The National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) created a no-fault compensation program to stabilize a vaccine market adversely affected by an increase in vaccine-related tort litigation…
The Act provides that a party alleging a vaccine-related injury may file a petition for compensation… and that the claimant can then decide whether to accept the court’s judgment or reject it and seek tort relief from the vaccine manufacturer.
[M]anufacturers enjoy significant tort-liability protections. Most importantly, the Act eliminates manufacturer liability for a vaccine’s unavoidable, adverse side effects.
“[N]o 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.”
[A] vaccine’s design is not open to question in a tort action.
A vaccine side effect could always have been avoidable by use of a different vaccine not containing the harmful element.
[A]lthough products-liability law establishes three grounds for liability — defective manufacture, inadequate directions or warnings, and defective design — the Act mentions only manufacture and warnings.
[D]esign defects were not mentioned because they are not a basis for liability.
[B]etween 1978 and 1981 only nine product-liability suits were filed against DTP manufacturers, by the mid-1980’s the suits numbered more than 200 each year. This destabilized the DTP vaccine market, causing two of the three domestic manufacturers to withdraw; and the remaining manufacturer, Lederle Laboratories, estimated that its potential tort liability exceeded its annual sales by a factor of 200.
Hannah Bruesewitz was born on October 20, 1991. Her pediatrician administered doses of the DTP vaccine according to the Center for Disease Control’s recommended childhood immunization schedule. Within 24 hours of her April 1992 vaccination, Hannah started to experience seizures. She suffered over 100 seizures during the next month, and her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.” Hannah, now a teenager, is still diagnosed with both conditions.
Hannah’s parents, Russell and Robalee Bruesewitz, filed a vaccine injury petition…
A Special Master [of the Court] denied their claims on various grounds…
The Bruesewitzes elected to reject the unfavorable judgment, and in October 2005 filed this lawsuit in Pennsylvania state court. Their complaint alleged… that defective design of Lederle’s DTP vaccine caused Hannah’s disabilities, and that Lederle was subject to strict liability, and liability for negligent design, under Pennsylvania common law.
[T]he United States District Court for the Eastern District of Pennsylvania… [held] that the Pennsylvania law providing those causes of action was preempted by 42 U. S. C. §300aa–22(b)(1).
A side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element.
[T]he design itself is not open to question.
Design defects… do not merit a single mention in the NCVIA or the FDA’s regulations. Indeed, the FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.
A special master in the Act’s compensation program determines whether someone has suffered an injury listed on the Injury Table and, if not, whether the vaccine nonetheless caused the injury.
Vaccine manufacturers have long been subject to a legal duty, rooted in basic principles of products liability law, to improve the designs of their vaccines in light of advances in science and technology. Until today, that duty was enforceable through a traditional state-law tort action for defective design.
[T]he National Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act)… leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.
Although the Vaccine Act charges the Secretary of Health and Human Services with the obligation to “promote the development of childhood vaccines” and “make or assure improvements in . . . vaccines, and research on vaccines,” §300aa–27(a), neither the Act nor any other provision of federal law places a legal duty on vaccine manufacturers to improve the design of their vaccines to account for scientific and technological advances. Indeed, the FDA does not condition approval of a vaccine on it being the most optimally designed among reasonably available alternatives, nor does it (or any other federal entity) ensure that licensed vaccines keep pace with technological and scientific advances.
Rather, the function of ensuring that vaccines are optimally designed in light of existing science and technology has traditionally been left to the States through the imposition of damages for design defects.
‘[T]he specter of damage actions may provide manufacturers with added dynamic incentives to continue to keep abreast of all possible injuries stemming from use of their product[s] so as to forestall such actions through product improvement’…
[T]he FDA has “traditionally regarded state law as a complementary form of drug regulation” as “[s]tate tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly”
The normal competitive forces that spur innovation and improvements to existing product lines in other markets thus operate with less force in the vaccine market, particularly for vaccines that have already been released and marketed to the public.
[The Act] eliminate[s] the traditional incentive and deterrence functions served by state tort liability in favor of a federal regulatory scheme providing only carrots and no sticks.
[T]he majority’s decision leaves a regulatory vacuum in which no one—neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements.
Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins.