Baker v. U.S., 86-5578

CourtUnited States Courts of Appeals. United States Court of Appeals (9th Circuit)
Citation817 F.2d 560
Docket NumberNo. 86-5578,86-5578
PartiesWade BAKER and Rita Baker, Plaintiffs-Appellants, v. UNITED STATES of America, Defendant-Appellee.
Decision Date18 May 1987

James D. Crosby, San Diego, Cal., for plaintiffs-appellants.

Kathryn A. Snyder, Asst. U.S. Atty., argued, Peter K. Nunez, U.S. Atty., Karen M. Shichman and Kathryn A. Snyder, Asst. U.S. Attys., on the briefs, San Diego, Cal., for defendant-appellee.

Appeal from the United States District Court for the Southern District of California.

Before SNEED and SCHROEDER, Circuit Judges, and MARQUEZ, * District Judge.

SNEED, Circuit Judge:

Appellants, Wade Baker and Rita Baker, brought this action against the United States under the provisions of the Federal Tort Claims Act (FTCA), 28 U.S.C. Secs. 1346(b), 2671-80. The appellants allege that Wade Baker's contraction of poliomyelitis was caused by the negligence of the United States Department of Health, Education and Welfare (HEW), 1 which had licensed the vaccine in question for marketing by Lederle Laboratories. The district court dismissed the action for lack of subject matter jurisdiction, ruling that the action was barred by the discretionary function exception to the FTCA. We reverse.


In June 1963, the Secretary of HEW licensed Lederle Laboratories to manufacture a trivalent, live, oral poliovirus vaccine (Vaccine). The Vaccine is composed of all three Sabin strains of live poliovirus corresponding to the three different types of polio and therefore is called "trivalent." A characteristic of live Sabin polio vaccine is that not only is the vaccine's recipient immunized from polio, but unimmunized persons who come into close contact with the vaccinated person also may be immunized through a "shed virus" that spreads from the person vaccinated to the person in close contact. Because Sabin strains contain the live polio virus, either or both persons could develop polio. Consequently, the Secretary has promulgated regulations pertaining to safety, purity, and potency standards that serve to protect susceptible persons from contracting the disease. See 21 C.F.R. Secs. 630.10-. 17. 2 Drug manufacturers must establish their product's conformity to these regulations before the Secretary will issue a license for manufacturing. 42 U.S.C. Sec. 262(d).

In November 1983, Wade Baker was exposed to the shed virus after a doctor had inoculated his infant nephew with the Vaccine only a month earlier. On November 12, 1983, Baker developed symptoms of vaccine-associated poliomyelitis and was hospitalized two weeks later. Baker has been permanently injured as a result of having contracted the disease.

On August 6, 1985, the appellants brought suit in district court against the United States and unknown employees of HEW. The gravamen of the complaint is that HEW failed to adhere to its own regulations in supervising the Lederle testing of the Vaccine. The three counts of the complaint allege that HEW was negligent in

failing (1) to require Lederle to test adequately the safety and effectiveness of the Sabin poliovirus strain used to manufacture the Vaccine; (2) to require Lederle to test adequately the Vaccine itself prior to licensing; and (3) to require Lederle to obtain a license for manufacture of the shed virus and to test the shed virus for safety. The government filed a Motion to Dismiss or in the Alternative for Summary Judgment. The court granted the motion, finding that the plaintiff's claims were barred by the discretionary function exception to the FTCA. The Bakers timely filed this appeal.


The proper standard for review of a district court's determination that it lacks subject matter jurisdiction under the discretionary function exception is de novo. Chamberlin v. Isen, 779 F.2d 522, 523 (9th Cir.1985).


The United States can be sued only to the extent that it has waived its sovereign immunity. United States v. Orleans, 425 U.S. 807, 814, 96 S.Ct. 1971, 1976, 48 L.Ed.2d 390 (1976). A party bringing a cause of action against the federal government bears the burden of showing an unequivocal waiver of immunity. Holloman v. Watt, 708 F.2d 1399, 1401 (9th Cir.1983), cert. denied, 466 U.S. 958, 104 S.Ct. 2168, 80 L.Ed.2d 552 (1984). Thus, the United States may not be sued without its consent and the terms of such consent define the court's jurisdiction.

