The Supremes Hold that the Vaccine Act Preempts State Law Design Defect Claims
Yesterday the SCOTUS handed down the long-awaited decision in Bruesewitz v. Wyeth LLC, No. 09-152 (U.S. Feb. 22, 2011). In a 6-2 decision, the Court held that the National Childhood Vaccine Injury Act of 1986 preempts state law claims for design defect. Justice Scalia wrote the majority opinion for Chief Justice Roberts and Justices Kennedy, Thomas, Breyer and Alito. Justice Breyer wrote a concurrence. And Justice Sotomayor wrote a dissent joined by Justice Ginsburg. Justice Kagan took no part in the decision.
This opinion has and will have a lot of coverage, so I'm not going to give it the long-form analysis here. I'll trust my colleagues at Drug & Device Law to do that better than I could.
But there are a few things I'd like to point out about this opinion. First, the majority opinion is written in a very chatty style by Justice Scalia. Second, nowhere in the majority opinion do you hear anything about the dreaded "presumption against preemption." Grant it, this is an express preemption case. The Vaccine Act provides that:
"No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
Slip op. at 7.
But as Justice Sotomayor points out in her well-written dissent, there also is a savings clause:
Section 22(a) expressly provides that the "[g]eneral rule" is that "State law shall apply to a civil action brought for damages for a vaccine-related injury or death.
Sotomayor's dissent at 18.
And yet there is no discussion in the majority opinion of narrowly construing the preemption provision as a result of any presumption against preemption.
Third, the majority looks exclusively to the text of the statute to conclude that design defect claims are categorically preempted. It does not need legislative history to make that conclusion.
The whole question posed in Bruesewitz was what do the clauses after the "if" mean in the preemption provision. Looking solely to the text of the statute, the majority concluded that it meant that all design defect claims are preempted and did not impose additional prerequisites to establishing that preemption. Justice Sotomayor argued forcefully in dissent that the provision did not even mention the terms "design defect," let alone preempt it, and that the provision set up three prerequisites for preemption upon which manufacturers bear the burden of proof: (1) that the harm was "unavoidable," (2) that the vaccine was properly prepared (i.e., had no manufacturing defects), and (3) that the vaccine bore proper directions and warnings (i.e., there was no failure to warn). The majority rejected this approach, arguing that the "even though" clause is a "concessive subordinate clause" that clarifies and describes the word that precedes it: "unavoidable." Slip op. at 7-11.
Justice Sotomayor, on the other hand, argues that "the 'even though' clause requires a vaccine manufacturer in each civil action to demonstrate that its vaccine is free from manufacturing and labeling defects to fall within the liability exemption of section 22(b)(1)." Sotomayor's dissent at 3. She supports this by saying that the conditional term, "if," is used in two other provisions of the Vaccine Act that require an inquiry to establish preemption. Id. at 3-4. She concludes that "[i]t would be highly anomalous for Congress to use a conditional 'if' clause in [these sections] to require a specific inquiry in each case while using the same conditional 'if' clause in section 22(b)(1) to denote a categorical exemption from liability." Id. at 4.
To support her argument that another prerequisite to Vaccine Act preemption is the "unavoidable" nature of the harm, Justice Sotomayor cites Committee Reports describing the principle at issue in comment k to Section 402A of the Restatement (Second) of Torts. Justice Sotomayor argues that in 1986 -- when the Vaccine Act was drafted -- it was generally held that to receive the protection of comment k, medicines had to be proven to be "unavoidably unsafe," and that this is the concept that was written into the Vaccine Act. Justice Scalia points out, however, that many courts treated comment k as a categorical exemption from liability for prescription medicines. He also argues that comment k is irrelevant here, as the word "unavoidable" is not a term of art and can be read -- given its ordinary meaning -- to be generally describing side effects of prescription medical products.
A fourth thing that struck me about Bruesewitz is the majority's clear concession that the preemption provision could have been written more clearly to preempt design defect claims, but that this fact did not matter:
Petitioners and the dissent contend that the interpretation we propose would render part of [section 22(b)(1)] superfluous: Congress could have more tersely and more clearly preempted design defect claims by barring liability "if . . . the vaccine was properly prepared and was accompanied by proper directions and warnings." The intervening passage ("the injury or death resulted from side effects that were unavoidable even though") is unnecessary. True enough. But the rule against giving a portion of text an interpretation which renders it superfluous does not prescribe that a passage which could have been more terse does not mean what it says. The rule applies only if verbosity and prolixity can be eliminated by giving the offending passage, or the remainder of the text, a competing interpretation. That is not the case here.
Slip op. at 12.
The fifth thing that struck me about Bruesewitz was that much of what the Court relies on to find preemption also applies in the ordinary prescription medicine context, except for the Vaccine Act's unique compensation scheme:
. . . But the lack of guidance for design defects combined with the extensive guidance for the two grounds of liability specifically mentioned in the Act strongly suggests that design defects were not mentioned because they are not a basis for liability.
The mandates contained in the Act lead to the same conclusion. Design-defect torts, broadly speaking, have two beneficial effects: (1) prompting the development of improved designs, and (2) providing compensation for inflicted injuries. . . . And the Act provides many means of improving vaccine design. It directs the Secretary of Health and Human Services to promote "the development of childhood vaccines that result in fewer and less serious adverse reactions. . . . The [National Vaccine] Program is to set priorities for federal vaccine research, and to coordinate federal vaccine safety and efficacy testing. The Act requires vaccine manufacturers and health-care providers to report adverse side effects, and provides for monitoring of vaccine safety through a collaboration with eight managed-care organizations. And of course whenever the FDA concludes that a vaccine is unsafe, it may revoke the license.
These provisions for federal agency improvement of vaccine design, and for federally prescribed compensation, once again suggest that [section 22(b)(1)'s] silence regarding design-defect liability was not inadvertent. It instead reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.
Slip op. at 14-15.
Justice Breyer's concurrence goes beyond the plain language and looks to legislative history and agency interpretation to conclude that the Vaccine Act preempts design defect claims. See Breyer's Concurrence at 7. Like the majority opinion, the concurrence exhibits a trust of agencies and scientists -- rather than juries -- with issues of promoting the optimal design of prescription medicines.
Does Bruesewitz represent a sea change in SCOTUS preemption jurisprudence? Probably not, although it arguably is too early to tell. It does, however, provide a tool for addressing some of the hyperbole from earlier preemption decisions, and for that, the defense bar can be grateful.
Bruesewitz also reveals Justice Sotomayor to be a strong advocate for state tort litigation who can be expected to narrowly construe even express preemption provisions to allow state law claims.
