On February 22, the U.S. Supreme Court handed a landmark victory for vaccine makers.  In a 6-2 decision, the Court held that the National Childhood Vaccine Injury Act of 1986 (the “Vaccine Act”) preempts all design-defects claims against vaccine manufacturers for injuries caused by a vaccine’s side effects.

Facts.  Bruesewitz involved a diphtheria-tetanus-pertussis (DTP) vaccine, Tri-Immunol, formerly manufactured by Lederle (later acquired by Wyeth, and subsequently, Pfizer).  Plaintiffs alleged that Tri-Immunol caused their daughter’s seizures and developmental problems.  Plaintiffs’ complaint alleged that the vaccine was defectively designed, and that Wyeth could have used an alternative, safer design.  (The Bruesewitz’s previously prevailed in Vaccine Court and was awarded a payment of roughly $103,000.  They subsequently rejected the payment and decided to pursue their tort claims instead.)

Presumption for Preemption.  Justice Scalia’s opinion for the majority reminds us of a quote from The Princess Bride (1996):  “ ‘Inconceivable.’  You keep using that word.  I do not think it means what  you think it means.”  In this case, at issue was the interpretation of the words “even though” and “unavoidable” in the Vaccine Act (42 U.S.C. §300aa-22(b)(1)), and whether such language allows for the inference of preemption.   Bruesewitz v. Wyeth, 562 U.S. __, slip op. at 7-8 (2011). In a classic textualist interpretation, Justice Scalia concluded that the language of the provision suggests a complete defense for unavoidability with respect to a particular design (e.g., the terms “even though” clarifies the words that precede it and “delineates the preventative measures that a vaccine manufacturer must have taken for a side-effect to be considered ‘unavoidable’ under the statute.”)  Id. at 8.  The Act’s failure to mention defective design was “by deliberate choice, not inadvertence” and gives further credence to the argument that the Legislature intended to preempt design claims.  Id. (internal citations omitted).

Comment k not codified in the Vaccine Act.  The Court also rejected Plaintiffs’ argument that the Vaccine Act codified the strict liability provisions of Restatement § 402A, comment k.  This is significant because under Plaintiffs’ interpretation, vaccine manufacturers would lose significant protection in states that allow comment K (e.g. such states would require a case-by-case adjudication of design defect claims). Under the Court’s analysis, comment k’s “unavoidably unsafe products” does not equal to the statute’s “side effects that were unavoidable.” Id. at 10.  Indeed, just because the Vaccine Act “uses the adjective ‘unavoidable’ and [comment k uses] the adverb ‘unavoidably’ does not establish that Congress had comment k in mind.”  Id.

Philosophical underpinnings. Finally, in a nod to policy arguments, the Court recognized that the presumption for preemption reinforces the legislative intent of the Vaccine Act:  the creation of a generous no-fault compensation program for vaccine injuries in exchange for avoiding costly tort litigation and disproportionate jury verdicts.  Id. at 15.  Justice Scalia notes that the Vaccine Act “reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.” Id.

Justice Sotomayor’s Dissent.  Not surprisingly, the dissent took the opposite interpretation of the textual arguments.  As the dissent’s argument goes, because the statute clearly refers to manufacturing and labeling defects (in the “even though” clause), then the “if” clause’s reference to side effects must refer to design defects.  Id. (Sotomayor, J., dissenting) (joined by Justice Ginsburg).  Therefore, under the dissent’s reasoning, § 22(b)(1) preempts some—but not all—design defect claims.  Id.  The dissent also argues that the House Energy and Commerce Committee’s Report on the Vaccine Act refers to comment k, and thus validates the argument that comment k is incorporated in the Act.  Id.  (The majority, however, points out that this report was a post-legislative enactment report, and is thus, an improper tool for statutory construction.)

Where do we go from here? 

Certainly, Bruesewitz was by no means a surprising decision.  However, its ramifications will be felt far and wide.  First, it cements the idea that Vaccine Court is the exclusive remedy for those injured by vaccines.  In so doing, Bruesewitz underscores the idea that the Vaccine Act and the Vaccine Court are both fulfilling the philosophies for which they were created by Congress.

Second, Bruesewitz follows after another landmark preemption decision, Wyeth v. Levine, and approximately 15 years after the last vaccine case decision.  At the very least, Bruesewitz is another peg in the evolving preemption jurisprudence.  Certainly, it puts to rest a potential conflict in another well-publicized opinion by the Georgia Supreme Court on thimerosal vaccines and autism, AHP v. Ferrari, 668 S.E.2d 236 (2008), and the Pennsylvania Superior Court’s opinion in Wright v. Aventis Pasteur, Inc., 2011 Pa. Super. 9, slip op. (Pa. Super. Jan. 11, 2011).

Third, Bruesewitz will help resolve the 5,000 petitions in the “Omnibus Autism Proceeding” currently pending in Vaccine Court.  Had Bruesewitz gone the other way, there would have been a potential for a flood of design defect litigation in state courts.

Lastly and crucially, the court’s decision in Bruesewitz today signifies an important public health achievement.  It re-focuses the public’s attention on the importance of vaccines in preventing childhood diseases.  That may be the greatest victory of all.

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