Sabin Oral Polio Vaccine Products Liability Litigation, In re, 91-2398

• Decision Date: 21 January 1993
• Docket Number: No. 91-2398,91-2398
• Citation: 984 F.2d 124
• Parties: In re SABIN ORAL POLIO VACCINE PRODUCTS LIABILITY LITIGATION. Deborah MILLER, Individually and as Administrator of the Estate of William Miller and as mother and natural guardian of Kristen Miller and Michael Miller, minors; Randy L. Musgrove; Cynthia J. Musgrove, Plaintiffs-Appellees, and Lederle Laboratories; Connaught Laboratories, Ltd., Plaintiffs, v. UNITED STATES of America, Defendant-Appellant.
• Court: U.S. Court of Appeals — Fourth Circuit

Page 124

984 F.2d 124

In re SABIN ORAL POLIO VACCINE PRODUCTS LIABILITY LITIGATION.

Deborah MILLER, Individually and as Administrator of the

Estate of William Miller and as mother and natural guardian

of Kristen Miller and Michael Miller, minors; Randy L.

Musgrove; Cynthia J. Musgrove, Plaintiffs-Appellees, and Lederle Laboratories; Connaught Laboratories, Ltd., Plaintiffs, v. UNITED STATES of America, Defendant-Appellant.

No. 91-2398.

United States Court of Appeals, Fourth Circuit.

Argued July 7, 1992.

Decided Jan. 21, 1993.

Rupert Mark Mitsch, Sr. Trial Counsel, Torts Branch, Civ. Div., U.S. Dept. of Justice, Washington, DC, argued (Stuart M. Gerson, Asst. Atty. Gen., Jeffrey Axelrad, Director, Torts Branch, Civ. Div., U.S. Dept. of Justice, Washington, DC, Richard D. Bennett, U.S. Atty., Baltimore, MD, Margaret Jane Porter, Chief Counsel, and Ann H. Wion, Associate Chief Counsel for Drugs and Biologics, Food & Drug Admin., Dept. of Health and Human Services, Rockville, MD, on brief), for appellant.

Marc Simon Moller, Kreindler & Kreindler, New York City, argued (Stanley P. Kops, Philadelphia, PA, on brief), for appellees.

Before PHILLIPS and MURNAGHAN, Circuit Judges, and BUTZNER, Senior Circuit Judge.

OPINION

PER CURIAM:

The United States appeals judgments awarding damages to Randy Musgrove and to the administratrix of the estate of William Miller for injuries caused by live trivalent and polio vaccine approved by the Department of Biological Services (DBS) in violation of pertinent regulations. Infants who had been vaccinated with live polio vaccine transmitted type III, crippling poliomyelitis to their respective fathers, Musgrove and Miller. The judicial panel on multidistrict litigation transferred seven actions, including Musgrove's and Miller's, to Judge J. Frederick Motz in the District of Maryland for resolution of their common factual and legal issues.

The district court denied the government's motion for summary judgment that sought to bar the plaintiffs' actions by application of the discretionary function exception to the Federal Torts Claims Act, 28 U.S.C. § 2680(a). In re Sabin Oral Polio Vaccine Products Liability Litigation, 743 F.Supp. 410 (D.Md.1990) (Sabin I ). After a 15-day trial, conducted by consent of the parties without the intervention of a jury, the district court held that DBS violated two regulations governing the manufacture and release of oral polio vaccine. In re Sabin Oral Polio Vaccine Products Liability Litigation, 763 F.Supp. 811 (D.Md.1991) (Sabin II ). After a subsequent trial on the issues of duty, breach, and causation, the court entered final judgments for Musgrove and for Miller's administratrix, awarding damages in amounts stipulated by the parties. In re Sabin Oral Polio Vaccine Products Liability Litigation, 774 F.Supp. 952 (D.Md.1991) (Sabin III ).

In its assignments of error on appeal, the government contends:

I. The discretionary function exception bars this action because plaintiffs' claims confront policy decisions relating to the safety of vaccines;

II. Since DBS approved only state of the art vaccine, it did not breach its duty to the plaintiffs;

III. DBS's failure to amend the OPV regulations was not the proximate cause of plaintiffs' injuries because a safer vaccine could not have been released to the public.

In its three opinions, the district court reviewed the regulations governing the production of OPV. It carefully considered the contentions of the parties, and it explained in detail its rationale of decision. Concluding that the district court correctly decided this controversy, we affirm for reasons set forth in its opinions.

