Abbot v. American Cyanamid Co.

WILKINS, Circuit Judge,

concurring:

I agree with the majority, but for different reasons, that Congress did not intend to completely preempt state tort actions for DTP vaccine-related injuries. The majority reaches this conclusion without deciding what congressional intent is reflected in the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.A. §§ 300aa-1, et seq. (West Supp.1987). Prior to the passage of this Act, federal law appeared to preempt any state action alleging defective design of the DTP vaccine. But, this Act unmistakably demonstrates that Congress intended to preempt state law in only limited areas of this field. See Grove City College v. Bell, 465 U.S. 555, 567, 104 S.Ct. 1211, 1218, 79 L.Ed.2d 516 (1984) (evidence of congressional intent may be gleaned from subsequent actions).

In deciding whether federal law preempts state law, “our sole task is to ascertain the intent of Congress.” California Fed. Sav. & Loan Ass’n v. Guerra, 479 U.S. 272,-, 107 S.Ct. 683, 689, 93 L.Ed.2d 613, 623 (1987). In the absence of express congressional intent, preemption may be inferred to the extent that “the state law stands ‘as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’ ” Id. (quoting Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 404, 85 L.Ed. 581 (1941)). Although preemption should not be lightly presumed, id., the legislative history of the Act presents some compelling reasons in support of a finding of preemption. H.R.Rep. No. 908, 99th Cong., 2d Sess. 1-7,. reprinted in 1986 U.S.Code Cong. & Admin.News 6287, 6344-48 (Legislative History).

For many years, one of this nation’s main public health priorities has been the prevention of childhood diseases by immunization. Through federal leadership and state immunization laws, most children are vaccinated against the major childhood diseases prior to entering school. As a result, polio, diphtheria, and tetanus have been virtually eliminated in this country. While the immunization programs have been widely successful in preventing the deaths of thousands of children each year, a small but significant number of children have been injured from unavoidable side effects of some vaccines.

There is no “perfect” vaccine currently available on the market. Some vaccines have potentially fatal side effects, especially the pertussis component of the DTP vaccine. Notwithstanding the potential hazards, the medical community and parent groups have taken the position that the risk of contracting the diseases is greater than the possible side effects of immunization. The federal government continues to support immunization programs and in the majority of states, vaccination is still mandatory for school admission.

Injured children have sought compensation in the courts with increasing frequency. This has resulted in an increase in the price of vaccines, and a decrease in the level of immunization of certain diseases with a corresponding increase in the incidence of those diseases. As a further consequence of the increase in litigation, particularly regarding the DTP vaccine, manufacturers are reconsidering their future role in the vaccine market. Very few companies now manufacture childhood vaccines. American Cyanamid is one of the only two which manufactures the DTP vaccine. The withdrawal of any manufacturer from the market poses a serious threat to public health, in the form of vaccine shortages with resulting decreased immunization and a possible resurgence of these diseases.

Under these circumstances alone, preemption would be warranted because state tort actions for design and warning defects stand as an obstacle to a major federal *1117purpose. However, read as a whole, the legislative history and the Act demonstrate that congressional intent was not to resolve these problems by complete preemption of state tort actions. Rather, Congress established a no-fault compensation system which in part preempts state law, but largely complements the state tort systems.

By requiring claimants to exhaust their administrative remedies in a speedy, no-fault system prior to filing court actions, Congress hoped to divert a significant number of potential litigants. Legislative History, supra at 6354. Children injured from vaccines administered after the effective date of the Act must proceed through the system as a prerequisite to filing a court action. 42 U.S.C.A. § 300aa-ll. Those, such as Tracy Abbot, who were injured prior to the effective date are eligible to participate in the new system, but are not required to exhaust its remedies before resorting to the courts. Id. While the purpose of the system is to reduce litigation, the Act does not entirely preempt state laws.

The Act generally provides that “State law shall apply to a civil action brought for damages for a vaccine-related injury or death.” 42 U.S.C.A. § 300aa-22(a). However, the Act does expressly preempt state law in several respects by: (1) adopting comment k of Section 402A of the Restatement of Torts (Second), precluding liability for damages arising from unavoidable side effects of a properly prepared vaccine accompanied by proper directions and warnings; (2) establishing a rebuttable presumption that warnings are adequate if they comply with federal regulations; and (3) codifying the learned-intermediary doctrine. 42 U.S.C.A. §§ 300aa-22(b), (c). Significantly, the Act also preempts state statutes which prohibit civil actions against manufacturers for vaccine-related injuries. 42 U.S.C.A. § 300aa-22(e); see also Legislative History, supra at 6368.

Finally, in the Vaccine Compensation Amendments of 1987, which set the effective date of October 1, 1988, Congress clearly expressed its intent:

[A]t the time of original enactment and in passing this legislation, the Committee acted with the understanding that tort remedies were and are available....
It is not the Committee’s intention to preclude court actions under applicable law. The Committee’s intent at the time of considering the Act and in these amendments was and is to leave otherwise applicable law unaffected, except as expressly altered by the Act and Amendments.

H.R.Rep. No. 391, 100th Cong., 1st Sess. 691 (1987), U.S.Code Cong. & Admin.News 1987, pp. 2313-1, 2313-365. Despite our differing analyses, we have reached the same conclusion: Congress did not intend to completely preempt state tort law in the area of vaccine-related injuries.