Court Opinion

ID: 9460854
Source: CourtListenerOpinion
Date Created: 2023-08-04 22:01:39.714517+00
Date Added: 2024-06-11T17:36:48.434310
License: Public Domain

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—
“(a) any claim . . . 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.” “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.
“. . . the ‘discretionary function or duty’ that cannot form a basis for suit under the Tort Claims Act includes more than the initiation of programs and activities. It 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. It necessarily follows that acts of subordinates in carrying out the operations of government in accordance with official directions cannot be actionable. If it were not so, the protection of § 2680(a) would fail at the time it would be needed, that is, when a subordinate performs or fails to perform a causal step, each action or non-action being directed by the superior, exercising, perhaps abusing discretion.”
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 :
346 U.S. at 34-36, 73 S.Ct. at 967-968.
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:
“. . . the alleged ‘negligence’ does not subject the Government to liability. The decisions held culpable were all responsibly made at a plan*1074ning rather than operational level and involved considerations more or less important to the practicability of the Government’s fertilizer program.”
346 U.S. at 42, 73 S.Ct. at 971.
For reasons which appear below, I believe that the implementation by DBS of the regulations governing the neuroviru-lence 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 regulations1 governing the neuroviru-lence testing of production lots, 42 C.F. R. §§ 73.110-73.118, is necessary in order to demonstrate why I believe that a discretionary function was involved in the instant case. The district court found that, after adoption of the regulations governing neurovirulence testing, DBS was in primary charge of administering both testing and evaluation under the regulations and held the power of approval or disapproval. 351 F.Supp. at 25. While the Surgeon General could have changed this power or overridden it, the approvals and disapprovals of production lots such as Lot 56 were issued by DBS in the name of DBS. Moreover, the primary responsibility for evaluating the monkey neurovirulence tests conducted pursuant to the regulations lay in the hands of Dr. Ruth Kirschstein, the chief pathologist at DBS. It was Dr. Kirschstein who signed the review approving Lot 56 for neurovirulenee on July 5, 1961 (P-48), which led to its release on July 9, 1961 (D-96). That Dr. Kirschstein was a central and dominant figure not only in supervision of the monkey neurovirulence testing but also generally in the'overall planning2 and administration of the live polio virus vaccine licensing program is made clear by the district court’s statement that “[ajlthough she was not an official member of the Surgeon General’s Committee, she took [an] active part in most discussions and was extremely influential on the final recommendations of the Committee.” 351 F.Supp. at 25.
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,” re*1075quired that at specified time periods after the monkeys were injected, they would be sacrificed, their brains and spinal cords examined pathologically, and that a
“comparative evaluation shall be made of the evidence of neurovirulence of the virus under test and the NIH Reference Attentuated Poliovirus with respect to (a) the number of animals showing lesions characteristic of po-liovirus infection, (b) the number of animals showing lesions other than those characteristic of poliovirus infection, (c) the severity of the lesions, (d) the degree of dissemination of the lesions, and (e) the rate of occurrence of paralysis not attributable to the mechanical injury resulting from inoculation trauma.”
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 neuro-virulence 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”3 and from grade 1 to grade 4, in accordance with the damage observed to the anterior horn cells.4
In addition to testing a particular vaccine lot for neurovirulence, DBS periodically performed neurovirulence tests of NA-2, the reference strain.5 Such tests, typically performed in 30-monkey batches, often yielded varying results,6 pre sumably as a result of biological variation. DBS then compared the test results of a particular test lot of vaccine with the “cumulative experience” of all the test results of the reference strain.7
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.8 For example, the record indicates the DBS officials considered the number of lesions produced as far more significant in the determination of neuroviru-lence than the severity of lesions produced. See N.T. 930-31; N.T. 798-99. In fact, the decision to release Lot 56 was ultimately predicated on the fact that, while Lot 56 produced more severe lesions than any lesions produced by the reference strain, the number of lesions *1076produced by Lot 56 was comparable to the cumulative experience of NA-2.9 N.T. 798-99.
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
“was that of a professional measuring neurovirulence . . . 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.”
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.9a
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 *1077the coating used. With respect to these activities, the Supreme Court concluded:
“The acts found to have been negligent were thus performed under the direction of a plan developed at a high level under a direct delegation of plan-making authority from the apex of the Executive Department. The establishment of this Plan, delegated to the Field Director’s Office, . clearly required the exercise of expert judgment.
“This is to be seen, for instance, in the matter of the coating. The PRP was added in order to insure against water absorption. At stake was no mere matter of taste; ammonium nitrate when wet cakes and is difficult to spread on fields as a fertilizer. So the considerations that dictated the decisions were crucial ones, involving the feasibility of the program itself, ■ balanced against present knowledge of the effect of such a coating and the general custom of similar private industries.
“And, assuming that high bagging temperatures in fact obtained as the District Court found, the decision to bag at the temperature fixed was also within the exception. Maximum bagging temperatures were first established under the TYA specifications. That they were the product of an exercise of judgment, requiring consideration of a vast spectrum of factors, including some which touched directly the feasibility of the fertilizer export program, is clear.”
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.10 See also Mahler v. United States, 306 F.2d 713, 723-724 (3d Cir. 1962).
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. 956.11
Based on the foregoing reasons and because of the potential for governmen*1078tal liability which the majority opinion creates, given the ever expanding scope of Government participation in testing, inspection, and certification activities, particularly in the field of food and drug administration,12 I respectfully dissent from the majority’s conclusion that the “discretionary function” exception does not preclude the instant action. I believe that the congressional language, as interpreted by the Supreme Court, requires a holding that activities performed by DBS in implementing the regulations governing neurovirulence testing occurred at the “planning,” not the “operational,” level of government activity and, as such, are immunized from suit by the above-quoted language of 28 U.S.C. § 2680(a).
I concur in part IV of the majority opinion.

