OK, not really. But we have had a chance to review yesterday afternoon’s oral argument transcript in Bruesewitz v. Wyeth, and here’s what went down (for a lot of Bruesewitz backstory, click here for our prior posts).
David Frederick argued on behalf of the petitioners. Adhering to the rule of three, Frederick said the Third Circuit was wrong for three reasons when it ruled that the Vaccine Act expressly preempts state-law design defect claims. First, argued Frederick, the language of the Act itself does not explicitly preempt design defect claims. Second, the question of whether or not an injury was “unavoidable” should be determined on a case-by-case basis, rather than triggering a broad express preemption of all design defect claims (Section 22(b)(1) of the Vaccine Act, which lies at the heart of this dispute, states that manufacturers are not liable if the side effects were “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”). Finally, Frederick advanced the “think about the children” policy argument – i.e., preemption of design defect claims exposes kids to unnecessary safety risks. He also suggested that it will be very rare to see a design defect case get out of vaccine court and go to a state court jury, because proving causation and the availability of an alternative design is not easy. In other words, don’t worry about disincentivizing manufacturers with the specter of massive liability, because it is unlikely to happen.
Kathleen Sullivan argued on behalf of Wyeth. Although she was immediately beset by questions, primarily from Justice Sotomayor and Justice Ginsburg, Sullivan was able to argue (persuasively, in our opinion) that the petitioners’ reading of the statute ignores its plain language and meaning. In essence, there are three types of products claims one could bring against a manufacturer: manufacturing defect, design defect, and warning defect. Section 22(b)(1), read as a whole, makes clear that only manufacturing and warning defect claims survive; manufacturers are not liable for unavoidable risks where the vaccine was “properly prepared” and accompanied by proper…warnings.” In other words, if the vaccine wasn’t made right, you lose the protection of 22(b)(1). If you didn’t slap an appropriate warning on the vaccine, you lose the protection of 22(b)(1). Otherwise, you’re protected, since the statute did not include any clauses recognizing design defect claims. Sullivan also hit hard on the policy arguments supporting preemption of design defect claims, highlighting that the legislative history shows Congress was concerned about a vaccine “crisis,” where “manufacturers were being driven out of the vaccine business, imperiling the nation’s…vaccine supply by design defect claims that did survive summary judgment.”
So how did the Justices react to these core arguments? Of course, we have to offer the caveat that it is often a Talmudic exercise to guess at the meaning behind a particular Justice’s question, but the following patterns seem to have emerged:
Chief Justice Roberts, Justice Alito, and Justice Scalia appeared to be most concerned about the plain language of the statute, and the extent to which the Court may go beyond that language to infer (or not infer) that Section 22(b)(1) has preemptive effect. For example:
Chief Justice Roberts asked whether the compensation scheme set up in the Vaccine Act evidenced a Congressional intent to preclude state law claims. Justice Sotomayor, on the other hand, asked Sullivan why Congress did not simply make vaccine court the exclusive forum for recovery, thereby foreclosing state lawsuits.
Justice Alito seized on the defense’s statutory construction argument, asking Frederick pointedly whether his interpretation ignores the last clause of 22(b)(1). Frederick tried to hide behind comment k, arguing that the word “unavoidable,” which was lifted from comment k, was typically determined on a case-by-case basis under the Restatement, and thus it should be determined similarly here. Justice Scalia then called out Frederick for dodging Justice Alito’s question.
Justice Ginsburg, on the other hand, characterized the statutory language as “confusing,” and asked Sullivan whether “Congress could have simply said that no vaccine manufacturer may be held civilly liable if the vaccine is properly prepared and accompanied by proper directions and adequate warnings.” At a later point, however, Justice Ginsburg echoed Sullivan’s statutory argument, saying, “the warning claims, the manufacturing those are always avoidable…. [S]o the only thing that can be unavoidable is the design defect.”
Similarly, Justice Kennedy asked whether this was an instance of “sloppy drafting,” to which Sullivan conceded it could have been written a different way “and it would have meant the same thing.” In the end, however, Congress’s choice of words showed that Section 22(b)(1) was intended to denominate vaccines as a comment k product.
FDA approval and efficacy was a big concern of the Justices. For example, Justice Ginsburg, Justice Scalia, and Chief Justice all explored whether FDA approval cabins or otherwise impacts the “unavoidability” inquiry. In one exchange, Justice Scalia raised serious concerns that allowing design defect claims to proceed would in effect enable plaintiffs to argue that a less efficacious vaccine was available and thus the injury was “avoidable.” (Importantly, this led to Frederick conceding that the safer feasible alternative must be “just as effective” as the vaccine at issue).
Similarly, Justice Breyer, relying on an amicus brief submitted by the American Academy of Pediatrics, expressed concern that allowing design defect issues to be decided by state court juries rather than the FDA and other specialized agencies would lead to certain vaccines leaving the market and children dying. In a moment of levity, after Frederick cited Justice Breyer’s opinion in Schafer v. American Cyanamid Co., 20 F.3d 1 (1st Cir. 1994) to bolster his policy argument that it would be rare to see a design defect case proceed in state court, Justice Breyer retorted, “Frankly, if I see the Academy of Pediatrics telling me one thing, and I in an earlier case wrote the other thing, I do tend to think I could have been wrong. And that’s – that’s why I am asking you: is that the best you can find on the other side, namely something I once wrote in a case? Or are there other – are there other things?”
