“Our ultimate task in any pre-emption case is to determine whether state regulation is consistent with the structure and purpose of the statute as a whole.”
How later courts described this case
- “Our ultimate task in any pre-emption case is to determine whether state regulation is consistent with the structure and purpose of the statute as a whole.”
- “If a federal law contains an express pre-emption clause, it does not immediately end the inquiry because the 13 question of the substance and scope of Congress’ displacement of state law still remains.”
- “To discern Congress’ intent we examine the explicit statutory language and the structure and purpose of the statute.”
- overruled in part on other grounds
Written by the judges who cited it.
The opinion
Opinions of the United
2009 Decisions States Court of Appeals
for the Third Circuit
3-27-2009
Bruesewitz v. Wyeth Inc
Precedential or Non-Precedential: Precedential
Docket No. 07-3794
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PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
_____________
No. 07-3794
_____________
RUSSELL BRUESEWITZ; ROBALEE BRUESEWITZ,
parents and natural guardians of Hannah Bruesewitz,
a minor child and in their own right,
Appellants
v.
WYETH INC.
f/k/a
WYETH LABORATORIES, WYETH-AYERST
LABORATORIES,
WYETH LEDERLE, WYETH LEDERLE VACCINES,
AND
LEDERLE LABORATORIES
___________________
On Appeal from the United States District Court
for the Eastern District of Pennsylvania
District Court No. 05-cv-05994
District Judge: The Honorable Michael M. Baylson
____________________
1
Argued September 11, 2008
Before: McKEE, SMITH, and WEIS, Circuit Judges
(Filed: March 27, 2009)
Collyn A. Peddie (Argued)
Williams, Kherkher, Hart & Boundas
8441 Gulf Freeway
Suite 600
Houston, TX 77017-5001
Counsel for Appellant
Reetu Dandora
1650 Market Street
2500 One Liberty Place
Philadelphia, PA 19103-7301
Counsel for Appellee
Lauren Elliott
Richard W. Mark (Argued)
Daniel J. Thomasch
Orrick, Herrington & Sutcliffe
666 Fifth Avenue
New York, NY 10103
Counsel for Appellee
Henry F. Reichner
Michael T. Scott
Reed Smith
1650 Market Street
2
2500 One Liberty Place
Philadelphia, PA 19103
Counsel for Appellee
______________
OPINION
______________
SMITH, Circuit Judge.
This appeal presents three questions related to the
National Childhood Vaccine Injury Act: (1) whether the Act
preempts all design defect claims against the manufacturer of a
vaccine; (2) whether the plaintiffs demonstrated that the
manufacturer failed to adequately warn the plaintiffs of the risks
associated with the vaccine; and (3) whether the plaintiffs
provided sufficient evidence of a manufacturing defect to
survive the defendant’s motion for summary judgment. The
District Court held that the Act preempted all design defect
claims and concluded that the plaintiffs failed to provide
sufficient evidence to support the other two claims. For the
reasons that follow, we will affirm.
I.
A.
Historically, the states have possessed “great latitude
3
under their police powers to legislate as to the protection of the
lives, limbs, health, comfort, and quiet” of their citizens. Metro.
Life Ins. Co. v. Massachusetts, 471 U.S. 724, 756 (1985). This
has been true with regard to drugs, as the Supreme Court has
declared it “well settled that the State has broad police powers
in regulating the administration of drugs by the health
professions.” Whalen v. Roe, 429 U.S. 589, 603 (1977). And
the police powers extend to immunization, as state and local
authorities have responded to illnesses like smallpox and sought
to inoculate members of the populous. Center for Biologics
Evaluation and Research, Food and Drug Administration,
Science and the Regulation of Biological Products: From a Rich
History to a Challenging Future 8 (2002). Despite calls in the
late nineteenth-century for the federal regulation of vaccines to
promote uniform safety regulations, Congress did not act until
1902, when thirteen children died after being vaccinated with
contaminated diptheria antitoxin. Id. at 12. Over the past
century, however, the federal government has taken a
predominate role in approving, regulating, and promoting
vaccines—from the passage of the Biologics Control Act in
1902, Pub. L. No. 57-244, which authorized a federal agency to
issue regulations related to vaccines, to the Public Health
Service Act, Pub. L. No. 78-410, which required federal
authorities to license vaccines and vaccine manufacturers, to the
Emergency Supplemental Appropriations Act for Recovery from
and Response to Terrorist Attacks on the United States, Pub. L.
No. 107-9, which appropriated money for the acquisition of a
sufficient quantity of the smallpox vaccine to inoculate the
4
country.
The National Childhood Vaccine Injury Act (“Vaccine
Act”) is one such effort. P.L. 99-660, Title III, 100 Stat. 3743,
3756–3784 (codified at 42 U.S.C. § 300aa-1 et seq.). Enacted
in 1986, the Vaccine Act established a national vaccine program
to “achieve optimal prevention of human infectious diseases
through immunization and to achieve optimal prevention against
adverse reactions to vaccines.” 42 U.S.C. § 300aa-1. It sought
to accomplish this primarily through the creation of the National
Vaccine Injury Compensation Program (“NVICP”) for claims
against drug manufacturers for vaccine-related injuries and
deaths. 42 U.S.C. § 300aa-10 et seq.
The NVICP has two parts. Part A creates a mandatory
forum for the administration of claims—it requires a petitioner
seeking compensation, including the injured party’s legal
representative, to file a petition in the “Vaccine Court,” which
is part of the United States Court of Federal Claims. Id. at §
300aa-11. The petitioner is entitled to receive compensation if:
(1) the affected person received a vaccine covered by the
Vaccine Act; (2) the affected person suffered a “Table injury”;1
1
The Vaccine Act created the “Vaccine Injury Table.” 42
U.S.C. § 300aa-14. It sets forth the “vaccines, the injuries,
disabilities, illnesses, conditions, and deaths resulting from the
administration” of vaccines for which individuals may seek
compensation. Id.
5
and (3) it cannot be shown by a preponderance of the evidence
that the injuries or death were not caused by the vaccine. Id. at
§§ 300aa-11, 300aa-13. Alternatively, a petitioner who suffers
a non-Table injury may still obtain compensation by proving
affirmatively that the vaccine caused the injury. See Grant v.
Sec’y of HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992). Part B of
the NVICP permits a petitioner, after the Vaccine Court has
issued a final judgment, to either accept or reject that judgment.
42 U.S.C. § 300aa-21 et seq. If the petitioner rejects the
judgment, she may pursue certain limited claims in state or
federal court.2 42 U.S.C. § 300aa-21.
B.
Hannah Bruesewitz was born on October 20, 1991. At
the time, the federal Advisory Committee on Immunization
Practices recommended that children receive five doses of the
diphtheria-pertussis-tetanus (“DPT”) vaccine during the course
of their childhood, one dose at each of the following ages: (1) 2
months; (2) 4 months; (3) 6 months; (4) 15-18 months; and (5)
4-6 years. Hannah received her first three shots of the DPT
vaccine according to this schedule. After the third DPT shot,
marketed under the trade name TRI-IMMUNOL and
administered on April 1, 1992, she suffered a series of seizures.
2
The party also has the option of appealing the Court of
Federal Claims’ judgment to the United States Court of Appeals
for the Federal Circuit. 42 U.S.C. § 300aa-12(f).
