As with ObamaCare, here too Congress was addressing a “national problem,” but one that seemed more clearly to call for a national solution — to handle the risks inherent in vaccinations through a federal no-fault system rather than through the vagaries of state tort law. No liability without fault is a principle that works well in a great range of tort claims. But here the inability to make vaccines entirely safe, plus uncertainty surrounding causation, coupled with the penchant of state juries to discount those issues in favor of sympathetic plaintiffs, had rendered most manufacturers unwilling to produce needed vaccines at reasonable costs.
Into the breach stepped Congress, creating a mandatory federal Vaccine Court — a less adversarial no-fault forum designed to enable alleged victims to be compensated quickly from federal funds drawn from surcharges on vaccines. With “Table injuries,” found to result from particular vaccines, the system seems to have worked well. If victims suffer a non-Table injury, however, they can still prevail, but they must prove that the vaccine caused the injury. Nonetheless, critics claim that the court has not worked as intended, with unconscionable delays, among much else, and victims wrongly being denied relief.
One such case, they argue, is that of Hannah Bruesewitz, who was administered her third dose of diphtheria-pertussis-tetanus (“DPT”) vaccine on schedule, just short of her six-month birthday. She then suffered a series of seizures, later diagnosed as residual seizure disorder and developmental delay. Now a teenager, she’ll likely require medical care related to her condition for the rest of her life.
Hannah’s parents filed a petition with the Vaccine Court when she was three, one month after new regulations deleted her disorder as a DPT Table injury. Nearly eight years later the court ruled that they had not proven causation, dismissing the claim with prejudice. The parents then filed a federal suit against Wyeth, which manufactured the vaccine, claiming, among other things, that Wyeth was strictly liable for a design defect. Again they lost in both the district and appellate courts.
The narrow question before the Supreme Court is whether a unanimous Third Circuit panel correctly applied the Act’s pre-emption language — made more pressing because only five months before the panel ruled, a unanimous Georgia Supreme Court, facing a similar case, read the same language as not pre-empting design defect suits. In relevant part, that language reads: “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… 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.”
Although the Act allows victims to sue over manufacturing defects, conduct that would subject a manufacturer to punitive damages, and a manufacturer’s failure to exercise due care, nowhere does it define “unavoidable” — and there’s the nub of the matter. The fact that Congress included that term implies, the Georgia court argued, that at least some vaccine-related injuries could be avoided, and so in those cases federal law did not pre-empt state civil suits to determine whether the injury was in fact “avoidable.” Indeed, pre-empting all design defect suits would render the text superfluous, the Georgia court added, contrary to a cardinal principle of statutory construction that text is there for a reason.
But the Third Circuit panel countered that if that reading were correct, statutory construction rules aside, the Act would not bar any design defect claims, because every such claim would be subject to case-by-case determination by a court — precisely what Congress sought to avoid.
Sound as that rejoinder is, based on the Act’s purpose as seen in its structure and legislative history, it hardly helps that that history includes two inconsistent committee reports following the Act’s passage. Thus, the report of the House Energy and Commerce Committee, which had jurisdiction over the matter, focused on the core problem of state imposed strict liability without fault, the implications for vaccine manufacturing, and the need for a no-fault victim compensation system — which would be undermined, the Third Circuit panel argued, if state courts were permitted to determine case-by-case whether a manufacturer might have created a safer vaccine.
But a year later, when Congress finally provided funding for the program, the House Budget Committee’s report claimed that Congress never undertook “to decide as a matter of law whether vaccines were unavoidably unsafe.” It left that decision instead to the courts, the report said, prompting this from the Third Circuit panel: “The views of a subsequent Congress form a hazardous basis for inferring the intent of an earlier one.”
Congress’s opaque language, its legislative history, and the Supreme Court’s own checkered past with pre-emption all suggest that the Court may only add to the confusion, all of which points in turn to the perils of seeking public law solutions to private law problems. Here, that solution likely was needed, albeit with better drafting. But with ObamaCare, concerning which the litigation is only beginning, the need for so vast a public law was hardly self-evident. Perhaps the new Congress can spare us the uncertain litigation that otherwise surely lies ahead.
