Determining whether or not the National Childhood Vaccine Injury Act ("NCVIA") of 1986 preempts specific state tort claims has been a debated issue for several years. In 2008, the Georgia supreme court took up this issue with regard to design defect claims, and ruled that in those cases, preemption is determined on a "case-by-case basis." American Home Products Corp. v. Ferrari, 284 Ga. 384, 668 S.E.2d 236 (2008). This ruling was contrary to what many other states and jurisdictions had previously held. See Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007); Blackmon v. American Home Products Corp., 328 F. Supp. 2d 659, (S.D. Tex. 2004); and Militrano v. Lederle Laboratories, 26 A.D.3d 475, 810 N.Y.S.2d 506 (2d Dep't 2006), leave to appeal denied, 7 N.Y.3d 713, 824 N.Y.S.2d 606, 857 N.E.2d 1137 (2006). Recently, the 3rd Circuit issued an opinion specifically rejecting a "case-by-case" analysis and the reasoning of the Georgia Supreme Court. Bruesewitz v. Wyeth Inc., 561 F.3d 233, C.A.3 (Pa., 2009). The United States Supreme Court has now granted certiorari in Bruesewitz and will finally resolve the issue.
The National Childhood Vaccine Injury Act created a federal no-fault compensation system for victims of certain vaccine-related injuries or death. 42 U.S.C. §§ 300aa-1 et seq. The system was enacted to prevent vaccine manufacturers from abandoning vaccine production or significantly increasing their prices as a result of costly and difficult litigation exposure, while at the same time compensating victims of vaccine-related injuries much more quickly than in traditional courts. While the Vaccine Act does not completely preempt all state actions in tort based on vaccine-related injuries or death, it does limit certain claims.
The Vaccine Act states in part:
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.
42 U.S.C. § 300aa-22 (b)(1) (emphasis added). It goes on to explain:
. . . a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. §§ 301 et seq.] and § 262 of this title . . . unless the plaintiff shows . . . by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
42 U.S.C. § 300aa-22 (b)(2).
In Ferrari, the appellants argued to the Georgia Supreme Court that under the plain language of the Act, all design defect claims are "unavoidable" and thus preempted from state claims, upon a showing by the manufacturer that the vaccine was properly prepared and accompanied by proper warnings. Ferrari, 284 Ga. at 385 (2008). However, the Court disagreed and was not persuaded that the Vaccine Act is a bar to all liability for defective design. Rather, the Court held, that the conditional nature of the "unavoidable" clause "contemplates the occurrence of side effects which are avoidable, and for which a vaccine manufacturer may be civilly liable." Id. at 390. The court explained, "it is best understood as barring liability only for those side effects which were unavoidable by means other than proper manufacturing and packaging." Id. Thus, "if such effects were avoidable by a feasible alternative design, liability is not completely barred." Id.
The Ferrari Court also reasoned that if Congress had intended to preempt all design defect claims by this section, it could have achieved that result by omitting the "unavoidable" clause at issue. Id. Omitting the "unavoidable" requirement, would effectively prevent liability in all cases so long as the vaccine was "properly prepared" and "accompanied by proper directions and warnings." Id.
Ultimately, the Georgia Supreme Court held that a design defect claim is not preempted by the Vaccine Act unless the court determines, on a case-by-case basis, that there was no safer design that could have been used to avoid injury, making the injury or death "unavoidable." It further noted that to hold that the Vaccine Act expressly preempts all design defect claims, "would 'have the perverse effect of granting complete [tort] immunity from design defect liability to an entire industry." Id at 394 (additional citations omitted).
Conversely, the 3rd Circuit in Bruesewitz rejected this "case-by-case" approach and the Georgia Supreme Court's reasoning in Ferrari. Bruesewitz, 561 F.3d 233 (Pa., 2009). It held the Vaccine Act expressly preempts all design defect claims, including both negligence and strict-liability claims.
The 3rd Circuit began its analysis much the same as the Georgia Supreme Court, by noting that, "in areas of traditional state regulation," such as health and safety which we have in the Vaccine Act, "we assume that a federal statute has not supplanted state law unless Congress has made such an intention 'clear and manifest'" and "when faced with two equally plausible readings of statutory text, we 'have a duty to accept the reading that disfavors preemption.'" Id. at 240, citing Bates v. Dow Agrosciences, 544 U.S. 431, 449, 125 S. Ct. 1788, 161 L.Ed.2d 687 (2005).
In Bruesewitz the Court acknowledged that the language at issue in the Vaccine Act could be interpreted two different ways. 561 F.3d at 245 (Pa., 2009). One interpretation, and the analysis adopted by the Ferrari Court, is that design defect claims are preempted only if the side effects are determined to be unavoidable on a case-by-case basis. Id. The other interpretation, and the ruling adopted by the 3rd Circuit, is that vaccine injuries are unavoidable and subject to preemption so long as the vaccine was properly prepared and accompanied by proper directions and warnings.
Because the term "unavoidable" is not defined in the Act, the 3rd Circuit looked at the entire provision for context and ultimately held Congress intended the Vaccine Act to "be an outright bar to some claims." Id. at 245. Under the reasoning in Ferrari, which requires a case-by-case analysis of claims, every design defect claim would be subject to evaluation by a court and no design defect claim would be barred by the Act. The 3rd Circuit found this to be contrary to the purpose of the Act. Id. at 246.
The Bruesewitz Court also pointed out that its interpretation does not render the "unavoidable" clause redundant or unnecessary as the Georgia Court in Ferrari suggested it would, because of the conditional language allowing preemption only, "if the injury or death resulted from side effects that were unavoidable . . ." Id. at 245-246 (emphasis added). This conditional language allows some vaccine-related injuries and deaths to be excluded from this provision, while preempting the rest.
Ultimately, the 3rd Circuit held a case-by-case analysis like the one used in Ferrari "would lead to litigation that Congress clearly intended to bar with the Act." Id. at 249. According to the Bruesewitz Court, a case-by-case analysis would undermine the objectives of the Vaccine Act, as explained in the Commerce Report from the House Committee on Energy and Commerce, which had jurisdiction over the Vaccine Act and guided the legislation through passage. H.R.Rep. No. 99- 108 (1986). A case-by-case analysis would increase costs and risks associated with litigation for manufacturers, and impose an affirmative obligation on vaccine manufacturers to pursue every avenue, regardless of cost, to develop a safer vaccine. These were "the very problems which led to instability in the vaccine market and which caused Congress to intervene through the passage of the Vaccine Act." Bruesewitz, 561 F.3d 233, at 249 (Pa., 2009).
With the U.S. Supreme Court recently granting certiorari in the Bruesewitz case, the issue of federal preemption of design defect claims will be clarified. Its ruling will certainly impact the filing and defense of state claims across the country, but also the vaccine manufacturing market as well.
Amanda Matthews is a trial attorney practicing insurance defense at Nall & Miller in Atlanta, Georgia. She works in the healthcare practice group specializing in products liability, premises liability, and professional malpractice, as well as the transportation practice group in which she focuses on claims for personal injury, wrongful death, and motor carrier liability and cargo issues. She has undergraduate and graduate degrees from the University of Alabama, and graduated from Georgia State University College of Law with honors in litigation.
