United States District Court, D. Utah, Central Division
VICTORIA CERVENY, CHARLES CERVENY, and ALEXANDER CERVENY, Plaintiffs,
AVENTIS, INC., Defendant.
MEMORANDUM DECISION AND ORDER
BENSON UNITED STATES DISTRICT JUDGE
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 Order.
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.
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.
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.
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
warranty 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.
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. . . .
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.
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 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.
Failure to Warn Claim - While Pregnant
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 ...