Court Finds ‘Clear Evidence’ in Clomid Preemption Case

A Utah federal court has agreed with Aventis that there was “clear evidence,” as required under Wyeth v. Levine, that FDA would not have approved labeling changes for its Clomid to include a warning against using the drug before pregnancy. The case was brought by a woman who used Clomid before becoming pregnant and gave birth to a child with birth defects. The plaintiff claimed that the birth defects were the result of Clomid remaining in her body during conception and said that Aventis had a duty to warn her prescribing doctor that the drug could cause birth defects if taken before pregnancy.

Writing in an online post, attorney Emily Pincow (Weil Gotshal & Manges) says that since 1976 the drug’s labeling has consistently warned about the risk to a fetus if Clomid is ingested during pregnancy. But FDA has never required that the label warn about birth defects if ingested prior to pregnancy.

Pincow describes several unsuccessful efforts through citizen petitions to persuade FDA to change its position and require additional information in the labeling. She also says that the current label, approved in 2012, does not contain language suggesting an association between Clomid use prior to pregnancy and birth defects.

The court agreed with Aventis that the denied citizen petitions and the current labeling were “clear evidence” that FDA would not have permitted the company to change the labeling in the way sought by the plaintiff and thus her state law claims were preempted.