OPINION OF THE COURT
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.
(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);
(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.
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.
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.
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 "[i]n 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.
I. Discretionary Function
The threshold question confronting us is whether this action is barred because of the "discretionary function" exception
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
346 U.S. at 34, 73 S.Ct. at 967 [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, 73 S.Ct. 956. 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:
346 U.S. at 35, 36, 73 S.Ct. at 968 [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, 76 S.Ct. 192, 100 L.Ed. 796 (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.
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
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.
The Supreme Court has stated on another occasion:
Bowles v. Seminole Rock and Sand Co., 325 U.S. 410, 413-414, 65 S.Ct. 1215, 1217, 89 L.Ed. 1700 (1945). We find the DBS interpretation of the regulation to allow weighting of the five criteria of neurovirulence neither "plainly erroneous" nor "inconsistent with the regulation."
We acknowledge that under DBS' construction of the regulation, the implementation called for a judgmental determination as to the degree to which each of the enumerated criteria indicated neurovirulence in monkeys. The judgment, however, was that of a professional measuring neurovirulence. It was not that of a policy-maker promulgating regulations by balancing competing policy considerations in determining the public interest. Neither was it a policy planning decision nor a determination of the feasibility or practicability of a government program. At issue was a scientific, but not policy-making, determination as to whether each of the criteria listed in the regulation was met and the extent to which each such factor accurately indicated neurovirulence.
Where the conduct of Government employees in implementing agency regulations requires only performance of scientific evaluation and not the formulation of policy, we do not believe that the conduct is immunized from judicial review as a "discretionary function." As Judge Waterman of the Second Circuit has stated:
Hendry v. United States, 418 F.2d 774, 783 (2d Cir. 1969).
351 F.Supp. at 33.
Even were we to conclude arguendo, however, that DBS' approval of vaccine lots for release, had it complied with the regulation, was a "discretionary function," we would not hold plaintiffs' action barred by the "discretionary function" exception in the instant case. The Government's release of Lot 56 was predicated upon its reliance on a factor called "biological variation." Reliance on this factor, however, was not authorized by the regulations. We therefore conclude, as discussed below, that DBS' activity was not immunized from judicial review.
The district court found that the undisputed test results showed that Lot 56 "probably exceeded" the reference strain in neurovirulence.
We are unaware of any authority conferred by the regulation to permit DBS to discount the results of particular tests because of "biological variation." 42 C.F.R. § 73.114(b)(1)(iii) provided that
is the test lot satisfactory for vaccine manufacture. On its face the regulation required that DBS consider all test results as a meaningful indication of neurovirulence.
Even were we to concede that discretion was otherwise conferred upon DBS by the regulation, no discretion was conferred to disregard the mandatory regulatory command. In discounting test results that were required to be considered significant, DBS acted outside the scope of the authority conferred by the regulation. The violation of a non-discretionary command takes what otherwise might be characterized as a "discretionary function" outside the scope of
Having concluded that this action is not barred by the discretionary function exception to the Tort Claims Act, we turn to the district court's findings on the merits. The district court held that plaintiffs satisfied their burden of proving that the Government was negligent in releasing Lot 56 and that the Government's negligence proximately caused Mrs. Griffin's condition. With respect to the issue of causation the court found first, that Mrs. Griffin had polio; second, that Mrs. Griffin's polio was of Type III variety; third, that the polio was caused by the vaccine; and fourth, that the vaccine ingested came from Lot 56.
We are unable to state that the findings of fact of the district court as to negligence
On the question of proximate cause, the district court found
On appeal the Government does not contest Finding 20. However, the Government forcefully contends that the court erred in finding that Mrs. Griffin ingested a dose of vaccine from Lot 56. We have independently examined the documentary evidence introduced on this issue. We are satisfied that plaintiffs have met their burden of proving by a preponderance of the evidence that Mrs. Griffin ingested a dose of vaccine from Lot 56. Plaintiffs' evidence adequately established the presence of Lot 56 in Montgomery County at the time Mrs. Griffin ingested her dose of Sabin Type III vaccine. Although the evidence also shows the presence of vaccine produced from an additional lot, Lot 71, in perhaps greater quantity than Lot 56, we conclude, for the reasons stated by the district court, 351 F.Supp. at 18-23, that the trier of fact could properly find that Mrs. Griffin ingested vaccine from Lot 56 rather than Lot 71.
For the foregoing reasons the judgment of the district court on the question of liability will be affirmed.
