Cerveny v. Aventis, Inc., 855 F.3d 1091

Background

Alexander Cerveny allegedly born with birth defects; family contends mother's 1992 use of Clomid caused them and sued Aventis under Utah tort theories (failure to warn, breach of implied warranty, negligent misrepresentation, fraud).
District court granted summary judgment for Aventis on federal preemption grounds, concluding Aventis could not have complied with both FDA requirements and the state-law warning the Cervenys sought.
Plaintiffs advanced two failure-to-warn theories: (1) Aventis should have warned of risks from taking Clomid prior to pregnancy; (2) Aventis should have used the FDA’s 1987 proposed wording warning of fetal harm if Clomid is taken during pregnancy.
FDA regulatory history: Clomid labels since 1967 warned against use during pregnancy; FDA proposed a Pregnancy Category X phrasing in 1987; FDA later denied a citizen petition (by Terence Mix) requesting label changes concerning pre-pregnancy risks.
Tenth Circuit affirmed preemption as to the pre-pregnancy-warning theory (holding FDA denial of the citizen petition was clear evidence the FDA would have rejected such a warning) but reversed/remanded on the second theory (use of the FDA’s own 1987 wording) and on non–failure-to-warn claims (fraud, negligent misrepresentation, implied warranty), and affirmed denial of additional discovery.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether state-law duty to warn about risks from taking Clomid prior to pregnancy is preempted	Cervenys: Aventis should have warned of risks from pre-pregnancy use (long half-life, cholesterol effects)	Aventis: FDA would not have approved a pre-pregnancy warning; impossible to comply with both federal law and state duty	Held: Preempted — FDA’s denial of the citizen petition constituted clear evidence FDA would have rejected that warning
Whether state-law claim based on failure to use the FDA’s 1987 proposed wording (warning of fetal harm when taken during pregnancy) is preempted	Cervenys: FDA itself proposed wording; Aventis could have used it and Mrs. Cerveny would not have taken Clomid if it had	Aventis: 1987 wording irrelevant because Mrs. Cerveny took Clomid before pregnancy; district court relied on relevance under state law	Held: Not resolved on preemption — remanded for district court to address relevance under Utah law and preemption interplay
Whether denial of a citizen petition can be "clear evidence" that FDA would have rejected a manufacturer-proposed label change	Cervenys: citizen-petition denials should not automatically qualify; agency treats manufacturer proposals differently	Aventis: denial addressed virtually identical evidence under the same FDA standard; denial can be clear evidence	Held: Denial of a closely parallel citizen petition may constitute clear evidence; here it does for the pre-pregnancy warning theory
Whether claims for fraud, negligent misrepresentation, and breach of implied warranty were preempted because they relate to warnings	Cervenys: these claims allege affirmative misrepresentations and product unfitness, not just omission	Aventis: characterizes these as failure-to-warn claims and thus preempted	Held: Remanded — district court erred by treating these claims as automatically preempted; they may survive because they involve affirmative misrepresentations and non-label-based theories

Key Cases Cited

Wyeth v. Levine, 555 U.S. 555 (2009) (articulates the "clear evidence" standard for impossibility preemption of state failure-to-warn claims)
PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (pre-emption analysis requires comparing federal and state law duties)
Dobbs v. Wyeth Pharm., 606 F.3d 1269 (10th Cir. 2010) (Tenth Circuit applies Wyeth’s clear-evidence framework)
Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir. 2013) (remand required where district court dismissed state claims on preemption grounds without addressing state-law sufficiency)
Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) (summary judgment standards and Rule 56(d) discovery principles)