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KEVAN BERKOVITZ, ET AL., PETITIONERS V. UNITED STATES OF AMERICA
No. 87-498
In the Supreme Court of the United States
October Term, 1987
On Writ of Certiorari to the United States Court of Appeals for the
Third Circuit
Brief for the United States
TABLE OF CONTENTS
Opinions below
Jurisdiction
Statutory provision involved
Statement
Polio and the Sabin vaccine
Facts and proceedings below
Summary of argument
Argument:
The discretionary function exception to the Federal
Tort Claims Act bars liability based on the
alleged negligence of the FDA in carrying out its
regulatory task of licensing vaccines and other
drugs
A. The discretionary function exception bars
claims against the government for alleged negligence
in the execution of a safety-related regulatory
program
B. The FDA licensing process is indistinguishable
from the FAA certification process for purposes
of the discretionary function exception
1. The product license
2. The lot release
C. The national childhood vaccine injury act confirms
that Congress did not intend for the FDA
to be held liable under the FTCA for injuries
caused by vaccines
Conclusion
OPINIONS BELOW
The opinion of the court of appeals (Pet. App. 1a-27a) is reported
at 822 F.2d 1322. The opinion of the district court (Pet. App.
28a-36a) is unreported.
JURISDICTION
The judgment of the court of appeals was entered on June 30, 1987.
The petition for a writ of certiorari was filed on September 25, 1987,
and was granted on January 11, 1988. The jurisdiction of this Court
is invoked under 28 U.S.C. 1254(1).
STATUTORY PROVISION INVOLVED
28 U.S.C. 2680 provides, in pertinent part:
The provisions of this chapter and section 1346(b) of this
title shall not apply to --
(a) Any claim * * * 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.
* * * * *
QUESTION PRESENTED
Whether the discretionary function exception to the Federal Tort
Claims Act, 28 U.S.C. 2680(a), bars petitioners' claims that the
government was negligent in its 1963 decision to license production of
the Sabin oral polio vaccine and in its subsequent approval of the
release of a specific lot of that vaccine.
STATEMENT
Polio and the Sabin Vaccine
Prior to 1955, poliomyelitis was a major crippler of children in
the United States and throughout the world. In 1952 alone, 57,879
cases of polio were reported in the United States, of which 21,269
cases resulted in crippling paralysis to the victims. See 77(12) Pub.
Health Rep. 1011-1020 (1962). /1/ The first major step in the
eradication of polio came with the development of the Salk
inactivated-virus vaccine, which was licensed in this country in 1955.
/2/ The Salk vaccine immediately registered great progress against
the disease, but it was not a perfect solution. A 1962 Report of the
Surgeon General recognized that "extensive use of the Salk-type,
killed-virus vaccine during the past seven years has greatly lowered
the incidence of paralytic disease but has not prevented either
sporadic cases or occasional epidemics in highly-vaccinated
communities." HEW, Revised Recommendations and Report: The Surgeon
General's Advisory Committee on Poliomyelitis Control 1 (Feb. 17,
1962) (hereinafter Surgeon General Report). After a record low of
2,499 cases of paralytic polio in 1957, the number of cases began to
increase and had more than doubled to 6,289 in 1959. Moreover, data
regarding antibody levels 2 to 4 years after inoculation with the Salk
vaccine indicated that repeated, possibly frequent, booster shots
would be required for an individual to retain immunity. Report of
Committee on Infectious Diseases, Am. Acad. of Pediatrics 47 (1966)
(hereinafter Infectious Diseases Report).
The second major breakthrough in combating the disease occurred
with the development of the Sabin oral polio vaccine which was
introduced here in the early 1960s. Unlike the Salk vaccine, the oral
vaccine contains a weakened, but live, polio virus. The Sabin vaccine
offered several advantages over the Salk vaccine. First, it induces
effective, lasting immunization without need of subsequent booster
shots. Second, it can be administered with comparative ease, since it
is taken orally instead of by injection. Third, it protects against
infection as well as disease, thereby insuring that infected persons
would not become transmitters of the wild poliovirus. Finally, and of
particular importance, the virus in the Sabin vaccine is also
communicated to persons in close contact with the vaccinee. By this
means, individuals not directly reached through the vaccination
program nevertheless receive the benefits of immunization. See
Infectious Diseases Report 47-48. Because of these advantages, the
Sabin vaccine rapidly displaced the Salk vaccine in the early 1960s.
It became "the vaccine of choice for community-wide vaccination
programs and for routine immunization in infancy and childhood" (id.
at 48). See Surgeon General Report 1. By the mid-1970s, the total
number of cases of paralytic polio reported in the United States had
declined to approximately ten to twenty per year. See Center for
Disease Control, 28(54) Morbidity and Mortality Weekly Report 12 (Nov.
16, 1984). Current figures reveal an annual average of ten cases.
Nkowane & Wassilak, et al., Vaccine-Associated Paralytic
Poliomyelitis, United States: 1973 Through 1984, 257(10) J. Am. Med.
A. 1335 (Mar. 13, 1987).
Despite this record of success, there has been continued debate
over the relative merits of the Salk and Sabin vaccines. See, e.g.,
Boffey, Polio: Salk Challenges Safety of Sabin's Live-Virus Vaccine,
196 Science 35 (1977). It has been determined that the Sabin vaccine
creates a very slight risk that the vaccinee or someone in close
contact with him will contract the disease. /3/ No similar risk
exists with the Salk vaccine, provided the virus used in the vaccine
is successfully killed. After exhaustive study, however, /4/ the
United States remains firmly committed to the Sabin vaccine. /5/
Facts and Proceedings Below
1. Petitioner Kevan Berkovitz contracted polio in June 1979 shortly
after receiving Orimune, a Sabin oral polio vaccine manufactured by
Lederle Laboratories. Berkovitz, joined by his parents as guardians,
filed suit in federal district court in December 1984 alleging that
the United States was liable for his injuries under the Federal Tort
Claims Act (FTCA) because the government was negligent in licensing
Orimune on June 25, 1963, and because the Food and Drug Administration
(FDA) was negligent in releasing the specific lot of vaccine from
which Berkovitz received his dose on May 10, 1979 (Pet. App. 4a). /6/
As to the first claim, petitioners alleged that the Division of
Biologic Standards (DBS), at that time part of the National Institutes
of Health, issued a license for Lederle's Sabin poliovirus strain when
it had not been tested in accordance with DBS's own regulations, and
that DBS failed to require Lederle to show that a particular "seed
virus" had been subjected to all required testing and had complied
with all regulatory standards. Br. 4-6; Pet. App. 4a-5a. On the
second issue, petitioners claimed that the Bureau of Biologics of the
FDA improperly issued a lot release approval, permitting the vaccine
containing Berkovitz's dose to be distributed to the public, despite
the fact that the virus in the vaccine had been tested and found to
exceed the standards for neurovirulence set forth in regulations
applicable to live polio vaccines. Br. 6-7, 20-21; Pet. App. 4a-5a.
/7/
2. The government moved to dismiss the suit as barred by the
discretionary function exception to the FTCA, 28 U.S.C. 2680(a). The
district court (Pet. App. 28a-36a) agreed that the government was
immune from two of petitioners' original claims, /8/ but nonetheless
concluded that both the licensing of Lederle to produce the vaccine
and the release of the specific vaccine lot were not "discretionary
function(s)" within the meaning of the FTCA (id. at 33a). The
district court noted that the Third Circuit had already held in
Griffin v. United States, 500 F.2d 1059 (1974), that negligent release
of a non-complying lot of polio vaccine was not a discretionary
function. The government maintained in its motion to dismiss that
Griffin had been effectively overruled by this Court's decision in
United States v. S.A. Empresa De Viacao Aerea Rio Grandense (Varig
Airlines), 467 U.S. 797 (1984). The district court declined to
consider the effect of Varig Airlines, however, noting that, as a
reported decision of the Third Circuit, Griffin was binding on the
district courts in that circuit "no matter how persuasive the
arguments may be that Griffin is no longer valid" (Pet. App. 33a).
3. At the government's request, the district court certified its
decision for immediate appeal to the Third Circuit pursuant to 28
U.S.C. 1292(b), which reversed in a divided opinion (Pet. App.
1a-27a). The court of appeals initially rejected the government's
argument that the discretionary function exception bars all claims
arising out of the regulatory activities of federal agencies (id. at
12a-15a). Concluding that it "need not treat separately the licensing
claim and the lot release claim" (id. at 15a), the court then
proceeded to analyze the question whether the government had a
nondiscretionary duty to ensure that Lederle followed regulatory
standards in the production and distribution of the Sabin polio
vaccine (ibid.).
The court of appeals canvassed the applicable regulations and noted
that, while they required the manufacturer to perform certain tests
and submit qualifying results to the government, they did not require
the government to do anything (Pet. App. 16a-18a). The court
concluded that, as in Varig Airlines, the onus was on the manufacturer
to comply with applicable safety standards, while the role of the
government agency was "'merely to police the conduct of private
individuals by monitoring their compliance with (the applicable)
regulations'" (id. at 22a (quoting 467 U.S. at 815). See Pet. App.
16a ("the safety regulations governing live polio vaccine leave at
least as much enforcement discretion to the FDA as the regulations at
issue in Varig left to the FAA").
The court of appeals also examined the statutory requirement that
licenses may be issued "only upon a showing that * * * 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" (42 U.S.C. 262(d)). The court rejected the dissent's
contention that this statute created a non-discretionary duty for the
FDA "to 'insure' compliance with its safety regulations" (Pet. App.
18a). /9/ "(T)he FDA's statutory duty," the court concluded, "is not
different in substance from the duty that the Supreme Court in Varig
found rests with the FAA" (ibid.). In both cases, the agency is left
with a policy choice as to how to construct and implement a mechanism
for compliance review. Because "neither the statute nor the
regulations mandate the FDA's choice of how to secure Lederle's
compliance" (id. at 22a), the court concluded that the discretionary
function exception bars suit for alleged negligence in the
government's performance of that role.
