cerveny would not have taken Clomid if Aventis had added the 1987
warning. Aventis’s argument that the 1987 warning is “irrelevant” to the
Cervenys’ case is based on Utah law, not preemption.
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In sum, the district court did not consider whether it could rest on
Utah law when deciding a summary judgment motion that had relied solely
on federal preemption. Because the district court did not consider this
question and it has not been fully briefed on appeal, we leave this question
for the district court to address on remand. 15 See Bell v. Pfizer, Inc., 716
F.3d 1087, 1096 (8th Cir. 2013) (remanding for the district court to decide
whether state claims were sufficient under state law when the claims had
been mistakenly rejected on preemption grounds).
III.

Claims of Fraud, Negligent Misrepresentation, and Breach of
Implied Warranty
On the basis of federal preemption, the district court granted

summary judgment to Aventis not only on the failure-to-warn claims but
also on the claims of fraud, negligent misrepresentation, and breach of
implied warranty. In doing so, the district court did not distinguish
between the claims.

15

Even if the district court could consider whether the 1987 proposed
warning was relevant to the Cervenys’ state-law claim, the district court
did not adequately address Utah law. The court said simply that the 1987
warning was “irrelevant” because Mrs. Cerveny had taken Clomid before
she became pregnant. Appellants’ App’x vol. 3, at 731. But the Cervenys
argued that the 1987 proposed warning had stated that (1) the fetus could
be harmed if Clomid is taken during pregnancy and (2) Mrs. Cerveny
would not have taken Clomid if Aventis had used the FDA’s proposed
language. The district court did not explain why these arguments would
render the 1987 proposed warning irrelevant under Utah law.
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The Cervenys urge remand for further consideration of the claims
involving fraud, negligent misrepresentation, and breach of implied
warranty, even if the failure-to-warn claims are preempted. We agree that
remand is required.
The district court implicitly characterized all of the Cervenys’ claims
as failure-to-warn claims that had been preempted. Aventis defends this
implicit characterization, stating that all of the claims were based on a
failure to warn rather than on affirmative misrepresentations. But this
characterization of the claims is too restrictive. For instance, on the claims
of fraud (Count VIII) and negligent misrepresentation (Count IX), the
Cervenys allege that Clomid’s label falsely represented that no one had
seen any evidence of causation between the use of Clomid and fetal harm.
In contrast, the preemption discussion focuses on whether the FDA would
have allowed Aventis to add a warning about fetal harm when Clomid is
taken prior to pregnancy. The fact that the FDA would have rejected the
addition of a warning does not mean that the FDA would have disallowed
the removal of language that was false or misleading.
Aventis essentially responds that the Clomid label is accurate
because there was no evidence of a causal relationship between Clomid and
birth defects. But this argument goes to the merits rather than to Aventis’s
ability to delete false or misleading information.

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Similarly, the warranty claim (Count IV) alleges in part that
“[c]ontrary to the implied warranty . . . Clomid was not of merchantable
quality, and [was] not safe or fit for its intended uses and purposes.”
Appellants’ App’x vol. 1, at 30. The Cervenys argue that Clomid causes
birth defects, making Clomid unfit for its ordinary purpose (having a
baby). Appellants’ Reply Br. at 26-27. That claim is not necessarily related
to Clomid’s labeling and is therefore not automatically preempted.
In sum, we reverse and remand the award of summary judgment on
the claims of fraud, negligent misrepresentation, and breach of an implied
warranty. See Bell v. Pfizer, Inc., 716 F.3d 1087, 1095-96 (8th Cir. 2013)
(remanding because the district court mistakenly treated claims for design
defect and breach of an implied warranty as claims involving a failure to
warn). We do not foreclose the possibility that these claims might be
preempted. But on remand, the district court should explain the effect of
preemption on the claims of fraud, negligent misrepresentation, and breach
of an implied warranty. We reverse the entry of summary judgment on
these claims.
IV.

Additional Discovery
The Cervenys alternatively urge reversal and remand on the ground

that the district court should have allowed more time for discovery. In
district court, the Cervenys’ attorney filed an affidavit seeking more time

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for discovery under Federal Rule of Civil Procedure 56(d). 16 Nonetheless,
the district court awarded summary judgment to Aventis without allowing
the additional time. 17
In reviewing the district court’s refusal to allow further discovery,
we apply the abuse-of-discretion standard. Ellis v. J.R.’s Country Stores,

16

Federal Rule of Civil Procedure 56(d) provides:
When Facts Are Unavailable to the Nonmovant. If a
nonmovant shows by affidavit or declaration that, for specified
reasons, it cannot present facts essential to justify its
opposition, the court may:
(1)

defer considering the motion or deny it;

(2)

allow time to obtain affidavits or declarations or to take
discovery; or

(3)

issue any other appropriate order.

