Health Law Daily Clomid® manufacturer adequately warned of ingestion risk during pregnancy
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Monday, August 12, 2019

Clomid® manufacturer adequately warned of ingestion risk during pregnancy

By Jeffrey H. Brochin, J.D.

Patient could not premise a pre-pregnancy-ingestion failure-to-warn claim on the alleged inadequacy of a label’s warning about ingestion risk during-pregnancy.

A federal appeals court in Utah has affirmed the district court’s grant of summary judgment in favor of drug manufacturer Aventis, Inc., over alleged failure-to-warn claims arising out of the use of the fertility drug, Clomid®. The district court accurately characterized the patient’s failure-to-warn theory as being that she would not have taken Clomid before she was pregnant if she had known that taking it after she was pregnant could cause birth defects (Cerveny v. Aventis, Inc., August 9, 2019, Phillips, G.).

1992 labeling. In September and October 1992, the patient was prescribed the fertility drug Clomid, and sometime after the October round of the drug, she became pregnant. In July, 1993 her son was born with serious birth defects, and twenty-one years later the patient sued Aventis in district court asserting various state tort claims under Utah law including failure to warn. From the time Clomid entered the market in 1967, its labels have consistently warned about the risk of fetal harm if the mother takes Clomid while pregnant.

However, in 1986, the FDA ordered Aventis to add a "Pregnancy Category X" designation to the label that would indicate that the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit. The FDA recommended that designation on the ground that Clomid does not benefit pregnant women and that any risk to pregnant women would be unjustified. 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 the drug. In her Amended Complaint, the patient alleged that the 1992 version of the Clomid label had inadequately warned Clomid users of the risks to the fetus from ingesting the drug.

Preemption and previous remand. The appeals court had previously ruled that federal law preempted her claim that Aventis had failed to warn of alleged risks from pre-pregnancy Clomid use (see State failure to warn claim not pre-empted where FDA had proposed same warnings, (May 3, 2017). Her remaining failure-to-warn claim was for failure to adequately warn about during-pregnancy ingestion of Clomid—even though she had not ingested Clomid during her pregnancy. The court noted that even if she were able to surmount the difficulties in that failure-to-warn theory, she would still need to prove that pre-pregnancy ingestion of Clomidhad caused her son’s birth defects—a causation argument that the FDA had not adopted during Clomid’s 52-year history.

Mixing failure-to-warn timelines. In considering Aventis’s post-remand motion for summary judgment, the district court characterized the failure-to-warn theory as being that "she would not have taken Clomid before she was pregnant if she had known that taking it after she was pregnant could cause birth defects." The district court considered Aventis’s argument that the patient could not premise a pre-pregnancy-ingestion failure-to-warn claim on the alleged inadequacy of the 1992 label’s warning about during-pregnancy-ingestion risk, and again ruled in favor of Aventis, stressing the undisputed fact that the son was not harmed by his mother’s ingesting Clomid while she was pregnant with him because she did not ingest Clomid while she was pregnant (see Court rejects failure to warn claim against drug manufacturer, November 30, 2017).

A risk never encountered. As the district court further noted, the patient never encountered the risk that she claimed was inadequately warned of: she did not ingest Clomid during her pregnancy, and she cited no Utah law authorizing a failure-to adequately-warn claim pursuant to her unusual theory. Furthermore, the appeals court found that this was not a case where the court could confidently expand Utah law to include the patient’s claims on grounds that the Utah Supreme Court likely would do so.

The appeals court agreed with the district court that the 1992 version of the Clomid label adequately warned of risk from Clomid use during pregnancy, and the adequacy of that warning broke a link in her failure-to-warn theory and claim. Simply put, the warning about the risk of ingesting Clomid during pregnancy sufficed even if it did not dissuade the patient from using Clomid before pregnancy. For the foregoing reasons, the appeals court affirmed the district court’s grant to summary judgment to Aventis.

The case is No. 17-4204.

Attorneys: Eric David Barton (Wagstaff & Cartmell, LLP) for Victoria Cerveny. William F. Northrip (Shook, Hardy & Bacon, LLP) for Aventis, Inc.

Companies: Aventis, Inc.

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