United States: Tenth Circuit Finally Shuts The Door Completely On Cerevny

Last Updated: August 21 2019
Article by Michelle Yeary

We've been posting about this case since 2016 when the district court first dismissed plaintiff's failure to warn claim as preempted on the grounds that there was clear evidence the FDA would have rejected the warning plaintiff sought. We celebrated again in 2017 when the Tenth Circuit affirmed that decision. Since then we've been waiting to see what would happen to the claims the Tenth Circuit remanded. The wait is over. The remaining claims are not recognized under Utah law.

A quick reminder first. The case involves the drug Clomid which has been FDA approved and on the market since 1967 and is prescribed to women to induce ovulation. Plaintiff was prescribed Clomid in 1992 and took Clomid only prior to becoming pregnant. Plaintiff's son was born with serious birth defects which plaintiff alleges were caused by Clomid. Cerevny v. Aventis, Inc., 2019 WL 3763441, *1 (10th Cir. Aug. 9, 2019). Remaining on this appeal are claims for failure to warn of the risk of using Clomid during pregnancy, fraud, and negligent misrepresentation. Id.

Before the court even considers the legal viability of these remaining claims, it notes that plaintiff's prior claim for failure to warn of the risk of birth defects from pre-pregnancy use of Clomid was dismissed because there was clear evidence that the FDA would have rejected any such warning. That earlier decision was based on FDA's rejection of a Citizen's Petition in 2012 requesting that just such a warning be added. Id. at *3. Plaintiff argued to the court that the Supreme Court's decision in Merck Sharp & Dohme Corp. v. Albrecht, — U.S. —, 139 S. Ct. 1668 (2019) undercuts this earlier preemption decision. Cerevny at *7 n.9. Plaintiff argues that Albrecht held "that only labeling changes sought by the manufacturer can lead to preemption." Id. In other words, clear evidence can't be the rejection of a Citizen's Petition. The argument is erroneously based on the following from Albrecht:

In a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug's label to include that warning.

Albrecht, 139 S.Ct. at 1678. But plaintiff relies solely on the "requires the drug manufacturer to show that it fully informed the FDA," without putting it in context as the Supreme Court did with its preface "[i]n a case like Wyeth." We pointed out this exact issue in one of our post-Albrecht posts. Albrecht does not address situations where the FDA was "fully informed" (or not) by someone else, such as through a third-party Citizen's Petition. Those weren't the facts before the Court and the decision clearly emphasized it was based on the "particular set of circumstances" in Wyeth. Id. Now we have circuit court authority to back us up:

Here, Aventis argues a different ground to show that the FDA would have rejected the Cervenys' proposed warning. Unlike Wyeth, Aventis is not left to show clear evidence that the FDA would have rejected any unilateral label change under the CBE regulation, but Aventis has a separate avenue—the FDA's unequivocally having rejected Terry Mix's citizen petition advocating for the warning that the Cervenys now assert. We see nothing in Wyeth or Albrecht excluding Aventis from justifying preemption on this basis.

Cerevny, at *7 n.9 (citation omitted).

Moving back to the substance of the claims on appeal, plaintiff's primary claim is that defendant failed to warn about the risk of using Clomid during pregnancy and that that breach caused the alleged injury. Id. at *5. But it is undisputed that plaintiff did not use Clomid during her pregnancy. So, what plaintiff is actually arguing is that if the manufacturer had warned about condition X, plaintiff wouldn't have used the product, and therefore wouldn't have suffered from condition Y. Neither the district court nor the Tenth Circuit could find any law to support that Utah would recognize a failure to warn claim based on risk plaintiff never encountered. The Tenth Circuit also cited an Erie-rationale for not "expanding" Utah law to adopt this "unusual theory." Id.

Furthermore, both courts also found that plaintiff's theory wouldn't survive because the 1992 label for Clomid adequately warned of the risk of birth defects if used during pregnancy. "Simply put, the warning about the risk of ingesting Clomid during pregnancy sufficed even if it did not frighten [plaintiff] from using Clomid before pregnancy." Id.

Plaintiff's remaining fraud and misrepresentation claims were based entirely on the opening sentence to the Contraindications section of the label:

Although no causative evidence of a deleterious effect of Clomid (clomiphene citrate) therapy on the human fetus has been seen, such evidence in regard to the rat and rabbit has been presented (see Animal Pharmacology and Toxicology).

Id. at *6. But plaintiff ignores the remainder of the paragraph that goes on to detail the risk of fetal harm if used during pregnancy and how to avoid the risk. Moreover, deleting the first sentence would not "sound an alarm about risk to a fetus from a mother's ingesting Clomid before pregnancy" — the only risk at issue in this case. Id.

Also, in assessing the veracity of the sentence plaintiff focuses on, the court again acknowledged that the FDA had reviewed the data in 2007 and 2009 and "concluded that the data is insufficient to demonstrate reasonable evidence of an association between [the drug] and congenital abnormalities." Id. In fact the warning remains nearly the same today.

We wondered back in 2017 whether plaintiff would appeal the preemption decision, but instead she played out the remaining claims back at the district court and now again at the circuit level. The case is fully resolved now. So, we ask again – does plaintiff roll the dice?

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