17

The district court did not expressly rule on the Rule 56(d) affidavit.
Ordinarily, remand to the district court may be appropriate. See Patty
Precision v. Brown & Sharpe Mfg. Co., 742 F.2d 1260, 1264 (10th
Cir.1984) (remanding for the trial court to “specifically rule” on the
plaintiff’s Rule 56(d) affidavit “before making any ruling on the
defendants’ summary judgment motion”); see also Greystone Constr., Inc.
v. Nat’l Fire & Marine Ins. Co., 661 F.3d 1272, 1290 (10th Cir. 2011)
(“[T]he better practice on issues raised [below] but not ruled on by the
district court is to leave the matter to the district court in the first
instance.” (alteration in original) (internal quotation marks omitted)). But
we have declined to remand when the district court did not explicitly rule
on a Rule 56(d) issue. See Comm. for First Amendment v. Campbell, 962
F.2d 1517, 1522 (10th Cir. 1992) (holding that the district court did not
abuse its discretion by implicitly denying a Rule 56(d) motion through the
grant of summary judgment). The Cervenys do not complain that the
district court failed to rule on the issue, and we conclude that a remand on
this issue is unnecessary here.
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Inc., 779 F.3d 1184, 1206 (10th Cir. 2015). Thus, we “defer to the district
court’s judgment so long as it falls within the realm of [the] rationally
available choices.” Id. (alteration in original) (internal quotation marks
omitted). The district court did not abuse its discretion.
“[S]ummary judgment [should] be refused where the nonmoving
party has not had the opportunity to discover information that is essential
to his opposition.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250 n.5
(1986). Requests for further discovery should ordinarily be treated
liberally. Comm. for First Amendment v. Campbell, 962 F.2d 1517, 1522
(10th Cir. 1992). But relief under Rule 56(d) is not automatic. Burke v.
Utah Transit Auth. & Local 382, 462 F.3d 1253, 1264 (10th Cir. 2006).
To obtain relief under Rule 56(d), the movant must submit an
affidavit (1) identifying the probable facts that are unavailable, (2) stating
why these facts cannot be presented without additional time, (3)
identifying past steps to obtain evidence of these facts, and (4) stating how
additional time would allow for rebuttal of the adversary’s argument for
summary judgment. Valley Forge Ins. Co. v. Health Care Mgmt. Partners,
Ltd., 616 F.3d 1086, 1096 (10th Cir. 2010); Burke, 462 F.3d at 1264.
The Cervenys’ Rule 56(d) affidavit did not satisfy requirements (3)
and (4). For example, the affidavit did not identify the discovery steps that
had been taken or explain how additional discovery would rebut Aventis’s
preemption defense. Rather, the affidavit merely stated that additional
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discovery would “outline the facts of the case” and provide “expert
foundation.” Appellants’ App’x vol. III, at 618-19.
The Cervenys’ summary judgment response arguably contains the
information required in Rule 56(d). But we may not look beyond the
affidavit in considering a Rule 56(d) request. See Campbell, 962 F.2d at
1522 (“[C]ounsel’s unverified assertion in a memorandum opposing
summary judgment does not comply with Rule [56(d)] and results in a
waiver.”). As a result, the district court did not abuse its discretion in
declining to postpone its summary judgment ruling under Rule 56(d). See
Valley Forge, 616 F.3d at 1096 (holding that an affidavit did not meet Rule
56(d)’s requirements when the affiant listed additional materials sought by
the defendants, but made “no attempt to explain” why the defendants had
lacked the evidence or how they had attempted to obtain it).
V.

Disposition
We reverse the grant of summary judgment to Aventis on the failure-

to-warn claims. We uphold the ruling on the Cervenys’ theory that Aventis
had a duty to warn of the risks of using Clomid prior to pregnancy, for
claims based on this theory are preempted by federal law. But on remand,
the district court should further address the claim based on the failure to
use the FDA’s own wording on the risk of harm to the fetus when Clomid
is taken during pregnancy.

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We affirm the district court’s implicit denial of the Cervenys’ request
for additional time to conduct discovery.
Finally, we remand to the district court to address anew the
Cervenys’ claims involving fraud, negligent misrepresentation, and breach
of an implied warranty.

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