662 F.2d 1268 (8th Cir. 1981), 80-1886, Loge v. United States

Docket Nº:80-1886.
Citation:662 F.2d 1268
Party Name:Lora E. LOGE and Roger S. Loge, Plaintiffs/Appellants, v. UNITED STATES of America and unknown employees of the Department of Health, Education, and Welfare, Defendants/Appellees.
Case Date:November 06, 1981
Court:United States Courts of Appeals, Court of Appeals for the Eighth Circuit

Page 1268

662 F.2d 1268 (8th Cir. 1981)

Lora E. LOGE and Roger S. Loge, Plaintiffs/Appellants,

v.

UNITED STATES of America and unknown employees of the

Department of Health, Education, and Welfare,

Defendants/Appellees.

No. 80-1886.

United States Court of Appeals, Eighth Circuit

November 6, 1981

Submitted June 15, 1981.

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Walter S. Kyle, Fort Lauderdale, Fla., for plaintiffs/appellants.

Thomas S. Martin, Acting Asst. Atty. Gen., Washington, D. C., Larry R. McCord, U. S. Atty., Fort Smith, Ark., Robert Greenspan, Katherine Gruenheck, argued, Attys., Civ. Div., Dept. of Justice, Washington, D. C., for defendants/appellees.

Before ROSS and ARNOLD, Circuit Judges, and HANSON, Senior District Judge. [*]

HANSON, Senior District Judge.

Lora Loge contracted paralytic polio after her infant son was inoculated with a trivalent, live, oral poliovirus vaccine trade named Orimune. She and her husband sued the United States and unknown employees

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of the Department of Health, Education, and Welfare 1 (HEW) under the Federal Tort Claims Act 2 (FTCA) and the Constitution alleging liability based on negligent and willful acts and omissions committed in the regulating, testing, and licensing of Orimune. The government moved to dismiss the complaint for lack of subject matter jurisdiction and for failure to state a claim upon which relief could be granted. F.R.Civ.P. 12(b)(1) and (6). The district court 3, 494 F.Supp. 883, dismissed the complaint "for failure to state a cause of action" (R. 83), and the Loges appeal. We affirm in part and reverse in part.

I.

In testing the sufficiency of the Loges' amended complaint, the district court was constrained to accept all material allegations as true and to construe them liberally in favor of plaintiffs. Park View Heights Corp. v. City of Black Jack, et al., 467 F.2d 1208, 1212 n.3 (8th Cir. 1972). Only if "it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief" should the complaint be dismissed. Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 102, 2 L.Ed.2d 80 (1957). The material allegations in this case indicate the following.

In June 1963, the Secretary of HEW licensed Lederle Laboratories to manufacture Orimune-a trivalent, live, oral poliovirus vaccine. See 42 U.S.C. § 262(a); 21 C.F.R. § 630.10(a). Orimune is composed of all three Sabin strains of live poliovirus corresponding to the three different types of polio (known as Types 1, 2, and 3), thus the designation "trivalent." A characteristic of live Sabin polio vaccines such as Orimune is that not only is the vaccine's recipient immunized from polio, but unimmunized persons who come into close contact with the recipient also are immunized through a shed virus which spreads from the recipient to the "contact." Because Sabin strains contain the live polio virus, there is a risk that either a recipient or a contact could develop polio. Accordingly, the Secretary has promulgated regulations pertaining to the safety and potency of these strains which serve to protect susceptible persons from contracting the disease. 4 Drug manufacturers must prove their product's conformity to these regulations before the Secretary will issue a license to manufacture. 42 U.S.C. § 262(d).

A risk-free alternative to inoculation with the live Sabin vaccine is the Salk vaccine in which the virus is killed so that the recipient cannot contract polio nor can the recipient shed a live virus to unimmunized contacts. But the Secretary has promoted the use of risk-bearing live vaccines because they are able to effect total immunization of the public through transmission of the shed virus with less than total inoculation.

