Cerveny et al v. Sanofi et al
MEMORANDUM DECISION and ORDER granting 62 Defendant's Renewed Motion for Summary Judgment. Signed by Judge Dee Benson on 11/29/2017. (blh)
IN THE UNITED STATES COURT FOR THE DISTRICT OF UTAH
VICTORIA CERVENY, CHARLES
CERVENY, and ALEXANDER CERVENY,
MEMORANDUM DECISION AND
Case No. 2:14-cv-545-DB
Judge Dee Benson
Before the Court is Defendant’s Renewed Motion for Summary Judgment. [Dkt. 62].
The motion has been fully briefed and oral argument was held before the Court on November 14,
2017. Plaintiffs were represented at the hearing by Eric Barton and Defendant was represented
by Eric Swan and Gary Wight. Having considered the written and oral arguments of the parties,
and the relevant facts and the law, the Court enters the following Memorandum Decision and
Clomid is a prescription fertility drug that is manufactured by Defendant. Its chemical
name is clomiphene citrate and it was approved by the FDA on February 1, 1967. In September,
1992, Plaintiff, Victoria Cervey’s treating physician prescribed Clomid to aid her in becoming
pregnant. She took her first round of the medication in September and her second round the next
month, in October, 1992. She thereafter became pregnant and her son, Alexander, was born on
July 27, 1993. He was born without a thumb and a pinky finger on his left hand and a congenital
dislocation of his left elbow.
Exactly twenty-one years later, on July 28, 2014, Plaintiffs filed this lawsuit against
Defendant alleging several causes of action and seeking compensatory, punitive and statutory
damages plus interest and attorneys’ fees. The Court dismissed Plaintiffs’ design defect,
manufacturing defect, strict liability failure to warn, negligent failure to warn, punitive damages,
breach of express warranty, negligent design, negligence per se and unjust enrichment causes of
action based on Defendant’s motion to dismiss for failure to state a claim pursuant to Federal
Rule of Civil Procedure 12(b)(6). Dkt. 28. Defendant moved for summary judgment on the
remaining claims arguing they were federally preempted. Dkt. 38. Following briefing and oral
argument, the Court granted Defendant’s motion. Dkt. 47.
The Tenth Circuit Court of Appeals affirmed the Court’s ruling granting summary
judgment for Defendant on Plaintiffs’ failure to warn claim that was based on the content of its
warning regarding taking Clomid before becoming pregnant. It is undisputed that Victoria
Cerveny took Clomid as prescribed, before she became pregnant, and not after.
The appeals court remanded Plaintiff’s failure to warn claim that is based on the theory
that Defendant should have included a 1987 FDA-approved warning that harm to the fetus could
occur if Clomid is taken during pregnancy. Because the FDA had approved this warning but
Defendant had not used it, the appeals court questioned whether this claim could be dismissed
based on preemption grounds. The appeals court also remanded Plaintiffs’ negligent
misrepresentation, fraud and breach of implied warranty1 causes of action and questioned
whether the remanded claims are subject to dismissal based on federal preemption or rather,
based on state law. Defendant filed this renewed motion for summary judgment.
When Victoria Cerveny took Clomid, the label did not directly state it could harm a
human fetus if taken during pregnancy. It did, however, contain the following contraindication
against use during 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 (see Animal Pharmacology and Toxicology). 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. . . .
In 1987, the FDA proposed a warning directly about potential harm to the fetus when
Clomid is taken during pregnancy: “Clomid may cause fetal harm when administered to pregnant
women.” That wording was not used by Defendant at that time. Victoria Cerveny argues that if
she had known that birth defects could result from taking Clomid during pregnancy, she would
not have taken it as she did, before pregnancy.
The issue presented by this motion is whether the undisputed facts in the record give rise
to a cause of action for failure to warn against taking the drug while pregnant, fraud, or negligent
Plaintiffs concede their breach of implied warranty claim. See Dkt. 63 at p. viii.
misrepresentation. Defendant argues they do not because Victoria Cerveny did not take Clomid
while she was pregnant. Therefore, such a warning would not have applied to her and Alexander
was never exposed to that risk.
A. Failure to Warn Claim - While Pregnant2
“[U]nder Utah law, a manufacturer may be held strictly liable for any physical harm
caused by its failure to provide adequate warnings regarding the use of its product.” House v.
Armour of America, Inc., 929 P.2d 340, 343 (Utah 1996)(quoting House v. Armour of American,
Inc., 886 P.2d 542, 547 (Utah Ct. App. 1994)(citing Grundberg v. Uphohn Co., 813 P.2d 89, 97
(Utah 1991)). An adequate warning is one that “disclose[s] all the risks involved, as well as the
extent of those risks.” House, 886 P.2d at 551.
