The United States Court of Appeals for the Tenth Circuit took on this challenge in Cerveny v. Aventis, No. 16-450 (10th Cir. 2017).
Alexander Cerveny was born more than 20 years ago with birth defects. Defects his parents blame on the fact that his mother took Clomid prior to getting pregnant. The Cervenys sued the manufacturer of Clomid (“Aventis”), asserting various tort claims under Utah law. The district court granted summary judgment to Aventis based on federal preemption, saying the FDA would not have approved the drug warnings the Cervenys say are required under Utah law. The state law tort claim conflicts with federal law and is preempted. The district court granted summary judgment to Aventis on all of the Cervenys’ claims.
In 2007, everything in the Cervenys’ amended complaint was presented to the FDA in a citizen’s petition. It asked the FDA to adopt precise language about the dangers of Clomid prior to pregnancy. After two years of review, the FDA denied the citizen’s petition. The petition denial satisfied the ‘clear evidence’ standard.
The Court looked at the history of Clomid and the FDA warnings on the labels over the years. For more than 50 years, the FDA never required Clomid to carry warnings suggesting birth defects associated with Clomid use prior to pregnancy. Another warning said Clomid exposure prior to pregnancy does not cause birth defects at a rate greater than that observed in the general population. The FDA approved labeling put forth almost the exact opposite warning the Cervenys wanted.
The district court did not consider whether it could rely on Utah law when deciding a summary judgment motion that had relied on federal preemption. Because the district court did not consider this question and it has not been fully briefed on appeal, the Court left this question for the district court to address on remand.
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