On the other hand, Justice Sotomayor expressed grave concern that immunity from state court lawsuits removes any motivation for manufacturers to voluntarily remove a vaccine that is causing harm before the FDA acts. Picking up on this concern, Justice Kennedy asked whether there is still “complete preemption” even if the manufacturer fails to give information to the government. Sullivan responded that there would still be preemption of design defect claims, but warning claims would survive, and the Act itself contains “grave consequences” for withholding knowledge of adverse effects from the FDA – such as losing the statutory presumption of FDA-approved warnings being adequate. Since most vaccine claims actually are warning claims, that’s a significant deterrent.
Justice Sotomayor also asked Sullivan to identify specific regulations requiring the FDA to look at whether a particular vaccine is the most efficacious (as opposed to simply efficacious) treatment. She couldn’t point to any such regulations for the FDA, but as we’ll discuss in a bit, it turned out that precisely such judgments are the province of another federal agency.
Turning to Frederick’s “rara avis” argument – whether exposure to state court liability on design defect is really so big a concern that it could drive manufacturers out of business – Justice Sotomayor, and possibly Justice Breyer, seemed intrigued by this argument. Justice Breyer asked whether it is in fact true that there would be “very few cases” and “not enough liability” to drive manufacturers from the vaccine market. Justice Sotomayor seized on the difficulties of proving causation (and attendant Daubert issues, at least in federal court) as an effective gatekeeper to prevent crippling liability. As she put it, “I do think there’s a whole lot of hurdles in place before a plaintiff wins on one of these claims.” Sullivan responded that summary judgment is difficult in design defect cases because you are often “shadowboxing against an infinite number of theories about how there could have been a safer vaccine.”
On the other hand, Justice Kennedy pointed out that subjecting manufacturers to a case-by-case determination in every state would leave them worse off than if the Vaccine Act was not enacted, since some big states (notably CA, NY, and PA) don’t allow this theory, and further that individual state court suits put a “tremendous expense” on manufacturers. In the same vein, in response to Frederick’s “there won’t be many cases” mantra, the Chief Justice pointed out that it only takes a few $60 million verdicts to drastically alter the calculus of whether the Vaccine Act appropriately protects manufacturers. Picking up on this theme, Justice Ginsburg expressed concern that Frederick was understating the number of cases that could ultimately end up in state court, because plaintiffs unhappy with their vaccine court awards could go to state court to challenge the sufficiency of the award.
Oh right, there was an actual case underlying this whole dispute. Not surprisingly, the parties disagreed about whether there was in fact an alternative, equally efficacious vaccine available at the time of the injury. The most important factual piece, however, was supplied by Benjamin Horwich, arguing briefly on behalf of the government as amicus. Horwich made clear that the Court should take into account and honor not only FDA’s determinations of efficacy, but more importantly, the determinations of the Centers For Disease Control (CDC). In this particular case, the CDC made the determination that manufacturers should not pursue the alternate design pushed by the petitioners. More globally, Horwich explained that the CDC’s mission is to determine which vaccines are the “most” efficacious, and its determinations are reported in the Morbidity and Mortality Weekly Report. He used the Salk vs. Sabin polio vaccine decision as a specific example. This directly addressed Justice Sotomayor’s concerns that FDA review was insufficient to provide guidance on comparative efficacy of vaccines. As Horwich argued, “CDC is making determinations in this regard in a comparative way; and I think it would be extraordinary then to…imagine that Congress set up a system in which juries would effectively be second-guessing decisions like that.” Under intense questioning about this point on rebuttal, Frederick argued that he found “no law” giving the CDC the authority to make judgments on comparative vaccine efficacy. He also admitted that, under his theory, a state-court plaintiff could ask a state jury to re-examine the CDC’s Salk vs. Sabin vaccine determination.
So what’s the takeaway? Well, first of all, no discussion of the presumption against preemption. That’s good news for Wyeth. The government’s argument also seemed to take the wind out of any suggestion that the current regulatory scheme is somehow insufficient to make reasoned, science-based decisions about the comparative efficacy of vaccines. It will be interesting to see whether CDC’s oversight assuages all of Justice Sotomayor’s apparent concerns about giving manufacturers a “free pass” in this area. In general, the policy considerations seemed to align with Wyeth’s arguments, and a recurring theme, particularly for Justice Breyer, our favorite technocrat, was the degree to which we want to let lay juries monkey with difficult scientific judgments. And on the ultimate question of what the statutory language means, it seems that both sides scored some points. As we pointed out in our preview of the oral argument, the intent of Congress to preempt is pretty clear here, but the preemptive language itself probably could have been written more clearly. Now it will be up to the Court to decide whether that language is sufficient to preempt state-law design defect claims.