6
Doctors subsequently diagnosed Hannah as having residual
seizure disorder and developmental delay. Hannah, who is now
seventeen, will likely require some medical care related to that
condition for the remainder of her life.
Defendant Wyeth, Inc. and its predecessors 3 (“Wyeth”)
manufactured TRI-IMMUNOL until 1998. Approved in 1948,
this vaccine contains the “whole-cell” pertussis vaccine—it is
prepared using whole, inactivated pertussis bacterial cells.
Although the whole-cell vaccine effectively reduced pertussis
infections and deaths associated with these infections, it was
also linked to a variety of adverse events. This led to interest in
and efforts to develop a safer, acellular pertussis vaccine.
In December 1991, the Food and Drug Administration
(“FDA”) approved the defendant’s application for an alternate
DPT vaccine, which was known as ACEL-IMUNE. ACEL-
IMUNE contains an acellular pertussis component. While the
acellular vaccine contains parts of pertussis bacterial cells,
because it does not contain a complete cell, it has less endotoxin
3
The National Health Institute first issued a product
license for TRI-IMMUNOL in 1948 to American Cyanamid
Company (“Cyanamid”). Lederle Laboratories, an
unincorporated division of Cyanamid, produced TRI-
IMMUNOL. In 1994, American Home Products Corporation
(“AHPC”) acquired Cyanamid. In March 2002, AHPC changed
its name to Wyeth.
7
and is less likely to cause adverse events.4 The FDA initially
approved ACEL-IMUNE, however, for administration as the
fourth and/or fifth DPT dose in the series of five. The FDA did
not approve an acellular pertussis vaccine for the first three
shots in the series until July 1996 when it approved the license
of Connaught Laboratories, Inc. Defendant’s ACEL-IMUNE
did not receive approval for these same doses until December
1996.
Nonetheless, at the time of vaccination in April 1992,
Hannah’s doctor administered the TRI-IMMUNOL vaccine
because there were no acellular pertussis vaccines commercially
available for the third dose. Hannah’s particular vaccine came
from a lot that generated sixty-five reports of adverse reactions
with the FDA and Centers for Disease Control and Prevention,
including thirty-nine em ergency room visits, six
hospitalizations, and two deaths. Hannah’s physician later
4
The acellular pertussis vaccine contains pertussis toxin
and other bacterial components. These components, however,
are less reactive and cause fewer adverse events because they
have been detoxified using chemical or genetic techniques.
Centers for Disease Control and Prevention, Pertussis
Vaccination: Acellular Pertussis Vaccine for the Fourth and
Fifth Doses of the DPT Series; Update to Supplementary ACIP
Stat Recommendations of the Advisory Committee on
Immunization Practices, October 9, 1992,
http://www.cdc.gov/mmwr/preview/mmwrhtml/00048610.htm.
8
indicated, as part of this litigation, that she would not have
immunized Hannah had she known of the adverse event reports
associated with this lot of the vaccine.
In 1998, Wyeth voluntarily discontinued manufacturing
TRI-IMMUNOL.
C.
Hannah’s parents (“plaintiffs”) filed a petition in the
Vaccine Court in April 1995, alleging that Hannah suffered an
on-Table residual seizure disorder and encephalopathy.5
Bruesewitz v. Sec’y of Dep’t of HHS, No. 95-0266V, 2002 WL
31965744, at *1 n.1 (Fed. Cl. Dec. 20, 2002). The Court held a
hearing in July 2002 and concluded in December of that year
that Hannah’s injuries were non-Table injuries and that the
petitioners had not proven causation in fact. Id. at *13–17.
Accordingly, it dismissed the claim with prejudice. Id. at *17.
Hannah’s parents rejected the Court’s judgment on February 14,
5
Effective March 10, 1995, approximately one month
before the plaintiffs filed their petition with the Vaccine Court,
new regulations deleted residual seizure disorder as a Table
injury for DPT vaccine. Bruesewitz v. Sec’y of Dep’t of HHS,
No. 95-0266V, 2002 WL 31965744, at *1 n.1 (Fed. Cl. Dec. 20,
2002); see also National Vaccine Injury Compensation Program
Revision of the Vaccine Injury Table, 60 Fed. Reg. 7678,
7689–91 (Feb. 8, 1995 ).
9
2003.
Having exhausted their administrative remedies, the
plaintiffs filed a Complaint in the Philadelphia Court of
Common Pleas in October 2005. The complaint sought
recovery on four claims: (I) negligent failure to produce a safer
vaccine; (II) negligent failure to warn; (III) strict liability for
design defect; and (IV) strict liability for manufacturing defect.
Wyeth removed the action on the basis of diversity to the
Eastern District of Pennsylvania and filed a motion for summary
judgment. The District Court denied the motion without
prejudice because the parties had not engaged in discovery.
Following completion of discovery, Wyeth again moved for
summary judgment on all four counts.
Although the District Court did not accept all of Wyeth’s
theories, it granted summary judgment in Wyeth’s favor on all
counts on August 24, 2007. The District Court concluded that
Section 22(b)(1) of the Vaccine Act, 42 U.S.C. § 300aa-
22(b)(1), preempts all design defect claims arising from a
vaccine-related injury or death and dismissed Counts I and III on
that basis. Regarding Count II, which alleged negligent failure
to warn, the District Court concluded that the plaintiffs had not
rebutted the statutory presumption created by Section 22(b)(2)
of the Vaccine Act, 42 U.S.C. § 300aa-22(b)(2), that Wyeth’s
FDA-compliant warnings were proper. As to Count IV, which
alleged that the particular lot from which Hannah’s dose
originated was especially prone to adverse reactions due to a
10
manufacturing defect, the District Court concluded that the
plaintiffs had failed to present sufficient evidence that the lot
was defective or that it caused Hannah’s injuries.
The District Court’s ruling on the first and third claims
warrants further examination. Both counts alleged a design
defect—Count I alleged that Hannah’s vaccine was negligently
designed because the defendant knew of a safer alternative and
failed to produce it, while Count III alleged strict liability design
defect. The District Court ruled that both claims were
preempted by the Vaccine Act. It rested this decision on four
points. First, it stated that a case-by-case consideration of
whether a vaccine was unavoidably safe would not protect
vaccine manufacturers from suit. Second, it reasoned that
Congress passed the Vaccine Act to “provide an umbrella under
which manufacturers would improve the safety of their products
while remaining immune from design defect claims.” Third, the
Court found that Congress achieved an appropriate balance by
offsetting the effect of the preemption of design defect claims
with creation of a compensation program for individuals injured
by vaccines. Finally, it concluded that the Vaccine Act
preempts both strict liability and negligent design defect claims
against FDA-approved vaccines. Accordingly, it dismissed
plaintiffs’ first and third claims.
The plaintiffs appealed. Their appeal presents this Court
with three questions: (1) does § 300aa-22(b)(1) act as a
complete bar to design defect claims; (2) have the plaintiffs in
11
this case met their burden under § 22(b)(2) of the Vaccine Act
to show that defendants failed to provide an adequate warning
of the alleged dangers of the vaccine; and (3) have the plaintiffs
provided sufficient evidence of a manufacturing defect to
survive the defendant’s motion for summary judgment.
II.
The District Court had jurisdiction under 28 U.S.C.
