Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Griffin v. United States

decided: June 25, 1974.


Appeal from the United States District Court for the Eastern District of Pennsylvania D.C. Civil Action No. 39099.

Van Dusen, Aldisert and Rosenn, Circuit Judges.

Author: Rosenn


ROSENN, Circuit Judge.

This appeal raises important questions concerning the Government's liability under the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2671 et seq.*fn1 Mary Jane Griffin and her husband, Richard Griffin, seek damages from the United States for injuries sustained by Mrs. Griffin allegedly as a result of ingestion of Sabin oral live-virus polio vaccine. The district court, after a two week non-jury trial, rendered a judgment in favor of the Griffins and awarded damages in the amount of $2,059,946.25. The Government has appealed challenging:

(1) The district court's failure to hold the action barred because the claim is based upon the exercise or performance of a "discretionary function," 28 U.S.C. § 2680(a);*fn2

(2) The district court's findings on negligence and proximate cause;

(3) The district court's award of allegedly excessive damages; and

(4) The district court's failure to give effect to a joint tortfeasor release given by the Griffins to Charles Pfizer & Co., the manufacturer of the vaccine Mrs. Griffin ingested.*fn3 We affirm the judgment of the district court as to liability and computation of damages but reverse its failure to give effect to the joint tortfeasor release.

In the fall of 1963, Mrs. Griffin participated in a program sponsored by the Montgomery County Medical Society to secure immunization against polio through the mass administration of the Sabin oral polio vaccine. The program called for three separate doses of vaccine to be administered on three different dates. Each dose was designed to protect against one of three particular polio virus types. On September 22, 1963, Mrs. Griffin ingested a dose of Sabin Type I vaccine at the Gladwyne School in Montgomery County, Pennsylvania. On October 27, 1963, she ingested a dose of Sabin Type III vaccine.*fn4 On November 22 she began to feel sick. By the following day her symptoms progressed to the point where hospitalization was required. She tragically emerged from the hospital one month later a permanent quadriplegic.

In 1965 the Griffins commenced four separate actions. Two were instituted in the Court of Common Pleas of Montgomery County against the Montgomery County Medical Society. Two were instituted in federal court -- one against Charles Pfizer & Co., and the second, the instant action, against the United States under the Federal Tort Claims Act. In 1971, the federal court action against Pfizer was settled for $350,000 and the Griffins executed a joint tortfeasor release in favor of Pfizer.*fn5 The plaintiffs obtained final judgment in the instant action on January 18, 1973.

In a thoughtful and thorough opinion, Judge Newcomer found that as a result of ingesting the Type III vaccine on October 27 Mrs. Griffin developed polio. The court found that the dose ingested by Mrs. Griffin was part of Pfizer production Lot 56. The court further found that Lot 56 had been subjected to testing for safety and potency by the Division of Biologic Standards (DBS), a division of the Department of Health, Education and Welfare.*fn6 On the basis of undisputed test results, the court found that Lot 56 was approved for release to the public by DBS in violation of agency regulations. Specifically, the court held that the release of Lot 56 was inconsistent with 42 C.F.R. § 73.114(b) (1) (iii)*fn7 in that:

40. A comparative analysis of the test results obtained in testing Lot 56 for monkey neurovirulence and the NA-2 experience did not demonstrate that Lot 56 did not exceed the reference in neurovirulence.

41. A comparison of the test results obtained in testing Lot 56 for monkey neurovirulence and the NA-2 experience demonstrated that Lot 56 probably exceeded the reference in neurovirulence.

351 F. Supp. at 16. The court concluded that Mrs. Griffin was a member of the class of persons the regulation was designed to protect, and that the hazard and particular harm she suffered were those the regulation was designed to prevent. Accordingly, the court found that the approval of Lot 56 by the officials of DBS constituted negligence per se. The court held that "the negligence of the United States was the proximate cause of plaintiff's injuries, because but for the negligence the harm would not have occurred." 351 F. Supp. at 34. Stating that "in this case, the nature of the rules is not attacked, but rather the way the rules were applied," the court held that this case did not fall within the discretionary function exception to the Federal Tort Claims Act.

The court awarded damages for Mrs. Griffin's past and future medical expenses, future earning capacity, and pain and suffering in the amount of $1,759,946.25. Mr. Griffin was also awarded $300,000 for past and future loss of consortium. The court rejected the Government's argument that the plaintiffs' recovery should be reduced by 50 percent due to the terms of the joint tortfeasor release. This appeal followed.


The threshold question confronting us is whether this action is barred because of the "discretionary function" exception*fn8 to the Torts Claims Act. Although there is some dispute as to whether the exception is jurisdictional or merely a defense available to the Government, this circuit has treated the exception as jurisdictional. Gibson v. United States, 457 F.2d 1391, 1392 n. 1 (3d Cir. 1972).

