O'Connell v. SHHS
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O'Connell v. SHHS, (1st Cir. 1996).
Opinion
USCA1 Opinion
UNITED STATES COURT OF APPEALS UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT FOR THE FIRST CIRCUIT
_________________________
No. 95-1355
FRANCIS O'CONNELL AND LISA O'CONNELL,
AS THE LEGAL REPRESENTATIVES OF THEIR MINOR DAUGHTER,
KELLIANN O'CONNELL, AND DISSATISFIED PARENTS TOGETHER,
A VIRGINIA NON-PROFIT CORPORATION,
Petitioners,
v.
DONNA E. SHALALA, SECRETARY OF THE UNITED STATES
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
Respondent.
____________________
PETITION FOR REVIEW OF A FINAL RULE OF
THE SECRETARY OF HEALTH AND HUMAN SERVICES
____________________
Before
Torruella, Chief Judge, ___________
Aldrich, Senior Circuit Judge, ____________________
and Selya, Circuit Judge. _____________
____________________
Curtis R. Webb, with whom Michael R. Hugo and Conway, _______________ ________________ _______
Crowley & Hugo, P.C. were on brief, for petitioners. ____________________
Charles R. Gross, Attorney, Civil Division, United States _________________
Department of Justice, with whom Frank W. Hunger, Assistant _________________
Attorney General, Helene M. Goldberg, Director, Civil Division, ___________________
Barbara C. Biddle, Attorney, Civil Division, David Benor and __________________ ___________
Deborah Harris, Office of the General Counsel, United States _______________
Department of Health and Human Services, were on brief, for
respondent.
____________________
March 11, 1996
____________________
SELYA, Circuit Judge. This is a petition for review SELYA, Circuit Judge. ______________
and vacatur of a final rule promulgated by the Secretary of
Health and Human Services (the Secretary) under the National
Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10
through 300aa-34 (1994). We have jurisdiction under 42 U.S.C.
300aa-32. In the pages that follow, we explore the pertinent
statutory framework, recount the proceedings to date, and then
examine the petitioners' three-pronged challenge. When all is
said and done, we deny the petition and leave the rule intact.
I. THE STATUTORY SCHEME I. THE STATUTORY SCHEME
The administration of childhood vaccines, though
critically important to public health, "is not always without
risk." Committee to Review the Adverse Consequences of Pertussis
and Rubella Vaccines, Institute of Medicine, Adverse Effects of ___________________
Pertussis and Rubella Vaccines 1 (1991) (IOM Report). Since ________________________________
vaccines generally contain either dead bacteria or live but
weakened viruses, it is not surprising that they are capable of
causing serious adverse effects. See id. Despite the ___ ___
infrequency of such episodes, Congress feared that the long
shadow of tort liability cast by vaccine-related injuries would
drive up prices and eventually force vaccine suppliers out of the
market. See H.R. Rep. No. 908, 99th Cong., 2d Sess. 1, 4, 6-7 ___
(1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6345, 6347-48. _________ __
Congress also worried that the vagaries of litigation, coupled
with the cost, might leave many deserving victims of vaccine-
related injuries undercompensated. See id. ___ ___
2
To protect the supply of vaccines while ensuring fair,
timely compensation for victims, Congress departed from the
traditional tort system and wrote the National Childhood Vaccine
Injury Act (the Act), Pub. L. No. 99-660, tit. III, 100 Stat.
3755 (1986). Among other things, the Act established a special
tribunal (the Vaccine Court), and moved vaccine-injury cases
partly outside the customary tort framework. See Schafer v. ___ _______
American Cyanamid Co., 20 F.3d 1, 2 (1st Cir. 1994) (explaining _____________________
the mechanics of the Act).1 In respect to cases brought before
this tribunal, Congress eased the complainants' burdens both by
dispensing with the requirement of proving negligence and by
greatly simplifying the requisite proof of causation. See 42 ___
U.S.C. 300aa-11. Of course, there are tradeoffs; for example,
Congress limited the damages that a victim could obtain for
vaccine-related injuries. See id. 300aa-15. ___ ___
In aid of the neoteric regulatory regime, the Act
provides, in tabular format, a listing of vaccines and a parallel
listing of medical conditions commonly associated with the use of
each vaccine. See id. 300aa-14(a). These listings, known ___ ___
collectively as the Vaccine Injury Table (the Table), are
accompanied by, and are to be read in light of, the
____________________
1The Act does not entirely supplant traditional tort
remedies. An injured person is required to repair first to the
Vaccine Court, but if she is not satisfied with the result she
may reject the judgment and proceed to litigate her claim in a
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USCA1 Opinion
UNITED STATES COURT OF APPEALS UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT FOR THE FIRST CIRCUIT
_________________________
No. 95-1355
FRANCIS O'CONNELL AND LISA O'CONNELL,
AS THE LEGAL REPRESENTATIVES OF THEIR MINOR DAUGHTER,
KELLIANN O'CONNELL, AND DISSATISFIED PARENTS TOGETHER,
A VIRGINIA NON-PROFIT CORPORATION,
Petitioners,
v.
DONNA E. SHALALA, SECRETARY OF THE UNITED STATES
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
Respondent.
____________________
PETITION FOR REVIEW OF A FINAL RULE OF
THE SECRETARY OF HEALTH AND HUMAN SERVICES
____________________
Before
Torruella, Chief Judge, ___________
Aldrich, Senior Circuit Judge, ____________________
and Selya, Circuit Judge. _____________
____________________
Curtis R. Webb, with whom Michael R. Hugo and Conway, _______________ ________________ _______
Crowley & Hugo, P.C. were on brief, for petitioners. ____________________
Charles R. Gross, Attorney, Civil Division, United States _________________
Department of Justice, with whom Frank W. Hunger, Assistant _________________
Attorney General, Helene M. Goldberg, Director, Civil Division, ___________________
Barbara C. Biddle, Attorney, Civil Division, David Benor and __________________ ___________
Deborah Harris, Office of the General Counsel, United States _______________
Department of Health and Human Services, were on brief, for
respondent.
