No. 99-1747 and 99-1749
In the Supreme Court of the United States
FRANK O'CONNELL AND LISA O'CONNELL,
LEGAL REPRESENTATIVES OF THEIR DAUGHTER,
KELLI-ANN O'CONNELL, PETITIONERS
v.
DONNA E. SHALALA, SECRETARY OF
HEALTH AND HUMAN SERVICES
MICHELE Y. TERRAN, AS LEGAL REPRESENTATIVE
OF JULIE F. TERRAN, A MINOR, PETITIONER
v.
DONNA E. SHALALA, SECRETARY OF HEALTH
AND HUMAN SERVICES
ON PETITIONS FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
BRIEF FOR THE RESPONDENT IN OPPOSITION
SETH P. WAXMAN
Solicitor General
Counsel of Record
DAVID W. OGDEN
Acting Assistant Attorney General
DOUGLAS N. LETTER
COLETTE G. MATZZIE
Attorneys
Department of Justice
Washington, D.C. 20530-0001
(202) 514-2217
QUESTIONS PRESENTED
1. Whether 42 U.S.C. 300aa-14(c) (1994 & Supp. IV 1998), a provision
of the National Childhood Vaccine Injury Act of 1986 that allows the Secretary
of Health and Human Services to promulgate regulations embodying modifications
to an initial Vaccine Injury Table set out in the Act, violates the Presentment
Clause of the Constitution Art. I, § 7, Cl. 2, or represents an unconstitutional
delegation of legislative power.
2. In No. 99-1749, whether the United States Court of Appeals for the Federal
Circuit applies a permissible standard for proof of causation in compensation
proceedings under the Act.
In the Supreme Court of the United States
No. 99-1747
FRANK O'CONNELL AND LISA O'CONNELL,
LEGAL REPRESENTATIVES OF THEIR DAUGHTER,
KELLI-ANN O'CONNELL, PETITIONERS
v.
DONNA E. SHALALA, SECRETARY OF
HEALTH AND HUMAN SERVICES
No. 99-1749
MICHELE Y. TERRAN, AS LEGAL REPRESENTATIVE
OF JULIE F. TERRAN, A MINOR, PETITIONER
v.
DONNA E. SHALALA, SECRETARY OF HEALTH
AND HUMAN SERVICES
ON PETITIONS FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
BRIEF FOR THE RESPONDENT IN OPPOSITION
OPINIONS BELOW
The opinion of the court of appeals in No. 99-1749 (99-1749 Pet. App. 1a-40a)
is reported at 195 F.3d 1302. The opinion of the Court of Federal Claims
in that case (99-1749 Pet. App. 41a-58a) is reported at 41 Fed. Cl. 330,
and the opinion of the Special Master (99-1749 Pet. App. 59a-92a) is unreported.
The opinion of the court of appeals in No. 99-1747 (99-1747 Pet. App. 1-5)
is unreported. The opinion of the Court of Federal Claims (99-1747 Pet.
App. 34-41) is reported at 40 Fed. Cl. 891. The opinion of the Special Master
(99-1747 Pet. App. 7-33) is unreported.
JURISDICTION
The judgments of the court of appeals were entered on October 27, 1999 (No.
99-1749) and November 1, 1999 (No. 99-1747). Petitions for rehearing were
denied on February 2, 2000 (99-1747 Pet. App. 45-46; 99-1749 Pet. App. 93a-94a).
The petitions for a writ of certiorari were filed on May 1, 2000 (No. 99-1749)
and May 2, 2000 (No. 99-1747). The jurisdiction of this Court is invoked
under 28 U.S.C. 1254(1).
STATEMENT
1. Congress enacted the National Childhood Vaccine Injury Act of 1986 (the
Vaccine Act or the Act), Pub. L. No. 99-660, Tit. III, 100 Stat. 3755 (codified
at 42 U.S.C. 300aa-1 et seq. (1994 & Supp. IV 1998)), to promote national
childhood immunization programs by establishing a tax-based federal compensation
scheme for children injured by vaccines, thus reducing the number of traditional
tort actions filed against vaccine manufacturers. See Pet. App. 5a-6a.1
The Act first creates a National Vaccine Program, "to achieve optimal
prevention of naturally occurring human infectious diseases through immunization
and to achieve optimal prevention of the adverse reactions to vaccines."
H.R. Rep. No. 908, 99th Cong., 2d Sess. Pt. I, at 9 (1986); see 42 U.S.C.
