Berkovitz v. United States

A. LEON HIGGINBOTHAM, Jr., Circuit Judge,

dissenting.

The amended complaint alleges the following: At the age of approximately two months, Kevan Berkovitz was administered the Sabin oral polio vaccine by his pediatrician. Less than one month later, this vaccine caused him to sustain a case of paralytic poliomyelitis. Among the disease’s many consequences is a curvature of Berkovitz’s spine as great as ninety degrees. He requires ventilatory assistance to breathe, and he has lost the use of his arms, legs and hands. These injuries are permanent.

While this is an extremely difficult case, to my view the majority’s tilt ignores the clear statutory language that defines the duty of the Division of Biologic Standards (“DBS”) to require the submission of test data. By not requiring the government to comply with a statute designed to insure the “safety, purity, and potency” of these drug products, the majority has expanded the discretionary function exception beyond the boundaries of any case reported to date. I respectfully dissent.

The regulations in this field place mandatory duties upon a drug manufacturer, such as Lederle, that seeks to obtain a federal license to market its drug product. First, the manufacturer must make its license application to the Director of the Office of Biologies Research and Review on the forms prescribed by regulation. 21 C.F.R. § 601.2 (a) (1987). Second, such application forms must be accompanied by “data derived from nonclinical laboratory and clinical studies [that] demonstrate that the manufactured product meets prescribed standards of safety, purity and potency____” Id. Third, where the manufacturer is seeking a license for Poliovirus Vaccine Live Oral, the data to be submitted must “establish that each [poliovirus] strain is free of harmful effect upon administration in the recommended dosage to at least 1 million people susceptible to polio *1333 myelitis, under circumstances where adequate epidemiological surveillance of neurological illness has been maintained____” 21 C.F.R. § 630.10 (b)(2) (1987). Fourth, the manufacturer must “demonstrate[ ]” the neovirulence of each seed virus used in its vaccine with data garnered in its performance of a specified series of tests. 21 C.F.R. § 630.10 (b)(4) (1987).

As the majority has recognized, “Berkovitz’s complaint can be read as alleging a [negligent] failure [by DBS] to require submission of test data.” Maj. typescript at 22 n. 6. In addition, Berkovitz’s amended complaint can be read as alleging a decision by DBS to license Lederle’s manufacture of this vaccine, even though the test data submitted showed that certain monovalent virus pools had failed the required neovirulence tests. 1 Amended Complaint ¶ 19(g); Joint Appendix at 31. Notwithstanding the prescribed duties of the manufacturer outlined in the preceding paragraph, however, the majority concludes that it is within the DBS’s discretion not to require even the submission of required test data, and to license the manufacture of a vaccine that has failed the required tests. This disregards the clear command of federal law:

Licenses ... may be issued only upon a showing that the establishment and the products for which a license is desired meet standards, designed to insure the continued safety, purity, and potency of such products, prescribed in regulations, and licenses for new products may be issued only upon a showing that they meet such standards.

42 U.S.C.A. § 262 (d)(1) (West Supp.1987) (emphasis added). Such statutory language creates, at a minimum, a duty 2 to receive the showing that the vaccine manufacturer is, under the regulations, required to make to the government. 3 As the Ninth Circuit recognized last month,

the Secretary may not issue a license for manufacturing poliovirus vaccine unless the relevant test data has been submitted. See 42 U.S.C. § 262 (d) [ (1982) ]; 21 C.F.R. § 630.10 (b)(2) [(1987)]. Agency employees charged with enforcing poliovirus vaccine safety standards must require the submission of the test data. As to that there is no discretion.

Baker v. United States, 817 F.2d 560, 566 (9th Cir.1987). The statute also creates a governmental duty not to license a manufacturer that has shown the government that its vaccine is defective. See Loge v. United States, 662 F.2d 1268, 1273 (8th Cir.1981) (“The Secretary [of Health and Human Services] has no discretion to disregard the mandatory regulatory commands pertaining to criteria a vaccine must meet before licensing its manufacture or releasing a particular lot of vaccine for distribution to the public.”), cert. denied, 456 U.S. 944 , 102 S.Ct. 2009 , 72 L.Ed.2d 466 (1982).

