Loge v. United States

• Decision Date: 28 July 1980
• Docket Number: Civ. No. 79-5088.
• Citation: 494 F. Supp. 883
• Parties: Lora E. LOGE and Roger S. Loge, her husband, Plaintiffs, v. UNITED STATES of America, Defendant.
• Court: U.S. District Court — Western District of Arkansas

494 F. Supp. 883

Lora E. LOGE and Roger S. Loge, her husband, Plaintiffs, v. UNITED STATES of America, Defendant.

Civ. No. 79-5088.

United States District Court, W. D. Arkansas, Fayetteville Division.

July 28, 1980.

COPYRIGHT MATERIAL OMITTED

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

Steven N. Snyder, Asst. U. S. Atty., W. D. Arkansas, Fort Smith, Ark., for defendant.

MEMORANDUM OPINION

PAUL X WILLIAMS, Chief Judge.

In this case, plaintiffs, Mr. and Mrs. Roger Loge, seek damages under the Federal Tort Claims Act, 28 U.S.C. § 2671 et seq. The case is before the Court on defendant's motion to dismiss.

The plaintiffs contend that all live virus poliomyelitis vaccines reproduce within the inoculated person and can spread to others who are in close contact with the one inoculated; that Mr. and Mrs. Loge decided to have their infant son inoculated with a live polio vaccine, but that Mrs. Loge chose not to subject herself to the risk involved in being vaccinated; that after the infant received a trivalent live poliomyelitis vaccine on July 26, 1976, manufactured under the tradename "Orimune," Mrs. Lora Loge contracted polio which rendered her permanently paralyzed; and that Mrs. Loge's poliomyelitis was caused by the inoculation given to her child.

In their complaint as amended, the Loges contend the United States is liable because the Secretary of Health, Education and Welfare was negligent in the following respects:

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

(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 I, II and III 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 Number 451-162 of the trivalent oral polio vaccine.

The plaintiffs also pleaded that the defendant had subjected Mrs. Loge to exposure to the vaccine without her consent in violation of her right to privacy and security guaranteed by the Fourth Amendment to the United States Constitution and had deprived her of life, liberty and property in violation of the Fifth Amendment. The plaintiffs pleaded that the constitutional deprivations were knowingly committed by the government in furtherance of the national policy to vaccinate everyone, including those such as plaintiff who do not voluntarily submit to the immunization program. The plaintiffs contend that non-shed-virus vaccines are available.

The constitutional claim is discussed at the end of this opinion, after discussion of the claim under the Federal Tort Claims Act.

In its motion to dismiss, the government contends that the plaintiffs have failed to state a cause of action.

The first issue raised by the government is that the Federal Tort Claims Act imposes liability on the government for acts which would be actionable if performed by individuals; and that since the granting or denial of a license is a particularly governmental function which can never be the basis of liability on the part of an individual, the government cannot be held liable under the Federal Tort Claims Act.

The United States Supreme Court has rejected the governmental function test, holding that the government is liable, if a private person would be liable, under like circumstances. Indian Towing Co. v. United States, 350 U.S. 61, 76 S.Ct. 122, 100 L.Ed. 48 (1955).

The second issue raised by the government is that plaintiffs' cause of action falls within 28 U.S.C.A. § 2680(a), which provides as follows:

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.

The second clause of this section reserves immunity for the government for the exercise or omission of discretionary functions regardless of due care.

In plaintiffs' complaint as amended, they contend the government is liable for promulgation of certain regulations in that the regulations failed to properly protect persons such as Mrs. Loge. In other allegations, plaintiffs contend that the government licensed the vaccine, without requiring the certain tests designed to measure its effect on those who never directly received the vaccine, but were recipients of the shed-viruses. The regulations did not and do not require such tests. Plaintiffs are therefore attacking the government for its failure to promulgate such regulations.

In other sections of their complaint, plaintiffs contend the government should not have licensed the live shed-virus vaccines without establishing its safety on nonrecipients. There is no regulation mandating such tests and, therefore, plaintiffs are contending the government is liable for failure to promulgate a certain regulation.

The promulgation of a regulation is a discretionary function. As stated by the Court in 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.'

We also hold that the government's decision to subject persons such as Mrs. Loge to inoculation by the shed-viruses, as distinguished from non-shed-virus vaccines, was a policy decision and cannot give rise to liability under the Federal Tort Claims Act.

It is unnecessary to define, apart from this case, precisely where the discretion ends. It is enough to hold, as we do, that 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 decisions, there is discretion. Emphasis added

Dalehite v. United States, 346 U.S. 15, 35-36, 73 S.Ct. 956, 968, 97 L.Ed. 1427 (1953).

The same principle protects the government for its decision concerning the warning on the package insert. The government contends that the discretionary function clause of section 2680(a) bars not just attacks on the regulations themselves, but also attacks on the issuance of every license or permit. We disagree. The regulations often establish mandatory criteria for the issuance or denial of a license or permit. In such a situation, the licensor lacks the discretion to waive the requirements. His actions, with respect to the issuance or denial of the license, are not discretionary within the meaning of 28 U.S.C. § 2680(a). Griffin v. United States, 500 F.2d 1059, 1068-1069 (3rd Cir. 1974).

In plaintiffs' complaint, they contend the government is liable for licensing all live virus vaccines, including Orimune, without requiring that data be produced showing the vaccine meets certain criteria. 21 C.F.R. § 360.10(b) (1980) is identical to the regulation in effect before 1976 which was codified as 42 C.F.R. § 73.114. The regulation provides as follows:

(b) Criteria for acceptable strains and acceptable seed virus. (1) Strains of attenuated poliovirus Types 1, 2, and 3 used in the manufacture of the vaccine shall be identified by: (i) Historical records including origin and techniques of attenuation, (ii) antigenic properties, (iii) neurovirulence for monkeys, (iv) pathogenicity for other animals and tissue cultures of various cell types, and (v) established virus markers including rct/40, d, and other markers shown to be associated with strain virulence.

(2) Poliovirus strains shall not be used in the manufacture of Poliovirus Vaccine, Live, Oral, unless (i) data are submitted to the Commissioner of Food and Drugs which establish that each such strain is free of harmful effect upon administration in the recommended dosage to at least 1 million people susceptible to poliomyelitis, under circumstances where adequate epidemiological surveillance or neurological illness has been maintained, and, (ii) each such strain produces a vaccine meeting the safety and potency requirements of §§ 630.11, 630.15 and 630.16(b). Susceptibility shall be demonstrated by blood tests, stool examinations and other appropriate methods.

(3) Each seed virus used in manufacture shall be demonstrated to be free of extraneous microbial agents except for unavoidable bacteriophage.

(4) No seed virus shall be used for the manufacture of poliovirus vaccine unless its neurovirulence in Macaca monkeys is no greater than that of the Reference Attenuated Poliovirus distributed by the Bureau of Biologics. The neurovirulence of

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