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# Clomid Decision ‘Clear Evidence of Conflict Preemption’
- URL: https://www.fdaweb.com/clomid-decision-clear-evidence-of-conflict-preemption/
- Published: 2016-03-23T12:00:00.000Z
- Updated: 2026-09-14T20:50:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135167

> Attorney **Michelle Yeary** (Dechert) says that a Utah federal court decision in a case involving Aventis’ Clomid demonstrates “clear evidence” that FDA would not have permitted a labeling warning sought by the plaintiff. Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=c5dcefc3-9b2d-4ec6-99cb-06b45339a603&ref=fdaweb.com), Yeary says that Clomid has been approved by FDA and on the market since 1967, indicated to induce ovulation in women. The labeling has always contained a warning that the drug should not be taken while pregnant due to the risk of fetal harm.  
>  
> The plaintiff in the case used two rounds of Clomid in 1992\. Following the second round she became pregnant and her son was born with birth defects. Her suit alleged that the birth defects were the result of the Clomid she took before becoming pregnant and remaining in her system during and after conception. She argued that Aventis had a duty to warn of the risks of birth defects from Clomid taken prior to pregnancy.  
>  
> The company sought summary judgment on the ground that the plaintiff’s claims were barred by federal conflict preemption since FDA would not have allowed the company to include the warning sought by the plaintiff. To succeed under the standard in *Wyeth v. Levine*, the company had to demonstrate the conflict between state and federal law by “clear evidence.” Yeary says that since that 2009 decision, courts have been grappling with what “clear evidence” means. “In this case,” she writes, “the court didn’t have to look too hard.”  
>  
> Yeary points out that all of the scientific literature cited in the plaintiff’s complaint had been presented to FDA in a 2007 citizen petition that the agency ultimately denied, as it denied a 2009 petition for reconsideration. The court relied on the agency action on the petition as “clear evidence” that FDA would not have approved a different warning along with the fact that the agency “consistently approved Clomid labeling that includes affirmative rejections of the plaintiff’s theories.”  
>  
> The court held that FDA’s failure to approve a label containing the warning sought by the plaintiff and its comprehensive review of any association between Clomid ingestion prior to pregnancy and birth defects “to be highly persuasive evidence that FDA would not permit Aventis to strengthen Clomid’s labeling as the plaintiff suggests.”  
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> According to Yeary, it is important that the court found that both the rejection of the citizen petition and FDA’s consistent labeling position could be independent sources of clear evidence to support conflict preemption. “It’s nice that this case had both,” she concludes, “but it’s even nicer to know that you may only need one.”