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This post is from the non-Reed Smith side of the blog.

Today we laud an excellent prescription drug preemption ruling finding “clear evidence” that the FDA would not have permitted the warning of the sort plaintiff demanded – Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016).

At issue is the prescription drug Clomid. Clomid has been FDA approved and on the market since 1967. Id. at *2. It is prescribed to women to induce ovulation. The drug is taken for 5 consecutive days with ovulation typically occurring within 5 to 10 days. Id. at *5. Since the drug has been on the market it has carried a warning that Clomid should not be taken while pregnant due to the potential risk of harm to the fetus. Id. at *2-5. While the warnings have been modified over time, the risk of ingestion while pregnant has always been present, along with warnings about carefully monitoring ovulation so as to avoid becoming pregnant while taking the drug. Id.

Plaintiff used two rounds of Clomid in 1992. Following her second round she became pregnant. Her son was born with birth defects. Id. at *12-13. Plaintiff alleges that those defects were the result of the Clomid she took prior to becoming pregnant remaining present in her system during and after conception. And that therefore, defendant had a duty to warn of the risks of birth defects from Clomid taken prior to pregnancy. Id. at *13-14. Defendant filed a motion for summary judgment on the ground that plaintiff’s claims were barred by federal conflict preemption. Defendant argued that the FDA would not have allowed it to include the warning sought by plaintiff and therefore plaintiff’s state law tort claim conflicts with federal law and is preempted. Id. at *16-17. Under the standard announced in Wyeth v. Levine, 555 U.S. 555 (2009), defendant has to demonstrate the conflict between state and federal law by “clear evidence.” Since that decision, courts have been grappling with what “clear evidence” means. In this case, the court didn’t have to look too hard.

“Every piece of scientific literature cited in the Plaintiffs’ Amended Complaint was presented to the FDA,” id. at *13-14, in a citizen’s petition submitted in 2007. That citizen’s petition asked the FDA to adopt the precise warning plaintiff also alleges defendant should have included – the risk of birth defects if ingested prior to conception. Id. at *7. After two years of review, testing, and “independent survey,” the FDA denied the citizen’s petition finding no relevant or reliable evidence to justify changing the label. Id. at * 8. A petition of reconsideration was filed shortly after the denial in 2009 and that too was subsequently denied in 2012. Id. at *11.

Plaintiff, of course, cited cases in which denial of citizen petitions did not amount to “clear evidence.” But, the court found them inapplicable to the current situation. Where a denial of a citizen’s petition was held insufficient, it typically either predated the injury alleged in the lawsuit or did not address the issue raised by the lawsuit. Where the denial predates the injury, it is not informative as to what the FDA would have allowed at the time of injury:

Indeed, in theory, scientific information improves over time and therefore a citizen petition rejected years prior to the injury is not clear evidence that the FDA would not approve a later warning on a drug label.

Id. at *26. In this case, the FDA rejected citizen petitions in 2009 and again in 2012 – 17 and 20 years after plaintiff’s use of Clomid.

The other cases finding citizen petitions unpersuasive involved petitions that failed to address the theory proffered by plaintiff. Id. at *28. Without delving into the details and whether we agree with each court’s conclusion on whether a particular theory was addressed, in general, the proposition makes sense. If the FDA didn’t look at the issue, it doesn’t count toward “clear evidence.” But in Cerveny, the FDA heard and rejected plaintiff’s theories as embodied in the citizen’s petition. The citizen’s petition was a “proxy” for plaintiff’s failure to warn claim. Id. at *33.

[The petition’s] request to alter Clomid’s label is the exact theory and substance on which the Plaintiffs’ case relies. Importantly, the FDA’s rejection of the Plaintiffs’ theories occurred many years after Mrs. Cerveny took Clomid to induce ovulation. If the FDA concluded in 2009 and 2012 that . . . if used as directed, Clomid does not pose a risk of causing birth defects, the Court cannot say the FDA would have approved a contrary warning prior to 1992. Indeed, the FDA’s regulations only require a warning if there is “reasonable evidence of an association of a serious hazard with a drug.” 21 C.F.R. § 201.80(e). The FDA’s denial of the Plaintiffs’ theories embodied in [the] citizen petitions is clear evidence that the FDA would not have permitted Aventis to strengthen Clomid’s label prior to 1992.

Id. at *35.

But wait, there’s more. An additional and independent source of clear evidence is the fact that the FDA “consistently approved Clomid labeling that includes affirmative rejections of the Plaintiffs’ theories.” Id. at *36. Approval of the label that plaintiff finds insufficient is not by itself clear evidence that the FDA would have rejected a different or additional warning. Id. at *39 (FDA inaction alone cannot support a preemption defense). But this is more than a case of just inaction. For over 5 decades, the FDA “never required Clomid to carry warnings suggesting birth defects associated with Clomid use prior to pregnancy.” Id. at *37. Add to that that since 1994, the FDA-approved labeling has stated that “Clomid exposure prior to pregnancy does not cause birth defects at a rate greater than that observed in the general population.” Id. In other words, the FDA-approved labeling addresses the very risk plaintiff puts at issue and provides almost the exact opposite warning that plaintiff seeks. Therefore,

[t]he Court finds . . .that the FDA’s inaction, coupled with the FDA’s comprehensive review of any association between Clomid ingestion prior to pregnancy and birth defects, to be highly persuasive evidence that the FDA would not permit Aventis to strengthen Clomid’s labeling as the Plaintiffs suggest.

Id. at *39.

Plaintiff apparently also relied on the FDA’s suggesting a label change in 1987 and requiring a label change in 1994 regarding the use of Clomid during pregnancy. But the court found any such reliance irrelevant to plaintiff’s claim that Clomid carries of risk of causing birth defects if used prior to pregnancy. Id. at *39-41. “It would be a nonsensical result if a plaintiff could avoid a preemption defense by arguing that a drug label could have been strengthened in any form, regardless of its relevance to the plaintiff’s case.” Id. at *42. This is the flip side of the FDA rejecting a warning that’s not the warning plaintiff seeks. If the FDA requires a different or stronger warning on a risk that plaintiff is not taking issue with, that doesn’t mean the court should assume the FDA would have allowed a different warning as to the risk at issue in the litigation. A different risk is a different risk.

It is important that the court found that both the rejection of the citizen’s petition and the FDA’s consistent labeling position could be independent sources of clear evidence to support conflict preemption. It is nice that this case had both, but it’s even nicer to know that you may only need one.