The court of appeals acknowledged that the allegations in this case
differ from those in Varig Airlines in that petitioners here claimed
that "the FDA exercised its discretion to verify compliance and then
negligently erred in finding compliance" (Pet. App. 20a). Petitioners
argued that "once the FDA had information that the vaccine did not
comply with the regulations, it had no discretion to approve either
the license for production or the lot for release" (ibid.). But the
court noted that "this argument is simply that the FDA acted
negligently" and "the issue of negligence is not relevant to the
discretionary function inquiry" (id. at 21a (citation and quotation
marks omitted)).
The FDA made a policy choice to attempt to monitor compliance by
manufacturers more closely than the "spot-check" review conducted by
FAA. But that policy choice does not subject an agency to liability
for "negligently fail(ing) to recognize and remove noncomplying
products" (Pet. App. 21a). An alternative holding, the court stated,
"would inhibit the agency's selection of the mechanism for compliance
review" and "(t)his is precisely what Varig instructs us not to do"
(ibid.). "It follows," the court concluded, "that when the FDA makes
the discretionary choice to examine or test samples which it has
discretion not to test, it cannot be held liable for subsequent
negligence at the operational level in implementing its decision to
test" (ibid.).
SUMMARY OF ARGUMENT
The Food and Drug Administration (FDA) has a general mandate to
construct and implement a licensing program for vaccines and other
prescription drugs. Its role is two-fold: it fashions standards of
safety, potency and purity that any such product must meet and it
polices compliance with those standards through licensing and
inspections. As with other regulatory programs, however, the primary
burden of compliance with FDA regulations (and, consequently, any
responsibility for non-compliance) rests upon the manufacturer. The
FDA's activities as a policeman of private conduct are accordingly
protected from suit by the discretionary function exception to the
FTCA. As this Court noted in Varig Airlines, 467 U.S. at 821,
regulatory agencies have "a statutory duty to promote safety" in the
industries they regulate, "not to insure it."
Petitioners contend that when licensing and inspection activities
are governed by mandatory regulations and an agency negligently
violates its own regulations in issuing a license or conducting an
inspection, the discretionary function exception does not apply.
There are three related flaws in this argument. First, it ignores the
wording of the discretionary function exception, which protects agency
functions, not individual acts, and which precludes liability whether
or not the government has acted negligently by breaching one of its
own regulations. The FDA's "implementation of a mechanism for
compliance review is plainly discretionary activity of the 'nature and
quality' protected by Section 2680(a)" (Varig Airlines, 467 U.S. at
819), and the discretionary function exception shields from liability
"both negligence and wrongful acts in the exercise of discretion."
Dalehite v. United States, 346 U.S. 15, 33 (1953). Second, it largely
eliminates the protection of regulatory functions -- thereby
frustrating the prime motivation for the discretionary function
exception -- because tort claims can almost always be couched in terms
of mandatory duties left unperformed. What was intended as a bar to
suit would become merely a rule of pleading. Third, contrary to
Congress's express intention, it interjects tort considerations into a
regulatory agency's fundamental policy decision on how specifically to
write its regulations (and, hence, how carefully to regulate private
industry) by providing agencies with a strong incentive towards
vagueness and a lack of guidelines for inspectors. "When an agency
determines the extent to which it will supervise the safety procedures
of private individuals, it is exercising discretionary regulatory
authority of the most basic kind." Varig Airlines, 467 U.S. at
819-820.
As a general principle, therefore, safety-related licensing and
inspection activities are shielded from suit by the discretionary
function exception regardless of claims that the agency in question
has violated its own regulations. In any event, petitioners are
unsuccessful in their attempt to portray the FDA's regulations as
imposing mandatory duties on FDA employees. In fact, the burden of
compliance in each instance cited by petitioners is placed squarely on
the private manufacturer. The regulations require the manufacturer to
perform certain tests and submit qualifying data to the FDA prior to
using a particular seed virus in its vaccine or prior to releasing a
lot of vaccine. But the regulations impose no duties on the FDA to
perform any tests on its own; nor do the regulations indicate the
extent to which FDA must review the data submitted to ensure
compliance. A decision to redo certain tests or examine certain test
results is clearly "discretionary regulatory authority of the most
basic kind" (Varig Airlines, 467 U.S. at 820). Petitioners claim that
the FDA performed this function negligently, thereby permitting
release of a noncomplying lot; but clearly the discretionary function
exception bars suit for alleged "negligence and wrongful acts in the
exercise of the discretion" (Dalehite, 346 U.S. at 33). Thus, "when
the FDA makes the discretionary choice to examine or test samples
which it has discretion not to test, it cannot be held liable for
subsequent negligence at the operational level in implementing its
decision to test" (Pet. App. 21a).
The FDA has not been delegated any authority by Congress to turn
itself into an insurer of the industry it regulates. Congress knows
how to set up an insurance program for a regulated industry when it
wants to, and when it does so the program looks very different from an
ordinary regulatory scheme. We know that because in 1986 Congress
passed just such a program in the National Childhood Vaccine Act of
1986. The Act establishes a National Vaccine Injury Compensation
Program that is intended to provide an exclusive remedy for
vaccine-related injuries. An essential premise of that program is
that persons injured by vaccines have no tort remedy against the
United States for licensing the vaccines. For the Court now to
overlay this insurance scheme with tort liability under the FTCA would
wholly distrupt the compensation scheme in the Act as well as
Congress's attempt to fund the program with a minimum drain on the
public fisc.
ARGUMENT
THE DISCRETIONARY FUNCTION EXCEPTION TO THE FEDERAL TORT CLAIMS ACT
BARS LIABILITY BASED ON THE ALLEGED NEGLIGENCE OF THE FDA IN CARRYING
OUT ITS REGULATORY TASK OF LICENSING VACCINES AND OTHER DRUGS
No biological product "applicable to the prevention, treatment, or
cure of diseases or injuries of man" may be sold in the United States
that has not been "propagated or manufactured and prepared at an
establishment holding an unsuspended and unrevoked license, issued by
the Secretary (of Health and Human Services) as hereinafter
authorized, to propagate or manufacture, and prepare such" product (42
U.S.C. 262(a)). This federal regulation of vaccines and other
biological products for human use was first enacted in 1902, Act of
July 1, 1902, ch. 1378, 32 Stat. 728, and later revised in 1944 as
part of the recodification of the Public Health Service Act, ch. 373,
Section 351, 58 Stat. 702.
The Act of July 1, 1902 did not specify any standards to govern the
licensing of biological products (which, under the Act, was the
ultimate responsibility of the Secretary of the Treasury). /10/ The
Act simply provided that "the Surgeon-General of the Army, the
Surgeon-General of the Navy, and the supervising Surgeon-General of
the Marine-Hospital Service, be, and they are hereby, constituted a
board with authority, subject to the approval of the Secretary of the
Treasury, to promulgate from time to time such rules as may be
necessary in the judgment of said board to govern the issue,
suspension, and revocation of licenses for the maintenance of
establishments for the propagation and preparation of viruses, serums,
toxins, antitoxins, and analogous products, applicable to the
prevention and cure of diseases of man" (Section 4, 32 Stat. 729). In
1944 Congress offered more specific guidance (42 U.S.C. 262(d)):
Licenses for the maintenance of establishments for the
propagation or manufacture and preparation of products described
in subsection (a) of this section 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. All
such licenses shall be issued, suspended, and revoked as
prescribed by regulations * * * .
Petitioners and the dissent below argue that this statutory
language imposes a "non-discretionary" duty on the FDA to guarantee
compliance by manufacturers with all regulatory standards prior to
issuing a license (see Br. 15-16, 19; Pet. App. 25a-26a). This
argument is clearly untenable. Section 262 is simply a general
mandate to construct a regulatory licensing program. In supporting
enactment of the section, the Committee Report to the Public Health
Act explained that "Subsection (d) would furnish criteria, not
expressed in the present law, to guide administrative action in the
issuance of licenses." H.R. Rep. 1364, 78th Cong., 2d Sess. 23 (1944)
(emphasis added). Congress thus established the general areas --
"safety, purity, and potency" -- within which the FDA was to
promulgate regulations for biological products. /11/ But the precise
nature of those regulations and, hence, the standards for safety,
purity and potency as well as the manner in which a manufacturer may
demonstrate compliance with the standards was left completely to the
discretion of the agency. Like the regulatory scheme at issue in
Varig, the FDA's choice and "implementation of a mechanism for
compliance review is plainly discretionary activity of the 'nature and
quality' protected by Section 2680(a)." Varig Airlines, 467 U.S. at
819. The court of appeals therefore correctly concluded that the
FDA's statutory instruction to establish standards and police
compliance, like the analogous statute considered in Varig Airlines,
is not "the type of mandate that makes the discretionary function
analysis inapplicable" (Pet. App. 20a).
The statute itself therefore does not deny the FDA discretion in
determining whether to license Lederle to produce the Sabin vaccine.
Petitioners accordingly devote the bulk of their brief to their
contention that the regulations promulgated by the FDA create a
mandatory, nondiscretionary duty on the part of FDA employees to
ensure compliance with the standards contained therein. It is our
contention that the FDA regulations governing the oral polio vaccine,
like the FAA regulations at issue in Varig Airlines, place no such
mandatory duty on the regulating agency. In both cases the ultimate
burden of compliance rests with the manufacturer, and the regulations
create no duty enforceable against the agency by a tort action. We
believe that this is demonstrable by reference to the particular
regulations in issue (see pp. 28-40, infra). More generally, however,
we submit that the discretionary function exception bars any and all
claims against the government for alleged negligence in the
implementation of a safety-related regulatory program.