§§ 1332 and 1441, and we have appellate jurisdiction under 28
U.S.C. § 1291. Our review of a District Court’s grant of
summary judgment is plenary, and we apply the same standard
as the District Court to determine whether summary judgment
was appropriate. Norfolk S. Ry. Co. v. Basell USA Inc., 512
F.3d 86, 91 (3d Cir. 2008). A grant of summary judgment is
appropriate “if the pleadings, the discovery and disclosure
materials on file, and any affidavits show that there is no
genuine issue as to any material fact and that the movant is
entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(c).
In making this determination, we must view the facts in the light
most favorable to the nonmoving party and draw all inferences
in that party’s favor. Norfolk, 512 F.3d at 91.
III.
Preemption doctrine is rooted in the Supremacy Clause
of the United States Constitution. Article VI declares that the
laws of the United States “shall be the supreme Law of the
12
Land; . . . any Thing in the Constitution or Laws of any State to
the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2.
“Under the Supremacy Clause, federal law may supersede state
law in several different ways.” Hillsborough County, Fla., v.
Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985). Over
the years, the Supreme Court has recognized three types of
preemption: express preemption, implied conflict preemption,
and field preemption. Id.
A federal enactment expressly preempts state law if it
contains language so requiring. Lorillard Tobacco Co. v. Reilly,
533 U.S. 525, 541 (2001). Thus, when construing an express
preemption clause, a reviewing court must necessarily begin by
examining the “plain wording of the clause,” as this “necessarily
contains the best evidence of Congress’ pre-emptive intent.”
Sprietsma v. Mercury Marine, 537 U.S. 51, 62–63 (2002)
(quoting CSX Transp. v. Easterwood, 507 U.S. 658, 664
(1993)). Though the language of the provision offers a starting
point, courts are often called upon to “identify the domain
expressly pre-empted by that language.” Medtronic, Inc. v.
Lohr, 518 U.S. 470, 484 (1996) (internal quotation marks and
citations omitted). This, in turn, is guided by two principles. Id.
at 485. First, “Congressional purpose is the ‘ultimate
touchstone’ of our inquiry.” Lorillard Tobacco Co., 533 U.S. at
541 (quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504,
516 (1992)); see also Altria Group, Inc. v. Good, 129 S. Ct. 538,
543 (2008) (“If a federal law contains an express pre-emption
clause, it does not immediately end the inquiry because the
13
question of the substance and scope of Congress’ displacement
of state law still remains.”). Second, courts must operate under
the “assumption that the historic police powers of the States
[a]re not to be superseded by the Federal Act unless that [is] the
clear and manifest purpose of Congress.” Cal. Div. of Labor
Standards Enforcement v. Dillingham Constr., N.A., Inc., 519
U.S. 316, 325 (1997).
Implied conflict preemption arises when state law
conflicts with a federal statute in one of two situations. First, it
arises when it is “impossible for a private party to comply with
both state and federal requirements.” English v. General Elec.
Co., 496 U.S. 72, 78–79 (1990). It is also present when state
law “stands as an obstacle to the accomplishment and execution
of the full purposes and objectives of Congress.” Hines v.
Davidowitz, 312 U.S. 52, 67 (1941). Furthermore, implied
preemption may exist even in the face of an express preemption
clause. As the Supreme Court observed in Freightliner Corp. v.
Myrick, 514 U.S. 280, 288 (1995), “Congress’ enactment of a
provision defining the preemptive reach of a statute implies that
matters beyond that reach are not pre-empted,” but that “does
not mean that the express clause entirely forecloses any
possibility of implied pre-emption.”
When confronting arguments that a law stands as an
obstacle to Congressional objectives, a court must use its
judgment: “What is a sufficient obstacle is a matter of judgment,
to be informed by examining the federal statute as a whole and
14
identifying its purpose and intended effects.” Crosby v. Nat’l
Foreign Trade Council, 530 U.S. 363, 373 (2000). In fact, we
must look to “‘the entire scheme of the statute’” and determine
“‘[i]f the purpose of the [federal] act cannot otherwise be
accomplished—if its operation with its chosen field [would] be
frustrated and its provisions be refused their natural effect.’” Id.
(quoting Savage v. Jones, 225 U.S. 501, 533 (1912)). Once
again, this requires an examination of the “‘whole law, and to its
object and policy.’” Gade v. Nat’l Solid Wastes Mgmt. Assn.,
505 U.S. 88, 98 (1992) (quoting Pilot Life Ins. Co. v. Dedeaux,
481 U.S. 41, 51 (1987)).
Field preemption arises by implication when state law
occupies a “field reserved for federal regulation.” United States
v. Locke, 529 U.S. 89, 111 (2000). This occurs when “Congress
[] left no room for state regulation of these matters.” Id.; see
also Lorillard Tobacco Co., 533 U.S. at 541. It may also be
inferred when “an Act of Congress ‘touch[es] a field in which
the federal interest is so dominant that the federal system will be
assumed to preclude enforcement of state laws on the same
subject.’” English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990)
(quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230
(1947)). Nonetheless, because field preemption typically arises
in areas traditionally regulated by states under their police
powers, “congressional intent to supersede state laws must be
‘clear and manifest.’” Id. (citation omitted).
Yet despite the development of the foregoing preemption
15
jurisprudence, courts must begin their analysis of these
questions by applying a presumption against preemption.
Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992). “In
areas of traditional state regulation, we assume that a federal
statute has not supplanted state law unless Congress has made
such an intention ‘clear and manifest.’” Bates v. Dow
AgroSciences, 544 U.S. 431, 449 (2005). When faced with two
equally plausible readings of statutory text, we “have a duty to
accept the reading that disfavors preemption.” Id; see also
Altria Group, Inc., 129 S. Ct. at 543; Cipollone, 505 U.S. at 518.
This is true even in the event of an express preemption clause.
Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1014 (2008) (quoting
Bates, 544 U.S. at 449). That issues of health and safety have
traditionally fallen within the province of state regulation is
beyond refute. That safety of vaccines is an issue of health and
safety is equally clear. See, e.g., Medtronic, Inc., 518 U.S. at
485. Nonetheless, in the face of clear evidence, the presumption
against preemption can be overcome. See Crosby, 530 U.S. at
374 n.8. (“Assuming, arguendo, that some presumption against
preemption is appropriate, we conclude, based on our analysis
below, that the state Act presents a sufficient obstacle to the full
accomplishment of Congress’s objectives under the federal Act
to find it preempted.”).
We must decide here whether the plaintiffs’ design defect
claims are preempted. As we have noted, the District Court
reasoned that four points counseled in favor of finding that both
claims were preempted by the Vaccine Act: (1) if the Vaccine
16
Act permitted case-by-case consideration of design defect
claims, the Act would do little to protect manufacturers from
suit; (2) Congress intended the Vaccine Act to encourage
vaccine improvements while providing immunity for design
defect claims; (3) Congress achieved a balance between
manufacturers and patients by creating the compensation system
to offset design defect immunity; and (4) the Vaccine Act is
broader than comment k of the Restatement (Second) of Torts
§ 402A such that the Act encompasses both strict liability and
negligence claims. At the same time, the District Court did not
explicitly lay out a framework for coming to these conclusions,
nor did it state whether they were predicated on express,
implied, or field preemption grounds.
