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Cerveny v. Aventis Inc.

United States District Court, D. Utah, Central Division

November 29, 2017

AVENTIS, INC., Defendant.



         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 Order.


         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 warranty[1] 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 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 Pregnant[2]

         “[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 ...

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