. As the majority opinion notes, see note 11 of majority opinion, the regulations prescribed various tests -which the manufacturer had to complete prior to the submission of a lot to DBS for release and provided that DBS was to review the manufacturer’s protocols relating to the history of the manufacture of eacii lot of vaccine and the results of all tests performed, as well as to receive a sample of the vaccine submitted by the manufacturer. The district court found, however, that in the case of the Type III test virus, because of the lack of the reliability of tiie manufacturers’ test results, DBS performed its own monkey neurovirulence tests on every sample of vaccine submitted. 351 F.Supp. at 27.

. The Committee relied on DBS to draft the regulations. 351 F.Supp. at 25-26. The district court used this language in recognizing the general acceptance of recommendations of the DBS staff by the Committee and thereafter the Surgeon General and the Secretary of HEW:
“The Committee reported directly to the Surgeon General, which is the reason the Director of the National Institutes of Health was not involved. Generally, any recommendations made to the Surgeon General by the Committee were accepted by the Surgeon General and Secretary of Health, Education and Welfare, and any recommendations on operational procedures and standards by the D.B.S. staff were accepted by the Committee.”

. See note 13 of majority opinion for an explanation of these terms.

. See 351 F.Supp. at 16 (finding 33) for further explanation of this aspect of the grading system used by DBS.

. See N.T. 781-86 (testimony of Dr. Kirseh-stein, DBS official in charge of neuroviru-lence testing, describing the test procedures) .

. See p. 1764 of the Appendix (chart entitled “Results of Neurovirulence Tests of Reference Vaccine NIH-NA-2 after Intrathalamic Inoculation,” showing dates and varying results of periodic retests of the reference strain).

. Dr. Kirschstein testified as follows with respect to the comparative analysis of vaccine lot tests results and the reference strain test results:
“Q Just exactly how do you perform this comparative analysis of the test results and how do you arrive at a conclusion whether the vaccine lot does or does not exceed the reference standard?
“A This is based on the total knowledge of the testing results of the reference preparation over the time previous to the time that the vaccine is tested and a comparison is made of the particular vaccine lot under test with that total accumulated knowledge of the previous tests of the reference, and it is based on a judgment of experience of work over a number of years.”
See N.T. 785-86.