A. The Discretionary Function Exception Bars Claims Against The
Government For Alleged Negligence In The Execution Of A Safety-Related
Regulatory Program
1. The FTCA waived the sovereign immunity traditionally enjoyed by
the United States against tort suits. See 28 U.S.C. 1346(b) and 2674.
This waiver of immunity was considered to be a "radical innovation,"
however, prompting Congress to move cautiously. Tort Claims Against
the United States: Hearings on H.R. 7236 Before Subcomm. No. 1 of the
House Comm. on the Judiciary, 76th Cong., 3d Sess. 22 (1940).
Congress only wanted to make the federal government amenable to suit
for "ordinary common-law torts." Dalehite, 346 U.S. at 28 (footnote
omitted). The legislative history of the FTCA, therefore, is
substantially devoted to discussions regarding the need to supply a
judicial remedy for automobile accidents involving government
employees who drive negligently in the course of their employment.
/12/ See Kosak v. United States, 465 U.S. 848, 855 (1984) (footnote
omitted) ("One of the principal purposes of the Federal Tort Claims
Act was to waive the Government's immunity from liability for injuries
resulting from auto accidents in which employees of the Postal Service
were at fault.").
Congress did not intend to extend the FTCA to suits against the
United States based on "that class of tort on the part of the
Government which has to do with a governmental function, so to speak."
86 Cong. Rec. 12021 (1940) (remarks of Rep. Gwynne). Accordingly,
Congress placed a number of significant limitations on the types of
tort suits that could be brought against the United States. See 28
U.S.C. 2680(a)-(n). "One only need read Section 2680 in its entirety
to conclude that Congress exercised care to protect the Government
from claims, however negligently caused, that affected the
governmental functions." Dalehite, 346 U.S. at 32. See Kosak v.
United States, 465 U.S. at 858 (one of the principal objectives of the
enumerated exceptions in Section 2680 was "ensuring that 'certain
governmental activities' not be disrupted by the threat of damages
suits"). /13/
The most important (see H.R. Rep. 1287, 79th Cong., 1st Sess. 5-6
(1945)) of the limitations on the types of torts suits that may be
brought against the United States is that embodied in 28 U.S.C.
2680(a), barring actions "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." This "discretionary
function exception," as it is commonly called, "marks 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." Varig Airlines, 467 U.S. at
808.
The boundary is not always clearcut. Where direct government
conduct is in issue -- as where the government produces a product
(e.g., a bridge built by the Army Corps of Engineers) or provides a
service (e.g., fire fighting by the Forest Service), the negligent
performance of that conduct may bring about injuries that would be
actionable under state law if similarly caused by a private person.
Where such actions flow from discretionary policy judgments, however,
they are immune from FTCA attack under the discretionary function
exception. Dalehite, 346 U.S. at 35-36. The precise limits of that
protection are not susceptible to easy definition, and this Court has
generally avoided speaking in broad terms. Varig Airlines, 467 U.S.
at 813; Dalehite, 346 U.S. at 35-36.
The Court has, however, indicated that where the government is not
the primary actor, but acts as a regulator of private conduct,
demanding compliance with regulatory standards, the discretionary
function exception precludes liability altogether. In Dalehite, the
Court referred to Section 2680(a) simply as "the governmental
regulatory function exception from suits" (346 U.S. at 26). The
dissent in Dalehite was even more emphatic in stressing that "what was
meant (by the exception) is the type of discretion which government
agencies exercise in regulating private individuals" (346 U.S. at 58
n.12 (Jackson, J., dissenting)). And in Varig Airlines, 467 U.S. at
813-814, the Court noted that "whatever else the discretionary
function exception 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." /14/
Indeed, protection for regulatory activities seems to have been the
prime motivation of Congress in creating this exception. The FTCA was
the product of more than two dozen different bills introduced since
1923. See United States v. Spelar, 338 U.S. 217, 219-220 (1949).
Many of the earlier bills contained specific exceptions from liability
that "were couched in terms of specific spheres of federal activity,
such as postal service, the activities of the Securities and Exchange
Commission, or the collection of taxes." Dalehite, 346 U.S. at 26
(footnote omitted). See, e.g., Section 303(7) of S. 2690, 76th Cong.,
1st Sess. (1939) and Section 303(7) of H.R. 5299, 77th Cong., 1st
Sess. (1941) (exempting claims arising from enforcement activities of
the Federal Trade Commission and the Securities Exchange Commission).
The 77th Congress -- in whose work the meaning of the exception "shows
most clearly" (Dalehite, 346 U.S. at 26) -- removed the exemptions
granted to specific agencies and expanded the exception to include all
discretionary functions. Varig Airlines, 467 U.S. at 809. Congress
made the change with the declared intent to bar all claims against
federal agencies growing out of their regulatory activities. "It was
considered unnecessary to except by name such agencies as the Federal
Trade Commission and the Securities and Exchange Commission, as had
earlier bills, because the language of the discretionary function
exception would 'exemp(t) from the act claims against Federal agencies
growing out of their regulatory activities.'" Varig Airlines, 467 U.S.
at 810 (quoting from Staff of the House Comm. on the Judiciary, 77th
Cong., 2d Sess., Federal Tort Claims Act, Memorandum, With Appendices,
Explanatory of Comm. Print of H.R. 5373, at 8 (Comm. Print 1942)
(emphasis added by Court)).
The rationale for this protection for regulatory functions is
two-fold. First, the actions of a government agency in enforcing
health and safety legislation pursuant to a program of inspection and
licensure have no counterpart in the private sector. Unlike private
testing labortories, which certify the quality of a product at the
request and for the benefit of a particular consumer, /15/ the
government inspects and licenses or certifies for the purpose of
protecting the general public by eliminating defective or dangerous
instrumentalities from the channels of interstate commerce. Thus,
government regulation of private industry is precisely the sort of
core governmental function for which Congress expressly intended to
preserve immunity.
Second, the potential liability of the United States for failure to
uncover defects or improprieties pursuant to regulatory inspections is
staggering. Numerous agencies of the federal government have
inspection and/or licensing authority and virtually every business
that engages in interstate commerce is subject to some form of
federally-administered licensing or certification requirement. To
name just a few, the Nuclear Regulatory Commission inspects nuclear
reactors (42 U.S.C. 2201(o)), the FDA inspects and certifies the
safety of food as well as drugs (21 U.S.C. 374), the Federal Deposit
Insurance Corporation inspects the financial records of
federally-insured banks (12 U.S.C. 1817), the Occupational Safety and
Health Administration inspects the safety and health conditions of
most work environments (29 U.S.C. 657), and the Mine Safety and Health
Administration inspects the safety and health conditions of mines (30
U.S.C. 813). /16/ It is implausible in the extreme that Congress,
while enacting the FTCA with an intention to proceed cautiously and
protect from suit certain core governmental functions, meant to waive
sovereign immunity for claims based on such administrative inspection
and licensing activities. /17/
2. In Varig Airlines, the plaintiffs sought to hold the United
States liable for alleged negligence of the FAA in inspecting
airplanes to check compliance with regulatory standards. This Court
held that the FAA's program of conducting safety inspections, with the
primary burden placed on the manufacturer to ensure compliance, "falls
squarely within the discretionary function exception" (467 U.S. at
820). "By fashioning an exception for discretionary governmental
functions," the Court stated, "including regulatory activities,
Congress took 'steps to protect the Government from liability that
would seriously handicap efficient government operations.'" Id. at 814
(quoting United States v. Muniz, 374 U.S. 150, 163 (1963)).
The principal lesson of Varig Airlines is that federal regulatory
agencies have "a statutory duty to promote safety" in the industries
they regulate, "not to insure it" (467 U.S. at 821 (emphasis in
original)). Most courts have heeded this Court's injunction not to
turn agency efforts to enhance safety into government insurance of
regulated industries. /18/ Several cases decided after Varig
Airlines, however, have imposed liability on the government for
negligence in conducting safety compliance checks. See Collins v.
United States, 783 F.2d 1225 (5th Cir. 1986) (decision by Mine Safety
and Health Administration to rescind an "Imminent Danger Order" and
not to reclassify mine as "gassy" after inspection revealed high
methane levels); National Carriers, Inc. v. United States, 755 F.2d
675 (8th Cir. 1985) (failure of meat inspector to require
condemnation, tagging and separation of contaminated beef); McMichael
v. United States, 751 F.2d 303 (8th Cir. 1985) (failure of Defense
Department inspectors to enforce safety requirements on defense
contractor). These courts distinguished Varig Airlines because the
inspectors in question had no discretion not "to enforce the detected
violations of the safety requirements" (McMichael, 751 F.2d at 307;
see Collins, 783 F.2d at 1230-1231).
Petitioners argue (Br. 9, 13-14), in reliance on such cases, that
when licensing and inspection activities are governed by mandatory
regulations and an agency violates its own regulations in issuing a
license or conducting an inspection, then the discretionary function
exception does not apply. A regulatory agency is therefore liable as
an insurer, petitioners assert, for the harm caused by any product
granted a license or any hazard not detected in an inspection because
of a failure to follow such "mandatory regulations."
That specific issue was not directly addressed in Varig Airlines.
But the answer is nonetheless clear. The wording of the regulations
does not change their essential nature, which is to promote safety by
policing compliance. The operational burden (and, hence, the burden
of negligence) remains with private industry. Allegations that the
policeman has failed to do his job, however specifically defined, do
not change his essential role from that of regulator to that of
insurer. /19/
More specifically, there are three related flaws with petitioners'
argument. First, it ignores the wording of the discretionary function
exception, which precludes liability whether or not the government has
acted negligently by breaching one of its own regulations. Second, it
largely eliminates the protection of regulatory functions -- thereby
frustrating the prime motivation for the discretionary function
exception -- because tort claims can almost always be couched in terms
of mandatory duties left unperformed. Third, contrary to Congress's
express intention, it interjects tort considerations into a regulatory
agency's fundamental policy decision on how specifically to write its
regulations (and, hence, how carefully to regulate private industry)
by providing agencies with a strong incentive to avoid clear
directives for enforcement personnel.