300aa-1 to 300aa-6. It then establishes a National Vaccine Injury Compensation
Program (the Program), funded by a special tax on vaccines, under which
"compensation may be paid for a vaccine-related injury or death."
42 U.S.C. 300aa-10(a); see 42 U.S.C. 300aa-15(i); see also 26 U.S.C. 9510
(1994 & Supp. IV 1998).
Claimants under the Program may establish a right to compensation in one
of two ways. An injury is presumed to have been caused by a vaccine, and
therefore to be compensable, if it is listed on the Program's Vaccine Injury
Table (the Table) and first manifests itself within a set period of time,
also prescribed by the Table, after administration of the vaccine. See 42
U.S.C., 300aa-14(a) (1994 & Supp. IV 1998); 42 U.S.C. 300aa-11(c)(1)(C)(i),
300aa-13(a)(1)(A); 42 C.F.R. 100.3(a). The Table is supplemented by a set
of "qualifications and aids to interpretation" providing relevant
definitions and explanations. See 42 U.S.C. 300aa-14(b) (1994 & Supp.
IV 1998); 42 C.F.R. 100.3(b). The presumption of causation, where it applies,
may be rebutted by evidence that the injury was "due to factors unrelated
to the administration of the vaccine." 42 U.S.C. 300aa-13(a)(1)(B).
If a claimant's injury is not presumed compensable under the Table, the
claimant may nonetheless obtain compensation by demonstrating, by a preponderance
of the evidence, that the vaccine in fact caused or significantly aggravated
the injury. 42 U.S.C. 300aa-11(c)(1)(C)(ii), 300aa-13(a).
A claimant under the Program is never required to demonstrate that a vaccine
was defective or that its manufacturer was negligent. The compensation available
includes unreimbursed medical expenses, rehabilitation, special education,
vocational training, residential and custodial care, special equipment,
lost earnings, pain and suffering, and attorneys' fees. 42 U.S.C. 300aa-15(a)
and (e). A claimant who is dissatisfied with an award made under the Program
may reject the award and litigate her claim under state tort law, subject
to certain limitations. 42 U.S.C. 300aa-11(a), 300aa-21. Applicable statutes
of limitations are tolled while the claimant exhausts the alternative remedy
provided by the Act. 42 U.S.C. 300aa-16(c).
The Act itself establishes an "initial" Vaccine Injury Table (the
Initial Table), and it authorizes the Secretary of Health and Human Services
to "promulgate regulations to modify" the Table by adding or deleting
injuries or changing the onset periods that trigger a presumption of compensability.
See 42 U.S.C. 300aa-14(c)(1) to (3) (1994 & Supp. IV 1998). The legislative
history indicates Congress's expectation that the Secretary would make appropriate
changes to the Initial Table once "research on vaccine injury and vaccine
safety * * * provide[d] more definitive information about the incidence
of vaccine injury." H.R. Rep. No. 908, supra, at 18. Changes to the
Table apply to petitions for compensation that are filed after the effective
date of the final regulation adopting the change. 42 U.S.C. 300aa-14(c)(4)
(1994 & Supp. IV 1998).
The Act establishes an Advisory Commission on Childhood Vaccines (ACCV)
that includes health professionals, legal experts, interested citizens (including
parents of children with vaccine-related injuries), and federal officials.
See 42 U.S.C. 300aa-5, 300aa-19. The Secretary is required to provide the
ACCV with a copy of proposed regulations before issuing them for notice
and comment. 42 U.S.C. 300aa-14(d) (1994 & Supp. IV 1998). The ACCV
may also ask the Secretary to propose regulations to amend the Table, and
it reviews such requests made by others. The Secretary must publicly explain
any decision not to undertake a rulemaking proceeding in response to a request.
42 U.S.C. 300aa-14(c)(2) (1994 & Supp. IV 1998).
2. Section 312 of the Act, 100 Stat. 3779-3780, directs the Secretary to
"complete a review of all relevant medical and scientific information"
on the relationship between certain vaccines and illnesses, to make and
publish findings on specified questions, and to "propose regulations
to amend the Vaccine Injury Table * * * as a result of such findings."
The Secretary arranged for the Institute of Medicine (IOM), an arm of the
National Academy of Sciences, to conduct the required study, and the Institute
released its report in 1991. See Institute of Medicine, Adverse Effects
of Pertussis and Rubella Vaccines (Christopher P. Howson et al. eds., 1991)
(the IOM Report).
