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:
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 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.
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.
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:
We hold that this regulation is mandatory. It does not vest the licensor with discretion concerning whether it can waive test results establishing the vaccine's effect on one million susceptible persons. To the extent that plaintiffs contend Orimune was licensed without complying with this regulation, we cannot say that plaintiffs' complaint is barred by the discretionary function exception to the Federal Tort Claims Act.
Plaintiffs also contend that defendant is liable for licensing all Sabin strains without requiring the mandatory test data of 21 C.F.R. § 630.10(b). The Sabin strains were licensed before promulgation of the regulations and their licensing in such a situation was discretionary. Griffin v. United States, 351 F.Supp. 10, 26 n. 20 (E.D.Pa.1972) rev'd on other grounds, 500 F.2d 1059 (3rd Cir. 1974).
The plaintiffs have also pleaded that the government is liable for failing to follow the review procedures set out in 21 C.F.R. § 601.25, which provides, in part, as follows:
The Court takes judicial notice that the advisory review panel has not yet issued its report. The vaccine which Mrs. Loge's son received was distributed pursuant to Lederle's original license issued in 1963. Any omissions in mandatory tests in conjunction with the review cannot have affected Mrs. Loge.
Plaintiffs have pleaded that the government failed to use due care in approving Lot 451-162. Since the promulgating or omission of regulations is discretionary, but adherence to them is not, we infer
In its motion to dismiss, the government contends that plaintiffs' complaint fails to state a cause of action because the government owes no duty, a sine qua non of negligence, concerning the issuance of licenses. We have held that the discretionary function exemption of 28 U.S.C. § 2680(a) bars each ground for relief asserted by plaintiffs under the Federal Tort Claims Act, except for two: failure to require the mandatory tests of 21 C.F.R. § 360.10(b) when Orimune was licensed in 1963; and failure to follow mandatory tests when Lederle's Lot 451-162 was approved. We now hold that these two remaining allegations of negligence fail to state a cause of action because under Arkansas law and the law of Washington, D. C., there is no duty to use due care imposed on one in a similar situation.
In Gelley v. Astra Pharmaceutical Products, Inc., 610 F.2d 558 (8th Cir. 1978), the plaintiff asserted liability on the part of the government for negligently failing to withdraw xylocaine from interstate commerce. The Court noted that under the law of the District of Columbia, no cause of action exists against an individual for similar activity.
The Court also noted that under Minnesota law, the place of the harmful impact, no cause of action exists. In the District of Columbia, there is no tort duty imposed on private persons to perform activities analogous to the granting or denial of licenses for drugs and in the absence of such duty, there can be no liability for negligence on the part of an individual or the government. Gelley v. Astra Pharmaceutical Products, Inc., 466 F.Supp. 182 (D.Minn.1979) aff'd on other grounds, 610 F.2d 558 (8th Cir. 1979).
Under Arkansas law, all political subdivisions of the state are immune from tort liability and therefore there are no Arkansas cases dealing with tort liability for regulatory acts and omissions. This does not of itself defeat a cause of action under the Federal Tort Claims Act. Rayonier Inc. v. United States, 352 U.S. 315, 77 S.Ct. 374, 1 L.Ed.2d 354 (1957). There also are no Arkansas cases which address the issue of duty owed by one to another who gratuitously undertakes services for a third party, but we hold that if the courts of Arkansas were faced with the issue they would follow the principles set out in the Restatement (Second) of Torts § 324 A which provides as follows:
Applying these principles to the case at bar, we hold that by licensing the trivalent polio oral vaccine the government gratuitously undertook services to the drug manufacturer which it should recognize as necessary for the protection of the residents of the United States. As such, the government would be liable if it were a private individual under Arkansas law if the government's failure to exercise reasonable care increased the risk, if the government undertook to perform a duty owed by the drug manufacturers to the recipients of the vaccines, or if the harm suffered by Mrs. Loge was because of reliance on the government.
We also find that the harm suffered by Mrs. Loge cannot be said to have been caused by reliance on the government.
We therefore hold that the Loges' complaint fails to state a cause of action.
The plaintiffs also contend that their constitutional rights to privacy, to due process of law and to just compensation have been abridged by the defendants, United States and unknown employees of the Department of Health, Education and Welfare.
We recognize that federal employees and agents may be liable for their unconstitutional acts. Bivens v. Six Unknown Fed. Narcotics Agents, 403 U.S. 388, 91 S.Ct. 1999, 29 L.Ed.2d 619 (1971). We also recognize that the Federal Tort Claims Act does not bar an action for deprivation of constitutional rights. Carlson v. Green, ___ U.S. ___, 100 S.Ct. 1468, 64 L.Ed.2d 15 (1980). We hold, however, that plaintiffs have not stated a cause of action for deprivation of constitutional rights. The Constitution does not include a guarantee to be free from personal injury under the circumstances of this case.
The Clerk will prepare an order in accord with this opinion which dismisses the action for failure to state a cause of action.