____________________
March 11, 1996
____________________
SELYA, Circuit Judge. This is a petition for review SELYA, Circuit Judge. ______________
and vacatur of a final rule promulgated by the Secretary of
Health and Human Services (the Secretary) under the National
Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10
through 300aa-34 (1994). We have jurisdiction under 42 U.S.C.
300aa-32. In the pages that follow, we explore the pertinent
statutory framework, recount the proceedings to date, and then
examine the petitioners' three-pronged challenge. When all is
said and done, we deny the petition and leave the rule intact.
I. THE STATUTORY SCHEME I. THE STATUTORY SCHEME
The administration of childhood vaccines, though
critically important to public health, "is not always without
risk." Committee to Review the Adverse Consequences of Pertussis
and Rubella Vaccines, Institute of Medicine, Adverse Effects of ___________________
Pertussis and Rubella Vaccines 1 (1991) (IOM Report). Since ________________________________
vaccines generally contain either dead bacteria or live but
weakened viruses, it is not surprising that they are capable of
causing serious adverse effects. See id. Despite the ___ ___
infrequency of such episodes, Congress feared that the long
shadow of tort liability cast by vaccine-related injuries would
drive up prices and eventually force vaccine suppliers out of the
market. See H.R. Rep. No. 908, 99th Cong., 2d Sess. 1, 4, 6-7 ___
(1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6345, 6347-48. _________ __
Congress also worried that the vagaries of litigation, coupled
with the cost, might leave many deserving victims of vaccine-
related injuries undercompensated. See id. ___ ___
2
To protect the supply of vaccines while ensuring fair,
timely compensation for victims, Congress departed from the
traditional tort system and wrote the National Childhood Vaccine
Injury Act (the Act), Pub. L. No. 99-660, tit. III, 100 Stat.
3755 (1986). Among other things, the Act established a special
tribunal (the Vaccine Court), and moved vaccine-injury cases
partly outside the customary tort framework. See Schafer v. ___ _______
American Cyanamid Co., 20 F.3d 1, 2 (1st Cir. 1994) (explaining _____________________
the mechanics of the Act).1 In respect to cases brought before
this tribunal, Congress eased the complainants' burdens both by
dispensing with the requirement of proving negligence and by
greatly simplifying the requisite proof of causation. See 42 ___
U.S.C. 300aa-11. Of course, there are tradeoffs; for example,
Congress limited the damages that a victim could obtain for
vaccine-related injuries. See id. 300aa-15. ___ ___
In aid of the neoteric regulatory regime, the Act
provides, in tabular format, a listing of vaccines and a parallel
listing of medical conditions commonly associated with the use of
each vaccine. See id. 300aa-14(a). These listings, known ___ ___
collectively as the Vaccine Injury Table (the Table), are
accompanied by, and are to be read in light of, the
____________________
1The Act does not entirely supplant traditional tort
remedies. An injured person is required to repair first to the
Vaccine Court, but if she is not satisfied with the result she
may reject the judgment and proceed to litigate her claim in a
more conventional forum subject to certain substantive and
procedural limitations established by the Act. See Schafer, 20 ___ _______
F.3d at 2-3 (discussing interplay between the Act and the tort
system).
3
Qualifications and Aids to Interpretation (QAI). The QAI is a
separate subsection that provides definitions and explanations
for the terms used in the Table. See id. 300aa-14(b). To ___ ___
receive compensation for a vaccine-related injury, a recipient
must simply petition the Vaccine Court and show that, within a
prescribed time span, she suffered one or more of the disorders
listed in the Table as associated with the particular vaccine
that she received. Thus, the content of the Table (a sample of
which is excerpted in the Appendix) is critical: it is only when
a vaccinated child suffers a listed condition within applicable
temporal parameters that compensation will be forthcoming without
the time, expense, proof requirements, and uncertainty of full-
blown litigation.
The Table is not intended to be static. Congress gave
the Secretary express power to promulgate regulations adding to
or subtracting from the tabular list of conditions, and changing
the delineated time periods. See 42 U.S.C. 300aa-14(c)(3). ___
This is a rather odd approach because it authorizes the
Secretary, in effect, to amend the statutorily enacted Table by
way of administrative rulemaking.2 This grant of power probably
reflected a congressional consensus that the first iteration of
the Table was not perfect. Driven by a sense of urgency to put
____________________
2As such, the Act may raise questions under the Presentment
Clause, which requires that all federal laws must be passed by
both houses of Congress and signed by the President. See U.S. ___
Const. art. 1, 7; see also INS v. Chadha, 462 U.S. 919, 954 ___ ____ ___ ______
(1983) ("Amendment and repeal of statutes, no less than
enactment, must conform with Art[icle] I."). Since this issue is
not raised in the instant petition, we take no view of it.
4
something into place, the solons knowingly used incomplete data
when forging the causal links between vaccines and associated
medical conditions. Mindful of its haste, Congress directed the
Secretary to have the Institute of Medicine (IOM) an arm of the
National Academy of Science conduct an extensive review of all
available information bearing on the relationship between
vaccines and medical conditions, and thereafter to publish
findings and revise the Table based on the IOM's study. See ___
Vaccine Act 312, 100 Stat. at 3779.
To assist the Secretary in updating the Table, Congress
created the Advisory Commission on Childhood Vaccines (ACCV) a
body composed of a cross-section of health professionals, legal
experts, interested citizens (including two who are parents of
children victimized by vaccine-related injuries), and federal
officials. See 42 U.S.C. 300aa-19. Congress directed the ___
Secretary to provide the ACCV with a copy of each contemplated
regulation before formally proposing it, and then to await the
expiration of a ninety-day comment period before moving forward.
