Does the National Childhood Vaccine Injury Compensation Act Really Prohibit Design Defect Claims?: Examining Federal Preemption in Light of American Home Products Corp. v. Ferrari

Publication year2010

Georgia State University Law Review

Volume 26 j ^

Issue2 Winter 2009 1Ce

3-21-2012

Does the National Childhood Vaccine Injury Compensation Act Really Prohibit Design Defect Claims?: Examining Federal Preemption in Light of American Home Products Corp. v. Ferrari

Tara Guffrey

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Recommended Citation

Guffrey, Tara (2009) "Does the National Childhood Vaccine Injury Compensation Act Really Prohibit Design Defect Claims?: Examining Federal Preemption in Light of American Home Products Corp. v. Ferrari," Georgia State University Law Review: Vol. 26: Iss. 2, Article 6.

Available at: http://digitalarchive.gsu.edu/gsulr/vol26/iss2/6

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DOES THE NATIONAL CHILDHOOD VACCINE INJURY COMPENSATION ACT REALLY PROHIBIT

DESIGN DEFECT CLAIMS?: EXAMINING FEDERAL PREEMPTION IN LIGHT OF AMERICAN HOME PRODUCTS CORE V. FERRARI

Tara Guffrey*

Introduction

By the time he reached eighteen months of age, Stefan Ferrari had received many of his required childhood vaccines.1 His parents recall that he was a healthy child who displayed no difficulty communicating verbally.2 Following his last set of booster shots, however, Stefan stopped talking. Now ten years old, Stefan still has not spoken.4

Stefan's parents filed suit against the manufacturers of the various vaccines he received, alleging their son suffered neurological damage from thimerosal, a mercury-containing preservative in the vaccines.5 Stefan's parents claim that the vaccines could have been made with a safer, mercury-free preservative, or they could have been manufactured in single-dose vials, which do not require a

» J.D. Candidate, 2010, Georgia State University College of Law.

1. Bill Rankin, Allow Vaccine Suit, Parents Ask Justices; Federal Law a Roadblock: Lawyer for Couple Says Boy Who Hasn't Spoken for Almost Nine Years Deserves Day in Court, ATLANTA J.-CONST., May 21, 2008, at Bl, available at 2008 WLNR 9552686.

2. Id.

3. Id.

4. Id.

5. Ferrari v. Am. Home Prods. Corp., 650 S.E.2d 585, 586 (Ga. Ct. App. 2007), ajfd, 668 S.E.2d 236,243 (Ga. 2008). For a discussion of the use of thimerosal in vaccines and its potential link to severe side effects, see Centers for Disease Control and Prevention, Mercury and Vaccines (Thimerosal), http://www.cdc.gov/vaccinesafety/updates/thimerosal.htm (last visited Sept. 25, 2008). The CDC maintains there is no scientific evidence of harm caused by the low doses of thimerosal in vaccines. Id. Nevertheless, the CDC and other organizations recommended the removal of thimerosal from childhood vaccines in 1999. Centers for Disease Control and Prevention, Recommendations Regarding the Use of Vaccines That Contain Thimerosal As a Preservative, 48 morbidity & mortality wkly Rep. 985, 996-98 (1999). With the exception of some influenza vaccines, thimerosal has not been used as a preservative in routinely recommended childhood vaccines since 2001. Centers for Disease Control and Prevention, Mercury and Vaccines, supra.

617

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preservative.6 In effect, the Ferraris argued the vaccines administered to their son were defectively designed because safer reasonable alternative designs were available.

The adverse effects allegedly suffered by Stefan as a result of vaccination, though rare, are not unheard of.8 The use of vaccines throughout the world has undoubtedly led to some of the greatest advancements in public health—the eradication of small pox, the elimination of major disease outbreaks, and the prevention of thousands of deaths annually.9 Despite these successes, a small but significant number of children suffer severe injuries each year as a result of vaccination.10

What is quite unique about Stefan's case, however, is the treatment it received in the Georgia appellate courts in 2007 and 2008. In 2005, the trial court granted summary judgment in favor of the vaccine manufacturers on the majority of the Ferraris' claims, including their design defect claims.11 The Ferraris elected to appeal.12 In July of 2007, the Georgia Court of Appeals announced its novel decision. On appeal, the vaccine manufacturers argued the Ferraris' state law design defect claims were preempted by the National Childhood Vaccine Injury Act of 1986 (the Vaccine Act or the Act), and pointed to a series of holdings that support this position.14 The Court of

6. Ferrari, 650 S.E.2d at 588.

7. See id. at 587.

8. See, e.g., Elizabeth A. Breen, Note, A One Shot Deal: The National Childhood Vaccine Injury Act, 41 Wm. & Mary l. Rev. 309, 314-15 n.46 (1999-2000) (explaining that of the approximately 10,000 reports of adverse reactions received annually, less than fifteen percent describe serious events or reactions); id. at 314 (stating more than 100 million doses of vaccines are administered annually, yet in 1997, fewer than one hundred children died as a direct result of immunization).

