Three new justices have been appointed to the United States Supreme Court by a Republican president in the last four years. With the loss of the socially liberal Justice Ruth Bader Ginsburg and the gain of the socially conservative Amy Coney Barrett, the balance of power in the Supreme Court has shifted. What does that mean for the enduring vitality of the decisions attorneys rely on to prosecute pharmaceutical mass tort cases, particularly in the context of preemption? If given the chance, would a majority of the Supreme Court justices vote to overturn Wyeth v. Levine,[i] and hold that all traditional failure to warn claims against pharmaceutical companies are preempted?
These questions are best answered by looking at recent Supreme Court preemption holdings and considering how the justices voted in the past.
WYETH V. LEVINE
Plaintiffs Can Recover Against Branded Pharmaceutical Companies Unless Defendant Can Show “Clear Evidence” that the FDA Would Have Rejected the Proposed Label
The first case of import is Wyeth v. Levine. In a five-to-four decision, the Wyeth Court held that failure to warn claims against branded pharmaceutical companies are not preempted unless there is “clear evidence” that the FDA would have prohibited the company from changing its label.
That holding is pretty complex, especially for attorneys who are not on the front lines fighting the preemption defense. The first step in unpacking this holding is to look to the Supremacy Clause of the United States Constitution, which provides that federal law is “the Supreme Law of the land.”[ii] When a state law conflicts with federal law, the state law is “null and void.” As a practical matter, this means that when a defendant can successfully argue that federal law conflicts with a state law failure to warn claim, the state law is null and the plaintiff cannot recover for the injuries caused by the pharmaceutical product—at least not on a traditional failure to warn theory.
A. The Defense of “Conflict Preemption” is Not Available to Branded Pharmaceutical Companies.
In Wyeth v. Levine, Plaintiff Diana Levine brought a state law failure to warn claim against the pharmaceutical company Wyeth, LLC, after Wyeth’s drug, Phenagrin, damaged her arm such that it required amputation. Defendant Wyeth put forth two arguments that federal law preempted plaintiff’s state law claims. First, it argued for conflict preemption. Wyeth said that it can only be held liable under plaintiff’s failure to warn claims if the jury found that the Phenagrin warning was insufficient—that Wyeth needed to make the warning stronger. According to Wyeth, as a federal regulatory body, the FDA prohibited Wyeth from changing the warning on Phenagrin and, therefore, federal law conflicted with state law making the state law failure to warn claims null and void.
The Supreme Court disagreed with Wyeth’s conflict preemption argument, pointing out that Phenagrin was the branded form of the drug (as opposed to generic) and a pharmaceutical company that makes the branded drug can unilaterally change its label through the Changes Being Effected (“CBE”) regulation. However, the Supreme Court further explained that if the brand pharmaceutical company could set forth “clear evidence” that the FDA would have rejected the unilateral label change and required the company to change the label back to its previous form, the claim would be preempted. It would be impossible to change the label as required by state law while simultaneously keeping the current label as required by federal law. Thus, under those circumstances, the traditional state failure to warn claim would be preempted.
B. Claims Against Branded Companies Do Not Frustrate Congress’s Intent.
Second, the defense argued that allowing state law to require a stronger label on brand pharmaceutical products frustrates the purpose of the Food Drug and Cosmetic Act (“FDCA”) and accompanying regulations. According to Wyeth, the FDA’s labeling requirements created both a floor and a ceiling, meaning that the FDA, with the help of the brand pharmaceutical company, struck a balance when approving the label that ensures the label is no stronger or weaker than that which serves the public interest. Again, the Supreme Court rejected this argument, noting that although Congress could have expressly preempted state law failure to warn claims sometime over the seventy-year history of the FDCA, it has not elected to do so. To the contrary, Congress has given every indication that state law failure to warn claims are complementary to the federal regulatory scheme.
C. Justices Breyer and Thomas Voted that Brand Pharmaceutical Companies Do Not Have the Preemption Defense. Justice Alito and Chief Justice Roberts Disagreed.
Only four of the current justices were on the Supreme Court when Wyeth v. Levine was decided in 2009. Of those, only Justice Breyer joined in the majority decision. Justice Breyer also wrote a concurring opinion indicating that FDA regulations could preempt state law failure to warn claims if the regulations were revised to further the interests that state law failure to warn claims protect.[iii] Since Wyeth, the FDA has not undertaken a revision of the regulatory scheme as described by Justice Breyer. Accordingly, Justice Breyer would not likely vote to overturn Wyeth v. Levine.
Justice Thomas also wrote a concurring opinion.[iv] Thomas is clear that he will not find preemption unless federal law directly conflicts with state law. As branded pharmaceutical companies can still use the Changes Being Effected regulation to unilaterally change drug labels, Justice Thomas would probably still find no direct conflict and therefore no preemption unless the brand company can set forth “clear evidence” that the FDA would not have permitted the label change required by state law.
Justice Alito delivered the dissent, joined by Chief Justice Roberts, finding that failure to warn claims against branded pharmaceutical companies would be preempted. Presumably, Alito and Roberts would vote to overturn Wyeth.
PLIVA V. MENSING
Plaintiffs Cannot Recover Against Generic Pharmaceutical Companies
Two years after Wyeth, the Supreme Court decided PLIVA v. Mensing,[v] holding that traditional failure to warn claims against generic pharmaceutical companies are preempted because generics cannot change their warnings to be different than the warnings in the brand’s label. The CBE regulation permitting a brand company to unilaterally change the warnings on a drug’s label does not apply to the generics. As such, it is impossible for generic companies to strengthen the warnings as required by state law and leave the warnings the same as required by federal law.