III. Computation of Damages
We have reviewed the district court's assessment of damages and, contrary to the Government's position, "we cannot say that the award was in any way shocking, unfair or biased." The hospital and medical bills as of the time of trial in July 1972 totaled $89,223.25. After considering plaintiffs' expert's calculations the court awarded $421,581.-00 as future medical expenses, based on a 25-year life expectancy and a very modest inflation factor of 2½ percent,
After finding that Mrs. Griffin's sensitivity to pain has not been impaired
As Judge Hastie stated in Frankel v. Heym, 466 F.2d 1226, 1228 (3d Cir. 1972):
IV. Joint Tortfeasor Release
The Government maintains that the district court erred in refusing to reduce the plaintiffs' recovery by 50 percent in accordance with the joint tortfeasor release executed by the Griffins in favor of Pfizer.
the Government contends that under the Uniform Contribution Among Tortfeasors Act,
As the district court points out, Pennsylvania has established the rule that in order to give effect to a "pro rata share" clause in a release, the joint tortfeasor status of the settling party must be judicially determined.
The release executed in the instant case, however, differs from the releases in Davis, supra note 31, and Mazer in one crucial respect. The Griffin-Pfizer agreement provides:
This language constitutes an express waiver by plaintiffs of the benefits of the Davis holding. The Pennsylvania Supreme Court has stated:
Brown v. City of Pittsburgh, 409 Pa. 357, 186 A.2d 399, 401 (1962). That court has also stated:
Hanover Construction Co. v. Fehr, 392 Pa. 199, 139 A.2d 656 (1958). The above-cited clause of the Pfizer-Griffin agreement is unambiguous. The Griffins have conceded the joint tortfeasor status of Pfizer for the purpose of determining damages in the case of a judgment tortfeasor. It is obvious that the release was drafted with Davis specifically in mind. Having waived their right to insist upon a judicial determination of Pfizer's joint tortfeasor status, the Griffins may not object to a reduction of their judgment against the United States to the extent of Pfizer's pro rata share.
The district court refused to give effect to the foregoing language in the release because it believed it inoperative until Pfizer was actually made a party to the Griffin v. United States action. The language of the provision on this point is ambiguous.
The case will be remanded for proceedings consistent with this opinion.
VAN DUSEN, Circuit Judge (dissenting, and concurring in part).
I respectfully dissent from the majority's conclusion that plaintiffs' action is not barred by the "discretionary function" exception of the Federal Tort Claims Act. The majority affirms the district court's conclusion that the implementation by DBS of the regulations governing the neurovirulence testing of the live, oral poliovirus vaccine, 42 C.F. R. §§ 73.110-73.118, and decision by DBS to release Lot 56 pursuant to such regulations did not involve a "discretionary function" within the meaning of 28 U.S.C. § 2680(a).
Section 2680 provides, in pertinent part, as follows:
"The provisions of this chapter and section 1346(b) of this title shall not apply to —
In Dalehite v. United States, 346 U.S. 15, 73 S.Ct. 956, 97 L.Ed. 1427 (1953), the landmark decision dealing with the "discretionary function" exception, the Supreme Court construed the above language as follows:
The Supreme Court further stated, in holding that various allegedly negligent decisions relating to the manufacture, packaging, labeling and shipping of an explosive ammonium nitrate fertilizer fell within the discretionary function exception, that:
For reasons which appear below, I believe that the implementation by DBS of the regulations governing the neurovirulence testing of the poliovirus vaccines fell within the above language of the Supreme Court in Dalehite and, hence, is immunized from judicial review as a "discretionary function."
A description of the procedures followed by DBS in implementing the regulations
The procedures of the neurovirulence tests conducted by Dr. Kirschstein pursuant to the regulations were as follows. 42 C.F.R. § 73.114(b)(1) provided that each lot of vaccine would be tested in comparison with the NIH Reference Attenuated Poliovirus, commonly referred to as NA-2. Subsection (b)(1)(i) required intrathalamic testing (injection of the vaccine into a specific portion of the brain of the monkey, N.T. 771-73) and "comparative evaluations" of the test lot with NA-2. Subsection (b)(1)(ii) required intraspinal testing (injection of the vaccine into the lumbar area of the spinal canal, N.T. 798) and "comparative evaluations" of the results of such tests with the test results of NA-2. Subsection (b)(1)(iii), entitled "determination of neurovirulence," required
Finally, subsection (b)(1)(iii) provided that the virus pool under test is satisfactory "if a comparative analysis of the test results demonstrate that the neurovirulence of the test virus pool does not exceed that of the NIH Reference Attenuated Poliovirus."