The Secretary referred the IOM Report to the National Vaccine Advisory Committee
(NVAC), a Public Health Service task force (the Task Force), and the ACCV.
Based on the report's conclusion that there was no credible evidence of
prolonged neurological damage from diphtheria-pertussis-tetanus (DPT) vaccines,
the Task Force and the NVAC recommended that the Table be revised to delete
encephalopathy, hypotonic hyporesponsive episode (HHE), and residual seizure
disorders (RSD) as conditions presumptively associated with DPT vaccination.
The ACCV concurred with respect to HHE and RSD, but it recommended that
the Table continue to cover some forms of encephalopathy, under a more precise
standard.
In 1992 the Secretary issued proposed regulations adopting the ACCV approach.
See O'Connell v. Shalala, 79 F.3d 170, 174-175 (1st Cir. 1996).2 In 1995,
the Secretary issued a final rule removing HHE and RSD from the Table, and
modifying the definition of encephalopathy. See 42 C.F.R. 100.3(a) and (b)(2);
60 Fed. Reg. 7678-7696. The revised Table became effective on March 10,
1995, for all petitions filed after that date. See 42 C.F.R. 100.3(c).
Petitioners Francis and Lisa O'Connell sought judicial review of the 1995
regulation under the procedure set out in 42 U.S.C. 300aa-32. The United
States Court of Appeals for the First Circuit concluded that "[t]he
Secretary had authority to issue the regulations * * *, and she exercised
that authority in a procedurally appropriate and substantively permissible
manner." O'Connell, 79 F.3d at 182. In that proceeding, the O'Connell
petitioners did not challenge the constitutionality of the Act.
3. No. 99-1749 (Terran). Petitioner Terran sought compensation under the
Act on the ground that her daughter Julie first showed signs of RSD and
encephalopathy on the day after her third DPT vaccination. Neither RSD nor
Julie's non-acute encephalopathy gave rise to a presumption of compensability
under the revised Table. Pet. App. 79a. After considering the evidence,
the Special Master concluded that petitioner had not shown by a preponderance
of the evidence that the DPT vaccine caused Julie's chronic encephalopathy
or her afebrile seizures. Id. at 87a-91a. He accordingly denied compensation.
Id. at 91a.
a. The Court of Federal Claims sustained the Special Master's decision.
Pet. App. 41a-58a. The court concluded that it lacked jurisdiction to consider
petitioner's constitutional argument that the Secretary could not modify
the Initial Table. Id. at 47a-48a. It also held that petitioner's challenge
to the revising regulations was untimely or foreclosed by previous litigation,
id. at 48a-49a, and that application of the revised Table to petitioner's
case was not impermissibly retroactive, id. at 49a-51a. On the merits, the
court applied the standard of review set out in 42 U.S.C. 300aa-12(e)(2),
and concluded that the Special Master's determinations with respect to causation
were not arbitrary or capricious. Pet. App. 51a-58a.
b. The court of appeals affirmed. Pet. App. 1a-40a. Unlike the Court of
Federal Claims, the court of appeals held (id. at 10a-16a) that petitioner
was not barred from challenging the validity of the Secretary's 1995 regulations
modifying the Initial Table, and that the court had jurisdiction over petitioner's
claim that Congress could not constitutionally allow the Secretary to make
those modifications.
Reviewing the history of the Vaccine Act (Pet. App. 5a-9a), the court explained
(id. at 7a) that "Congress included the Initial Table in the * * *
legislation, rather than delegating the creation of the first injury table
to the Secretary, because it was concerned that the administrative process
would significantly delay the implementation of the Vaccine Compensation
Program." Congress gave the Secretary authority to promulgate regulations
modifying the Table, however, because it "intended the Secretary to
revise and update the Initial Table with more accurate information that
would become available as a result of the research on vaccine injuries mandated
by the Vaccine Act" itself. Id. at 8a.
The court rejected petitioner's contention that such an arrangement violates
the Presentment Clause of the Constitution (Art. I, § 7, Cl. 2). Pet.