(i) The applicability of the discretionary function exception is
determined by whether the agency function in question is
discretionary. If it is, then the function is protected regardless of
allegations of negligence or other wrongful acts. Section 2680(a)
contains two separate provisions, presented in the disjunctive. The
first half of Section 2680(a) precludes liability for any "act or
omission of any employee of the Government, exercising due care, in
the exception of a statute or regulation * * * ." No similar
requirement -- of due care in the execution of a statute or regulation
-- limits the second provision, the discretionary function exception.
The crucial inquiry in any case under the discretionary function
exception, therefore, is not whether an agency inspector acted wrongly
or negligently. Were that the test, the discretionary function
exception would provide little protection, since it is usually the
case that individual employees lack discretion to perform negligently
or violate agency regulations. But what is at issue is the
fundamental character of the function being performed. Licensing,
certification and inspection are paradigms of discretionary functions
as Congress understood that term. It follows that no liability may
attach to those functions despite claims that the employees carrying
them out disobeyed agency regulations or were otherwise negligent.
/20/
Petitioners here do not argue that the licensing of the Sabin
vaccine was negligent in the sense that its benefits do not outweigh
its costs. /21/ Rather, they are arguing that DBS (the predecessor of
FDA's Bureau of Biologics) was negligent per se because DBS failed, in
violation of its own regulations, to require submission by the
manufacturer of certain qualifying test results prior to licensing the
vaccine. If DBS violated its own regulations, then DBS may well have
acted wrongly or negligently. But the discretionary function
exception shields from liability "both negligence and wrongful acts in
the exercise of the discretion." Dalehite, 346 U.S. at 33.
(ii) To permit FTCA suits to be brought against regulatory agencies
for their licensing, certification and inspection activities whenever
it is alleged that a particular licensing or certification decision
was reached or a particular inspection conducted in violation of
agency regulations would transform the discretionary function
exception from a bar to suit into a rule of pleading. Plaintiffs
would merely be required to couch their pleadings in terms not of
negligence -- which is protected by the exception -- but in terms of a
violation of the regulations governing some employee's actions.
In most cases, it will be possible to break a particular regulatory
action down into component parts and identify some element that
arguably violates an applicable regulatory requirement. Litigation of
the merits of such an assertion -- concluding in a finding of
liability if the assertion is borne out -- would completely defeat the
purpose of the discretionary function exception, which was to bar from
the outset such challenges to the performance of discretionary
governmental functions through the medium of an action in tort. Other
remedies exist for a government agency's alleged breach of its
statutory and regulatory obligations. /22/ "The purpose of the FTCA
is to provide individuals with a means of obtaining tort damages from
the United States for injuries negligently inflicted by U.S. employees
or agents, and it should not be used to solve the entirely separate,
modern problem of alleged bureaucratic inaction and ineptitude."
Baxley v. United States, 767 F.2d 1095, 1098 (4th Cir. 1985).
(iii) The injection of a tort remedy as a means of challenging
regulatory action would create incentives that are particularly
disruptive of certain sorts of regulatory activity. It would motivate
agencies to avoid as much as possible regulations imposing mandatory
duties on their own employees because such duties might serve as the
basis for government tort liability. In many instances, this may
greatly impair the effectiveness of the regulatory program.
In view of local pressures to keep mines open, for example,
effective protection of the nation's miners may warrant mandatory
regulations that direct subordinates to shut down mines or issue
citations in certain specifically-defined circumstances. See Collins
v. United States, supra. But if the discretionary function exception
does not include all such activity within its ambit, regulators will
have a significant disincentive to adopt such regulations. And this
disincentive will be strongest in areas where such regulation is
needed the most, areas in which the danger (and, hence, the potential
liability) is greatest.
If licensing, certifications, and inspections are not completely
covered by the discretionary function exception, those administering
regulatory programs will be faced with the unpalatable choice of
avoiding mandatory regulations, and thus rendering their programs less
effective, or accepting the consequences in increased tort liability.
Yet the discretionary function exception was specifically designed to
permit a regulatory agency to fulfill its mission in the most
effective manner without subjecting the United States to tort
liability. Whether regulations should be written tightly or loosely,
and how an agency may best ensure performance by its own employees and
by the industry it regulates, are policy questions that the agency
should be able to resolve without fear of damaging tort liability.
See Varig Airlines, 467 U.S. at 819-820. If the Court's reading of
Section 2680(a) causes agency heads to propose regulations that eschew
direct governmental testing when such testing would be in the national
interest, then the exception is clearly not working as intended.
In sum, we submit that Congress did not intend to expose the United
States to monetary liability -- essentially as an insurer -- in
connection with its role in licensing and inspecting private parties
who fail to comply with mandatory health and safety requirements.
Congress knows how to make the United States an insurer of a regulated
industry when it wants to. See Section C, infra (discussing the
National Vaccine Compensation Act). When it has not done so
expressly, an agency cannot turn itself into an insurer of the
industry it regulates simply by the wording of its regulations.
B. The FDA Licensing Process Is Indistinguishable From The FAA
Certification Process For Purposes Of The Discretionary Function
Exception
Even if the Court were to conclude that an agency's alleged
violation of its own regulations governing licenses and inspections
could give rise to a cause of action under the FTCA, the judgment
below should still be affirmed. No violation of the regulations can
be made out on the facts alleged by petitioners because the
regulations at issue here do not impose mandatory duties on the FDA.
/23/ FDA regulations governing the licensing of vaccines, like FAA
regulations governing the certification of aircraft, place the primary
burden of compliance on the manufacturer. The method, mode and extent
of compliance review is left by the regulations to the discretion of
FDA. This is true both for the product license issued to Lederle and
for the release of the vaccine lot from which petitioner received his
dose.
1. The Product License
Two sets of regulations govern the licensing of a poliovirus
vaccine. First, there are generic regulations applicable to all
product licenses (42 C.F.R. 73.1-73.83 (1963); 21 C.F.R.
600.3-601.26, 610.1-610.65). /24/ Second, there are specific
regulations that set the standards any live, oral poliovirus vaccine
must meet (42 C.F.R. 73.110-73.118; 21 C.F.R. 630.10-630.17). The
generic regulations provide that "(a) product license shall be issued
only upon examination of the product and upon a determination that the
product complies with the standards prescribed in the regulations" (42
C.F.R. 73.5(a); 21 C.F.R. 601.4(a)). /25/
Petitioners contend (Br. 16) that this provision imposes a
mandatory duty that gives "agency employees no authority to exercise
policy judgment in determining whether the conditions of licensing
were met." However, this regulation does not, any more than the
general statute (see 12-14, supra), specify either the nature of the
"examination" to be conducted by DBS or the procedures to be used by
DBS in making a "determination" that the product complies with the
regulatory standards.
The regulations do not place any burden on DBS to conduct tests on
the proposed product. To the contrary, the burden is squarely on the
manufacturer to "submit data derived from laboratory and clinical
studies which demonstrate that the manufactured product meets
prescribed standards of safety, purity and potency" (42 C.F.R. 73.3;
21 C.F.R. 601.2(a)). /26/ What DBS then does with that data --
whether it duplicates certain tests, or painstakingly reviews the data
for compliance, or simply spotchecks the application -- is left to the
agency's discretion. The regulations do specifically provide that the
Surgeon General, when he deems it advisable "in matters involving the
safety, purity and potency of * * * products for which an application
for license is pending," may appoint a special board of three officers
to review the "reports of inspection and laboratory examinations,
together with any pertinent data the establishment may submit" (42
C.F.R. 73.12). The open-ended review process, of which this procedure
is a part, clearly calls for considerable judgment on the part of the
agency both in setting the standards and in policing compliance. /27/
Petitioners must therefore look to the specific regulations
governing the oral polio vaccine to make their case that DBS violated
mandatory regulations in granting Lederle a product license.
Accordingly, petitioners allege (Br. 4-5), first, that DBS licensed
the poliovirus strain used by Lederle even though "the strain violated
the conditions for licensing prescribed in the regulations." Second,
petitioners contend (Br. 5-6) that DBS licensed the particular "seed
virus" used by Lederle to produce its vaccine without requiring
Lederle to show that the "seed virus" had been subjected to all
required testing and complied with all regulatory standards.
Petitioners are confused on both counts. Contrary to their
assertions (Br. 4-5), a license is not issued for the original
poliovirus strain itself. Nor are seed viruses individually licensed.
Rather, a product license is issued to a manufacturer to produce a
vaccine using a particular poliovirus strain that has been found to
meet the criteria for acceptable strains set out in 42 C.F.R.
73.110(b)(2) (21 C.F.R. 630.10(b)(2)). The poliovirus strain at issue
here, and the only live poliovirus strain found acceptable for use in
the United States, is the strain developed by Dr. Sabin. The Sabin
strain is not produced by the manufacturer. Rather, it is obtained
directly from Dr. Sabin.
Once the manufacturer obtains the original virus strain from Dr.
Sabin, it grows a seed virus from that strain. The seed virus is in
turn used to produce the monopools from which portions are combined to
make up the actual vacine ingested by the public. But the seed virus
is not separately licensed. Rather, manufacturers are simply
forbidden by the regulations to use any seed virus without first
performing certain prescribed tests to ensure that the neurovirulence
of the seed virus "is no greater than that of the * * * Reference
Attenuated Poliovirus" distributed by the agency. 42 C.F.R.
73.110(b)(4); 21 C.F.R. 630.10(b)(4).