Parenthetically we note that the plaintiffs have settled with Lederle Laboratories, manufacturer of the vaccine. This litigation is not governed by the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 to 300aa-34, which compensates for vaccine related injuries or deaths. This litigation is governed by the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2671 et seq.; the Public Health Service Act, 42 U.S.C. §§ 262 et seq.; the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; and regulations, 42 C.F.R. §§ 73.110-73.118 (recodified as 21 C.F.R. §§ 630.10-630.17 (1991)). For consistency with the district court, we will refer to the regulations as originally promulgated.

I

In Sabin I, 743 F.Supp. 410, the district court denied the plaintiffs' motion for summary judgment. The court sustained in part the government's motion for summary judgment. It denied part of the government's motion for summary judgment by rejecting the application of the discretionary function defense to DBS's actions that involved two regulations governing the implementation of the OPV program. This aspect of DBS's conduct is the principal issue in this appeal.

Federal law requires a product license for marketing live oral polio vaccine. 42 U.S.C. § 262(a). DBS may issue a license only upon a showing that the product meets the standards prescribed by the regulations. § 262(d). Pertinent to this litigation are two regulations that embody the recommendations of the Surgeon General's ad hoc committee on the feasibility of the OPV program:

Virus passages. Virus in the final product shall represent no more than five tissue culture passages from the original strain, each of which shall have met the criteria of acceptability prescribed in § 73.110(b).

42 C.F.R. § 73.113(b).

Musgrove claims that he contracted type III polio because DBS released vaccine derived from seed 45 B 165 that did not comply with this regulation since it was more than five tissue passages from the original strain.

Regulation 73.114 requires a "test for safety." The test involves inoculation of monkeys to determine neurovirulence. The regulation provides in part:

The virus pool under test is satisfactory for poliovirus vaccine manufacture only if at least 80 percent of the animals in each group survive the observation period and if a comparative analysis of the test results demonstrate[s] that the neurovirulence of the test virus pool does not exceed that of the NIH Reference Attenuated Poliovirus.

42 C.F.R. § 73.114(b)(1)(iii). The NIH Reference Attenuated Poliovirus type 1 was the control or reference for the monkey tests. § 73.111.

Miller's administratrix claims that Miller contracted type III polio because DBS, in violation of § 73.114(b)(1)(iii), released a vaccine derived from seed 45 B 85 that exceeded the NIH reference.

Berkovitz v. United States, 486 U.S. 531, 108 S.Ct. 1954, 100 L.Ed.2d 531 (1988), deals with the application of the discretionary function defense to the OPV program. The Court reversed a judgment that "the licensing and release of polio vaccines were wholly discretionary actions and, as such, could not form the basis for suit against the United States." 486 U.S. at 534, 108 S.Ct. at 1957. The Court explained its reasoning by setting forth two cardinal principles: "[T]he discretionary function exception will not apply when a federal statute, regulation, or policy specifically prescribes a course of action for an employee to follow. In this event, the employee has no rightful option but to adhere to the directive." 486 U.S. at 536, 108 S.Ct. at 1958-59.

The second principle describes the other side of the coin: "[T]he discretionary function exception insulates the Government from liability if the action challenged in the case involves the permissible exercise of policy judgment." 486 U.S. at 537, 108 S.Ct. at 1959.

Referring to the release of vaccine, the Supreme Court stated, "if the Bureau's policy leaves no room for an official to exercise policy judgment in performing a given act, or if the act simply does not involve the exercise of such judgment, the discretionary function exception does not bar a claim that the act was negligent or wrongful." 486 U.S. at 546-47, 108 S.Ct. at 1964. The Court then applied these principles to the allegations of the Berkovitz complaint, which charged that government employees knowingly released vaccine that did not comply with safety standards. The Court concluded that if the evidence subsequently sustained these allegations, the discretionary function exception would not bar the claim. 486 U.S. at 547, 108 S.Ct. at 1964.

Relying on Berkovitz, the district court concluded that the regulations set forth the policy decisions regarding the appropriate standards for release of the vaccine. It held that the government employees were obliged to abide by these standards. It rejected DBS's interpretation of the regulations that departed substantially from their plain language. Consequently, the district court correctly held that the discretionary function exception does not bar the plaintiffs' action. Accord Baker v. United States, 817 F.2d 560 (9th Cir.1987); Loge v. United States, 662 F.2d 1268, 1272-73 (8th Cir.1981); Griffin v. United States, 500 F.2d 1059, 1063-69 (3d Cir.1974).

II

In Sabin II, 763 F.Supp. 811, the district court decided the...