App. 17a-23a. Considering the matter in context, the court was "convinced
that the Vaccine Act does not authorize the Secretary to amend or repeal
portions of the Act, but rather merely grants her the power to promulgate
new regulations as contemplated in the Act." Id. at 18a. The court
noted that regulations promulgated by the Secretary "do[] not change
in any way the original injury table," but rather promulgate a new
Table that applies only prospectively. Id. at 19a. Analogizing that process
to a routine "sunset" provision, the court reasoned that Congress
had merely "itself decided to render the Initial Table ineffective
upon the Secretary's action" in promulgating a replacement Table by
regulation. Id. at 20a.
The court distinguished this case from Clinton v. City of New York, 524
U.S. 417 (1998), which invalidated the Line Item Veto Act, on three grounds.
First, the line-item veto had to be exercised quickly, and was therefore
"necessarily based on the same conditions contemplated by Congress"
when it passed the affected legislation. Pet. App. 21a. In contrast, replacement
of the Initial Table set out in the Vaccine Act itself by a later regulatory
Table is "contingent on conditions that did not exist when [the Act]
was passed." Ibid. Congress simply "anticipated that the facts
underlying its legislation might change in the future," and granted
the Secretary appropriate authority to establish a superseding Table, through
the usual administrative process, "when more accurate information linking
vaccines to injuries became available." Ibid.
Second, unlike the Line Item Veto Act, which "provided little constraint
on the President's discretion to cancel a particular appropriation line
item," the Vaccine Act sets forth "detailed procedures and substantive
considerations" that "channel" the Secretary's discretion.
Pet. App. 21a-22a. And third, whereas Clinton concluded that the President
was "clearly contravening Congress's policy judgment when he canceled
spending items under the Line Item Veto Act," under the Vaccine Act
"the Secretary was executing congressional policy when she promulgated
the 1995 Table." Id. at 22a.
The court of appeals also rejected petitioner's claim that the Vaccine Act
effects an unconstitutional delegation of legislative power. Pet. App. 23a-25a.
The court noted the existence of various "substantive guideposts and
procedural requirements" (id. at 23a) under the Act: Revised Tables
"must adhere to [the] same format" as the Initial Table; the Secretary
must consult with the ACCV before proposing revised regulations; the compensation
program automatically terminates if the total number of awards exceeds a
specified number within a specified period; and the Act establishes a "broad
program to study and reduce the risk of childhood vaccines," which
"Congress clearly intended [to guide] the Secretary * * * when she
decides to promulgate regulations to revise the injury table." Id.
at 24a- 25a. Under those circumstances, the court concluded, "Congress
provided ample guidance and limits on the Secretary's authority to promulgate
revised vaccine injury tables," and therefore stayed within the permissible
bounds of delegation. Id. at 25a.
Turning to the merits of petitioner's case, the court rejected the argument
that the Special Master should have evaluated the claim using the Initial
Table because Julie Terran's condition manifested itself before the effective
date of the 1995 regulations. Pet. App. 25a-26a. The court explained that
the Act's specific direction that new regulations would govern "petitions
for compensation * * * filed after the[ir] effective date" was sufficient
to "conclusively resolve[] the question" of applicability against
petitioner. Id. at 26a.
Finally, the court considered and rejected petitioner's argument that the
Special Master erred by "discounting the causation-in-fact testimony
of [petitioner's] expert" and resolving the causation question against
petitioner. Pet. App. at 26a-29a. The court held that the Master's conclusions
with respect to the expert testimony were reasonable (id. at 26a-28a), and
its "review of the record [did] not uncover[] any finding of fact or
conclusion of law that [was] 'arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with law.'" Id. at 29a (quoting 42 U.S.C.
300aa-12(e)(2)(B)). The court accordingly affirmed the Master's rejection
of petitioner's claim.
Judge Plager dissented. Pet. App. 30a-40a. In his view, because Congress
"included the initial Vaccine Injury Table in the statute itself,"
its further provisions "purport[ing] to empower the Secretary to modify
the statutorily-created" Table were inconsistent with the Presentment
Clause. Id. at 39a.
4. No. 99-1747 (O'Connell). The O'Connell petitioners sought Vaccine Act
compensation on the ground that their daughter Kelli-Ann first showed signs
of RSD and encephalopathy on the day after her second DPT vaccination. 99-1747
Pet. App. 8-9 & n.2. Her symptoms did not create a presumption of compensability
under the revised Table. Id. at 8 n.2. After considering the evidence, the
Special Master concluded that petitioners had not shown by a preponderance
of the evidence that the DPT vaccine caused Kelli-Ann to suffer from encephalopathy
(id. at 26-29) or RSD (id. at 30-32). She accordingly denied compensation.