Accordingly, petitioners' claims must be slightly recast. They
apparently intend to argue that DBS should not have granted Lederle a
product license for Orimune because, first (Br. 4), the original Sabin
strain never met the criteria for acceptable strains set out in 42
C.F.R. 73.110(b)(2), and, second (Br. 5), a seed virus to be used by
Lederle -- production seed 45-B-85 -- "had not been subjected to the
neurovirulence testing required by" 42 C.F.R. 73.110(b)(4). Neither
allegation, however, supports petitioners' contention that DBS
violated a nondiscretionary regulatory requirement. /28/
The Sabin Strain. 42 C.F.R. 73.110(b) establishes "(c)riteria for
acceptable strains" of attenuated poliovirus. It provides, inter
alia, that "(p)oliovirus strains shall not be used in the manufacture
of Poliovirus Vaccine, Live, Oral, unless * * * data are submitted to
the Surgeon General which establish that each such strain is free of
harmful effect upon administration in the recommended dosage to at
least 100,000 people susceptible to poliomyelitis, under circumstances
where adequate epidemiological surveillance of neurological illness
has been maintained" (42 C.F.R. 73.110(b)(2)). /29/ Petitioners
allege (Br. 4) that DBS violated this regulation because "(t)he
application submitted to DBS demonstrated that the virus strain for
which a license was sought caused paralysis in the human test
population and was not, therefore, 'without harmful effect.'"
Even assuming, arguendo, that this regulation constitutes a
mandatory direction to the Surgeon General not to grant a license
without first receiving data qualifying the strain (rather than, as
the words expressly state, a direction to the manufacturer not to
"use( )" a strain for which such data have not been "submitted"),
there is a major flaw in petitioners' argument. The Sabin strain was
found acceptable for use in the United States based on data reviewed
by a specially appointed committee of scientists eight months before
the regulation in question (which was designed to state the
requirements any new strain would have to meet) was promulgated and
almost three years before Lederle was licensed to produce a vaccine
using that strain. See Polio Vaccines: Hearings Before a Subcomm. of
the House Comm. on Interstate and Foreign Commerce, 87th Cong., 1st
Sess. 346 (1961) (hereinafter Hearings) (statement of Surgeon General
Burney). Under these circumstances, new data on the Sabin strain
clearly were not required by the regulations.
In June 1958, Surgeon General Burney appointed a committee of six
experts to examine the data available from field and laboratory
studies on live poliovirus vaccine, recommend an acceptable strain for
use in such a vaccine, and propose licensing requirements. See
Hearings 328 (first report of the Public Health Service Ad Hoc
Committee on Live Poliovirus Vaccine). At that time, three different
strains of live virus had been developed and were being tested in
vaccines throughout the world: the Sabin strain, the Cox strain and
the Koprowski strain. Based on field experience with all the
candidate strains, on August 19, 1960, the Committee recommended that
the Sabin Strain, Types I, II and III (corresponding to the three
types of the polio virus) be selected for use in the United States.
In world-wide tests over 100 million people had received vaccines
produced from the Sabin strain without significant adverse effects.
See id. at 36 (statement of Dr. Murray); id. at 332 (second report of
the Public Health Service Ad Hoc Committee on Live Poliovirus Vaccine)
("No evidence had been reported to indicate that any of these vaccines
produced any harm to these individuals to whom they were
administered"). /30/ Accordingly, on August 24, 1960, Surgeon General
Burney announced that the Sabin strain had been found "suitable for
use in the United States." Id. at 346 (statement of Surgeon General
Burney).
Dr. Roderick Murray, the Director of DBS, was a member of the
Committee. The Committee worked closely with DBS in drafting
regulations to govern the licensing of the live poliovirus vaccine.
Although the Sabin strain alone had been found acceptable among the
three candidates then known, DBS did not foreclose, and indeed
encouraged, the possibility that a fourth strain would be developed.
Hearings 347 (statement of Surgeon General Burney). Accordingly,
instead of writing regulations that simply approved the Sabin strain
for use in vaccines, the Committee drafted generic requirements that
any new candidate would have to meet. These requirements were
specifically written to reflect the criteria by which the Sabin strain
had been evaluated, and which the Committee determined had been met by
that strain. See Hearings 333 (second Committee Report recommending
approval of Sabin strain contains same proposal as finally adopted for
judging future strains based on "(f)reedom from harmful effects").
/31/ Petitioners' contention that the Sabin vaccine itself does not
meet the criteria drafted with it in mind is thus wholly untenable.
/32/
Furthermore, even if the regulations had not been written by a
committee of experts to match the data already on hand concerning the
Sabin strain, the phrase "without harmful effect" is clearly a
wide-open term requiring considerable scientific and policy judgment
as to what constitutes an acceptable risk under the circumstances.
Petitioners' contention that the Sabin strain is unsafe is an attack
on the most fundamental scientific/policy decision made by the Surgeon
General on advice of the Committee. In effect, petitioners want a
chance to enter the Salk/Sabin debate on the side of Salk and to hold
the government liable for coming out the other way. That is precisely
the sort of "judicial 'second-guessing' of legislative and
administrative decisions grounded in social, economic, and political
policy through the medium of an action in tort" that Congress was at
pains to prevent. Varig Airlines, 467 U.S. at 814.
Seed Virus 45-B-85. Petitioners allege (Br. 5) that DBS should not
have issued Lederle a product license for Orimune because a seed virus
used by Lederle -- production seed 45-B-85 -- was never "subjected to
the neurovirulence testing required by the regulations." /33/
Petitioners, however, have ignored the language of the regulations,
which do not place any burden on DBS employees to conduct tests
themselves on the seed viruses used in the manufacture of the vaccine
or to obtain such results from the manufacturer prior either to
licensing the product or to approving the use of a particular seed
virus. Rather, the poliovirus regulations (like the generic
regulations discussed at 29-31, supra) are aimed directly at the
manufacturer. They state that "(n)o seed virus shall be used for the
manufacture of poliovirus vaccine unless its neurovirulence in Macaca
monkeys is no greater than that of the NIH Reference Attenuated
Poliovirus." 42 C.F.R. 73.110(b)(4) (emphasis added); 21 C.F.R.
630.10(b)(4). The regulations further specify in detail the "tests to
be performed by the manufacturer" to demonstrate "the neurovirulence
of the seed virus" (ibid.). "Subsequent and identical neurovirulence
tests" must be peformed by the manufacturers "upon introduction of a
new production seed lot and as often as necessary otherwise to
establish to the satisfaction of the Surgeon General that the seed
virus strains for vaccine manufacture have maintained their
neurovirulence properties" (42 C.F.R. 73.110(b)(5); 21 C.F.R.
630.10(b)(5)). The regulations nowhere purport to limit the
discretion of, or impose mandatory duties on, the Surgeon General by
specifying what he must do before he can be "satisf(ied)" that a
particular seed virus meets the requirements.
As the court of appeals here stated (Pet. App. 18a n.6), in taking
issue with the Ninth Circuit's decision in Baker v. United States, 817
F.2d 560 (1987), /34/ "(w)e do not agree * * * that the FDA is under a
duty to require submission of test data. Rather, the duty to submit
test data rests with the manufacturer." The Ninth Circuit inferred
from the detail of FDA's safety requirements that the agency had
exercised its administrative discretion in favor of exhaustive
inspection designed to guarantee the safety of vaccines. But the
purpose of the detailed standards is to guide manufacturers in
producing safe vaccines; the standards do not lessen the FDA's
inherent discretion to decide how to allocate its resources in
attempting to enforce the regulations or shift the burden to the FDA
to guarantee compliance. Accordingly, an alleged failure by the
agency to ensure that the manufacturer submitted test results, as
required by the regulations, cannot form the basis for an FTCA suit.
/35/ "When an agency determines the extent to which it will supervise
the safety procedures of private individuals, it is exercising
discretionary regulatory authority of the most basic kind" (Varig
Airlines, 467 U.S. at 819-820).
2. The Lot Release
Petitioners' final allegation (Br. 6-7, 20-21) is that the FDA
wrongfully released the specific lot of vaccine from which Kevan
Berkovitz received his dose on May 10, 1979. Petitioners acknowledge
(Br. 20-21) that the regulations place the burden directly on the
manufacturer "to test each vaccine lot for compliance with prescribed
neurovirulence criteria and to submit the test results to the agency."
They note, however (Br. 21), that the FDA is "empowered" to prevent
distribution of a noncomplying lot. Petitioners contend (Br. 7) that
the data submitted by the manufacturer concerning the particular
vaccine lot in question here revealed excessive neurovirulence and
that independent agency tests "confirmed that the vaccine exceeded the
regulatory standards." /36/ Under these circumstances, petitioners
argue, the agency had a mandatory duty not to release the noncomplying
lot.
As the court of appeals correctly noted (Pet. App. 20a-21a),
petitioners are simply arguing that release of the lot, under these
circumstances, was negligent or otherwise wrongful. The discretionary
function exception, however, shields from liability "both negligence
and wrongful acts in the exercise of the discretion." Dalehite, 346
U.S. at 33. The crucial point is that the FDA is exercising
discretion when it decides to examine test results or to conduct its
own tests. Failure to block release of a noncomplying product
following such an examination may be an abuse of that discretion --
see ibid. 346 U.S. at 33 ("The exercise of discretion could not be
abused without negligence or a wrongful act") -- but Section 2680(a)
precludes suit "whether or not the discretion involved be abused."
The FDA should not be held to a higher standard -- as a guarantor
of compliance -- because it elected to do more than "spot-check"
compliance. An alternative holding, as the court of appeals noted
(Pet. App. 21a), "would inhibit the agency's selection of the
mechanism for compliance review" and "(t)his is precisely what Varig
instructs us not to do." The court of appeals therefore correctly
concluded (ibid.) "that when the FDA makes the discretionary choice to
examine or test samples which it has discretion not to test, it cannot
be held liable for subsequent negligence at the operational level in
implementing its decision to test." The ultimate responsibility for
ensuring that a vaccine complies with regulatory requirements rests
with the manufacturer, /37/ and FDA does not relieve the manufacturer
of, or itself assume, that responsibility however "methodically (FDA)
examine(s) test results or test(s) vaccine samples" (Pet. App. 21a).