See id. 300aa-14(d). ___ ___
II. THE COURSE OF EVENTS II. THE COURSE OF EVENTS
In 1991, the IOM completed its study and, on August 27,
issued the IOM Report. Among the many conclusions contained in
this tome the IOM found a causal relation between DPT
(diphtheria-pertussis-tetanus) vaccine, on one hand, and acute
encephalopathy and hypotonic, hyporesponse episodes (HHE), on the
5
other hand.3 See IOM Report at 118, 177. However, the IOM found ___
insufficient evidence to indicate a causal relationship between
DPT vaccine and residual seizure disorders (such as epilepsy).
See id. at 118 n.3. The project director gave the ACCV a full ___ ___
briefing on the IOM Report in September of 1991.
In anticipation of receiving the IOM Report, the
Secretary formed a Public Health Service Task Force as a vehicle
for revising the Table. She also enlisted yet another helpmate,
the National Vaccine Advisory Committee (NVAC). Unlike the ACCV,
which by statute counsels the Secretary in respect to the injury
compensation program, see 42 U.S.C. 300aa-19, the NVAC's ___
statutory responsibility is to advise the director of the
separate national program for developing and administering the
public health aspects of immunization policy, see id. 300aa-5. ___ ___
The Secretary transmitted the IOM Report to the Task Force, which
then recommended a number of changes to the Table (including the
removal of encephalopathy, HHE, and residual seizure disorders as
associated medical conditions vis-a-vis DPT vaccination).4 The
NVAC concurred in these recommendations.
____________________
3Encephalopathy is a general term that refers to "any
disease of the brain." Stedman's Medical Dictionary 508 (25th ____________________________
ed. 1990). HHE, also known as shock, shock-like state, or shock
collapse, refers to "an unusual reaction consisting of an acute
diminution in sensory awareness or loss of consciousness
accompanied by pallor and muscle hypotonicity [reduced tension]."
IOM Report at 171-72.
4Even though the IOM Report verified a causal relation
between the first two conditions (encephalopathy and HHE) and DPT
vaccinations, the Task Force did not believe the study disclosed
credible evidence of prolonged neurological damage.
6
Despite the fact that the ACCV had not yet formally
received the Task Force's or the NVAC's recommendations, it took
up the substance of the proposed revisions at its December 1991
meeting. In lieu of the literal text of the suggested changes,
the ACCV members received what has been referred to as a "matrix"
essentially, a table comparing a synthesis of Task Force and
NVAC recommendations and summarizing the rationales advanced by
those bodies. The ACCV discussed these recommendations at length
and approved all but the one that suggested dropping
encephalopathy from the Table. As a counter-proposal, the ACCV
encouraged the Secretary to modify the QAI definition of
encephalopathy in a way that would restrict its meaning to acute
or chronic episodes of a type more likely to result in
significant harm.
In due season, the Secretary published a Notice of
Proposed Rulemaking (the Notice). See 57 Fed. Reg. 36,878 ___
(proposed Aug. 14, 1992). The Notice included the required
scientific findings and set forth regulations designed to revise
the Table accordingly. These covered all the Task Force's
recommendations save only for the dropping of encephalopathy. On
that point the Secretary acquiesced in the ACCV's view and
proposed a new definition of the condition similar in most
respects to the definition discussed at the ACCV's December 1991
meeting. See id. at 36,880. A comment period and public hearing ___ ___
ensued.
In 1993, the results of a ten-year study of acute
7
childhood neurologic illnesses became available. Recognizing the
potential importance of the study, the Secretary stayed her hand
and requested the IOM to review the newly compiled material. In
March 1994, the IOM concluded that the "balance of the evidence
is consistent with a causal relationship" between DPT vaccination
and certain forms of chronic nervous system dysfunction suffered
by children who experience an acute neurologic illness shortly
after vaccination. Committee to Study New Research on Vaccines,
Institute of Medicine, DPT Vaccine and Chronic Nervous System _________________________________________
Dysfunction: A New Analysis 2-3 (1994). On March 24, 1994, the ____________________________
Secretary reopened the comment period for a limited time,
restricting discussion to the question whether the previously
proposed revisions should be modified in light of the
supplemental report.
At its June 1994 meeting the ACCV discussed the new
information as it concerned the proposed definition of
encephalopathy. This time, the ACCV did not achieve consensus on
the subject, and simply transmitted the minutes of its meeting to
the Secretary. On February 8, 1995, the Secretary promulgated a
final rule (under attack in this proceeding) that removed HHE and
residual seizure disorders from the Table and changed the
definition of encephalopathy in a manner very similar (but not
identical) to the manner originally suggested by the ACCV and
proposed in the Notice. See 60 Fed. Reg. 7678 (1995). ___
Francis and Lisa O'Connell (parents and legal
representatives of Kelliann O'Connell), joined by a parents'
8
advocacy group, now seek judicial review and vacatur of the final
rule.5
III. THE PETITIONERS' CHALLENGE III. THE PETITIONERS' CHALLENGE
The petitioners raise three objections to the
Secretary's action. First, the petitioners assert that the Act
does not empower the Secretary to change the definitions included
in the QAI, but, rather, only authorizes the Secretary to add and
subtract entries (i.e., vaccines and associated medical
conditions) and change time periods specified in the Table
proper. Second, the petitioners contend that, even if the
Secretary otherwise had authority to effectuate the contested
change, she failed to follow the procedures mandated by the Act.
Finally, the petitioners insist that a decision to remove a
medical condition from the Table must be based on definitive
evidence refuting the existence of a causal relationship between
the vaccine in question and the condition, and that the Secretary
eliminated HHE and residual seizure disorders from the Table
notwithstanding the absence of such an evidentiary predicate. We
address each remonstrance separately.