Id. at 33.
The Court of Federal Claims sustained the Special Master's decision. 99-1747
Pet. App. 34-41. As in Terran, the court concluded that it lacked jurisdiction
to consider petitioners' constitutional argument that the Secretary could
not modify the Initial Table. Id. at 37-38, 39-41. The court rejected petitioners'
argument that the Special Master had applied too high a standard of proof
to their off-Table causation claim, and instead sustained the Master's judgment
that petitioners had failed to demonstrate the existence of post-vaccine
symptoms meeting "any generally accepted definition of acute encephalopathy."
Id. at 38; see id. at 36-39.
The court of appeals affirmed for the reasons given in its opinion in Terran.
99-1747 Pet. App. 1-5. Judge Plager dissented, also for the reasons given
in his opinion in Terran. Id. at 4-5. The court did not reach the Secretary's
argument that petitioners' constitutional claim was precluded by their failure
to raise it in their previous challenge to the validity of the 1995 regulations.
Id. at 4.
ARGUMENT
1. Petitioners argue that the Vaccine Act violates the Presentment Clause
by authorizing the Secretary to promulgate a revised Vaccine Injury Table
that supersedes the Initial Table set out in the Act itself. 99-1747 Pet.
9-17; 99-1749 Pet. 16-21. The court of appeals correctly rejected that contention.
The Presentment Clause regulates the enactment of laws, not Executive rulemaking
or other steps in the administration of enacted laws. See, e.g., INS v.
Chadha, 462 U.S. 919, 953 n.16 (1983). While Congress may not confer on
the Executive the power to amend or repeal laws, see Clinton, 524 U.S. at
438-441, bicameral passage and presentment are not required as a check on
Executive rulemaking because such "administrative activity cannot reach
beyond the limits of the statute that created it." Chadha, 462 U.S.
at 953 n.16.
In this case, the Vaccine Act expressly authorizes and contemplates the
issuance of revised Vaccine Injury Tables through administrative rulemaking.
See 42 U.S.C. 300aa-14(c) (1994 & Supp. IV 1998). The only distinction
between the authority granted to the Secretary to promulgate those Tables
and innumerable other statutory conferrals of regulatory authority on the
Executive is that in this instance Congress set out an "Initial Table"
in the Act itself, so that there would be a basis for providing compensation
under the Act during the period after its passage and before the Secretary
could complete the study, consultation, and public comment steps necessary
to consider and adopt a revised Table. That distinction is not enough to
turn an authorized rulemaking into a statutory "amendment" that
would require passage by Congress and presentment to the President.
As the court of appeals recognized (Pet. App. 17a-23a), the Secretary's
exercise of her statutory authority to promulgate regulations superseding
the Initial Table does not amount to an amendment or partial repeal of the
Vaccine Act. The 1995 regulations, which the Act makes applicable to petitions
filed after their effective date (see 42 U.S.C. 300aa-14(c)(4) (1994 &
Supp. IV 1998)), simply implement Congress's direction to issue regulations
making appropriate adjustments to the Initial Table in light of research
conducted after the enactment of the Act. See Pet. App. 19a. Congress itself
provided that once such regulations were issued they would supersede contrary
provisions in the Initial Table, although only for proceedings commenced
after the effective date of the new regulations. Compare Clinton, 524 U.S.
at 446 n.40 (provision of Rules Enabling Act, 28 U.S.C. 2072(b), that "[a]ll
laws in conflict with [procedural] rules [adopted by this Court] shall be
of no further force or effect after such rules have taken effect" is
valid because "Congress itself made the decision to repeal prior rules
upon the occurrence of a particular event-here, the promulgation of procedural
rules by this Court"). Such a statutory provision is constitutionally
permissible, even if it in some respects "alter[s] the substantive
rights" (99-1749 Pet. 17) otherwise conferred by a particular statute.
See Touby v. United States, 500 U.S. 160 (1991) (upholding conferral on
the Attorney General of authority to add or remove substances from the schedules
of controlled substances initially prescribed by statute); J.W. Hampton,
Jr., & Co. v. United States, 276 U.S. 394 (1928) (upholding provision
authorizing President to raise tariffs, above amounts fixed by statute,
under certain conditions); Field v. Clark, 143 U.S. 649, 680, 690-694 (1892)
(upholding provision authorizing President to "suspend" the Tariff
Act "for such time as he shall deem just," thereby raising tariffs,
if foreign governments were imposing "reciprocally unequal and unreasonable"
tariffs on specified commodities).