C. The National Childhood Vaccine Injury Act Confirms That Congress
Did Not Intend For The FDA To Be Held Liable Under The FTCA For
Injuries Caused By Vaccines
Nothing in the Public Health Service Act remotely shows a
Congressional intent to make the FDA an insurer of vaccines and other
drugs, and the FDA has not been delegated any authority to turn itself
into such an insurer by the wording of its regulations. Congress
knows how to set up an insurance program for a regulated industry when
it wants to, and when it does so the program looks very different from
an ordinary regulatory scheme. We know that, because in 1986 Congress
passed just such a program in the National Childhood Vaccine Injury
Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. /38/
The Act establishes a National Vaccine Injury Compensation Program
applicable to all claims in excess of $1,000 against a vaccine
manufacturer or health service provider that administers a vaccine,
based on vaccine-related injuries. Sections 2110-2111. Claimants
must file an affidavit in Claims Court setting forth the nature of
their injuries, the date, place and nature of the vaccine taken, and
assurances that they have not previously collected any award or
settlement of a damage action for the injuries in question. Section
2111(c). Hearings are held by a Special Master on the issues of
causation and damages, with de novo review by the court. No showing
of fault or negligence is required. Section 2112. Compensation
includes actual and projected unreimbursable expenses that resulted
from the vaccine-related injury, such as reasonably necessary medical,
remedial, and rehabilitative care, including special education,
vocational training, emotional or behavioral therapy, special
equipment, and residential and custodial care ($250,000 is awarded for
any vaccine-related death). Section 2115(a). Actual and projected
pain and suffering and emotional distress are also reimbursable in an
amount not to exceed $250,000. Ibid. The Act also provides for
reasonable attorneys' fees. Section 2115(e). No punitive damages are
permitted. Section 2115(d). Those with pending civil actions against
a manufacturer or administrator of the vaccine may withdraw them
without prejudice and elect to file a petition. Section
2111(a)(5)(A). Those, however, who have already received damages
awarded either under a judgment of a court or a settlement of such
action may not file a petition. Section 2111(a)(7). /39/
Once a compensation award is fixed, the claimant may elect either
to accept the award or to file a civil action against the
manufacturer. Section 2121. The Act, however, makes certain changes
in state tort law that make such an action more difficult. /40/ Thus,
the claimant would have to forego a guaranteed compensation package
from the program in order to pursue a more uncertain remedy against
the manufacturer of the vaccine. The Act was spurred by a perceived
need not only to compensate the rare victims of a program that
provides overwhelming benefits to the population generally, but also
to protect manufacturers of vaccines from ruinous damage awards so as
to ensure the continued availability of those vaccines. Congress
wanted to substitute a national insurance program for the vagaries of
the tort system in this essential area. /41/
Congress thus provided claimants with a remedy against the United
States as a substitute for a tort action against the manufacturer or
the provider that administers the vaccine. A crucial premise of this
program is that persons injured by vaccines do not already have a tort
remedy against the United States for having licensed the vaccine.
"Currently," Congress noted (H.R. Rep. 99-908, supra, at 6),
"vaccine-injured persons can seek recovery for their damages only
through the civil tort system or through a settlement arrangement with
the vaccine manufacturer." Accordingly, in order to make the program
an exclusive remedy for vaccine-related injuries, Congress only barred
tort suits against "manufacturers and administrators" of vaccines
except pursuant to the terms of the Act. No similar bar was placed on
FTCA suits against the United States, presumably because Congress
viewed the discretionary function exception as a bar to such suits.
/42/ For the Court now to overlay this insurance scheme with tort
liability under the FTCA would wholly disrupt the Act and undermine
Congress's attempt to fund the program with a minimum drain on the
public fisc. See note 38, supra.
CONCLUSION
The judgment of the court of appeals should be affirmed.
Respectfully submitted.
CHARLES FRIED
Solicitor General
JOHN R. BOLTON
Assistant Attorney General
DONALD B. AYER
Deputy Solicitor General
MICHAEL K. KELLOGG
Assistant to the Solicitor General
JOHN F. CORDES
WILLIAM COLE
Attorneys
THOMAS SCARLETT
Chief Counsel
ANN H. WION
Associate Chief Counsel for Drugs and Biologics Food and Drug
Administration
MARCH 1988
/1/ Polio is caused by an enterovirus that is introduced into the
body orally and begins to reproduce rapidly in the intestinal tract.
In only about one percent of cases will this original "infection"
result in clinical symptoms of poliomyelitis. When the disease does
result, it is caused by a spread of the virus from the intestinal
tract to the brain and spinal column, where it causes damage to the
nervous system, resulting in the characteristic muscular paralysis.
See J. Melnick, "Enteroviruses," in Viral Infections of Humans
217-218, 220 (A. Evans 2d ed. 1982).
/2/ Salk vaccine is a killed virus vaccine produced by growing the
virus in a tissue culture and killing it chemically to render it
incapable of replicating and thereby causing disease, but capable of
acting as an antigen to stimulate the production of antibodies. If a
wild or virulent strain of poliovirus subsequently enters the body,
the antibodies will block the live virus and prevent the contraction
of polio. J. Melnick, supra, at 228.
/3/ There is a very slight risk that paralytic poliomyelitis may be
contracted by persons who ingest the Sabin oral polio vaccine, or by
persons coming in close contact with the vaccinee. Between 1972 and
1983, 87 vaccine-associated cases in apparently immunologically normal
individuals were reported. During that period, 278.8 million OPV
(oral polio vaccine) doses were distributed in the United States.
Thirty-two vaccine-associated cases of poliomyelitis occurred among
vaccine recipients (one case per 8.7 million OPV doses distributed)
and 55 cases occurred among household and non-household contacts of
vaccinees (one case per 5.1 million doses distributed).
Center for Disease Control, 33(45) Morbidity and Mortality Weekly
Report: Paralytic Poliomyelitis -- United States, 1982 and 1983, at
637 (Nov. 16, 1984).
/4/ See, e.g., Nightengale, Recommendations for a National Policy
on Poliomyelitis Vaccination, 297 New Eng. J. Med. 249-253 (1977)
(reporting results of study by Institute of Medicine of the National
Academy of Sciences commissioned by HEW); Center for Disease Control,
26(40) Morbidity and Mortality Weekly Report: Recommendation of the
Public Health Service Advisory Committee on Immunization Practices 329
(Oct. 7, 1977); id. 31(3) Morbidity and Mortality Weekly Report:
1982 ACIP Report 22 (Jan. 29, 1982).
/5/ Congress has actively promoted use of the Sabin vaccine since
1961 when it appropriated $1 million for a stockpile of the
newly-developed vaccine to be used in combatting epidemics. Act of
Mar. 31, 1961, Pub. L. No. 87-14, 75 Stat. 23. In the Vaccination
Assistance Act of 1962 Congress launched mass immunization campaigns
using the Sabin vaccine. Pub. L. No. 87-868, 76 Stat. 1155. Although
Congress originally envisioned an intensive three-year effort, the
need for ongoing federal support for immunization programs became
apparent and continues to be provided through the Act, now codified at
42 U.S.C. 247b. All fifty states and the District of Columbia require
vaccination before a child enters school.
/6/ Petitioners also sued Lederle Laboratories in a separate civil
action. That suit was settled shortly before the instant case was
filed. Pet. App. 5a n.3. See Berkovitz v. Lederle, No. GD 80-28592
(Alleghany County C.P. Ct. filed Nov. 17, 1980). The terms of the
settlement are under seal.
/7/ Petitioners also claimed in district court that the United
States was negligent in failing to withdraw the vaccine from the
market and in failing to require the manufacturer to provide adequate
warnings. These allegations were dismissed in the district court as
barred by the FTCA's "discretionary function" exception (Pet. App.
33a), and petitioners conceded the propriety of that dismissal on
appeal (id. at 6a n.4). The petition for a writ of certiorari did not
ask this Court to review those issues (see Pet. 3-5). Without
acknowledging their prior concession, in their Brief on the Merits (at
6, 19-20) petitioners once again argue that the government is liable
for failing to revoke Lederle's license and withdraw the vaccine from
the market.
/8/ See note 7, supra.
/9/ Judge Higginbotham, in his dissenting opinion (Pet. App. 25a),
argued that 42 U.S.C. 262(d) "creates a governmental duty not to
license a manufacturer that has shown the government that its vaccine
is defective." He compared the FDA's mandate with the statutes
governing the FAA, which he said "are not commands at all." "Rather,"
the dissent argued (Pet. App. 26a (emphasis in original)), "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."
/10/ For 46 years, the biologics control program operated under the
immediate supervision of the director of the Hygenic Laboratory and
its successor, the National Institutes of Health (NIH). In 1948 it
was made a part of the National Microbiological Institute, a unit of
NIH. In 1955, the Division of Biologics Standards (DBS) was
established within NIH. DBS was then transferred from NIH to the FDA
in 1972 and renamed the Bureau of Biologics. See 37 Fed. Reg. 12865
(1972).
/11/ Vaccines are also classified as prescription drugs under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), and are,
thus, subject to certain provisions of that Act as well. See, e.g.,
21 U.S.C. 351(a)(2)(B) (conformity with current good manufacturing
practice).
/12/ See, e.g., 67 Cong. Rec. 11092, 11100 (1926) (remarks of Reps.
Celler, Underhill); 69 Cong. Rec. 2192, 3118 (1928) (remarks of Reps.
Lozier, Box); General Tort Bill: Hearings Before a Subcomm. of the
House Comm. on Claims, 72d Cong., 1st Sess. 17 (1932); Tort Claims
Against the United States: Hearings on H.R. 7236 Before Subcomm. No.
1 of the House Comm. on the Judiciary, 76th Cong., 3d Sess. 16 (1940);
Tort Claims Against the United States: Hearings on S. 2690 Before a
Subcomm. of the Senate Comm. on the Judiciary, 76th Cong., 3d Sess.