The majority believes that this statutory duty is not “different in substance” from the statutory duty of the Federal Aviation Administration (“FAA”) that was analyzed by the Supreme Court in Varig. Maj. typescript at 23. This belief rests upon a misreading of Varig and the federal laws that were considered therein. As the Varig Court noted, “[t]he FAA certification process is founded upon a relatively simple notion: the duty to ensure that an aircraft conforms to FAA safety regulations lies *1334 with the manufacturer and operator, 4 while the FAA retains the responsibility for policing compliance.” 5 467 U.S. at 816, 104 S.Ct. at 2766 (footnote and emphasis added). The FAA’s legal duties are limited — as the majority’s “illustrations” plainly show, see maj. typescript at 23-24 — to making, or requiring the manufacturer to make, such tests “as the Secretary of Transportation deems reasonably necessary in the interest of safety,” 49 U.S.C.A. § 1423 (a)(2) (West Supp.1987), and to “mak[ing] such inspection ... as may be necessary to assure manufacture of each unit in conformity with [its type] certificate....” 49 U.S.C.A. § 1423 (b) (West Supp.1987). These statutes are not commands at all. Rather, they amount to requests for the prudent exercise of agency discretion, and they are truly different in substance from the statute that prohibits vaccine licensure by the government whenever the requisite showing has not been made.

The majority’s analysis distorts the discretionary function exception by extending its immunity to a government function that simply is not discretionary. “[Fjederal officials do not possess discretion to” violate federal law. 6 Pooler v. United States, 787 F.2d 868, 871 (3d Cir.), cert. denied, — U.S. -, 107 S.Ct. 175 , 93 L.Ed.2d 111 (1986). Accordingly, I would affirm the judgment of the district court.

. Thus, contrary to the majority’s characterization, Berkovitz’s position is not “simply that the FDA acted negligently.” Maj. typescript at 25-26; see, e.g., Brief for Appellees at 21 (DBS decided "to allow distribution to the public of a discrete live poliovirus vaccine [that] it knew exceeded explicit regulatory definitions of what is safe”) (original emphasis); id. at 36 ("What must be accepted as true is that DBS knew that the vaccine lot in question exceeded the regulatory standard.”).

. That this section creates non-discretionary governmental duties is certainly implied by its subsection that prohibits ”interfere[nce] with any officer, agent, or employee of the [Department of Health and Human] Service[s] in the performance of any duty imposed on him [or her] by this section or by regulations made by authority thereof.” 42 U.S.C.A. § 262 (e) (West 1982) (emphasis added).

. By contrast, this statute creates no DBS duty to receive what the manufacturer is not, by regulation, obliged to send. See, e.g., 21 C.F.R. § 610.2 (a) (1987) (product ”[s]amples ... may at any time be required to be sent”).

. Accord Waymire v. United States, 629 F.Supp. 1396, 1402 (D.Kan.1986) ("in Varig, the FAA made a policy decision ... that the owner or manufacturer has the primary responsibility for inspecting the plane and for the complying with FAA regulations").

. The FAA’s choice to fulfill this policing function by ”feview[ing] the data for conformity purposes by conducting a 'spot check’ of the manufacturer’s work” is the discretionary function that was assessed by the Varig Court. 467 U.S. at 817, 104 S.Ct. at 2766.

. After carefully analyzing the Supreme Court’s Varig and Dalehite opinions, Judge Bork recently noted that

a decision cannot be shielded from liability if the decisionmaker is acting without actual authority. A government official has no discretion to violate the binding laws, regulations or policies that define the extent of his [or her] official powers. An employee of the government acting beyond his [or her] authority is not exercising the sort of discretion the discretionary function exception was enacted to protect. This proposition is implied in Varig and Dalehite, and has been uniformly followed.

Red Lake Band of Chippewa Indians v. United States, 800 F.2d 1187, 1196 (D.C.Cir.1986) (footnote omitted).