The court of appeals also properly distinguished the table revision provision
in the Vaccine Act from the "line-item veto" provision struck
down by this Court in Clinton v. City of New York. See Pet. App. 20a-22a.
Unlike the Vaccine Act, the Line Item Veto Act at issue in Clinton did purport
to give the President the power to "cancel in whole" certain types
of provisions contained in duly enacted legislation. See 524 U.S. at 436;
see also id. at 446-447. As the court below explained, this Court's invalidation
of that authority turned in large part on the Court's conclusions that the
Line Item Veto Act provided few constraints on the President's discretion
to cancel particular appropriation items for his own policy reasons; required
the President to act within five days of the enactment of a law, so that
"the President's action was necessarily based on the same conditions
contemplated by Congress" in enacting the measure; and authorized exercises
of "veto" authority through which the President was "clearly
contravening Congress's policy judgment" concerning the canceled items.
Pet. App. 21a-22a. In the present case, by contrast, "Congress set
forth detailed procedures and substantive considerations in the Vaccine
Act that channel [the Secretary's] discretion" to supersede the Initial
Table by regulation; regulations are to be issued under Section 300aa-14(c)
after study and consultation and "when more accurate information linking
vaccines to injuries bec[omes] available"; and the Secretary is implementing-not
contravening- congressional policy when she issues superseding regulations
in conformance with the plain provisions of the Act. Id. at 21a; compare
Clinton, 524 U.S. at 443-444, 445.
2. The court of appeals also correctly rejected (Pet. App. 23a-25a) petitioners'
argument (97-1747 Pet. 18-25; 99-1749 Pet. 21-26) that the Vaccine Act unconstitutionally
delegates legislative power to the Secretary. While Congress may not delegate
its legislative power to the Executive Branch, this Court's cases reflect
"a practical understanding that in our increasingly complex society,
replete with ever changing and more technical problems, Congress simply
cannot do its job absent an ability to delegate power under broad general
directives." Mistretta v. United States, 488 U.S. 361, 372 (1989).
Congress may authorize the Executive to promulgate legally binding regulations,
so long as it "clearly delineates the general policy, the public agency
which is to apply it, and the boundaries of th[e] delegated authority."
Id. at 373 (quoting American Power & Light Co. v. SEC, 329 U.S. 90,
105 (1946)).
As the court of appeals recognized, the Vaccine Act's directions to the
Secretary with respect to revising the Vaccine Injury Table satisfy these
requirements. As the court explained, "the Initial Table in the Act
itself operates as an intelligible principle that governs subsequent, administratively
created tables," because "[i]n the Initial Table, Congress identified
the vaccines covered by the table, the illnesses or conditions for which
compensation might be had, and the time period required for the first symptom
or onset of each illness," and "revised tables must adhere to
this same format." Pet App. 24a. In addition, the Act requires the
Secretary to undertake further scientific study and to consult with experts
and interested parties (compare Mistretta, 488 U.S. at 376 n.10), and then
to consider, through the normal public notice-and-comment process, whether
and how to modify the conditions and symptom-appearance times set out in
the Initial Table. See 42 U.S.C. 330aa-1 note (Related Studies); 42 U.S.C.
300aa-14(c) (1994 & Supp. IV 1998).3 This sensible use of the administrative
process properly combines an assignment of regulatory authority to an Executive
official with more-than-adequate "substantive guideposts and procedural
requirements" (Pet. App. 23a) to guide and limit its exercise-limits
that are enforceable through appropriate judicial review. 42 U.S.C. 300aa-32.