For purposes of the comparative analysis described above, DBS graded lesions that appeared in the slides for both "spread" and "severity"
In addition to testing a particular vaccine lot for neurovirulence, DBS periodically performed neurovirulence tests of NA-2, the reference strain.
I believe that the above procedures involved the exercise of "planning", or policy, discretion in at least two respects. First, in making the comparative analysis of the vaccine lot test results and the reference strain test results, DBS had to determine, as a preliminary matter, how much weight to accord to each of the five factors enumerated in the regulation, 42 C.F.R. § 73.114(b)(1)(iii), based on the degree to which it believed each factor reflected neurovirulence.
The second respect in which the above procedures involved planning discretion concerned the determination of exactly what the neurovirulence level of the reference strain was at any given time. As mentioned above, the neurovirulence of the reference strain, against which the neurovirulence of all test lots was to be compared, was a constantly varying standard depending upon the most recent retest of the reference strain, largely because each retest of the reference strain produced different results. Thus DBS was constantly called upon, as a result of these retests, to determine what weight to give each retest of the reference strain, what level of neurovirulence the reference represented, and what level the other lots could not exceed.
The majority opinion, while recognizing that it was necesary for DBS to exercise judgment and discretion in the above two respects, nevertheless concludes that the judgment
I believe that the implementation of the regulations by DBS in the above-described way involved the exercise of policy or planning discretion within the meaning of Dalehite, as well as the exercise of professional judgment.
At the heart of DBS's regulatory function with respect to the live polio virus vaccine licensing program was the responsibility of deciding which production lots of vaccine submitted by the licensed manufacturers were safe for release to the public. The determination of what factors were the best indicators of neurovirulence in assessing whether a vaccine lot was safe for release to the public, as well as the determination of what the safe level of neurovirulence, as represented by the reference strain, was at any given time, appears to be central to the performance by DBS of its regulatory function. Such determinations constitute the planning of the method and procedures by which DBS would undertake to perform regulatory duty.
In addition to the above, I find it difficult to distinguish the activities performed by DBS in the instant case from the activities challenged by the plaintiffs in Dalehite and held by the Supreme Court in Dalehite to fall within the "discretionary function" exception. In Dalehite, the plaintiffs cited, among other grounds for liability, four specific acts of negligence on the part of the Government in the manufacture and shipment of the ammonium nitrate fertilizer: the temperature at which the fertilizer was bagged, the type of bagging used, the type of labeling used, and
These activities held immune from judicial review in Dalehite would appear to involve no more policy or planning components than the activities of DBS in the instant case. It is important to note that the activities in Dalehite, like the activities of DBS, required the exercise of essentially technical or professional judgment — i. e., the type of bagging used — but the Supreme Court nevertheless held that such activities fell within the "discretionary function" exception.
I recognize in the instant case that DBS may have improperly relied upon the factor of biological variation in its decision to release Lot 56, but I believe that such reliance constituted at most an abuse of discretion which, unfortunate as the results of such abuse of discretion may be, is nevertheless immunized by the "discretionary function" exception. See Dalehite, supra, 346 U.S. at 33-34, 73 S.Ct. 956.
Based on the foregoing reasons and because of the potential for governmental
I concur in part IV of the majority opinion.
Subject to the provisions of chapter 171 of this title, the district courts . . . shall have exclusive jurisdiction of civil actions on claims against the United States, for money damages, accruing on and after January 1, 1945, for injury or loss of property, or personal injury or death caused by the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred.
351 F.Supp. at 25.
The "NIH Reference Attenuated Poliovirus" was designated by regulation to be Type I poliovirus. 42 C.F.R. § 73.111. It was referred to by the district court as NA-2 and will be referred to herein as the "reference strain."
The regulation specifically refers to "virus pool" under test. Both the district court and the briefs filed with this court treat "virus pool" and "lots" interchangeably. We continue this treatment.
42 C.F.R. § 73.114(b)(1)(iii) is a regulation promulgated by the Surgeon General pursuant to the Public Health Service Act, 42 U.S.C. § 201 et seq.; see 42 U.S.C. § 262(d).
The provisions of this chapter and section 1346(b) of this title shall not apply to — (a) Any claim based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused.
At the time the neurovirulence test of any given test lot was to be compared with the neurovirulence of the reference strain, the neurovirulence of the latter was determined by the cumulative experience of the reference strain as of that date.
