The Georgia Supreme Court recently held in American Home Products Corp. v. Ferrari that the National Childhood Vaccine Injury Compensation Act of 1986 (“Vaccine Act”) does not preempt all design defect claims against vaccine manufacturers.1 To date, Georgia is the only state in the country to reach such a holding.2 Two federal district courts and state courts in both New York and Pennsylvania have considered similar cases, but reached a different result.3

The holding in Ferrari makes Georgia a likely target for plaintiffs seeking a venue to file claims against vaccine manufacturers. Georgia courts will now make a “case-by-case” determination of whether the injury or death alleged in such claims resulted from unavoidable side effects. Accordingly, vaccine manufacturers may see an increase in products liability litigation filed in Georgia courts as a direct result of the Supreme Court’s holding in Ferrari.

In Ferrari, Marcelo and Carolyn Ferrari, parents of an autistic child, sued American Home Products Corporation (now known as Wyeth) and eight other vaccine manufacturers. The plaintiffs alleged mercury contained in thimerosal, a vaccine preservative, caused neurological damage to their son.4 The plaintiffs specifically claimed that the defendant vaccine manufacturers were negligent and strictly liable for manufacturing the vaccines with thimerosal prior to the plaintiffs’ son’s vaccination in 1998.5

The trial court granted partial summary judgment in favor of the vaccine manufacturers, finding that the Vaccine Act preempted the design defect claims. The trial court based its holding on subsection (b)(1) of the Vaccine Act, which reads:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccinerelated 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.6

The Georgia Court of Appeals, however, found that preemption was disfavored and that U.S. Supreme Court precedent mandated the exclusion of legislative history from the interpretation of the Vaccine Act.7 The Court of Appeals found that, where two alternative readings of subsection (b)(1) existed, Bates v. Dow Agrosciences, 544 U.S. 431 (2005), imposed “‘a duty to accept the reading (of the Vaccine Act) that disfavors preemption,’ and we cannot resort to an examination of legislative history to discern Congress’s intent.”8

The Georgia Supreme Court granted certiorari to consider this ruling and ultimately affirmed the decision of the Court of Appeals. Although the Court found that the Court of Appeals erred in holding that Bates mandated the exclusion of all legislative history, the Court affirmed the Court of Appeals’ decision based on an examination of the text and congressional intent behind the Vaccine Act. Ultimately, the Court held that not all design defect claims were meant to be preempted.9 Instead, the Court interpreted the Vaccine Act to provide that manufacturers could not be held liable for defective design “if it is determined, on a case-by-case basis, that the injurious side effects of the particular vaccine were unavoidable.”10 The Court went on to hold that courts must make a preemption analysis on a case-by-case basis.

Analysis of the Statutory Text

The Supreme Court began its preemption analysis of subsection (b)(1) of the Vaccine Act, which dealt with limiting liability for vaccine design defect claims, by noting that, in construing that subsection, it was “‘presented with the task of interpreting a statutory provision that expressly pre-empts state law’.”11 In express preemption cases, the Court stated, it should begin its analysis with the assumption that state law should not be invalidated by a federal act unless that was Congress’ “clear and manifest purpose.”12 Next, the Court noted that congressional intent must be discerned by examining the language of the preemption statute.13 Ultimately, the Court concluded that U.S. Supreme Court precedent did not require it to automatically accept a plausible interpretation of a statute disfavoring preemption.14 The Court of Appeals had misapplied Bates by taking its presumption against preemption out of context and applying it too broadly.15 Thus, the Supreme Court found that an examination of congressional intent was an appropriate inquiry under preemption analysis as established by the U.S. Supreme Court in Bates.16

Turning its attention to determining whether subsection (b)(1) of the Vaccine Act preempted all design defect claims, the Court found that Congress modeled subsection (b)(1) after comment k to § 402A of the Restatement (Second) of Torts.17 Courts have interpreted comment k differently, but the majority of courts, including those in Georgia, have applied comment k “in a more limited fashion and on a case-by-case basis.”18 The Court determined that subsection (b)(1) was consistent with the majority understanding of comment k, such that a vaccine manufacturer is not liable if the injury or death resulted from unavoidable side-effects.19 Thus, the Court found that “[t]he conditional nature of this clause contemplates the occurrence of side effects which are avoidable, and for which a vaccine manufacturer may be civilly liable.”20 The Court reasoned that Congress could have written the statute to bar all liability for vaccine manufacturers, but chose to add in the “unavoidable” language. Thus, the Supreme Court found that determinations of unavoidability should be made on a case-by-case basis.21

Analysis of the Legislative History

The Court reasoned that textual interpretation of the statute is further bolstered by the legislative history evidencing congressional intent. The Court examined a 1986 committee report in which the wording “‘appears to leave open the possibility of a design defect claim with respect [to] vaccines covered by the Vaccine Act …’”22 Nowhere in the committee report did it state that the use of a no-fault compensation system (provided as an alternative to the traditional tort system for vaccine injuries) was mandatory.23 In fact, the report states that “‘[v]accine-injured persons will now have an appealing alternative to the tort system.’”24 The Court went on to interpret these statements as indication that the plaintiff remained authorized to prove the existence of a safer product design in the tort system.25 Thus, the Court found that Congress intended subsection (b)(1) not to preempt all design defect claims.26 Policy Considerations

In Ferrari, the Supreme Court opined that, although the text of subsection (b)(1) may be ambiguous on its face, the legislative history was clear.27 The legislative history did not support a “clear and manifest” congressional intent to supplant state tort law.28 Absent clear purpose, the Court concluded that any ambiguity in the language of the statute should be resolved against preemption.29

The Court relied on policy considerations to distinguish its holding from other cases finding in favor of preemption. First, it concluded that subsection (b)(1) protects vaccine manufacturers from liability for unavoidable side effects, not design defects.30 Second, it found that blanket tort immunity would not encourage the discovery of safer alternative vaccine designs.31 Third, it noted that the legislative history did not support reading (b)(1) as preempting all state law claims.32 Finally, it noted, briefly and without much detail, that FDA approval alone should not dictate whether a drug is considered unavoidably unsafe.33

After examining the text of the statute, the legislative history and the policy arguments, the Supreme Court determined that construing subsection (b)(1) as it had previously been decided in other jurisdictions “would have the perverse effect of granting complete [tort] immunity from design defect liability to an entire industry.”34 Thus, Georgia currently stands alone in allowing design defect claims against vaccine manufacturers on a case-by-case basis. The Georgia Supreme Court’s decision in Ferrari, therefore, represents an opening for the plaintiffs’ bar for vaccine-related claims currently unavailable in other jurisdictions.