The Federal Tort Claims Act renders the United States liable for damages:

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.

28 U.S.C. Sec. 1346(b).

The Act, however, does not waive the sovereign immunity of the United States in all cases. Several classes of tort claims are excepted from the Act's waiver of immunity. The "discretionary function exception," found in 28 U.S.C. Sec. 2680(a), is the exception we must consider in this case. It exempts from the reach of the FTCA

[a]ny 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.

28 U.S.C. Sec. 2680(a) (emphasis added).

The plaintiff in this case alleges the negligent failure of HEW to require the mandatory tests of 21 C.F.R. Sec. 630.10(b) 3 when Lederle was licensed to manufacture live, oral poliovirus vaccine in 1963 for release to the public. Baker contends that the failure by the government to do what its own regulations command it to do is actionable under the FTCA.

The Supreme Court most recently addressed the discretionary function exception in United States v. S.A. Empresa de Viacao Aerea Rio Grandense (Varig Airlines), 467 U.S. 797, 104 S.Ct. 2755, 81 L.Ed.2d 660 (1984). The Court characterized the exception as "the boundary between Congress' willingness to impose tort liability upon the United States and its desire to protect certain governmental activities from exposure to suit by private individuals." Id. at 808, 104 S.Ct. at 2762. The inquiry in this case centers around whether the government's alleged failure to follow its own regulatory commands is the type of decision that Congress intended to shield from tort liability in order to preserve a zone within which choice by governmental personnel can be exercised without threat of suit under the FTCA.

The issue can be stated from the standpoint of those subject to the government. Most governmental action imposes costs and confers benefits on different persons. Regulatory action fits this pattern. The discretionary exception may be said to fix an area within which the burdens of government must be borne by those upon whom they fall. No government can shift all losses. To attempt to do so would only visit greater losses more widely. In a sense the search is for the congressionally designated victims.

Our search must employ the map provided by Varig. There the Supreme Court held that the United States was not liable for the negligence of the Federal Aviation Administration (FAA) in certifying certain aircraft for use in commercial aviation. 467 U.S. at 819-21, 104 S.Ct. at 2767-68. The FAA had developed a system of spot checking aircraft manufacturers to police compliance with minimum safety standards. Id. at 816-19, 104 S.Ct. at 2765-67. However, the Court held that the ultimate responsibility of assuring compliance was left with the manufacturer. See id. at 821, 104 S.Ct. at 2768.

In considering the reach of the discretionary function exception, the Court discussed two factors in its analysis. "First, it is the nature of the conduct, rather than the status of the actor, that governs whether the discretionary function exception applies in a given case." Id. at 813, 104 S.Ct. at 2764. Or, put another way, "the basic inquiry concerning the application of the discretionary function exception is whether the challenged acts of a Government employee--whatever his or her rank--are of the nature and quality that Congress intended to shield from tort liability." Id.

The second factor was predicated upon the underlying basis for the discretionary function exception. From a review of the legislative history of the exception the Court concluded that, whatever else Sec. 2680(a) may include, "it plainly was intended to encompass the discretionary acts of the Government acting in its role as a regulator of the conduct of private individuals." Id. at 813-14, 104 S.Ct. at 2764. In protecting regulatory activity, "Congress wished to prevent judicial 'second-guessing' of legislative and administrative decisions grounded in social, economic, and political policy through the medium of an action in tort." Id. at 814, 104 S.Ct. at 2765.

In deciding Varig the Court reaffirmed its decision in Dalehite v. United States, 346 U.S. 15, 73 S.Ct. 956, 97 L.Ed. 1427 (1953). In Dalehite, plaintiffs sued the United States on claims arising from a massive explosion of nitrate fertilizer being exported as a part of a post-World War II United States relief program. Id. at 17-19, 73 S.Ct. at 958-59. The plaintiffs claimed that the government had been negligent in adopting the fertilizer program as a whole, in various phases of manufacturing plan, and in policing shipboard loading. Id. at 23-24, 73 S.Ct. at 961-62. The Court held that the government's conduct came within the discretionary function exception. Id. at 37-45, 73 S.Ct. at 969-72.


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