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March 30, 2016 - FDA, Drug & Medical Device, Product Liability

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Bristol-Myers Squibb: A Dangerous Sword

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA’s rejection of additional warnings and consistent approval of labeling contrary to plaintiff’s demands constituted “clear evidence” of a conflict between federal and state law, and therefore served as grounds for preemption.


Plaintiff Victoria Cerveny was prescribed and used Clomid in 1992. Following her Clomid use, Mrs. Cerveny became pregnant and gave birth to a son, who was missing two fingers and had a congenital dislocation of the left radial head on his left elbow. The Cervenys alleged that the defects were caused by the residual Clomid in Mrs. Cerveny’s body during conception and organogenesis, and that Aventis breached its duty to warn of potential birth defects associated with Clomid use before pregnancy.

Aventis moved for summary judgment on the basis of conflict preemption, arguing that it was impossible for Aventis to comply with federal and state requirements for labeling because the FDA would not have permitted Aventis to include the exact warnings the Cervenys demanded should be added to the label. Specifically, Aventis relied on evidence that the FDA had previously considered Plaintiff’s argument and determined that using Clomid before pregnancy posed no heightened risk of future birth defects. In sum, the Cervenys argued that Aventis should have changed the label and Aventis responded that its hands were tied by the FDA—even if Aventis had sought the requested change, the FDA would not have approved it.

Changing a Drug Label

The central dispute was Aventis’s ability to add the warnings that the Cervenys sought. In general, manufacturers bear responsibility for the content of drug warning labels, but cannot change the labeling of a drug without seeking prior approval from the FDA.  See 21 C.F.R. § 314.70(b). In limited circumstances, however, a drug manufacturer can strengthen warnings without prior approval through a changes being effected (CBE) supplement, but the FDA retains authority to reject those changes.

The FDA also has a process whereby interested parties may submit “citizen petitions” seeking modifications to a drug’s labeling. Parties may submit these petitions accompanied by scientific and other evidence of potential health risks associated with a drug’s use. Although a causal relationship is not required, FDA standards mandate that if there is “reasonable evidence of an association of a serious hazard with a drug,” the drug’s label should be revised to include a warning. 21 C.F.R. § 201.80(e). Sometimes, “newly acquired information” (i.e., testing performed subsequent to a drug label’s approval or reports of negative drug reactions) is included in these reports and leads the FDA to require stronger warnings.

In 2007 and again in 2009, the FDA received citizen petitions about Clomid and its association with birth defects. Both petitions embodied the exact failure-to-warn theories presented by the Cervenys and included supplemental scientific research, seeking the same additional warnings that the Cervenys sought.  Ultimately, the FDA rejected both petitions. Importantly, both of these petitions came many years after Mrs. Cerveny’s Clomid use.

Clear Evidence

To demonstrate conflict preemption, a defendant must present “clear evidence” of a conflict between federal and state law. The “clear evidence” standard was first enunciated in Wyeth v. Levine, 555 U.S. 555 (2009) but was not defined.  Ever since, courts have grappled with this legal standard, which remains anything but clear.

The Cerveny court shed welcome new light on this “clear evidence” standard. Specifically, Judge Benson found that Aventis met its burden with evidence that the FDA had denied the two previous requests for strengthened warnings in the form of citizen petitions, “based on the same theories and substance on which Plaintiff’s case relies.” In fact, “every piece of scientific literature cited in the Plaintiffs’ Amended Complaint was presented to the FDA” in the 2007 citizen petition.

The court found additional “clear evidence” of the FDA’s position because the FDA “consistently approved Clomid labeling that includes affirmative rejections of the Plaintiffs’ theories.” Specifically, since 1994, Clomid’s FDA-approved label stated that “Clomid exposure prior to pregnancy does not cause birth defects at a rate greater than that observed in the general population.” Thus, not only did the FDA previously consider Plaintiff’s argument, but it also determined that drug ingestion before pregnancy raised no additional risk of future birth defects. This determination was clear from the FDA’s prior approval of Clomid labeling.

The court’s ruling represents a step in the right direction for pharmaceutical defendants, especially in light of the recent Dolin decision muddying the “clear evidence” burden of proof on defendant manufacturers arguing for preemption. Defendant manufacturers should also note that this court found that both the rejection of the citizen petitions and the FDA’s consistent approval of Clomid’s labels operated as independent sources of clear evidence to support conflict preemption. This is a clear departure from the Dolin court’s ruling, which seems to require an actual denial by FDA of a label change. As courts continue to analyze what “clear evidence” is without concrete guidance, the Cerveny ruling sets a favorable precedent and provides new guideposts to follow.