See, e.g., Skinner v. Mid-America Pipeline Co., 490 U.S. 212, 218-219 (1989)
(citing various examples of valid conferrals of broad regulatory authority
on administrative agencies).4
Petitioners object (see 99-1749 Pet. 23-26; 99-1747 Pet. 20-21) to Congress's
decision to vest the Secretary with the authority to narrow the coverage
of the Initial Table, at least in the absence of new scientific evidence
definitively establishing the absence of any causal connection between a
vaccine and a type of injury or condition. Nothing in the Constitution or
in the text or purposes of the Act, however, supports that suggested limitation
on the scope of the Secretary's authority to "add to, or delete from,
the [Table's] list of injuries, conditions, and deaths for which compensation
may be provided or [to] change the time periods for the first symptom or
manifestation" of a compensable condition. 42 U.S.C. 300aa-14(c)(3)
(1994 & Supp. IV 1998). To the contrary, Congress presumably conferred
regulatory authority in those broad terms because it understood that adapting
the Initial Table, in light of developing scientific knowledge, would require
the exercise of informed administrative judgment that might either increase
or decrease the scope of presumptive, Table-based compensability (always,
of course, leaving claimants the opportunity to receive compensation by
showing that a causal relationship is more likely than not on the facts
of a particular case). Cf. Touby, 500 U.S. at 162 (upholding provisions
authorizing the Attorney General to remove or add substances to initial
statutory schedules of controlled substances); Yakus v. United States, 321
U.S. 414, 425 (1944) (authorized activities may "call for the exercise
of judgment, and for the formulation of subsidiary administrative policy
within the prescribed statutory framework").
3. Petitioner Terran contends (99-1749 Pet. 26-30) that this Court should
grant review to resolve differences in the way different panels of the Federal
Circuit have approached the question of "causation-in-fact" in
Vaccine Act cases. Even if there were such an intra-circuit conflict, it
would be a matter for the court of appeals itself to resolve. See Wisniewski
v. United States, 353 U.S. 901, 902 (1957). But the cases petitioner cites
do not announce materially different standards of proof. Compare Knudsen
v. Secretary of the Dep't of HHS, 35 F.3d 543, 548-549 (Fed. Cir. 1994)
(citing Bunting v. Secretary of the Dep't of HHS, 931 F.2d 867, 873 (Fed.
Cir. 1991), and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579
(1993)) ("The determination of causation in fact under the Vaccine
Act involves ascertaining whether a sequence of cause and effect is 'logical'
and legally probable, not medically or scientifically certain," but
that conclusion must be supported by a sound and reliable medical or scientific
explanation.), with Grant v. Secretary of the Dep't of HHS, 956 F.2d 1144,
1148 (Fed. Cir. 1992) (requiring "proof of a logical sequence of cause
and effect showing that the vaccination was the reason for the injury").
The cases petitioner Terran cites do differ in that the first two, Grant
and Strother v. Secretary of the Dep't of HHS, 21 Cl. Ct. 365 (1990), aff'd,
950 F.2d 731 (Fed. Cir. 1991), involved causation in "off-Table"
cases, where the petitioner is not entitled to a presumption of compensability,
while the latter two, Knudsen and Bunting, were Table cases, where the petitioner
is entitled to compensation unless the Secretary can show that the claimant's
condition is more likely than not traceable to an identifiable cause other
than the vaccine.5 Thus, while all four cases require the same proof of
causation, they properly allocate the burden of persuasion to different
parties, based on whether the claimant is entitled to a Table-based presumption
of compensability. In the present cases, petitioners had the burden of showing
causation-in-fact to support their non-Table claims. The Special Master
and the courts below concluded, after reviewing the relevant evidence, that
petitioners had not borne that burden. That fact-bound determination does
not warrant review by this Court.
4. We note, finally, three additional factors that weigh against review
in these cases.6 First, as the Secretary argued in the court of appeals,
the O'Connell petitioners' constitutional claims are barred because they
could have been, but were not, raised in petitioners' previous lawsuit,
brought under the statutory provision for judicial review set out in 42
U.S.C. 300aa-32, challenging the validity of the Secretary's 1995 regulations.