1. Applicability of the Proposed Warning
While Plaintiffs assert that Victoria Cerveny would not have taken Clomid before she
was pregnant if she had known that taking it after she was pregnant could cause birth defects,
Defendant argues this is immaterial because one may not assert a failure to warn cause of action
based upon a claimed inadequacy in a warning that does not apply to her. See Harris v. Eli Lilly
& Co., 2012 WL 6732725 at *3 (N.D. Ohio 2012)(unpublished)(“for a plaintiff to succeed on an
inadequate warning claim, the risk about which the manufacturer allegedly failed to warn must
be the same risk which harmed the plaintiff.”). When a proposed warning does not apply to the
plaintiff, she cannot prove defect or inadequacy. See, e.g., Mills v. United States, 764 F.2d 373,
As discussed in the Court’s Order on Defendant’s 12(b)(6) Motion, under the Learned
Intermediary Doctrine, Defendant had no duty to warn Victoria Cerveny directly, as a matter of
law. Rather, its duty was only to warn the physician. Schaerrer v. Stewart’s Plaza Pharm., Inc.,
79 P.3d 922, 928 (Utah 2003).
397 (5th Cir. 1985); Mason v. Smithkline Beecham Corp., 2010 WL 2697173 at *5 n.3 (C.D. Ill.
2010)(unpublished). Failure-to-warn claims based on warnings that do not apply to the plaintiff
fail because they are too speculative to provide standing. See, Rivera v. Wyeth-Ayerst Labs, 283
F.3d 315, 321 (5th Cir. 2002) (rejecting as “absurd” and “too speculative to establish Article III
standing” a claim based on the allegation that “an extra warning, though inapplicable to [the
plaintiff], might have scared her and her doctor from Duract”).
Alexander Cerveny was not harmed by Victoria Cerveny ingesting Clomid while she was
pregnant with him because she did not ingest Clomid while she was pregnant. Accordingly, the
Court finds that Plaintiffs cannot prevail on their failure to warn cause of action based on
Defendant’s alleged failure to warn about the risk of taking Clomid during pregnancy.
Additionally, Defendant argues that the cause of action fails because when Victoria
Cerveny took Clomid, the label contained the contraindication against use during pregnancy.
The contraindication specifically discussed the potential for fetal harm. The Court finds that the
pregnancy contraindication Defendant used in 1991 when Victoria Cerveny took the medication
was an adequate warning as a matter of Utah law. See House v. Armour of America, Inc., 929
P.2d 340, 343 (Utah 1996); House v. Armour of America, Inc., 886 P.2d 542, 547 (Utah Ct. App.
1994)(citing Grundberg v. Upjohn Co., 813 P.2d 89, 97 (Utah 1991)).
B. Fraud and Negligent Misrepresentation Claims
Plaintiffs allege causes of action for fraud and negligent misrepresentation based on the
statement in the pregnancy contraindication that “no causative evidence of a deleterious effect of
Clomid therapy on the human fetus has been seen.”
Under Utah law, a claim for fraud exists where a false statement is directed toward the
plaintiff and is intended to induce the plaintiff to act. Armed Forces Inc., Ex. v. Harrison, 70
P.3d 35, 40 (Utah 2003). Similarly a negligent misrepresentation claim requires proof that “the
plaintiff reasonably relied on the defendant’s representation” and that the defendant ‘should have
reasonably foreseen that the injured party was likely to rely upon the misrepresentation.’”
Mitchell v. Smith, 2010 WL 5172906 at *8.
Defendants argue they are entitled to summary judgment on these claims because the
statement: (1) was not directed toward Plaintiff; and (2) is not an inducement. As discussed
above, the pregnancy contraindication was not directed to women like Victoria Cerveny who
were prescribed the medication specifically for use before becoming pregnant. Plaintiffs cannot
sustain a fraud or negligent misrepresentation claim that was not directed toward them and those
causes of action therefore fail as a matter of law.
Secondly, Clomid’s warning label, including its pregnancy contraindication, were not
intended to induce women to take the drug. The inducement element of a fraud claim requires
Plaintiffs to prove not only that Victoria Cerveny was induced, but also that the contraindication
was made for the purpose of inducing her to take the medication.
Rather than being a statement intended to induce women who are seeking to conceive,
the pregnancy contraindication is intended to inform through their physicians a different class of
women, those who are already pregnant, that they must not take Clomid.
specifically define the scope and purpose of the contraindication section of prescription drug
labeling. The regulations explain that the contraindication section “must describe any situations
in which the drug should not be used because the risk of use (e.g., certain potentially fatal
adverse reactions) clearly outweighs any possible therapeutic benefit.” 21 CFR 201.67(c)(5). If
there are no such situations, then the contraindication section must contain the statement “none.”
Id. Accordingly, the fraud claim fails for lack of inducement.
Similarly, given the purpose of the contraindication, there is no evidence that Defendant
foresaw that women, like Victoria Cerveny, to whom the contraindication did not apply, would
rely on statements contained within the contraindication when deciding whether to take Clomid
before pregnancy, as required for a negligent misrepresentation claim. The Court finds that
because the pregnancy contraindication was not addressed to and did not apply to Victoria
Cerveny, the pregnancy contraindication cannot support the Plaintiffs’ fraud and negligent
Defendant’s Renewed Motion for Summary Judgment is hereby GRANTED.
IT IS SO ORDERED.
DATED this 29th day of November, 2017.
United States District Judge
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