Product Liability and Vaccines: Key Court Cases Reviewed

Introduction

Biotechnology has been reported as a new technology capable of much good for humankind (Traynor & Cunningham, 1989, p. 1). However, vaccines are a persistent source of litigation, as some individuals claim to have been harmed by receiving vaccinations. Vaccinations are administered regularly to infants and children to protect them against diseases such as polio, diphtheria, and whooping cough, among other childhood illnesses. Adults, too, receive vaccinations to guard against influenza and other diseases.

This paper investigates vaccine-related cases and the decisions handed down by the judicial system regarding the liability of drug manufacturers in cases where individuals allege harm from vaccinations. There are, however, statutory protections afforded to developers of vaccine immunizations that serve to protect the interests of these companies. In addition, a special victim compensation provision is administered by the United States Secretary of Health and Human Services, through which individuals alleging harm from a vaccine may file to receive compensation for their injuries. Three cases are reviewed below, along with the court's findings and the compensation awarded to the petitioner in each.

Bruesewitz v. Wyeth: Supreme Court and the NCVIA Preemption

In the first case examined, the parents of a minor child alleged that the child suffered a series of seizures resulting in developmental delays following the receipt of a dose of the diphtheria-tetanus-pertussis (DTP) vaccine. The parents brought a products liability action against the vaccine's manufacturer after a judgment from the United States Court of Federal Claims was rejected. The motion was granted by the United States District Court for the Eastern District of Pennsylvania. The parents appealed, and the United States Court of Appeals for the Third Circuit, per Circuit Judge Smith, affirmed the decision. Certiorari was granted, and the case proceeded to the Supreme Court of the United States.

In Russell Bruesewitz, et al. v. Wyeth LLC, fka Wyeth, Inc., fka Wyeth Laboratories, et al., No. 09-152 (February 22, 2011), Justice Scalia, writing for the Court, held that the National Childhood Vaccine Injury Act (NCVIA) preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. The decision was affirmed, with Justice Breyer concurring. Justices Sotomayor and Ginsburg filed dissenting opinions, and Justice Kagan took no part in the consideration or decision of the case.

The Court's findings relied in part on the National Childhood Vaccine Injury Act of 1986, § 311(a), 42 U.S.C.A. § 300aa-22(b)(2), (c), which holds that vaccine manufacturers are generally immunized from liability for failure to warn if they have complied with all regulatory requirements—including, but not limited to, warning requirements—and have provided the required warning either to the claimant or to the claimant's physician. The decision also rested on § 311(a), 42 U.S.C.A. § 300aa-23(d)(2), which holds that under the Act, vaccine manufacturers are immunized from liability for punitive damages absent a failure to comply with regulatory requirements, fraud, intentional and wrongful withholding of information, or other criminal or illegal activity (Bruesewitz v. Wyeth, No. 09-152, 2011).

The National Childhood Vaccine Injury Act and Manufacturer Protections

The National Childhood Vaccine Injury Act of 1986 created a no-fault compensation program designed to stabilize a vaccine market adversely affected by an increase in vaccine-related tort litigation and to facilitate compensation for claimants who found pursuing legitimate vaccine-inflicted injuries too costly and difficult (Syllabus, Bruesewitz v. Wyeth, No. 09-152, 2011).

The Act provides that a party alleging a vaccine-related injury may file a petition for compensation in the Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent. The case must be resolved by the court within a specific deadline, after which the claimant may decide whether to accept or reject the court's judgment and, if rejected, seek tort relief from the vaccine's manufacturer. Any awards are made from a fund created through an excise tax levied on each dose of a covered vaccine. Manufacturer liability is eliminated for unavoidable adverse effects, and manufacturers enjoy significant tort-liability protections under the Act. Section 300aa-22(b)(1) further indicates that a vaccine's design is not subject to challenge in a tort action (Bruesewitz v. Wyeth, No. 09-152, 2011).

Conclusion

Finally, it is stated that the stipulation to this agreement will not be construed to mean that the United States Secretary of Health and Human Services has admitted that the Hepatitis B vaccine caused the damages claimed by the petitioner in this case.

References

Traynor, M., & Cunningham, B. C. (1989). Emerging product liability issues in biotechnology. High Technology Law Journal. Retrieved from

Table of Cases

Parker-Corell v. Secretary of the Department of Health and Human Services, Fed. Cl. 2011 (August 25, 2011).

Corkern v. Secretary of the Department of Health and Human Services, No. 08-651V, United States Court of Federal Claims (September 9, 2011).

Bruesewitz v. Wyeth LLC, fka Wyeth, Inc., fka Wyeth Laboratories, No. 09-152, Supreme Court of the United States (February 22, 2011).