A. Authority to Revise the QAI. A. Authority to Revise the QAI. ___________________________
The petitioners argue that the Secretary's attempt to
change the definition of encephalopathy provided in the QAI is
____________________
5When queried at oral argument as to his clients' standing,
the petitioners' attorney explained that Kelliann had suffered an
adverse reaction after vaccination that would have been included
within the original tabular definition of encephalopathy but
which fell outside the revised definition. The Secretary does
not challenge this recital, and we therefore accept counsel's
explanation at face value.
9
impuissant because it surpasses the authority granted to the
Secretary by the Act. The Act states:
A modification of the Vaccine Injury Table
under paragraph (1) [authorizing the
Secretary to "promulgate regulations to
modify" the Table] may add to, or delete _______________________
from, the list of injuries, disabilities, ________________
illnesses, conditions, and deaths, for which
compensation may be provided or may change ______________
the time periods for the first symptom or _________________
manifestation of the onset or the significant
aggravation of any such injury, disability,
illness, condition, or death.
42 U.S.C. 300aa-14(c)(3) (emphasis supplied). In the
petitioners' view, the underscored phrases limit the Secretary's
powers of alteration, and hence, because the QAI provision is
distinct from the Table proper, the Secretary's revisory
authority does not extend to it. Ergo, changing the definition
of encephalopathy contained in the QAI oversteps the Secretary's
bounds. The Secretary debunks this argument. She construes the
statute more broadly, urging that it gives her authority to
rewrite the QAI.
1. Chevron Deference. Before choosing between these 1. Chevron Deference. __________________
competing views, we must address a preliminary issue. The
Secretary, correctly observing that courts ordinarily defer to an
agency's plausible construction of a silent or ambiguous statute
as long as Congress has committed the statute to the agency for
purposes of administration, see Chevron U.S.A. Inc. v. Natural ___ ___________________ _______
Resources Defense Council, Inc., 467 U.S. 837, 842-43 (1984); ________________________________
Strickland v. Commissioner, Me. Dep't of Human Servs., 48 F.3d __________ _________________________________________
12, 16 (1st Cir.), cert. denied, 116 S. Ct. 145 (1995), asks that _____ ______
10
we defer to her construction of 300aa-14(c). There may be more
to this request than meets the eye. The petitioners' objection
is arguably not directed at a regulation that purports to apply a
particular statutory directive which the Secretary is concededly
empowered to implement, but instead at a regulation that lies in
an area as to which, the petitioners say, the statute grants the
Secretary no rulemaking authority at all. In the current state __ ___
of the law, it is unclear whether deference is appropriate under
such circumstances.6
Discretion is sometimes the better part of valor.
Because we decide, as a matter of original statutory
construction, that the Act grants the Secretary authority to
revise the QAI provision, see infra, we leave the question of ___ _____
deference unanswered.
2. Interpreting the Statute. We turn now to the 2. Interpreting the Statute. _________________________
disputed statute. While one can focus with Cyclopean intensity
____________________
6The Supreme Court has never taken a clear institutional
stand on the question. In Mississippi Power & Light Co. v. _______________________________
Mississippi, 487 U.S. 354 (1988), the Court affirmed an agency's ___________
interpretation of a statute in a comparable situation, but
without relying on Chevron-type deference. Justice Scalia, _______
writing separately, argued for deference even though the
interpretive question involved the scope of the agency's
authority under the statute. Id. at 381 (Scalia, J., ___
concurring). Justice Brennan, writing for himself and two other
Justices, expressed the view that deference was inappropriate
because the scope of an administrative agency's jurisdiction is
not a decision that Congress normally entrusts to the agency.
Id. at 387 (Brennan, J., concurring). The problem is complicated ___
by a realization that almost any administrative action can be
described by a challenger as either exceeding an agency's
authority or overstepping the authorized application of agency
authority. See generally Thomas W. Merrill, Judicial Deference ___ _________ __________________
to Executive Precedent, 101 Yale L.J. 969, 997-98 (1992). ______________________
11
on the words singled out by the petitioners and perhaps construct
a coherent argument that those words restrict the Secretary's
revisory authority to the Table proper, courts are bound to
afford statutes a practical, commonsense reading. See King v. ___ ____
St. Vincent's Hosp., 502 U.S. 215, 221 (1991). Instead of ____________________
culling selected words from a statute's text and inspecting them
in an antiseptic laboratory setting, a court engaged in the task
of statutory interpretation must examine the statute as a whole,
giving due weight to design, structure, and purpose as well as to
aggregate language. See National R.R. Passenger Corp. v. Boston ___ ______________________________ ______
& Me. Corp., 503 U.S. 407, 417 (1992); Dole v. United _____________ ____ ______
Steelworkers of Am., 494 U.S. 26, 36 (1990); K mart Corp. v. ____________________ _____________
Cartier, Inc., 486 U.S. 281, 291 (1988); Riva v. Massachusetts, _____________ ____ _____________
61 F.3d 1003, 1007 (1st Cir. 1995).
The petitioners' reading of the Act cannot survive the
application of this global standard. Reading the statute as a
whole, we are satisfied that Congress gave the Secretary
authority to revise the QAI. In the absence of such authority
the system for updating the Act is virtually unworkable. For
instance, when the Secretary exercises her undeniable power to
include an emergent condition in the Table, she must be able to
amend the QAI to reflect the addition. Surely Congress did not
intend either to leave added conditions unexplained or itself to
edit the QAI every time the Secretary saw fit to alter the Table.
In short, the power to revise the QAI is a necessary adjunct of
12
the power to revise the Table itself.7 Elsewise, the tension
that would be created within the structure of the Act would be
intolerable and would contravene the salutary principle that
statutes should, whenever possible, be construed sensibly. See ___
American Tobacco Co. v. Patterson, 456 U.S. 63, 71 (1982); Riva, ____________________ _________ ____
61 F.3d at 1008; United States v. Meyer, 808 F.2d 912, 919 (1st _____________ _____
Cir. 1987); see also Norman J. Singer, Sutherland Statutory ___ ____ ____________________
Construction 45.12, at 61 (5th ed. 1992). ____________
We add, moreover, that the petitioners' proffered
reading of the statute is excessively formalistic. If the
Secretary could not change the definition of encephalopathy
directly, she could certainly accomplish the same result
indirectly. She need simply delete encephalopathy from the
Table, thus rendering its definition nugatory, and then
immediately add encephalopathy, redefined, to the Table.
This reality is lethal to the petitioners' position.
We cannot imagine that Congress intended to force the Secretary
to go round and round the mulberry bush in order to revise the
Table and its accompanying explanations. The shortest distance
between two points is a straight line, and we will not lightly
presume that Congress lost sight of so abecedarian a principle.8
____________________
7In their reply brief, the petitioners seemingly concede
that this is so, but suggest that the Secretary may only revise
the QAI when she is in the process of modifying the Table itself.
The suggestion is meritless. Nothing in either the text or the
history of the statute supports such an artificial construction.
8Congress had a golden opportunity to express an intent
contrary to the Secretary's view that she possesses the power to
revise the QAI, but it chose not to do so. Originally, the Act
13
See Singer, supra, 45.12, at 61 (advocating the baseline ___ _____
assumption that an enacted statute should be construed to
"achieve[] an effective and operative result"). To cinch
matters, we note that the statutory grant of a greater power
typically includes the grant of a lesser power, see, e.g., United ___ ____ ______
States v. O'Neil, 11 F.3d 292, 296 (1st Cir. 1993) (describing ______ ______
this principle as "a bit of common sense that has been recognized
in virtually every legal code from time immemorial"), and the
overall structure of the Vaccine Act confirms its applicability
here: the brute power to subtract listed medical conditions from
the Table encompasses the more modest power to trim the
definitions associated with listed medical conditions.
We have said enough on this score. We hold that the
Act grants the Secretary the authority to revise the
Qualifications and Aids to Interpretation that accompany the
Vaccine Injury Table. Consequently, the petitioners' initial
remonstrance fails.
B. Notification. B. Notification. ____________
The petitioners accuse the Secretary of failing to
observe the required notification procedures when she promulgated
____________________
did not permit the Secretary to add vaccines to the Table. In
1993, Congress amended the law to allow the Secretary to add
vaccines without specific congressional authorization. See Pub. ___
L. No. 103-66, 13632(a)(2), 107 Stat. 312, 645-46 (1993).
Congress made this important modification almost a year after the
Secretary published the Notice (in which she proposed to alter
the QAI) and after a number of loud voices had been raised during
the comment period in strong opposition to the proposed action.
Despite this public clamor, Congress did not prohibit the
Secretary from altering the QAI.
14
the regulation. The accusation is unfounded.
The relevant statute provides:
Except with respect to a regulation
recommended by the [ACCV], the Secretary may
not propose a regulation under subsection (c)
of this section or any revision thereof,
unless the Secretary has first provided to
the [ACCV] a copy of the proposed regulation
or revision, requested recommendations and
comments by the [ACCV], and afforded the
[ACCV] at least 90 days to make such
recommendations.
42 U.S.C. 300aa-14(d). The petitioners contend that the
Secretary neglected to follow these procedures twice over, by
failing to provide the ACCV with (1) a copy of the Notice before
publishing it, and (2) a copy of the final rule before issuing
it. We examine each contention.
1. The Proposed Rule. We rehearse the relevant facts. 1. The Proposed Rule. _________________
Shortly after publication of the IOM Report, the Task Force made
its initial recommendations for changing the Table. The NVAC
substantially concurred in those recommendations. The
Secretary's proposal was then circulated at the ACCV's December
1991 meeting in the form of a matrix detailing the various
recommendations. During the ensuing discussion, the principal
objection was to the Secretary's proposal, reflected in the
matrix, for removing encephalopathy from the Table. The ACCV
urged instead that encephalopathy should be retained in the Table
but that its definition should be modified in the QAI. The
Secretary accepted the ACCV's unanimous recommendation and, in
15
August 1992, published a Notice that implemented this
recommendation.9 See 57 Fed. Reg. at 36,880 (accepting ACCV ___
recommendation to retain encephalopathy in the Table with a new
definition).
The petitioners argue that the rule ultimately
promulgated is invalid because the matrix distributed and
discussed in December of 1991 was not literally a "copy of the
proposed regulation" as required by 300aa-14(d). Although the
matrix may not have been produced in the typical format for a
proposed administrative regulation, we think that for all intents
and purposes it was a "copy" of the regulation that the Secretary
planned to propose. The matrix contained the substance of all
the proposed changes to the Table. The only real difference
appears to have been in manner of presentation. The statute
requires the Secretary to deliver all the meat of a planned rule
to the Secretary without regard to how it is arranged on the
platter. Thus, as long as the Secretary transmits the entire
substance of her proposed regulation to the ACCV in the
____________________
9Though there appears to have been substantial consensus
among ACCV members about the definition they would recommend to
the Secretary, it is not clear whether the ACCV members
irrevocably agreed on an exact definition. This uncertainty
arises because, while no formal vote was taken, the members
approved in principle a specific definition proposed by Dr.
Gerald Fenichel. The members also agreed that some refinements
to Dr. Fenichel's proposed definition might be necessary and
apparently agreed to a mechanism for expediting action on any
such refinements. The administrative record (including the
minutes approved at the next ACCV meeting) reveals no objections
to Dr. Fenichel's final proposed definition and discloses no
suggested refinements to it. The Secretary included in the
proposed rule a definition of encephalopathy that was
substantially the same as this definition.
16
appropriate time frame, the form of the transmission is
immaterial. This principle possesses particular force where, as
here, the unorthodox format does not obfuscate or mislead.
Indeed, the matrix's tabular format increased comprehension by
allowing the ACCV to discuss the revisions in a manner
corresponding to the format of the Vaccine Injury Table itself.
We hold, therefore, that the Secretary fulfilled her statutory
pre-publication duty in regard to the proposed regulation.
If there were any room for doubt about the adequacy of
the transmittal and we do not believe that there is the
ACCV's actions would dispel it. We are particularly impressed by
two things. First, the transcript of the ACCV's December 1991
meeting makes very clear that ACCV members thought they were
discussing the Secretary's proposed revisions to the Table.
Second, after the Secretary published the proposed regulation,
the ACCV did not cry "foul" or otherwise complain that it had
been bypassed. These facts plainly show that the ACCV understood
the matrix to be a "copy of the proposed regulation" and acted
upon it as such.
2. The Final Rule. The Secretary's issuance of the 2. The Final Rule. ______________
final rule poses a somewhat closer question. The Secretary
openly admits that she did not provide the ACCV with the text of
the final rule prior to its promulgation. She argues, however,
that the Act does not oblige her to do so, or that, if it does,
she substantially complied with that obligation.
Section 300aa-14(d) provides in material part that "the
17
Secretary may not propose a regulation . . . or any revision
thereof" without first furnishing the ACCV with a copy of "the
regulation or revision," requesting comment, and marking time for
ninety days. This aspect of the controversy between the parties
arises from the phrase "any revision thereof." In context, this
phrase is susceptible to at least two reasonable meanings. Under
one interpretation, favored by the Secretary, the phrase refers
to a revision of a regulation, so that, while the Secretary may
not propose either a new regulation or a revision to an existing
regulation without advance notice to the ACCV, she may proceed to
revise a proposed regulation without resubmitting it to the ACCV.
Under the second interpretation, favored by the petitioners, the
phrase "any revision thereof" refers to proposed regulations, so
that the Secretary may propose neither a new regulation nor any
later revision to that proposed regulation without first
informing the ACCV.
Once again our analysis begins with a nod in the
direction of Chevron. The rule of deference traditionally _______
applies when the agency's interpretation is a "product of
delegated authority for rulemaking," Stinson v. United States, _______ ______________
113 S. Ct. 1913, 1918 (1993), a sphere that ordinarily
encompasses legislative rules and agency adjudications. Here,
the Secretary's interpretation of the law is not embodied in a
legislative rule or an adjudication. The evidence of her view
about how 300aa-14(d) is supposed to operate comes exclusively
from two sources: the refusal of her subordinates to send the
18
ACCV a pre-publication copy of the final rule, and the tactical
position adopted by her counsel.
As for the first source, agency positions that are
pieced together from offhand conduct of bureaucratic fussbudgets
are entitled to little weight on judicial review, principally
because they do not reflect the kind of delegated authority for
policymaking that underlies the Chevron presumption.10 See _______ ___
Stinson, 113 S. Ct. at 1918; Martin v. OSHRC, 499 U.S. 144, 157 _______ ______ _____
(1991); Public Citizen v. United States Dep't of Justice, 491 ______________ ________________________________
U.S. 440, 463 n.12 (1989). As for the second source, courts
customarily withhold Chevron deference from agencies' litigating _______
positions. See, e.g., Bowen v. Georgetown Univ. Hosp., 488 U.S. ___ ____ _____ ______________________
204, 212 (1988); United States v. 29 Cartons of * * * an Article _____________ _______________________________
of Food, 987 F.2d 33, 38 n.6 (1st Cir. 1993); Director, OWCP v. _______ ______________
General Dynamics Corp., 980 F.2d 74, 79 (1st Cir. 1992). We see ______________________
no reason to take a different tack in this instance. We
therefore decline to defer to the Secretary's construction of
300aa-14(d).
Approaching the statutory question without the
Secretary's thumb on the scale, we believe that both suggested
interpretations are plausible but imperfect renditions of
problematic language. The petitioners' interpretation means that
____________________
10In point of fact, the record indicates that the
Secretary's minions were not even attempting to parse the Act's
requirements, but, rather, were simply enunciating "a matter of
procedure and policy" within the agency not to distribute final
rules prematurely. Quite obviously, this affords no basis for
deference.
19
every alteration to the text of a proposed rule even a minor
technical or grammatical alteration would have to be rerouted
through the ACCV, subject to a fresh notice-and-comment period.
This extra step would be necessary even when the Secretary
changes a proposed regulation in accordance with the ACCV's ________________________________
announced wishes or to correct a syntactical bevue. Such a _________________
construction would create a nearly endless circle and attenuate
the rulemaking process without achieving any corresponding
benefit. Because it is difficult to believe that Congress
intended to prolong the revisory process by directing the
Secretary to engage in a mindless minuet, the prospect of wasted
motion cuts against the petitioners' interpretation. See Alabama ___ _______
Power Co. v. Costle, 636 F.2d 323, 360 (D.C. Cir. 1980) (stating _________ ______
the obvious proposition that courts should be reluctant to
interpret the terms of a statute "to mandate pointless
expenditures of effort").
The Secretary's construction likewise presents a
problem in that it may render the phrase "any revision thereof"
superfluous to some extent. Since the Secretary would have to
issue a new regulation in order to change an existing one, see 42 ___
U.S.C. 300aa-14(c), Congress probably did not need to add the
requirement that a revision to an existing regulation must be
reviewed by the ACCV. Because courts usually presume that every
word and phrase in a statute is pregnant with meaning, see, e.g., ___ ____
United States v. Ven-Fuel, Inc., 758 F.2d 741, 751-52 (1st Cir. _____________ ______________
1985), the prospect of redundancy cuts against the Secretary's
20
interpretation.
Faced with no ideal choice, we conclude that Congress
more likely intended the statute to be read as the Secretary
urges. This interpretation is more plausible and better serves
the ends that the legislature sought to achieve. Though it is
possible that Congress could have accomplished its purpose ________
without adding the disputed phrase ("any revision thereof"), it
is not certain that it could have done so. A wily lawyer could
perhaps have argued that the unembellished word "regulation"
referred only to brand-new regulations, not to adjustments of
preexisting regulations. Cf. Public Serv. Co. v. United States ___ _________________ _____________
EPA, 682 F.2d 626, 633 (7th Cir. 1982), cert. denied, 459 U.S. ___ _____ ______
1127 (1983). Even more likely, Congress might have thought that
the Secretary would be able to style a revision to a preexisting
regulation as something other than a new regulation (perhaps as a
clarification), and thereby evade the statutory safeguards. See, ___
e,g., Detroit Edison Co. v. United States EPA, 496 F.2d 244, 249 ____ __________________ _________________
(6th Cir. 1974) (rejecting EPA's attempt to characterize agency
action as mere "clarification" of regulation as opposed to
revision); cf. United States v. LaBonte, 70 F.3d 1396, 1411 n.13 ___ _____________ _______
(1st Cir. 1995) (noting Sentencing Commission's practice of
styling certain pronouncements affecting the interpretation of
extant sentencing guidelines as "clarifications" rather than
amendments). Moreover, a belt-and-suspenders approach is not
uncommon when the Legislative Branch cedes rulemaking power to
the Executive Branch. Indeed, Congress has frequently employed
21
the phrase "revision thereof" to confirm that its procedural
mandates apply both to original regulations and future revisions
of such regulations. See, e.g., 15 U.S.C. 2934(f)(1); 16 ___ ____
U.S.C. 410cc-32(e); 33 U.S.C. 1314(c); 42 U.S.C.
4916(a)(3)-(4), 7521(a)(2), 7571(b).
Here, the Secretary's interpretation not only is
consistent with common congressional statute-drafting practice
but also ensures the ACCV's input into the rulemaking process
without inviting the wasteful circularity of proposal, notice,
comment, changed proposal, re-notice, additional comment, and so
on and so forth, ad infinitum. The petitioners' suggested
alternative, on the other hand, creates a perverse incentive. If
the Secretary is forced to recommit a proposed regulation and
twiddle her thumbs for an additional three months every time she
responds agreeably to an ACCV suggestion, she may be less
inclined to acquiesce in the first place. Hence, the
interpretation that we adopt actually may increase the chance
that the Secretary will pay attention to, and act upon, the
ACCV's advice.
In reaching the conclusion that the statute refers to
regulations and revisions thereof (and not to revisions of
proposed regulations), we necessarily override two other concerns
anent the ACCV's place in the scheme of things. First, the
petitioners boast that the ACCV's statutorily prescribed part in
the process of revising the Table evinces Congress's distrust of
the Secretary and proves that the reference to "any revision
22
thereof" is intended to give the ACCV a more prominent presence
in the rulemaking process. This distorts the statutory alignment
by grossly underestimating the Secretary's role and aggrandizing
the ACCV's importance. In crafting the Act, Congress delegated
unusually great authority to the Secretary, including the power
to rewrite the statute by updating one of its hallmark
provisions. In contrast, Congress assigned the ACCV a purely
advisory function. See 42 U.S.C. 300aa-19; see also H.R. Rep. ___ ___ ____
No. 908, supra, 1986 U.S.C.C.A.N. at 6365. Thus, far from _____
bolstering the petitioners' case, a comparison of the relative
responsibilities that Congress entrusted to the Secretary and the
ACCV, respectively, undermines the petitioners' argument.
Second, the Secretary's construction of the statute
does not permit her effectively to bypass the ACCV by proposing
one regulation and then issuing something radically different as
a final rule. The Administrative Procedure Act applies here, and
it is axiomatic under that regime that a final rule must be a
lineal descendant of, and in character with, the earlier proposed
rule. See, e.g., Kooritzky v. Reich, 17 F.3d 1509, 1513 (D.C. ___ ____ _________ _____
Cir. 1994); American Medical Ass'n v. United States, 887 F.2d ______________________ ______________
760, 767 (7th Cir. 1989). Put another way, changes must flow
logically from the prescribed notice and comment. See Natural ___ _______
Resources Defense Council, Inc. v. United States EPA, 824 F.2d ________________________________ _________________
1258, 1283 (1st Cir. 1987). If the final rule deviates
substantially from the proposed rule, it amounts to a new
proposal and must run the regulatory gauntlet afresh. Thus, the
23
ACCV's right to be consulted is not stunted by the reading of
300aa-14(d) that we adopt today.
To recapitulate, we believe that Congress might
reasonably have inserted the phrase "any revision thereof" to
close what it suspected were potential loopholes. We therefore
accept the Secretary's thesis that the phrase "any revision
thereof," as used in 300aa-14(d), refers exclusively to
revisions of existing regulations (not to revisions of proposed
regulations). On this understanding, we hold that the Secretary
complied with the statutory notice-and-comment requirement by
providing a pre-publication copy of her proposed regulation to
the ACCV in December of 1991.
C. Adding and Subtracting Medical Conditions. C. Adding and Subtracting Medical Conditions. _________________________________________
The petitioners' final shot injects a new notion into
the case: the idea that the Act does not authorize the Secretary
to remove HHE and residual seizure disorders from the Table in
the absence of "definitive information" attesting to the lack of
any causal link between DPT vaccination and these medical
conditions. Since both the IOM and the Secretary herself found
only that there was "insufficient evidence to indicate a causal
relation" between vaccination and the kind of permanent
neurological damage reflected in HHE and residual seizure
disorders over time, see IOM Report at 118; Notice, 57 Fed. Reg. ___
at 36,879, they tell us that the deletions cannot survive.