27-28 (1940); Tort Claims: Hearings on H.R. 5373 and H.R. 6463
Before the House Comm. on the Judiciary, 77th Cong., 2d Sess. (1942);
H.R. Rep. 2245, 77th Cong., 2d Sess. 10 (1942); H.R. Rep. 1287, 79th
Cong., 1st Sess. 5 (1945); S. Rep. 1400, 79th Cong., 2d Sess. 31
(1946). The Federal Tort Claims Act was adopted in 1946 after more
than 20 years of congressional consideration. This Court has
recognized that legislative statements made with regard to earlier
versions of the FTCA are useful in understanding the meaning of the
Act as eventually passed. Varig Airlines, 467 U.S. at 808-810;
Dalehite, 346 U.S. at 26-30.
/13/ Comparable, and overlapping, protection against damage
liability for engaging in core governmental activities was provided by
Congress in 28 U.S.C. 2674, which states that the United States may be
liable only "in the same manner and to the same extent as a private
individual under like circumstances."
/14/ Petitioners read this sentence (Br. 29-30) as a mere
tautology, stating that regulatory acts are covered by the
discretionary function exception whenever they are discretionary. But
there is no reason to think that the Court intended to add nothing by
this sentence. Indeed, as support for the proposition that regulation
is inherently a discretionary function, the Court in Varig noted that
"(e)ven the dissenters in Dalehite read the legislative history of the
discretionary function exception as protecting 'that type of
discretion which government agencies exercise in regulating private
individuals.'" 467 U.S. at 814 n.11 (quoting Dalehite, 346 U.S. at 58
n.12 (Jackson, J., dissenting)). Furthermore, petitioners' reading is
belied by the very next sentence, in which the Court stressed that
"(t)time and again the legislative history refers to the acts of
regulatory agencies as examples of those covered by the exception * *
* ." See also 467 U.S. at 814 n.11 (noting the legislative history's
"emphasis upon protection for regulatory activities").
/15/ See generally Note, Liability of Certifiers of Quality to
Ultimate Consumers, 36 Notre Dame Law. 176, 183 (1961); Note, Tort
Liability of Independent Testing Agencies, 22 Rutgers L. Rev. 299,
325-326 (1968); Note, Liability of a Testing Company to Third
Parties, 1964 Wash. U.L.Q. 77, 96-97. Some states have concluded that
such laboratories may be liable for negligently certifying the safety
of a product. See, e.g., Hanberry v. Hearst Corp., 276 Cal. App. 2d
680, 683, 81 Cal. Rptr. 519, 521 (1969). The basis for such
liability, however, is negligent misrepresentation, which is expressly
excluded from the waiver of sovereign immunity in 28 U.S.C. 2680(h).
See United States v. Neustadt, 366 U.S. 696 (1961).
/16/ Of course, the list in the text only touches the surface. A
cursory examination of the regulatory activities of several government
agencies reveals an extraordinary array of inspection and
licensing/certification activities. See, e.g., 42 U.S.C. 1472
(Farmers Home Administration inspects homes built with financial
assistance provided by the agency); 7 U.S.C. 77 (Department of
Agriculture inspects poultry products); 21 U.S.C. 603(a) (Department
of Agriculture inspects "all cattle, sheep, swine, goats, horses,
mules and other equines" before slaughtering, packing or
meat-canning); 7 U.S.C. 150ff (Department of Agriculture inspects for
plant pests persons or articles transported into this country); 21
U.S.C. 693 (Department of Agriculture inspects and certifies dairy
products intended for export); 33 U.S.C. 1318 (Environmental
Protection Agency inspects premises where work with chemical
substances is performed); 7 U.S.C. 136g (Environmental Protection
Agency inspects establishments where pesticides are distributed or
sold); 42 U.S.C. (& Supp. III) 6927 (Environmental Protection Agency
inspects hazardous waste facilities); 45 U.S.C. 23 (Department of
Transportation inspects locomotives); 15 U.S.C. 1401 (Department of
Transportation inspects facilities manufacturing or introducing motor
vehicles into commerce, see 49 C.F.R. 554.1 et seq.); 33 U.S.C. 1512
(Department of Transportation inspects deepwater ports); 33 U.S.C.
467a (Department of Army inspects dams); 38 U.S.C. 642 (Veterans
Administration inspects state nursing care homes); 18 U.S.C. (Supp.
IV) 923(g) (Department of Treasury inspects firearms or ammunition
kept by importers, manufacturers, dealers and collectors); 21 U.S.C.
44 (Department of Health and Human Services inspects teas entering the
United States); 15 U.S.C. 2065 (Consumer Product Safety Commission
inspects establishments manufacturing, holding or transporting
consumer products in commerce, see 16 C.F.R. 118.1 et seq. (1982), 16
C.F.R. 1605.1 et seq.); and 42 U.S.C. 5413 (Department of Housing and
Urban Development inspects the construction of mobile homes).
/17/ Needless to say, not a word in the voluminous legislative
history of the FTCA supports such a result. Compare Muniz, 374 U.S.
at 153-158.
/18/ See, e.g., Barnson v. United States, 816 F.2d 549 (10th Cir.
1987) (alleged failure of Public Health Service and AEC to warn
uranium miners of, and protect them against, radiation hazards), cert.
denied, No. 87-104 (Oct. 13, 1987); Bacon v. United States, 810 F.2d
827 (8th Cir. 1987) (alleged failure of HUD and EPA to warn of dioxin
levels during repair of roads at Times Beach under federal block
grant); Merklin v. United States, 788 F.2d 172 (3d Cir. 1986) (AEC
inspectors' alleged failure to warn uranium processing plant employees
of health hazards discovered during AEC inspections); Cunningham v.
United States, 786 F.2d 1445 (9th Cir. 1986) (alleged failure of OSHA
to exercise reasonable care in conducting plant inspections); Wendler
v. United States, 782 F.2d 853 (10th Cir. 1985) (FAA emergency
suspension of commercial pilot's certificate), cert. denied, 476 U.S.
112 (1986); Begay v. United States, 768 F.2d 1059 (9th Cir. 1985)
(alleged failure by federal agencies to warn of dangers of uranium
mining); Cisco v. United States, 768 F.2d 788 (7th Cir. 1985) (EPA's
alleged failure to warn that dirt contaminated with dioxin had been
used in residential land fill); Baxley v. United States, 767 F.2d
1095 (4th Cir. 1985) (FAA's allegedly negligent decision not to
regulate or inspect ultralite aircraft); Shuman v. United States, 765
F.2d 283 (1st Cir. 1985) (alleged negligence by Navy in not
controlling use and handling of asbestos by contractor); Russell v.
United States, 763 F.2d 786 (10th Cir. 1985) (alleged negligence by
MSHA in inspecting coal mine); Hylin v. United States, 755 F.2d 551
(7th Cir. 1985) (mine inspectors' alleged failure fully to inspect
clay mine); Feyers v. United States, 749 F.2d 1222 (6th Cir. 1984)
(Army's allegedly negligent failure to inspect contractor's operation
of government-owned railyard), cert. denied, 471 U.S. 1125 (1985);
General Public Utilities Corp. v. United States, 745 F.2d 239 (3d Cir.
1984) (NRC's alleged failure to warn of possible equipment defects at
Three Mile Island nuclear facility), cert. denied, 469 U.S. 1228
(1985); Natural Gas Pipeline Co. v. United States, 742 F.2d 502 (9th
Cir. 1984) (alleged negligence in FAA inspection and issuance of
certificates for aircraft).
/19/ Hatahley v. United States, 351 U.S. 173 (1956), upon which
petitioners rely (Br. 12-13), is not on point. In that case, federal
agents, "with complete disregard for the property rights" of certain
Navajo Indians (351 U.S. at 181), "vigorously prosecuted a campaign to
round up and destroy (the Indians') horses" in an effort to drive them
from public land (id. at 176). The Court held that these tortious
acts by the officials, committed within the scope of their employment,
gave rise to an FTCA claim against the United States. The Court
further held that these torts could not be excused post hoc by
reference to federal regulations governing impoundment of lifestock
unlawfully grazing on federal land because the notice procedures
provided in those regulations were not observed (id. at 180).
The Court in Hatahley did not find that actionable torts had been
committed because federal officials violated federal regulations.
Rather, the Court held simply that the otherwise actionable torts of
the officials were not excused by the regulations because, as the
government conceded, there was no "attempt at any time to comply with"
the regulations. 351 U.S. at 180. The government officials in
Hatahley were not acting as regulators of private conduct, but rather
as trespassers, and the Court thus said that no issue concerning the
discretionary function exception was presented (id. at 181).
/20/ Congress of course stressed that "the common-law torts of
employees of regulatory agencies would be included within the scope of
the bill to the same extent as torts of nonregulatory agencies." H.R.
Rep. 2245, 77th Cong., 2d Sess. 10 (1942). Thus, the negligent
driving of a mine inspector who gets in a car accident on his way to
inspect a mine will give rise to liability. But there is an obvious
and fundamental difference between driving a car to the site of an
inspection and the quintessentially regulatory function of performing
the inspection. That latter function is protected by the
discretionary function exception whether or not negligently performed,
and whether or not the alleged negligence is demonstrated by reference
to a violation of agency regulations.
/21/ That would be a foolish argument indeed in light of the fact
that the Sabin vaccine has all but eliminated polio in the United
States.
/22/ The APA, 5 U.S.C. (& Supp. IV) 551 et seq., offers a
comprehensive scheme for review of regulatory action.
/23/ This case was disposed of on the government's motion to
dismiss in lieu of an answer. Accordingly, the factual allegations in
petitioners' complaint, though they would be hotly contested were the
suit to go further, must be taken as true for purposes of this motion.