A. Justices Thomas and Alito and Chief Justice Roberts Vote to Expand the Preemption Defense.
Consistent with his concurring opinion in Wyeth, in writing for the majority in Mensing, Justice Thomas maintained his position that he will hold preemption is a defense to a state law claim if and only if federal law directly conflicts with state law. Even though he voted in favor of the defense in Mensing, Justice Thomas will likely maintain his reasoning regarding conflict preemption. That means he will likely again vote in a manner favorable to the plaintiffs if he is confronted with a case similar to Wyeth.
However, this decision does not add much to the analysis of Chief Justice Roberts or Justice Alito, who dissented in Wyeth and joined Justice Thomas in the Mensing majority two years later. Presumably, both would vote in favor of the defense if presented with a case similar to Wyeth in the future.
B. Justices Sotomayor, Kagan, and Breyer Believe Plaintiffs Should Be Able to Recover Against Generic Pharmaceutical Companies.
Justice Sotomayor wrote the dissent in Mensing, joined by Justices Ginsburg, Breyer, and Kagan.[vi] The dissenting opinion seems to arise in significant part from a policy of fairness. Justice Sotomayor’s dissent points out the inequity of the majority opinion in Mensing versus the decision in Wyeth. If the Mensing plaintiffs had used the branded version of the drug, they would be able to recover. However, because the pharmacy filled their prescriptions with a generic, they cannot. Based on their opinions in Mensing, if confronted with a case similar to Wyeth, Justices Sotomayor, Breyer, and Kagan would likely vote based on their values again. This means that they would probably vote for the more plaintiff-friendly position that state law failure to warn claims are not preempted and that the plaintiffs can recover against branded pharmaceutical companies.
MERCK V. ALBRECHT
Majority is Consistent with Wyeth v. Levine
In October 2019, the Supreme Court delivered the opinion in Merck Sharp & Dohme Corp. v. Albrecht et al.[vii] The law as articulated in Albrecht is nearly identical to what was described in Wyeth. The Supreme Court again held that traditional state law failure to warn claims against branded pharmaceutical companies are preempted when the company can set forth “clear evidence” that the FDA would have rejected the label required by state law. All justices agreed that the question of whether “clear evidence” exists is a question for the judge, not the jury. In other words, it is a question that can be resolved through summary judgment. The case was remanded.
A. Justices Breyer, Thomas, Sotomayor, Kagan, and Gorsuch Vote Consistently with Wyeth—the More Plaintiff-Friendly Position.
Justice Breyer wrote the majority opinion, which is consistent with the holding in Wyeth. Justices Thomas, Sotomayor, Kagan, and Gorsuch joined the majority. Possibly, Gorsuch’s decision to join the majority here hints that he would refuse to overturn Wyeth. If that is the case, future plaintiffs will have the five votes they need to keep the preemption defense from subsuming traditional failure to warn claims in all pharmaceutical cases.
Although Justice Thomas wrote a concurring opinion in Albrecht, that opinion does not change the analysis above.[viii] While he clarified his position by explaining that he does not require “physical impossibility” in order to find direct conflict, he also reiterated that he will find preemption only if there is a conflict between state and federal law.
B. Justices Alito and Kavanaugh and Chief Justice Roberts Dissent.
Justice Alito filed an opinion concurring in judgment, which was joined by Chief Justice Roberts and Justice Kavanagh. This concurrence agrees with the majority’s “decision on the only question that it actually decides,” which is that the viability of a preemption defense in this case was largely a question of law to be decided by the judge.[ix] Alito’s concurrence goes on to describe the facts of the case and decide that it would hold plaintiffs’ state law claims preempted. All the evidence reviewed here leads to the conclusion that Justices Alito and Roberts will vote in favor of defendants if presented with an opportunity to overturn Wyeth. Moreover, Justice Kavanaugh’s decision to join them in this opinion is worrisome.
C. Not Enough Information About Justice Barrett to Predict How She Would Vote.
That just leaves Justice Amy Coney Barrett. Research of her Seventh Circuit opinions unearthed no preemption decisions. She describes herself as an “originalist” and a protégé of the late Justice Antonin Scalia. Justice Scalia voted with the dissent in Wyeth and with the majority in Mensing. In other words, he voted in favor or preemption in both cases. On the other hand, Scalia was also a true believer in stare decisis.[x] Accordingly, it is hard to know whether Justice Scalia would have voted to overturn the relatively recent Wyeth decision. It is even harder to guess how Justice Barrett would vote.
PLAINTIFFS (LIKELY) HAVE THE VOTES
Based on all of the above, the predicted vote count is as follows:
Justice Alito and Chief Justice Roberts almost certainly would vote for the more defense-friendly position that traditional failure to warn claims against all pharmaceutical companies are wholesale barred as preempted.
Justices Breyer, Kagan, Sotomayor, and Thomas will probably come to the opposite, more plaintiff-friendly position.
Based on very little information, Gorsuch appears to be leaning in favor of plaintiffs and Kavanaugh in favor of the pharmaceutical companies.
Attempting to predict how the Supreme Court will vote on any issue is seldom easy, especially when three of the justices have been on the Supreme Court bench less than four years. However, based on the limited information available, the plaintiffs’ bar likely has the five votes needed to prevent the preemption defense from barring traditional failure to warn pharmaceutical claims entirely.