Plaintiffs now seek to turn such ambiguity to their
advantage by arguing that the District Court’s decision was
“based on some kind of implied or field preemption” when the
defendant’s motion for summary judgment raised only express
preemption. This, they maintain, violated “well-settled
summary judgment principles.” 6 Accordingly, we must consider
6
The plaintiffs argue that the District Court’s decision
violates the principle that a “district court may not grant
summary judgment sua sponte on grounds not requested by the
moving party.” John Deere Co. v. Am. Nat’l Bank, 809 F.2d
1190, 1192 (5th Cir. 1987). This Court has previously
remanded a claim because the District Court granted summary
judgment on a ground not offered in the moving party’s motion.
17
four questions related to the preemption of the design defect
claim: (1) whether § 300aa-22(b) constitutes an express
preemption provision; (2) whether we may use traditional tools
of statutory interpretation, including legislative history, when
construing such a provision; (3) whether this provision preempts
plaintiffs’ design defect claims; and (4) whether the District
Court’s decision is consistent with this analysis.
A.
Part B of the Vaccine Act establishes the circumstances
under which individuals who have rejected the judgment of the
Vaccine Court may subsequently file suit in state or federal
court. Section 300aa-22, entitled “Standards of Responsibility,”
sets forth both a general rule and several exceptions to that rule.
It states:
Brobst v. Columbus Servs. Intern., 761 F.2d 148, 159 (3d Cir.
1985). For the reasons that follow, we need not decide this
issue. We note, however, that our ruling in Brobst was
predicated on a district court’s obligation to provide notice to
the parties before ruling on a particular issue. In this case, the
plaintiffs argued in their response to the motion for summary
judgment about the propriety of ruling on implied preemption
grounds, thereby indicating that they were on notice that the
District Court may have been considering implied preemption
at that time and furthermore that they had an opportunity to
respond on this issue.
18
(a) General rule
Except as provided in subsections (b), (c), and (e)
of this section State law shall apply to a civil
action brought for damages for a vaccine-related
injury or death.
(b) Unavoidable adverse side effects; warnings
(1) No vaccine manufacturer shall be liable in a
civil action for damages arising from a vaccine-
related injury or death associated with the
administration of a vaccine after October 1, 1988,
if the injury or death resulted from side effects
that were unavoidable even though the vaccine
was properly prepared and was accompanied by
proper directions and warnings.
(2) For purposes of paragraph (1), a vaccine shall
be presumed to be accompanied by proper
directions and warnings if the vaccine
manufacturer shows that it complied in all
material respects with all requirements under the
Federal Food, Drug, and Cosmetic Act [21
U.S.C.A. § 301 et seq.] and section 262 of this
title (including regulations issued under such
provisions) applicable to the vaccine and related
to vaccine-related injury or death for which the
civil action was brought unless the plaintiff
shows—
(A) that the manufacturer engaged
in the conduct set forth in
subparagraph (A) or (B) of section
300aa-23(d)(2) of this title, or
19
(B) by clear and convincing
evidence that the manufacturer
failed to exercise due care
notwithstanding its compliance
with such Act and section (and
regulations issued under such
provisions).
(c) Direct warnings
No vaccine manufacturer shall be liable in a civil
action for damages arising from a vaccine-related
injury or death associated with the administration
of a vaccine after October 1, 1988, solely due to
the manufacturer’s failure to provide direct
warnings to the injured party (or the injured
party’s legal representative) of the potential
dangers resulting from the administration of the
vaccine manufactured by the manufacturer.
(d) Construction
The standards of responsibility prescribed by this
section are not to be construed as authorizing a
person who brought a civil action for damages
against a vaccine manufacturer for a vaccine-
related injury or death in which damages were
denied or which was dismissed with prejudice to
bring a new civil action against such manufacturer
for such injury or death.
(e) Preemption
No State may establish or enforce a law which
20
prohibits an individual from bringing a civil
action against a vaccine manufacturer for
damages for a vaccine-related injury or death if
such civil action is not barred by this part.
42 U.S.C. § 300aa-22.
We are guided by two cases interpreting language similar
to that which appears in § 300aa-22. In Lorillard Tobacco Co.,
the Supreme Court interpreted the Federal Cigarette Labeling
and Advertising Act, which stated that “‘[n]o statement relating
to smoking and health other than the statement required by
section 1333 of this title, shall be required on any cigarette
package.’” 533 U.S. at 541 (quoting 15 U.S.C. § 1334). This
language is analogous to subsection 22(b)(1) of the Vaccine Act,
which states that “[n]o vaccine manufacturer shall be liable in
a civil action for damages arising from a vaccine-related injury
or death . . . if the injury or death resulted from side effects that
were unavoidable.” In both provisions, without using language
such as “no state shall” or “state law is preempted,” Congress
has set forth an area in which state law may not operate. In CSX
Transportation, Inc., the Supreme Court construed the following
provision: “A state may adopt or continue in force any law . . .
until such time as the Secretary has adopted a rule . . . covering
the subject matter of such State requirement. A state may adopt
or continue in force an additional or more stringent law . . .
when not incompatible with any Federal law. . . .” 507 U.S. at
662 & n.2 (quoting 45 U.S.C. § 434 (repealed 1994)). Similarly,
Section 22(a) of the Vaccine Act establishes a general rule
permitting states to regulate vaccines subject to several
exceptions set forth in subsections (b), (c), and (e).
21
In both Lorillard Tobacco Co. and CSX Transportation,
Inc., the Supreme Court characterized the language at issue as
an express preemption provision. In the former case, the Court
declared that “Congress unequivocally preclude[d] the
requirement of any additional statements on cigarette packages
beyond those provided in § 1333.” Lorillard Tobacco Co., 533
U.S. at 542. In the latter case, the Court characterized the
quoted language as containing “express saving and preemption
clauses.” CSX Transp., Inc., 505 U.S. at 662. Accordingly, we
conclude that § 22(a) and § 22(b)(1) of the Vaccine Act also
contain express preemption clauses.
Our conclusion is consistent with prior jurisprudence
from this Court, stating that express preemption “arises when
there is an explicit statutory command that state law be
displaced.” St. Thomas-St. John Hotel & Tourism Ass’n, Inc. v.
Gov’t of the U.S., V.I., 218 F.3d 232, 238 (3d Cir. 2000).
Section 22(a) clearly states Congress’s intent to displace state
law in several enumerated instances, including as provided for
in subsection (b). Subsection (b) then declares that
manufacturers are immune from liability for claims arising from
“unavoidable” injuries and deaths related to vaccine
administration, thereby prohibiting states from regulating in this
area. The scope of a preemption provision stating that “no state
shall pass laws with the following exceptions” may well be
broader than a provision stating “state law applies with the
following exceptions.” Yet the breadth of a provision does not
alter the import of the underlying language, and here that
language conveys a clear intent to override state law civil action
claims in particular, defined circumstances.
22
Yet we must still determine the scope and reach of the
express preemption provision. The plaintiffs here concede that
the statute “expressly precludes only those state tort claims
involving vaccines with side effects first shown to be
‘unavoidable,’” but they argue that avoidability must first be
determined “on a case-by-basis” as part of a court’s examination
of a design defect claim. In response, Wyeth argues that this
language “preempts all claims arising from allegations of design
defect.” Accordingly, “we must [] ‘identify the domain
expressly pre-empted’ by [the] language” of the Vaccine Act.
Medtronic Inc., 518 U.S. at 484.
B.
Again, we are mindful that courts seeking to identify the
scope of an express preemption provision are compelled to
consider “Congressional purpose [] the ‘ultimate touchstone’ of
our inquiry.” Lorillard Tobacco Co., 533 U.S. at 541 (quoting
Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992)).
The Supreme Court has declared on numerous occasions that
reviewing courts have several tools to aid them in their
interpretation of congressional purpose. Courts may be guided
by the “structure and purpose of the statute as a whole, as
revealed not only in the text, but through the reviewing court’s
reasoned understanding of the way in which Congress intended
the statute and its surrounding regulatory scheme to affect
business, consumers, and the law.” Medtronic, Inc., 518 U.S. at
486 (internal quotation marks and citations omitted); see also
Gade, 505 U.S. at 98 (“Our ultimate task in any pre-emption
case is to determine whether state regulation is consistent with
the structure and purpose of the statute as a whole.”);
23
Ingersoll-Rand Co. v. McClendon, 498 U.S. 133, 138 (1990)
(“To discern Congress’ intent we examine the explicit statutory
language and the structure and purpose of the statute.”). Beyond
structure and purpose, the Court has also stated “that ‘[i]n
expounding a statute, we must not be guided by a single
sentence or member of a sentence, but look to the provisions of
the whole law, and to its object and policy.’” Pilot Life Ins. Co.
v. Dedeaux, 481 U.S. 41, 51 (1987) (quoting Kelly v. Robinson,
479 U.S. 36, 43 (1986).
The above analysis, allowing courts to consider a
statute’s purpose, structure, and regulatory scheme, applies even
in light of the presumption against preemption. The Court’s
preemption discussion in Cipollone is particularly instructive on
this point. In that case, the Court considered a statute stating
that “[n]o statement relating to smoking and health shall be
required in the advertising of [properly labeled] cigarettes.”
Cipollone, 505 U.S. at 518 (internal quotations and emphasis
omitted). The Court reaffirmed the presumption against
preemption. Id. at 516. It also noted the existence of an express
preemption clause, id. at 517, which it construed using several
tools of statutory construction, id. at 519. The Court noted the
Act’s explicit “statement of purpose,” and it read this against a
“backdrop of regulatory activity.” Id. It also considered the
“regulatory context,” namely the factors that served as “the
catalyst for the passage” of the statute. Id. The Court stated that
this backdrop and context supported a narrow reading of the
preemption clause. Id. at 518–19. In dissent, Justice Scalia
criticized the majority and argued for a broader interpretation of
the provision, predicated on the statute’s use of the phrase “no
statement.” Id. at 549–50 (Scalia, J., dissenting). The majority
24
rejected Justice Scalia’s interpretation because it “relie[d] solely
on an interpretation of those two words, artificially severed from
both textual and legislative context.” Id. at 519 n.16.
We have recognized that legislative history is not without
its shortcomings as a tool of interpretation. “As a point of fact,
there can be multiple legislative intents because hundreds of
men and women must vote in favor of a bill in order for it to
become a law.” Morgan v. Gay, 466 F.3d 276, 278 (3d Cir.
2006); see also Exxon Mobil Corp. v. Allapattah Servs., Inc.,
545 U.S. 546, 568 (2005) (noting that “legislative history is
itself often murky, ambiguous, and contradictory,” and that it
“may give unrepresentative committee members—or, worse yet,
unelected staffers and lobbyists—both the power and the
incentive to . . . secure results they were unable to achieve
through the statutory text”). Yet, resort to legislative history is
appropriate “when necessary to interpret ambiguous statutory
text.” BedRoc Ltd., LLC v. United States, 541 U.S. 176, 187 n.8
(2004) (plurality opinion). Although this Court has declined to
employ legislative history if a statute is clear on its face, we
have allowed recourse to legislative history in the face of
ambiguity. See, e.g., In re Mehta, 310 F.3d 308, 311 (3d Cir.
2002) (“We look to the text of a statute to determine
congressional intent, and look to legislative history only if the
text is ambiguous.”); United States v. Gregg, 226 F.3d 253, 257
(3d Cir. 2000) (“To determine a law’s plain meaning, we begin
with the language of the statute. If the language of the statute
expresses Congress’s intent with sufficient precision, the inquiry
ends there . . . Where the statutory language does not express
Congress’s intent unequivocally, a court traditionally refers to
the legislative history . . . .”).
25
It is, therefore, appropriate to consider legislative history
to resolve ambiguity in the scope of an express preemption
provision. In Cipollone, as part of the discussion of the
regulatory context of the statute at issue, the Court cited
language from a House of Representatives’ report that was
issued during Congress’s consideration of the legislation.
Cipollone, 505 U.S. at 519. Similarly, in Lorillard Tobacco Co.,
the Court stated that its task was to “identify the domain
expressly pre-empted,” 533 U.S. at 541, and that this was aided
“by considering the predecessor pre-emption provision and the
circumstances in which the current language was adopted.” Id.
at 542. It went on to cite reports from the United States Surgeon
General, the House of Representatives, and the Senate in the
course of its discussion. Id. at 542–44.
We cannot resolve from statutory text alone the scope of
the express preemption provision before us. Accordingly, we
will look at the language, structure, and purpose of the Vaccine
Act to ascertain whether it preempts all design defect claims,
and we will resort—as we must—to legislative history to aid our
interpretation.
C.
We are left to construe the scope of preemption created
by the phrase “if the injury or death resulted from side effects
that were unavoidable . . . .” § 300aa-22(b). The phrase hinges
on the word “unavoidable,” yet the term is not defined in the
Vaccine Act. Nor does the surrounding language answer
questions such as whether all design defect claims are
preempted or whether state courts may determine avoidability on
26
a case-by-case basis. According to the Oxford English
Dictionary, “unavoidable” means “[n]ot avoidable; that [which]
cannot be avoided or escaped; inevitable.” (2d ed. 1989). By
itself, this succinct definition is unhelpful. Yet, the structure of
the provision as a whole provides necessary context, and we can
conceive of two possible interpretations of this language.
1.
The first construction would result in the preemption of
some design defect claims. Subsection (a) expressly preempts
state law to the degree indicated in subsection (b). Subsection
(b), in turn, primarily relates to design defect claims, as
evidenced by the use of a subordinate clause introduced by
“even though” to reference claims that might arise from a
manufacturing defect or warning defect. That structure makes
it clear that we must consider design defects in the first instance.
Clearly, then, subsection (a) and (b) work in concert to preempt
state law and exempt manufacturers from liability for some
design defect claims.
Section 300aa–22, taken as a whole, further clarifies
Congress’s intent with regard to design defect claims.
Subsection (a) displaces state law only as defined in subsections
(b), (c), and (e). Subsections (b) and (c) employ identical
introductory language, stating that “[n]o vaccine manufacturer
shall be liable in a civil action for damages arising from a
vaccine-related injury or death associated with the
administration of a vaccine . . . .” Subsection (e) prohibits states
from foreclosing civil actions that are otherwise “not barred by
this part,” thereby stating that other parts of § 300aa-22 are
27
designed to not only limit liability but bar some claims entirely.
Thus, by reading these three provisions together, it becomes
clear that Congress intended that subsections (b) and (c) should
be an outright bar to some claims.
In a case presenting design defect claims similar to those
in the present case, the Georgia Supreme Court reached a
different conclusion regarding the meaning of § 22(b). Am.
Home Prods. Corp v. Ferrari, 669 S.E.2d 236 (Ga. 2008). It
focused on the clause “if the injury or death resulted from side
effects that were unavoidable.” That Court first noted that this
language is conditional and implies that some vaccine-related
injuries and deaths may be avoided. Id. at 240. The Ferrari
Court also reasoned that reading the preemption provision to
exclude all design defect claims would render the clause
superfluous. Id. at 240. That Court concluded that if Congress
intended to preempt all design defect claims, it could have
achieved that result by omitting the “unavoidable” clause such
that the provision would prevent liability “if the vaccine was
properly prepared and was accompanied by proper directions
and warnings.” Id.
We do not consider the Ferrari Court’s reading to be
compelling. First, while we recognize that the language is
conditional, such a reading does not foreclose the preemption
of some claims. Furthermore, it is always possible to construct
through hindsight an alternate structure for a statute with
alternative wording that would render it more clear. For
instance, subpart (b)(1) notes that manufacturers may not be
liable for unavoidable side effects caused by a vaccine that was
“properly prepared and was accompanied by proper directions
28
and warnings,” and subpart (b)(2) sets limits on this. In subpart
22(b)(2), the statute declares that vaccines issued in accordance
with federal labeling requirements are presumed to have proper
directions and warnings unless one of the following applies: (1)
the manufacturer engaged in conduct that would subject it to
punitive damages under § 300aa-23 of the Vaccine Act, or (2)
there is clear and convincing evidence that the manufacturer
failed to exercise due care. § 300aa-22(b)(2). If, as plaintiffs
claim, Congress intended to carve out from subsection 22(b) a
mechanism to enable states to determine what side effects could
have been avoided through an alternate design, Congress could
have done so in the manner used in subpart (b)(2) to preserve
some warning defect claims against vaccines that meet federal
labeling requirements.
More importantly, we think the Ferrari Court’s
construction is contrary to the structure of the Act because it
does not bar any design defect claims. If we interpret the
Vaccine Act to allow case-by-case analysis of whether particular
vaccine side effects are avoidable, every design defect claim is
subject to evaluation by a court. Furthermore, in 1986 when
Congress enacted the Vaccine Act, several courts had already
barred strict liability design defect claims against prescription
drug manufacturers under state law.7 The Ferrari Court’s
construction of § 300aa-22 could create an awkward dichotomy
in the case law of these states—their courts would be required
7
See, e.g., Davis v. Wyeth Labs., Inc., 399 F.2d 121, 128
(9th Cir. 1968); Lewis v. Baker, 413 P.2d 400, 404 (Or. 1966)
(overruled in part on other grounds).
29
to engage in case-by-case analysis of all strict liability and
negligent design defect claims brought under the Vaccine Act,
while barring strict liability design defect claims against
prescription drug manufacturers. As discussed above, Congress
could not have intended such a result, as § 300aa-22 makes clear
that Congress intended to preempt and bar certain claims.
Though there are two possible interpretations of
subsection (b), we conclude that a “clear and manifest”
expression of congressional intent supports the first
interpretation.8 Our construction, however, does not indicate
8
In Wyeth v. Levine, S. Ct. , No. 06-1249, 2009 WL
529172, at *1 (2009), the Supreme Court examined whether
federal law preempted state tort claims alleging that a drug
manufacturer failed to adequately warn of the dangers
associated with a drug. Id. at *1. Though we recognize that the
Supreme Court concluded that state tort law claims were not
preempted in that case, id. at 13, Levine is readily
distinguishable on several grounds. First, the Court explicitly
noted the absence of an express preemption provision and found
Congress’s silence, “coupled with its certain awareness of the
prevalence of state tort litigation, [] powerful evidence.” Id. at
10. In this case, however, Congress included an express
preemption provision that was prompted, as evidenced by the
Committee Report, by the prevalence of state tort litigation.
Second, it recognized that, under federal law, a drug
manufacturer could strengthen a drug's label without
preapproval from the FDA. Id. at 7. This stands in contrast to
the FDA’s far-more extensive control and oversight of the
30
whether subsection (b) preempts all design defect claims or only
strict liability design defect claims.
2.
There is no language in the statute indicating whether the
Vaccine Act preempts only strict liability design defect claims
or also those based in negligence, and the structure and purpose
of the Act are of little assistance in resolving that question. As
a result, there remains some inherent ambiguity in the statute,
and we must resort to legislative history to resolve that
ambiguity. The parties in this case cite to different
congressional reports to support their claims. Each argument
will be addressed in turn.
a.
Wyeth cites to a report (“Commerce Report”) from the
House Committee on Energy and Commerce (“Energy and
Commerce Committee”), which had jurisdiction over the
Vaccine Act and guided the legislation through passage. H.R.
Rep. No. 99-108 (1986). The Commerce Report declared that
childhood vaccinations have been “one of the most spectacularly
effective public health initiatives this country has ever
undertaken,” preventing countless deaths and saving billions of
dollars. Id. at 4. The Report stated, however, that “the Nation’s
ability to maintain this level of success has come into question”
as a result of tort claims by individuals gravely injured by
approval of a drug’s design and alteration.
31
vaccines. Id. This, in turn, caused an increase in the cost of
vaccines, the withdrawal of some manufacturers from the
market, and a decreased rate of immunization. Id. The Report
noted that these conditions prompted the Energy and Commerce
Committee to reevaluate the federal regulation of vaccines. Id.
at 5.
Though the Committee was concerned with
compensating individuals injured by vaccines, it also sought to
reduce the cost of such claims in order to safeguard the
development and availability of such vaccines. It noted that
there was “no ‘perfect’ or reaction-free childhood vaccine on the
market” and that a small number of children suffered serious
reactions. Id. at 6. It then stated that “despite these possibilities
. . . it is safer to take the required shots than to risk the health
consequences of contracting the diseases . . . .” Id. The
Committee expressed concern that the “withdrawal of even a
single manufacturer would present the very real possibility of
vaccine shortages, and, in turn, increasing numbers of
unimmunized children, and, perhaps, a resurgence of
preventable diseases.” Id. at 7. The Report demonstrates that the
Vaccine Act was motivated in great measure by Congress’s
belief that an alternate compensation system would reduce
awards and create a stable, predictable basis for estimating
liability: “[T]he Committee believes that once this system is in
place and manufacturers have a better sense of their potential
litigation obligations, a more stable childhood vaccine market
will evolve.” Id.
Importantly, the Commerce Report specifically addressed
§ 300aa-22, the section at issue here. First, it noted that some
32
provisions of the Vaccine Act would “change most State laws”
related to vaccine injuries and deaths. Yet, it deemed this an
appropriate change “in light of the availability of a
comprehensive and fair compensation system.” Id. at 25. Then,
the Commerce Report stated that the Vaccine Act reflected the
principle of Restatement (Second) of Torts § 402A comment k,9
9
The Georgia Supreme Court took this reference to mean
that Congress intended to preserve some design defect claims
and permit case-by-case consideration of whether a vaccine is
unavoidably harmful. See Ferrari, 668 S.E.2d at 239–40.
Specifically, the Ferrari Court pointed to the fact that a majority
of courts have interpreted comment k as permitting a case-by-
case analysis of whether a vaccine’s side effects are avoidable.
Id. at 239. It then drew on the Vaccine Act’s legislative history
to support its conclusion that Congress interpreted comment k
in the same manner as those other courts. Id. at 240.
Though we acknowledge that a majority of states permit
some design defect claims under comment k, we disagree with
the Georgia Supreme Court on the relevance of this fact. First,
it discounts that courts in a significant minority of states have
held that comment k preempts all strict liability design defect
claims against FDA-approved drugs. Second, the current state
of affairs with regard to the interpretation of comment k tells us
little about what Congress knew in 1986 when it passed the
Vaccine Act. As one court has noted, “in 1986 courts had not
yet reached a consensus on the meaning of Comment k, or the
proper treatment of prescription drugs in design defect
legislation. Thus, while some courts concluded that a case-by-
case analysis was necessary . . . others concluded that
33
which states that sellers of certain products, including vaccines,
should not be strictly liable for harm caused by their products
when it is not possible to make these products entirely safe.10 Id.
prescription drug manufacturers were generally not liable for
design defect claims.” Militrano v. Lederle Labs. 769 N.Y.S.2d
839, 844–45 (N.Y. Sup. Ct. 2003). Finally, we note that
regardless of state court consideration of comment k, we believe
Congress made it clear what it intended when it invoked
comment k.
10
Comment k states the following:
There are some products which, in the present
state of human knowledge, are quite incapable of
being made safe for their intended and ordinary
use. . . . An outstanding example is the vaccine
for the Pasteur treatment of rabies, which not
uncommonly leads to both serious and damaging
consequences when it is injected. Since the
disease itself invariably leads to a dreadful death,
both the marketing and the use of the vaccine are
fully justified, notwithstanding the unavoidable
high degree of risk which they involve. Such a
product, properly prepared, and accompanied by
proper directions and warning, is not defective,
nor is it unreasonably dangerous. . . . The seller of
such products, again with the qualification that
they are properly prepared and marketed, and
proper warning is given, where the situation calls
34
at 25–26. The Report described the type of vaccine cases in
which comment k would have import—cases in which innocent
children would be “badly injured or killed” by a vaccine, but in
which a jury would likely impose liability on the manufacturer
“even if the defendant manufacturer may have made as safe a
vaccine as anyone reasonably could expect.” H.R. Rep. 99–908
at 26 (emphasis added). Finally, it stated in precise and certain
terms that its reference to comment k and the language of 22(b)
results in immunity for liability for all design defects, whether
liability rests on theories of strict liability or negligence: “[i]f
[injured individuals] cannot demonstrate under applicable law
either that a vaccine was improperly prepared or that it was
accompanied by improper directions or inadequate warnings
[they] should pursue recompense in the compensation system,
not the tort system.” Id.
In our view, the Commerce Report supports the
conclusion that the Vaccine Act preempts all design defect
claims, including those based in negligence. First, the
Committee Report repeatedly stressed the importance of vaccine
development and availability. Second, it expressed serious
for it, is not to be held to strict liability for
unfortunate consequences attending their use,
merely because he has undertaken to supply the
public with an apparently useful and desirable
product, attended with a known but apparently
reasonable risk.
Restatement (Second) of Torts § 402A cmt k (1966).
35
concern over the withdrawal of even a single vaccine
manufacturer from the marketplace. Third, though it described
a regime that sought to compensate individuals, the Commerce
Report emphasized that the new system would reduce and
stabilize litigation costs while also enabling manufacturers to
estimate the costs associated with compensation. Finally, it
explicitly stated that injured individuals could only seek redress
in the state tort system for certain manufacturing defect and
warning claims.
Each of the objectives extolled by the Commerce Report
would be undermined if design defect claims were permitted
under the statute. The plaintiffs’ construction of the statute
would permit state courts to determine on a case-by-case basis
whether a vaccine manufacturer could have conceivably created
a safer vaccine. This would undoubtedly increase the costs and
risks associated with litigation and would undermine a
manufacturer’s efforts to estimate and control costs. It would
also effectively impose an affirmative obligation on vaccine
manufacturers to pursue, regardless of cost, the countless
avenues through which they could develop a safer vaccine.
These were the very problems which led to instability in the
vaccine market and which caused Congress to intervene through
the passage of the Vaccine Act.
b.
Unfortunately, our review of legislative history does not
end here. Rather than rely on the Commerce Report, the
plaintiffs respond that other language in the legislative history
strongly favors their position that design defect claims are not
36
preempted. The Vaccine Act, which Congress passed in 1986,
did not initially “include a source of payment for such
compensation and made the compensation program and
accompanying tort reforms contingent on the enactment of a tax
to provide funding for the compensation.” H.R. Rep. No. 100-
391(I), at 690 (1987). In 1987, Congress passed legislation to
fund the compensation program. On October 26, 1987, as part
of this funding legislation, the House Committee on the Budget
(“Budget Committee”) issued its own report (“Budget Report”)
which stated the following:
It is not the Committee’s intention to preclude
court actions under applicable law. The
Committee’s intent at the time of considering the
Act and in these amendments was and is to leave
otherwise applicable law unaffected, except as
expressly altered by the Act and the amendments.
An amendment to establish as part of this
compensation system that a manufacturer’s failure
to develop safer vaccine was not grounds for
liability was rejected by the Committee during its
original consideration of the Act. Further, the
codification of Comment (k) of The Restatement
(Second) of Torts was not intended to decide as a
matter of law the circumstances in which a
vaccine should be deemed unavoidably unsafe.
The Committee stresses that there should be no
misunderstanding that the Act undertook to
decide as a matter of law whether vaccines were
unavoidably unsafe or not. This question is left to
the courts to determine in accordance with
37
applicable law.
Id. at 691.
According to the plaintiffs, this language demonstrates
that Congress considered and rejected an amendment that would
have explicitly preempted all design defect claims. This
argument is premised on the well-settled notion that “[f]ew
principles of statutory construction are more compelling than the
proposition that Congress does not intend sub silentio to enact
statutory language that it has earlier discarded in favor of other
language.” INS v. Cardoza-Fonseca, 480 U.S. 421, 442–443
(1987) (internal quotation marks and citation omitted).
Additionally, plaintiffs claim that the Budget Report evidences
Congress’s intent to permit courts to determine on a case-by-
case basis whether a vaccine’s side effects were “unavoidable.”
The problems with the Budget Report, however, are
three-fold. First, the Budget Report repeatedly uses the term
“the Committee,” but it is unclear whether this refers to the
Budget Committee or the Energy and Commerce Committee.
While the Budget Committee did not play a role in the drafting
or passage of the Vaccine Act, the Energy and Commerce
Committee had jurisdiction over the bill and held several
hearings on childhood vaccines and the proposed legislation. A
subcommittee of the Energy and Commerce Committee also
held a hearing, known as a “mark-up” hearing, on the Vaccine
Act in September 1986 during which time it considered
38
amendments to the legislation.11 Because the Budget Committee
did not consider amendments to the Vaccine Act, we will
presume that references in the Budget Report to “the
Committee” refer to the Energy and Commerce Committee.
Second, though the Energy and Commerce Committee
conducted a mark-up hearing to consider proposed amendments,
no record is available to confirm that the Energy and Commerce
Committee considered and rejected an amendment related to
design defects at that time.12 Third, “the views of a subsequent
Congress form a hazardous basis for inferring the intent of an
earlier one.” United States v. Price, 361 U.S. 304, 313 (1960).