The Government contends that the decision to release Lot 56 involved the exercise of a discretionary function. It argues that the determination called for by the regulation [42 C.F.R. § 73.114(b) (1) (iii), supra note 8] that the neurovirulence of a particular lot does not exceed that of the "reference strain" involves the exercise of judgment. It maintains that Congress intended, by the discretionary function exception, § 2680(a), to exclude all claims "arising from acts of a regulatory nature."

We believe that the construction of § 2680(a) urged upon us by the Government is too broad. Activity of any consequence is rarely without its judgmental component. The effect of accepting the Government's contention would effectively immunize all Governmental activity from judicial review except the most ministerial acts. In its landmark decision, Dalehite v. United States, 346 U.S. 15, 97 L. Ed. 1427, 73 S. Ct. 956 (1953), the Supreme Court explicitly recognized that not all activity involving judgment is necessarily encompassed within the Act's exception:

The "discretion" protected by the section is not that of the judge -- a power to decide within the limits of positive rules of law subject to judicial review. It is the discretion of the executive or the administrator to act according to one's judgment of the best course, a concept of substantial historical ancestry in American law.

346 U.S. at 34 (footnotes omitted). The decisions held discretionary in Dalehite involved, at minimum, some consideration as to the feasibility or practicability of Government programs. 346 U.S. at 41. Such decisions involved considerations of public policy, calling for a balance of such factors as cost of Government programs against the potential benefit. The Court stated:

[The discretionary function] also includes determinations made by executives or administrators in establishing plans, specifications or schedules of operations. Where there is room for policy judgment and decision, there is discretion. [Emphasis supplied.]

346 U.S. at 35, 36 [footnotes omitted]. Where decisions have not involved policy judgments as to the public interest, the courts have not held the decisions to be immune from judicial review. Eastern Air Lines v. Union Trust Co., 95 U.S. App. D.C. 189, 221 F.2d 62 (1955), aff'd 350 U.S. 907, 100 L. Ed. 796, 76 S. Ct. 192 (1955); Hendry v. United States, 418 F.2d 774 (2d Cir. 1969). See also Ward v. United States, 471 F.2d 667 (3d Cir. 1973); Pigott v. United States, 451 F.2d 574 (5th Cir. 1971). To determine the applicability of the discretionary function exception, therefore, we must analyze not merely whether judgment was exercised but also whether the nature of the judgment called for policy considerations.

At the outset, we emphasize what is not being challenged on this appeal. Plaintiffs do not challenge the Surgeon General's determination to approve a live-virus immunization program.*fn9 Neither do plaintiffs challenge the regulation which established the standard against which all manufactured lots were to be measured. See note 8 supra. These were matters involving balancing of policy considerations in advancing the public interest. Plaintiffs, in the instant case, challenge solely the manner by which the regulation was implemented. They contend that in approving a particular lot, Lot 56, for release to the public, DBS failed to comply with the standard established by the Surgeon General.

The issue before us, therefore, is whether the implementation of regulation 73.114(b) (1) (iii) by DBS involved a "discretionary function." To decide this question we must first determine exactly what the regulation required be done in determining whether to release a particular lot.

The crucial action in approving a particular test lot for polio vaccine manufacture was the determination that the neurovirulence*fn10 of the test lot "[did] not exceed" that of the NIH "reference strain."*fn11 The regulation required a "comparative analysis" of the monkey neurovirulence test results of a particular test lot with the monkey neurovirulence test results of the reference strain.*fn12 The regulation enumerates five criteria as evidence of neurovirulence: the number of animals showing lesions characteristic of poliovirus infection, the number of animals showing lesions other than those characteristic of poliovirus infection, the severity of the lesions, the degree of dissemination of the lesions, and the rate of occurrence of paralysis not attributable to the mechanical injury resulting from inoculation trauma.*fn13

Plaintiffs contend that the test lot could not be approved if it exceeded the reference strain with respect to any one of the five enumerated criteria. Under this interpretation of the regulation DBS could not approve a lot which minimally exceeded the reference strain with respect to any one criterion, even if DBS considered that criterion the poorest indicia of neurovirulence of the enumerated criteria, and even though the test lot was far superior to the reference strain with respect to the other four criteria.

We do not agree with this construction of the regulation. The regulation merely lists five criteria as evidence of neurovirulence and calls for a "comparative analysis." DBS has consistently construed the regulation as permitting it to weight the criteria in accordance with the degree to which it believed each criterion reflected neurovirulence.*fn14

The Supreme Court has stated on another occasion:

Since this involves an interpretation of an administrative regulation a court must necessarily look to the administrative construction of the regulation if the meaning of the words used is in doubt . . . . The ultimate criterion is the administrative interpretation, which becomes of controlling ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.