See p. 6, supra; 99-1747 Pet. App. 4 (declining to reach preclusion question
in light of resolution of merits issue in Terran); Gov't C.A. Br. 22-29
(No. 98-5134); see generally, e.g., Federated Dep't Stores, Inc. v. Moitie,
452 U.S. 394, 398-399 (1981).
Second, as the Secretary also argued below, petitioner Terran did not challenge
the validity of the Secretary's 1995 regulation in the manner and within
the time specified by Congress in 42 U.S.C. 300aa-32. See Pet. App. 13a-16a
(rejecting this argument), 48a-49a (accepting the argument, at least for
non-constitutional claims); Gov't C.A. Br. 18-20 (No. 98-5161). Although
the court of appeals disagreed with the Secretary's argument that the failure
to bring such a challenge precluded petitioner Terran's present suit, that
question would remain open should the Court grant review. See, e.g., Northwest
Airlines, Inc. v. County of Kent, 510 U.S. 355, 364 (1994); Thigpen v. Roberts,
468 U.S. 27, 29-30 (1984).
Third, Section 322 of the original Vaccine Act, 100 Stat. 3783, sets out
a somewhat unusual "nonseverability" clause: "If any provision
of this title [including provisions codified at 42 U.S.C. 300aa-1 through
300aa-34] or the application of any provision of this title to any person
or circumstance is held invalid by reason of a violation of the Constitution,
the entire title shall be considered invalid."7 The existence of that
provision underscores that petitioners' constitutional challenge to the
Act's grant of regulatory authority to the Secretary also raises potentially
difficult questions of remedy, severability, and redressability. Compare
Chadha, 462 U.S. at 931-935 (addressing severability and related standing
argument); McCorkle v. United States, 559 F.2d 1258, 1261 (4th Cir. 1977)
(concluding that legislative veto provision was not severable and dismissing
action), cert. denied, 434 U.S. 1011 (1978); cf. Friends of the Earth, Inc.
v. Laidlaw Envtl. Servs., Inc., 120 S. Ct. 693, 703-704, 706-708 (2000)
(treating redressability as an aspect of Article III standing); Israel Friedman,
Inseverability Clauses in Statutes, 64 U. Chi. L. Rev. 903 (1997). The possible
need to address those issues before reaching the questions petitioners seek
to present counsels against granting review in these cases.
CONCLUSION
The petitions for a writ of certiorari should be denied.
Respectfully submitted.
SETH P. WAXMAN
Solicitor General
DAVID W. OGDEN
Acting Assistant Attorney General
DOUGLAS N. LETTER
COLETTE G. MATZZIE
Attorneys
AUGUST 2000
1 Unless otherwise noted, appendix citations are to the appendix to the
petition in No. 99-1749.
2 In 1993, the Secretary requested that the IOM review a newly published
follow-up study of acute childhood neurological illnesses. See 60 Fed. Reg.
7685 (1995). The IOM concluded that the evidence suggested a causal relation
between DPT vaccines and certain nervous system dysfunctions in children
who experienced acute neurologic illness shortly after vaccination. The
Secretary reopened the regulatory comment period to allow comment on the
new IOM report. See O'Connell, 79 F.3d at 175.
3 In Section 312(a) and (b) of the Act, 100 Stat. 3779-3780, for example,
Congress directed the Secretary to "complete a review of all relevant
medical and scientific information * * * on the nature, circumstances, and
extent of the relationship, if any, between vaccines containing pertussis"
and certain specified illnesses and conditions, and to make and publish
findings (through a public consultative process) concerning whether, under
what conditions, and how quickly such vaccines could reasonably be expected
to cause or significantly aggravate those illnesses or conditions. Section
312(c) of the Act then directed the Secretary, at the same time she published
those findings, to "propose regulations to amend the [Initial Table]
* * * as a result of such findings." Ibid.
4 See also American Power & Light Co. v. SEC, 329 U.S. 90, 105 (1946)
("Private rights are protected by access to the courts to test the
application of the policy in the light of these legislative declarations.");
cf. A.L.A. Schechter Poultry Corp. v. United States, 295 U.S. 495, 532-533
(1935) (distinguishing cases upholding broad legislative authorizations
on the ground that the statutes considered in those cases provided notice
and hearing procedures).
5 In demonstrating that "factors unrelated to the administration of
the vaccine" caused a child's injury, 42 U.S.C. 300aa-13(a)(1)(B),
the Secretary must meet the same standard of proof that applies to a petitioner's
proof of causation in "off-Table" cases. See Knudsen, 35 F.3d
at 548. It is not enough for the Secretary to identify some other possible
cause of an injury; rather, she must show, by a preponderance of the evidence,
that an identifiable alternate cause "in the particular case [was]
shown to have been the agent or agents principally responsible for causing
the petitioner's illness, disability, injury, condition, or death."
Ibid. (quoting 42 U.S.C. 300aa-13(a)(2)).
6 In light of these factors, and because petitioners do not rely upon (or
even cite) the District of Columbia Circuit's decision in American Trucking
Associations v. United States Environmental Protection Agency, 175 F.3d
1027 (1999), there is also no reason to hold the petitions in these cases
pending this Court review of that decision in No. 99-1257, Browner v. American
Trucking Associations, cert. granted (May 22, 2000).
7 Section 322 has been amended in ways not material to the point made here.
See 42 U.S.C. 300aa-1 note (severability).