What is certainly not assumed, however -- even for purposes of the
present litigation -- is that the facts as alleged make out a
violation of any mandatory regulations governing the FDA. That is a
legal question that turns on the proper interpretation of those
regulations. See Varig Airlines, 467 U.S. at 816-821. Indeed, it is
the question decided by the court below. Petitioners are simply wrong
in stating, however insistently (Br. 2, 8, 16, 20, 21, 22), that it is
"admitted" that FDA violated its regulations.
/24/ The first citation is to the regulations in effect at the time
DBS licensed Lederle to produce the vaccine. Where the regulations
have remained substantially in the same form, a parallel cite is given
to the current regulations.
/25/ In addition to the product license, manufacturers must also
obtain an establishment license (42 C.F.R. 73.2-73.4; 21 C.F.R.
601.1-601.2, 601.10) after passing an inspection demonstrating that
the establishment complies with applicable standards relating to
personnel, equipment, sterilization, care of lab animals, record
keeping and other matters (see 42 C.F.R. 73.35-73.38). No challenge
has been made here to the issuance of an establishment license to
Lederle.
/26/ The manufacturer is also required to designate a "responsible
head who shall exercise control of the establishment in all matters
relating to compliance with the provisions of this part" (42 C.F.R.
73.35(a); 21 C.F.R. 600.10(a)).
/27/ The decision to license a drug involves a determination, based
on limited data, that its known benefits outweigh its potential risks.
Thus, our level of uncertainty about a drug's unknown or unknowable
risks is deemed acceptable at some point and the decision is made to
license a drug with specific warnings. FDA Drug approval procedures
have long been scrutinized by Congress, and have been found to reflect
the highest standards for effectiveness and safety in the world.
Walsh & Klein, The Conflicting Objectives of Federal and State Tort
Law Drug Regulation, 41 Food Drug Cosm. L.J. 171, 178 (1986). In its
list of approved licenses, FDA itself makes clear that "(t)he licenses
granted to these establishments for the products listed in this
publication do not imply an endorsement of the respective preparations
nor do they make the Government a guarantor or insurer of the safety,
purity, and potency of such licensed products." FDA, HHS, Pub. No.
87-9003, Establishments and Products Licensed under Section 351 of the
Public Health Service Act ii (Apr. 1987).
/28/ Petitioners also allege (Br. 19) that "(a)fter production seed
45-B-85 was licensed, it demonstrated a change in neurovirulence,
triggering the requirement that its license be revoked." As already
noted (see note 7, supra), this claim is not properly presented.
Moreover, the allegation makes no sense since petitioners are wrong in
asserting (Br. 5) that "(e)ach production seed must be individually
licensed." But those problems aside, it is clear from the regulations
that the Surgeon General need only "recommend" revocation of a product
license if "he finds, after notice and opportunity for hearing, that *
* * the product for which the license has been issued, fails to
conform to the standards in the regulations * * * " (42 C.F.R. 73.9;
21 C.F.R. 601.5). The Surgeon General's decision whether or not to
institute such revocation proceedings is a classic exercise of
enforcement discretion. Heckler v. Chaney, 470 U.S. 821 (1985).
/29/ The current regulation (21 C.F.R. 630.10(b)(2) differs from
that in effect at the time of the events in issue only in the identity
of the official to whom such data must be submitted (the Director,
Office of Biologics Research and Review) and the number of persons
tested (one million).
/30/ The vaccine was also tested without harmful effect on 181,000
persons in Cincinnati in a program directed by Dr. Sabin starting in
April 1960. Hearings 188, 226 (statement of Dr. Sabin).
/31/ On November 23, 1960, A Notice of Proposed Rulemaking was
published in the Federal Register. 25 Fed. Reg. 11111-11114. On
March 25, 1961, the final regulations were published and became
effective on April 24, 1961. 26 Fed. Reg. 2564-2568. On August 17,
1961, the government issued the first license to manufacture the Sabin
live polio vaccine, Type 1, to Pfizer Limited. On June 25, 1963, the
government licensed Lederle to manufacture a trivalent live oral polio
vaccine using the Sabin strain, Types I, II, and III.
/32/ The Sabin strain was used as a "reference strain" by DBS, and
is still so used by FDA. Manufacturers are required to obtain the
strain from FDA for use as a control in performing required tests. 42
C.F.R. 73.111; 21 C.F.R. 630.14.
/33/ In fact, Lederle did not begin using production seed 45-B-85
until 1966, three years after Orimune was licensed. Although Lederle
did not have to obtain a new license in order to change its
manufacturing process, it did have to perform certain prescribed tests
and obtain DBS's approval to begin using the new seed virus. We will
assume, therefore, that it is DBS's approval of the seed virus that
petitioners are attacking.
/34/ In Baker, the plaintiff alleged that DBS violated its own
regulations when it failed to require submission of test data before
making its licensing decision. The Ninth Circuit concluded that the
agency "may not issue a license for manufacturing poliovirus vaccine
unless the relevant test data has been submitted," and that the agency
thus has a mandatory duty to require the submission of that data (id.
at 566). The court was unwilling to apply the discretionary function
exception to the plaintiff's allegations of "a negligent failure to
obey a mandatory regulatory command" (ibid.).
/35/ Failure to obtain such data from a manufacturer prior to
approval might indicate negligence on the part of the agency, but of
course the discretionary function exception shields from liability
"both negligence and wrongful acts in the exercise of the discretion"
granted to the agency. Dalehite, 346 U.S. at 33.
/36/ A trivalent vaccine such as Orimune is made from portions of
monopools of each of the three types of poliovirus, and neurovirulence
tests are performed on the individual monopools, not on the vaccine
itself, 21 C.F.R. 630.17(b). We assume, therefore, that what
petitioners intend to allege is that one of the monopools exceeded the
permissible level of neurovirulence.
A related misstatement by petitioners is more significant. On page
ten of their statutory appendix, petitioners purport to quote portions
of 21 C.F.R. 610.2, concerning "requests for samples and protocols"
and release "of any lot of any licensed product." Section 610.2(a), in
fact and as quoted, states that the Director of the Bureau of
Biologics "may" require submission of test results on a lot and
further may, "when deemed necessary for the safety, purity, or potency
of the product," notify the manufacturer "not (to) distribute a lot of
a product until the lot is released by the Director." 21 C.F.R.
610.2(a) (1978) (the current regulation is identical except for the
identity of the agency official). Clearly, this language embodies no
mandatory guideline limiting the Director's discretion in deciding
either to examine test results or to release a given lot.
Petitioners proceed, however, to set forth language which they
refer to as Section 610.2(b), which is in fact drawn from 21 C.F.R.
630.17(b). In its proper context, that language is plainly directed
at the manufacturer, indicating tests to be performed by the
manufacturer, not by the agency. The mis-labelling of this section
places it in a context where it might be misunderstood to impose an
obligation on the agency.
/37/ As already noted, note 6, supra, petitioners in fact obtained
a settlement from Lederle.
/38/ The 1986 Act had no effective date; rather it was not to
become effective until funded. Congress subsequently passed the
Vaccine Compensation Amendments of 1987 as part of the Omnibus Budget
Reconciliation Act of 1987, Pub. L. No. 100-203, 101 Stat. 1330.
These amendments made the effective date of the program October 1,
1988. Congress authorized (though it has not yet appropriated) $80
million for each year through 1992 to pay for claims arising before
the effective date of the Act. Cases arising after the effective date
are to be paid from a Trust Fund funded by an excise tax on certain
vaccines. See Section 2115(i)-(j) (all citations are to the Act as
amended in 1987). The Trust Fund is also subrogated to the rights of
claimants up to the amount of compensation paid, so that the Fund can
seek reimbursement for negligence by vaccine manufacturers. Section
2117. By way of fiscal control, the Act contains strict limitations
on the numbers of claims that may be filed in each category, and the
program automatically terminates if those numbers are exceeded.
Section 2184.
/39/ Thus, Kevan Berkovitz is not eligible for the program at all
in light of his settlement with Lederle.
/40/ For example, a manufacturer cannot be held liable for
unavoidable injuries caused by a vaccine that was properly prepared
and was accompanied by proper directions and warnings. A vaccine is
presumed to have been properly prepared if the manufacturer complied
with all FDA requirements. Section 2122.
/41/ H.R. Rep. 99-908, 99th Cong., 2d Sess. Pt. 1, at 4-5 (1986)
(program necessary because the great success of vaccines is being
threatened by mounting liability costs, which have caused prices to go
up and the number of manufacturers to go down). See also Mann, Mass
Immunization Cases: Drug Manufacturers' Liability for Failure to
Warn, 29 Vand. L. Rev. 235 (1976) ("Drug manufacturers have ceased, or
are threatening to cease, production of these essential. life-saving
vaccines. Consequently, these recoveries threaten the effectiveness
of the nation's preventative health care programs and contravene the
strong public policy of combating infectious disease through
widespread vaccination campaigns.").
The administration, it should be noted, does not believe that the
Act as passed will in fact have these salutory effects. The
Administration opposed the Act in its current form and offered its own
alternative bill, H.R. 4777, that would have established a program for
vaccine-related injuries along the lines of current workers'
compensation programs.
/42/ Thus, in the National Swine Flu Immunization Program of 1976,
42 U.S.C. (1976 ed.) 247b(j)-(l), the government, in an earlier effort
to provide necessary assurance to drug manufacturers by making
lawsuits against the government the exclusive remedy for all actions
connected with the Swine Flu Program, accepted all liability "for
personal injury or death arising out of the administration of swine
flu vaccine." In order to permit such suits, Congress expressly waived
the discretionary function exception. 42 U.S.C. (1976 ed.)
247b(k)(2). Similarly, Congress has made the discretionary function
exception inapplicable to any "grossly negligent" exercise or
performance of a discretionary function by the Consumer Products
Safety Commission. 15 U.S.C. 2053(h). Needless to say, waivers of
this sort would be unnecessary if Congress thought the United States
could be liable under the FTCA for its regulatory activity in
licensing products.
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