. I agree with the majority’s construction of the regulation as allowing DBS to weight the five factors according to each factor’s importance as an indicium of neurovirulence. See majority opinion at p. 1066.

. See defendant’s Exhibit 99 (graph entitled “Comparison of No. of Monkeys with Lesions of Poliomyelitis (per 30 monkeys) — Replicate Tests — NA-2—1961-1962, Released Pfizer Type III Lots [Intrathalimic Inoculation]”).

. The findings of the district court, such as those mentioned on page 1074 above and in notes 1 and 2 above, which were not clearly erroneous, make clear that the procedures in fact followed by DBS were not in accord with the wording of the regulations in several respects (see, for example, finding 30 and note 1 above) and, further, that the Surgeon General and the Committee “generally” accepted the recommendations of the DBS staff. The administrative construction and practice under a regulation should be followed unless plainly erroneous or inconsistent with the regulation. See Udall v. Tallman, 380 U.S. 1, 16-17, 85 S.Ct. 792, 13 L.Ed.2d 616 (1965); Bowles v. Seminole Rock Co., 325 U.S. 410, 413-414, 65 S.Ct. 1215, 89 L.Ed.2d 1700 (1945). The views of the DBS staff were thus instrumental, as a practical matter, in the formulation of policy by the Committee and ultimately by the Surgeon General. For these reasons, I respectfully dissent from the contents of note 16A of the majority opinion, particularly the implication that the approved procedure was to follow the regulations as worded.

. Also it is noted that the Court used this language in Dalehite, 346 U.S. at 43, 73 S.Ct. at 971, quoting from another decision:
“ ‘The power to adopt regulations or bylaws . . . for the preservation of the public health, ... are generally regarded as discretionary, because, in their nature, they are legislative.’ ”
The Court stated that such functions “were classically within the exception.” Id.

. The above-quoted language of 28 U.S.C. § 2680(a)
“. . . excepts acts of discretion in the performance of governmental functions or duty ‘whether or not the discretion involved be abused.’ Not only agencies of government are covered but all employees exercising discretion. It is clear that the just-quoted clause as to abuse connotes both negligence and wrongful acts in the exercise of the discretion because the Act itself covers only ‘negligent or wrongful act or omission of any employee,’ ‘within the scope of his office’ ‘where the United States, if a private person, would be liable.’ 28 U.S.C. § 1346(b). The exercise of discretion could not be abused without negligence or a wrongful act. The Committee reports, note 21, supra, show this. They say § 2680(a) is to preclude action for ‘abuse of discretionary authority . . . whether or not negligence is alleged to have been involved.’ They speak of excepting a ‘remedy on account of such discretionary acts even though negligently performed and involving an abuse of discretion.”
346 U.S. at 33-34, 73 S.Ct. at 966. (Footnotes omitted.)
Note 21 referred to in the above-quoted language includes this wording quoted from the congressional committee reports:
“It is also designed to preclude application of the bill to a claim against a regulatory agency, such as the Federal Trade Commission or the Securities and Exchange Commission, based upon an alleged abuse of discretionary authority by an officer or *1078employee, whether or not negligence is alleged to have been involved. . . . The bill is not intended to authorize a suit for damages to test the validity of or provide a remedy on account of such discretionary acts even though negligently performed and involving an abuse of discretion.” 346 U.S. at 29, 73 S.Ct. at 964.

. For a discussion of the significance of this case in the field of food and drug administration, see Merrill, Compensation for Prescription Drug Injuries, 59 Va.L.Rev. 1, last note on p. 120 (1973) ; Note, The Federal Seal of Approval: Government Liability for Negligent Inspection, 62 Geo.L.J. 937 (1974). In the above-mentioned last note on page 120 of 59 Va.L.Rev., the district court decision in this case (351 F.Supp. 1) is characterized as “the first recovery against the government ever obtained by a victim of an adverse drug reaction.”