Our position is likewise supported by those decisions holding the exception inapplicable to claims based upon allegedly negligent treatment rendered by Government physicians. See, e. g., Costley v. United States, 181 F.2d 723 (5th Cir. 1951) (injection of harmful substance causing paralysis). See also United States v. Gray, 199 F.2d 239 (10th Cir. 1952) (determination to leave deranged patient unattended); Fair v. United States, 234 F.2d 288 (5th Cir. 1956) (release of psychiatric patient); White v. United States, 317 F.2d 13 (4th Cir. 1963) (allowance of freedom of movement to psychiatric patient).
See Note, The Federal Seal of Approval: Government Liability for Negligent Inspection, 62 Geo.L.J. 937, 960 (1974).
Lot 56 Reference[*] _______________________________________________ Number of Monkeys with Lesions 4 2.4 Severity[**] Grade 4 2 0 " 3 1 .1 " 1, 2 1 2 Spread[**] Grade 4 0 0 " 3 3 .1 " 1, 2 1 2 Paralyzed monkey 1 0 [*] The reference strain in fact consisted of 305 monkeys. In the chart all reference strain test results have been divided by 10 to allow comparison with the 30-monkey test lot results. [**] For the significance of grade scores see note 13 supra.
See also note 23, infra.
Q. At the time that the DBS made these tests on Lot 56 of the Pfizer Type 3 vaccine, did you evaluate those results?
Q. And what conclusion or recommendation did you make?
A. These test results were evaluated and considerable discussion ensued between Dr. Murray, Dr. Hottle, and myself, because there was in the intrathalamic test one paralyzed monkey, and it was agreed that probably this was within biologic variation, and that since the total number of animals with polio was four on thirty, which was not that different from the total that might be expected from the reference, and in addition, this was one of five of a consistency series, the four previous lots having been satisfactory and released, that this vaccine lot was satisfactory for release.
The official's testimony on cross-examination reveals that DBS discounted the unfavorable results obtained in the Lot 56 tests because of the factor of "biological variation":
Q. Do you consider a score of two 4's and a paralysis and a 3 and a 2 being not in excess of that NA-2 score?
A. Mr. Adler, as I have said before, it gave me pause, it gave us all pause. We considered it and finally made the judgment that it was within biological variation, particularly based on the fact that in the totality of lesions as demonstrated in the chart it equalled many of the replicate tests of NA-2.
Further, § 73.115(a) provides:
Dr. Murray testified that DBS considered that:
He also suggested that the concluding language of § 73.114(b)(1)(iii) be revised to read:
Dr. Stones, chief virologist of Pfizer, Ltd., proposed that the concluding language of § 73.114(b)(1)(iii) be revised to read: "does not significantly exceed that of the NIH Reference Attenuated Poliovirus." [Emphasis in original.] Dr. Sabin suggested that the regulations provide that "the virus under test is satisfactory if the number of monkeys exhibiting persistent paralysis . . . is in the same range as that obtained by the same operator using the same technique of inoculation with the NIH Reference Attenuated Poliovirus." [Emphasis in original.]
We add that this action is not barred by the first clause of § 2680(a) first, because plaintiffs are not challenging the validity of a statute or regulation, see Dalehite, 346 U. S. at 32, 73 S.Ct. 956, and second, because our conclusion concerning the disregard of mandatory regulatory commands precludes a finding of "due care."
Quantitatively, Lot 56 had more lesions of all kinds than the mean experience with NA-2, and fell into the top of the distribution of the experience of NA-2 divided into 30 monkey lots. (See D-98) Qualitatively, the severity of the lesions demonstrated in Lot 56 are clearly in excess of anything ever encountered in NA-2. Further, Lot 56 demonstrated a paralyzed monkey, a phenomenon never encountered in NA-2.
351 F.Supp. at 27.
When Standard of Conduct Defined by Legislation or Regulation Will Not Be Adopted The court will not adopt as the standard of conduct of a reasonable man the requirements of a legislative enactment or an administrative regulation whose purpose is found to be exclusively
(b) to secure to individuals the enjoyment of rights or privileges to which they are entitled only as members of the public.
As the district court wrote, "it is clear that the conduct of DBS in releasing Lot 56 in violation of 42 C.F.R. 73.114(b)(1)(iii) was negligent per se by the law of Pennsylvania, Ennis v. Atkin, 354 Pa. 165, 47 A.2d 217 (1946)." 351 F.Supp. at 34. See also Ridley v. Boyer, 426 Pa. 28, 231 A.2d 307 (1967).
12 P.S. § 2086 provides:
Plaintiffs' counsel objected to introducing the matter at this stage of the proceedings.
See N.T. 785-86.
The Court stated that such functions "were classically within the exception." Id.
Note 21 referred to in the above-quoted language includes this wording quoted from the congressional committee reports: