In a ruling that is contrary to Supreme Court precedent, the district court presiding over the Zostavax MDL recently held that federal law does not preempt a state-law design-defect claim based on the manufacturer’s failure to seek FDA approval of a different, purportedly safer vaccine.

Zosatavax, a shingles vaccine, received FDA approval in 2006. The MDL plaintiffs, who allegedly contracted shingles after receiving Zostavax, claim that is defectively designed because it “contains a live-attenuated virus, that is, a weakened form of the wild type virus.” In re Zostavax (Zoster Vaccine Live) Prod. Liab. Litig., 2021 WL 5235225, at *1 (E.D. Pa. 2021). The plaintiffs contend that rather than seek FDA approval of Zostavax, its manufacturer should instead have sought approval of a vaccine that did not contain a live-attenuated virus. In 2017, eleven years after Zostavax was approved, the FDA approved a shingles vaccine that did not contain a live-attenuated virus.

The Zostavax manufacturer moved for summary judgment on the plaintiffs’ design-defect claim, arguing that it is impliedly preempted by federal law. The MDL court described Wyeth v. Levine, 555 U.S. 555 (2009), as the “seminal” preemption case involving prescription drugs, but then proceeded to misapply Levine. In re Zostavax, 2021 WL 5235225, at *2.

Federal law preempts state law when simultaneous compliance with federal and state law is impossible. In Levine, the Supreme Court held that federal law did not preempt a failure-to-warn claim involving a brand-name drug because—under the facts as construed by the Court—the FDA’s “changes being effected” regulation “permitted” the drug’s manufacturer “to unilaterally strengthen its warning” and thereby comply with its purported state-law duty. 555 U.S. at 573. In two subsequent cases—PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013)—the Court, applying Levine, held claims involving generic drugs preempted because federal law does not allow generic manufacturers to change their warning labels (or formulations) without prior FDA approval. Thus, for purposes of impossibility preemption in the pharmaceutical context, the critical distinction is between situations in which federal law allows the drug manufacturer to independently do what state law purportedly requires and situations in which the manufacturer must first obtain FDA approval before doing what state law purportedly requires.

In rejecting the defendant manufacturer’s preemption defense, the In re Zostavax court thought it significant that Zostavax is a brand-name drug, like the drug at issue in Levine, and that Mensing and Bartlett focused on conduct “after FDA approval” of the drugs at issue. 2021 WL 5235225, at *3. But neither fact supports the court’s conclusion.

According to the plaintiffs, the defendant manufacturer had a state-law duty to not sell a vaccine that contained a live-attenuated virus. Thus, to avoid liability under the plaintiffs’ theory, the manufacturer had to refrain from selling such a vaccine, either by selling a vaccine that did not contain a live-attenuated virus or by selling no vaccine at all.

Federal law prohibits the marketing of a new drug without prior FDA approval. Thus, although the Zostavax manufacturer could have sought FDA approval of a vaccine that did not contain a live-attenuated virus, it could not have sold that vaccine without having obtained FDA approval. In other words, the manufacturer could not “unilaterally” market a vaccine that did not contain a live-attenuated virus. Thus, a state-law duty to have marketed such a vaccine is, it would seem, preempted under any reasonable reading of Levine, Mensing, and Bartlett.

But the In re Zostavax court concluded otherwise. According to the court, simultaneous compliance with federal and state law was not impossible because “[t]here is nothing in federal law to prohibit a drug manufacturer from … submitting to the FDA for approval an application for a brand-name drug with a safer design required by state law.” 2021 WL 5235225, at *4. The fact that the Zostavax manufacturer could have requested FDA approval to market a vaccine that did not contain a live-attenuated virus is, however, irrelevant. The manufacturers in Mensing and Bartlett could have requested FDA approval to change their warning labels, but the claims at issue in those cases were nonetheless preempted, the Supreme Court held, because the manufacturers could not independently do what state law purportedly required.

The only action the Zostavax manufacturer could independently have taken to avoid state-law liability on plaintiffs’ theory is to have refrained from selling Zostavax altogether. But Bartlett rejected “the stop-selling theory” as “incompatible with … pre-emption jurisprudence,” explaining that “[i]f the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be ‘all but meaningless.’” 570 U.S. at 488 (quoting Mensing, 564 U.S. at 620).

The In re Zostavax court brushed Bartlett aside, finding it inapplicable because “the plaintiffs here are simply asserting that [the manufacturer] should have acted differently before it sought approval to sell Zostavax, not that it should have stopped selling it” once FDA approval was received. 2021 WL 5235225, at *4. Given that federal law prohibited the manufacturer from selling any vaccine absent FDA approval, that is a distinction without a difference. If Zostavax is defective as a matter of state law, the only unilateral action its manufacturer could have taken to avoid state-law liability is to have not sold the product at all.

The MDL court held that the Zostavax manufacturer was not entitled to summary judgment under Levine because it supposedly failed to present “clear evidence that the FDA would not have approved an application for a vaccine without a live-attenuated virus.” 2021 WL 5235225, at *4.

That statement is troubling as a matter of both law and fact.

As a matter of law, Levine does not require such a showing. Federal law explicitly allows brand-name drug manufacturers to unilaterally change previously approved warning labels under certain circumstances. Because brand-name manufacturers may, as a general matter, unilaterally change their labels to comply with supposed state law (so long as certain criteria are satisfied), Levine requires that a brand-name manufacturer produce “clear evidence” that the FDA would have rejected such a change to establish impossibility preemption in a particular case.

But manufacturers may not unilaterally bring drugs to market; they must obtain FDA approval before doing so. Because manufacturers are categorically prohibited from selling drugs without FDA approval, there is no need to present any evidence—let alone “clear” evidence—that the FDA would have rejected a particular application to establish the impossibility of unilaterally selling a drug.

As a matter of fact, the manufacturer presented evidence that the FDA would not have approved an application for a shingles vaccine without a live-attenuated virus at the time the manufacturer submitted its application for Zostavax. In particular, the manufacturer presented evidence that “the science” that allows such a vaccine “did not exist” when Zostavax was approved in 2006. 2021 WL 5235225, at *4.

Still, the MDL court found no clear evidence that the FDA would have rejected such a vaccine at the time. Indeed, ignoring how much science might have progressed in the interim, the court declared the purported “absence of such evidence … not surprising” given the FDA’s approval of a shingles vaccine without a live-attenuated virus in 2017. 2021 WL 5235225, at *4. Having found no clear evidence that the FDA would have rejected a shingles vaccine without a live-attenuated virus in 2006, the MDL court “reject[ed] as a matter of law any argument that the FDA would not have approved [the manufacturer’s] submission of an application for a drug without a live-attenuated virus.” 2021 WL 5235225, at *4.

That absolute ruling is puzzling. To be sure, “preemption is a matter of law to be decided by the court with no role for the jury” (2021 WL 5235225, at *2) following Merck Sharp & Dohme Corp. v. Albrecht, 193 S. Ct. 1668 (2019). But the MDL court itself found that were “genuine disputes of material fact” as to whether the science to allow a shingles vaccine without a live-attenuated virus even existed in 2006. Id. at *4. Given that the factual disputes “will have to be resolved at trial” (id.), how can it possibly be said that the manufacturer’s preemption defense fails as a matter of law?

Of course, the plaintiffs’ claims should never get to trial. Levine, Mensing, and Bartlett make clear—although, evidently, not clear enough—that federal law preempts design-defect claims implicating prescription drugs, whether based on pre- or post-approval conduct.