9. Frank A. Sloan et al., The Fragility of the U.S. Vaccine Supply, 351 new eng. J. med. 2443, 2443 (2004).

10. See H.R. Rep. NO. 99-908, at 4 (1986), as reprinted in 1986 U.S.C.C.A.N. 6344, 6345 ("While most of the Nation's children enjoy greater benefit from immunization programs, a small but significant number have been gravely injured.").

11. Ferrari, 650 S.E.2d at 587.

12. Mat587.

13. See id. at 590 (reversing the trial court's grant of summary judgment in favor of the defendant vaccine manufacturers on the plaintiffs' design defect claims and holding that the claims were not preempted under federal law).

14. Id. at 588; see also Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289, 302-03 (E.D. Pa. 2007) (holding plaintiffs' strict liability and negligent design defect claims against vaccine manufacturers were expressly preempted under the National Childhood Vaccine Injury Act of 1986); Blackmon v. Am.

2010] NATIONAL CHILDHOOD VACCINE INJURY COMPENSATION ACT 619

Appeals, however, found the preemption clause at issue in the Vaccine Act ambiguous, and in light of recent precedent from the Supreme Court, held the Ferraris' design defect claims were not preempted by federal law.15 In so doing, the Georgia Court of Appeals became the first court in the United States to interpret the Vaccine Act to allow plaintiffs to bring design defect claims against vaccine manufacturers under traditional tort law theories in state or federal courts.16

The vaccine manufacturers immediately filed a petition for certiorari, disputing the decision of the Georgia Court of Appeals.17 In October of 2008, the Georgia Supreme Court affirmed the conclusion reached by the Court of Appeals, albeit on different

1 8

grounds. Conflicting with the holdings of other state and federal courts throughout the country, the Georgia Supreme Court held that the National Childhood Vaccine Injury Act does not preempt all design defect claims against manufacturers.19 As a result, the Georgia Supreme Court's decision could open the door for design defect suits against vaccine manufacturers by the parents of children who have suffered adverse side effects from immunization.

By enacting the National Childhood Vaccine Injury Act of 1986, Congress aimed to both ensure adequate and timely compensation for those suffering from vaccine related injuries and discourage vaccine

Home Prods. Corp., 328 F. Supp. 2d 659, 666 (S.D. Tex. 2004) (holding plaintiffs' negligent design defect claims against several vaccine manufacturers were barred by the National Childhood Vaccine Injury Act); Militrano v. Lederle Labs., 769 N.Y.S.2d 839, 845-46 (N.Y. Sup. Ct. 2003) (finding that the National Childhood Vaccine Injury Act of 1986 barred any design defect claims brought against vaccine manufacturing defendants).

15. Ferrari, 650 S.E.2d at 590.

16. Alyson M. Palmer, High Court Hears Key Case on Vaccine Suits; Manufacturers Ask Georgia Supreme Court to Overturn Lower Appeals Court Decision Finding Vaccine Suits Aren't Automatically Pre-empted by Federal Law, daily REP. (Fulton County, Ga.), May 21, 2008, at 1.

17. See Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236,237 (Ga. 2008).

18. See id. at 243 (holding that the National Childhood Vaccine Injury Act does not preempt all design defect claims against vaccine manufacturers).

19. See R. Robin McDonald, Court Backs Vaccine Suit in Autism Case; Conflicting with Courts Around the Country, Justices Say Congress Didn't Intend to "Pre-empt All Design Defect Claims", daily Rep. (Fulton County, Ga.), Oct. 7,2008, at 1.

20. Id. (noting that the Georgia Supreme Court's decision may allow the parents of children suffering from autism to bring suits in Georgia alleging that the neurological effects are the result of vaccination).

620 GEORGIA STATE UNIVERSITY LAW REVIEW [Vol. 26:2

manufacturers from leaving the market or raising prices by insulating them from certain product liability claims. This Note examines whether, in light of recent decisions by the Georgia appellate courts, the Vaccine Act preempts a lawsuit for design defect claims against a vaccine manufacturer. Part I discusses the purposes of the Vaccine Act, exploring the circumstances that brought about its enactment and the subsequent case law that has come down in its wake. Part II of this Note analyzes the Georgia Supreme Court's decision in American Home Products Corp. v. Ferrari, and specifically discusses whether the Court's holding that design defect liability claims under traditional tort law are not preempted by the Vaccine Act is supported by the text of the Vaccine Act and its legislative history.23 Part III suggests that the inherent ambiguity of the Vaccine Act's preemption of design defect claims must be resolved...

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