The Secretary accepts the petitioners' premise the
available evidence does not flatly disprove the causal relation
24
but she vigorously disputes the petitioners' conclusion. In her
view, the criteria for revising the Table simply do not include
the requirement that the petitioners seek to impose. We agree
with the Secretary.
We need not tarry. Nothing in the text of the Act
prohibits the Secretary from eliminating a condition from the
Table if the evidence of a causal relationship between the
vaccination and that condition is equivocal. The only explicit
constraints on the Secretary are procedural. See, e.g., 42 ___ ____
U.S.C. 300aa-14(c) (requiring notice-and-comment period,
including public hearing); id. 300aa-14(d) (mandating referral ___
to the ACCV). While some other constraints may be readily
inferred from the terms, structure, and history of the Act, there
is no principled basis for the added constraint that the
petitioners would have us infer.
The petitioners' construct rests solely on a suggestion
in the committee report accompanying the Act to the effect that
the Secretary may revise the Table when "more definitive
information" is available. They read this terse reference as
superimposing on the text of the statute a requirement that the
Secretary must have definitive evidence rejecting a causal
relation between vaccination and a medical condition before she
may delete the condition from the Table.
The petitioners read the committee report through rose-
colored glasses. The passage on which they rely is reproduced in
25
its entirety in the margin.11 The passage as a whole makes it
abundantly clear that, though Congress, struggling with a lack of
information, itself used an initial presumption that the
conditions listed in the Table were caused by vaccination so long
as they occurred within the specified time period following
vaccination, it did not intend to carve this presumption into
stone. To the precise contrary, the authors of the committee
report explicitly recognized that the Table, as originally
devised, might in some cases go too far, and relied on the
Secretary to reconstitute it in light of the "more definitive
information" that would be available as a consequence of the ___________________________________________________
review, in order to reflect more accurately the causal relations ______
____________________
11The passage reads:
The Committee recognizes that there is public
debate over the incidence of illnesses that
coincidentally occur within a short time of
vaccination. The Committee further
recognizes that the deeming of vaccine-
relatedness adopted [in the Table] may
provide compensation to some children whose
illness is not, in fact, vaccine-related.
The Committee anticipates that the research
on vaccine injury and vaccine safety now
ongoing and mandated by this legislation will
soon provide more definitive information
about the incidence of vaccine injury and
that, when such information is available, the
Secretary or the [ACCV] may propose to revise
the Table . . . . Until such time, however,
the Committee has chosen to provide
compensation to all persons whose injuries
meet the requirements of the petition and the
Table and whose injuries cannot be
demonstrated to be caused by other factors.
H.R. Rep. No. 908, supra, 1986 U.S.C.C.A.N. at 6359. _____
26
between vaccines and allegedly associated medical conditions.12
Had Congress intended the Secretary to revise the Table
by removing a medical condition only after a causal link was
definitely disproven, it could quite easily have said so. It
said nothing of the sort. What is did say is that the Secretary
should update the Table in light of new and better information
about causation. The Secretary, in pursuance of this directive,
decided inter alia to remove HHE and residual seizure disorders _____ ____
from the Table because the medical evidence failed to establish a
causal connection between DPT vaccines and these disorders.
Since there is nothing in the record to suggest that this
decision is arbitrary or capricious, it must stand. See, e.g., ___ ____
Strickland, 48 F.3d at 17-18; United States v. Members of the __________ _____________ _______________
Estate of Luis Boothby, 16 F.3d 19, 21 (1st Cir. 1994); see also _______________________ ___ ____
5 U.S.C. 706(2)(A).
IV. CONCLUSION IV. CONCLUSION
We need go no further. The Secretary had authority to
issue the regulation about which the petitioners complain, and
she exercised that authority in a procedurally appropriate and
substantively permissible manner. No more is exigible.
The petition to review and vacate the final rule is The petition to review and vacate the final rule is _______________________________________________________
denied. denied. ______
____________________
12This is of a piece with the statute itself, which
indicates that the Secretary's revisions should be based on
findings about whether "each of the illnesses or conditions set
forth in [the Table] can reasonably be determined in some
circumstances to be caused or significantly aggravated by
pertussis-containing vaccines." Vaccine Act 312(b), 100 Stat.
at 3780.
27
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467 U.S. 837 (Supreme Court, 1984)
K Mart Corp. v. Cartier, Inc.
486 U.S. 281 (Supreme Court, 1988)
Mississippi Power & Light Co. v. Mississippi Ex Rel. Moore
487 U.S. 354 (Supreme Court, 1988)
Dole v. United Steelworkers
494 U.S. 26 (Supreme Court, 1990)
Martin v. Occupational Safety & Health Review Commission
499 U.S. 144 (Supreme Court, 1991)
King v. St. Vincent's Hospital
502 U.S. 215 (Supreme Court, 1991)
National Railroad Passenger Corporation v. Boston & Maine Corp.
503 U.S. 407 (Supreme Court, 1992)
Stinson v. United States
508 U.S. 36 (Supreme Court, 1993)
United States v. 29 Cartons of an Article of Food
987 F.2d 33 (First Circuit, 1993)
United States v. Members of the Estate of Boothby
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Schafer v. American Cyanamid Co.
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Riva v. Commonwealth of MA
61 F.3d 1003 (First Circuit, 1995)
The Detroit Edison Company v. United States Environmental Protection Agency
496 F.2d 244 (Sixth Circuit, 1974)
Alabama Power Company v. Douglas M. Costle, as Administrator, Environmental Protection Agency, Sierra Club, Intervenors.
636 F.2d 323 (D.C. Circuit, 1980)
Public Service Company of Indiana, Inc. v. United States Environmental Protection Agency and Douglas M. Costle
682 F.2d 626 (Seventh Circuit, 1982)
United States v. Ven-Fuel, Inc.
758 F.2d 741 (First Circuit, 1985)
United States v. Robert E. Meyer
808 F.2d 912 (First Circuit, 1987)
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