Mrs. Loge was exposed to the shed virus in 1976 after a doctor inoculated her infant son Todd with Orimune. Within one month after her son's inoculation, Mrs. Loge was stricken with a vaccine-associated case of poliomyelitis, Type 2. As a result, she is now a paraplegic. The Loges brought suit in the United States District Court for the Western District of Arkansas against the United States and unknown employees of the Department of HEW. The district court liberally construed their amended complaint to state the following claims against the United States under the FTCA based on the Secretary of HEW's negligence in:

(1) licensing all spread virus vaccines including Orimune, without requiring the manufacturer to produce the information required by 21 C.F.R. § 630.10(b) (2);

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(2) licensing all live oral poliovirus vaccines without testing their safety for persons in close proximity to those inoculated, but who themselves have not received the vaccine;

(3) licensing all live oral poliomyelitis vaccines when the Secretary knew that the viruses reproduced within the inoculated person would not pass the safety requirements applicable to the viruses contained within the inoculant;

(4) licensing Types 1, 2, and 3 of the Sabin poliomyelitis live vaccine without establishing that it was free from harmful effect on individuals who had been determined to be particularly susceptible to the disease;

(5) licensing Orimune without issuing regulations designed to insure its continued safety;

(6) failing to apply the review procedures set forth in 21 C.F.R. § 601.25;

(7) failing to enact regulations which would assure the safety of trivalent oral polio vaccine as defined in 21 C.F.R. § 600.3(p);

(8) subjecting Mrs. Loge to shed virus inoculation without her knowledge or consent;

(9) failing to approve a stronger package insert warning about adverse reactions;

(10) failing to use due care in approving Lederle Lot No. 451-162-the vaccine lot from which Todd Loge received his inoculation-of the trivalent, live, oral polio vaccine.

R. 73-74.

Additionally the Loges pleaded that under Bivens v. Six Unknown Federal Narcotics Agents, 403 U.S. 388, 91 S.Ct. 1999, 29 L.Ed.2d 619 (1973) and Carlson v. Green, 446 U.S. 14, 100 S.Ct. 1468, 64 L.Ed.2d 15 (1980), they have a cause of action for damages directly under the Constitution for deprivation of Mrs. Loge's rights under the Fifth Amendment and her right of privacy. They claim that the government knowingly deprived Mrs. Loge of these rights in pursuing a national policy to vaccinate everyone against polio, including persons such as Mrs. Loge who did not voluntarily submit to the immunization program.

II.

A. Before a cause of action against the United States can be stated, the hurdle of sovereign immunity must be overcome. This is the purpose of the FTCA.

The Federal Tort Claims Act is not a federal remedial scheme at all, but a waiver of sovereign immunity that permits an injured claimant to recover damages against the United States where a private person "would be liable to the claimant in accordance with the law of the place where the act or omission occurred." 28 U.S.C. § 1346(b); see also 28 U.S.C. § 2674.

Carlson v. Green, supra at 28 n.1, 100 S.Ct. at 1477 n.1 (Powell, J. concurring). The district court construed the Loges' amended complaint to state several causes of action which failed to overcome this initial hurdle because they attacked acts or omissions by the Secretary of HEW that were "discretionary." The FTCA does not waive sovereign immunity for "(a)ny 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." 28 U.S.C. § 2680(a). Insofar as the Loges' amended complaint alleged that the government was negligent in promulgating or failing to promulgate regulations that would ensure the safety of live, oral poliovirus vaccines and properly protect susceptible persons such as Mrs. Loge, the district court correctly found that such actions by the government were discretionary functions and therefore immune from suit under FTCA. Cf. Dalehite v. United States, 346 U.S. 15, 27, 73 S.Ct. 956, 963, 97 L.Ed. 1427 (1953) ("It was not 'intended that the constitutionality of legislation, the legality of regulations, or the propriety of a discretionary administrative act, should be tested through the medium of a damage suit for tort.' ").

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On appeal the Loges challenge this finding in only one respect: the district court found that the regulations do not require the shed virus to be tested for safety, concluded that the Loges were essentially attacking the government for its failure to promulgate such regulations, and held that a non-actionable discretionary function was therefore implicated. The Loges claim that the regulations do require testing of the shed virus. They contend the shed virus is an "analogous product" to a virus; therefore it is within the definition of "biological products" 5 which are subject to licensing regulations. Title 21 C.F.R. § 600.3(h)(5)(i) states that a product is analogous to a virus "if prepared from or with a virus or agent actually or potentially infectious, without regard to the degree of virulence or toxicogenicity of the specific strain used." (emphasis added). The "analogous product" obviously being referred to is a vaccine, which is prepared from a virus. Thus the live, oral polio vaccine is an analogous product to the Sabin viral strains because it is prepared from those strains. The same cannot be said for the shed virus. It is not a product analogous to a virus because it is not "prepared from or with a virus or agent;" it is itself a virus.

Nor is the shed virus, as the Loges further contend, a "recommended dosage" of a poliovirus...

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