That danger is amply present here, where the subsequent report
was not issued by the committee with jurisdiction over the
legislation, but by a committee which played no role in passage
of the Vaccine Act. See United States v. United Mine Workers
of Am., 330 U.S. 258, 281–82 (1947). Without more, we have
no basis to conclude that the Budget Report is an accurate
11
Information pertaining to Congressional passage of the
Vaccine Act, including the dates of the markup hearing and
Committee consideration, can be found on the Library of
Congress’s website for legislative information. Library of
Congress, THOMAS, S.1744 (P.L. 99-660): All Congressional
Actions with Amendments, http://thomas.loc.gov/
cgi-bin/bdquery/z?d099:SN01744:@@@S|TOM:/bss/d099qu
ery.html.
12
The Energy and Commerce Committee retains a
transcript of this hearing, but this transcript was not available to
us.
39
reflection of what transpired before the Energy and Commerce
Committee, or for that matter, the motivations underlying
Congress’s enactment of the Vaccine Act in 1986.
For these reasons, and despite plaintiffs urging, we refuse
to view the relevant legislative history as containing “dueling”
committee reports.
3.
Even if Congress did not intend to prohibit all design
defect claims against vaccine manufacturers, the legislative
history indicates that it intended to preempt the specific claim at
issue here. In the days prior to passage of the Vaccine Act, the
Energy and Commerce Committee issued a report containing
“background information on the various issues concerning
childhood vaccines . . . .” (“Background Report”). Staff of H.
Comm. on Energy & Commerce, 99th Cong., Childhood
Immunizations, at III (1986). This report stated that the
pertussis vaccine “is considered the most reactive of all the
commonly used vaccines and has been the one of most concern
in debates over adverse effects of vaccines.” Id. at 24. It
recounted the risks and side effects associated with the pertussis
vaccine, including neurological problems and even death, and
the efforts of parent groups to raise awareness of these serious
consequences. Id. at 24–29. The Background Report also stated
that “research is proceeding on the effort to develop an acellular
vaccine that would cause fewer side effects.” Id. at 38.
Namely, it explained that researchers were attempting to isolate
the reactive components of the pertussis bacterial cell so that
these components could be excluded from the vaccine. Id. at 24.
40
The Background Report also explained that Japan had used such
a vaccine, but it indicated that the safety and efficacy of this
vaccine had not been reported. Id. It then warned that
“conducting clinical trials to test any new pertussis vaccine will
pose major logistic, legal, and ethical problems.” Id.
The Commerce Report on the Vaccine Act also contained
numerous references to the DPT vaccine. H.R. Rep. 99-908. It
noted the “serious—and sometimes deadly—consequences” of
vaccines and that this was “particularly true with regard to the
pertussis” component of the DPT vaccine. Id. at 6. Before
warning of the ramifications of the withdrawal of “even a single
manufacturer,” the Report also highlighted the increasing
number of lawsuits related to the DPT vaccine and recognized
that there were only two manufacturers of the DPT vaccine at
that time. Id. at 6–7.
Whereas the plaintiffs contend that Wyeth and its
predecessors knew “for more than 25 years that the acellular
vaccine was less reactogenic and, therefore, safer for the
children who receive it” and seek to establish liability by virtue
of that knowledge, the two reports discussed immediately above,
taken together, establish that Congress intended to preempt such
claims. The Background Report indicates that Congress was
well aware of the state of the art concerning development of an
acellular DPT vaccine. It also evidences that Congress believed
there were hurdles before such a vaccine could undergo clinical
testing in the United States. The Commerce Report stresses the
particular problems faced by DPT vaccine manufacturers,
including the high number of lawsuits and existence of only two
producers. The Commerce Report then concludes that the
41
“withdrawal of even a single manufacturer would present the
very real possibility of vaccine shortages . . . [and] a resurgence
of preventable diseases” and that the vaccine market will
stabilize once “manufacturers have a better sense of their
potential litigation obligations.” Id. at 7. This evidence
indicates that Congress weighed the various concerns related to
the pertussis vaccine and concluded that DPT manufacturers
should be shielded from liability for injuries arising from the
whole-cell pertussis vaccine.
4.
As we stated at the beginning of this part, “Congressional
purpose is the ‘ultimate touchstone’ of our inquiry.” Lorillard
Tobacco Co., 533 U.S. at 541 (quoting Cipollone, 505 U.S. at
516). Section 22(a) and 22(b)(1) of the Vaccine Act contain
express preemption clauses. Further, the structure and purpose
of § 300aa-22 of the Act make clear that Congress intended to
preempt some design defect claims. The legislative history
identifies the scope of this preemption, which encompasses both
strict liability and negligent design defect claims.
D.
The District Court did not clearly explain the basis of its
summary judgment decision. It neither discussed the three types
of preemption nor mentioned that the motion for summary
judgment raised only express preemption. Nevertheless, the
District Court decision is consistent with an express preemption
analysis, and we take it to have intended application of that
doctrine. The four points discussed in the District Court’s
42
opinion were grounded in the purpose of the Vaccine Act. As
discussed in Part III.B above, such an analysis is permitted when
construing an express preemption clause. Furthermore, in
response to the motion for summary judgment, the plaintiffs
cited to the Vaccine Act’s legislative history and purpose to
support their argument that design defect claims were not
preempted. As a result, we reject plaintiffs’ argument that the
District Court’s decision was based on implied or field
preemption grounds or that it violated well-settled principles of
summary judgment.
IV.
Plaintiffs also allege that Wyeth is liable for failing to
warn Hannah’s doctor, Jane M. Breck, M.D., that the vaccine
administered to Hannah came from a lot of TRI-IMMUNOL
associated with at least two deaths and more than thirty injuries
prior to April 1992. Dr. Breck testified that had she known that
the vaccine came from this lot, she would not have administered
the dose. Although § 22(c) of the Vaccine Act expressly
preempts failure-to-warn claims based on “the manufacturer’s
failure to provide direct warnings to the injured party (or the
injured party’s legal representative),” 42 U.S.C. § 300aa-22(c),
nothing in the Vaccine Act expressly bars claims based on
failure to warn “doctors and other medical intermediaries.” 13
13
The parties disagree as to whether Section 22(b)(2) is a
preemption clause. Though Wyeth classified it as such, the
District Court expressly held that the failure-to-warn claim was
not preempted. We need not reach this issue, however, for the
43
As discussed above, § 22(b)(1) states that manufacturers
shall not be liable for injuries caused by “side effects that were
unavoidable even though the vaccine . . . was accompanied by
proper directions and warnings.” Section 22(b)(2) states that
proper directions and warnings will be presumed when the
manufacturer “complied in all material respects with all
requirements under the Federal Food, Drug, and Cosmetic Act
. . . and section 262 of this title . . . .” Nevertheless, the Vaccine
Act provides two circumstances in which this presumption can
be overridden: (1) when the manufacturer engages in conduct
that would subject it to punitive damages under the Vaccine Act;
and (2) when the manufacturer “failed to exercise due care.” 42
U.S.C. § 300aa-22(b)(2)(A)-(B). As the District Court correctly
noted, this creates a shifting burden—once the manufacturer
establishes that it complied with federal law, the burden shifts
to the plaintiff to establish that either § 22(b)(2)(A) or §
22(b)(2)(B) has been met.
The District Court dismissed this claim on the ground
that Wyeth was entitled to the statutory presumption of proper
warning and that the plaintiffs had failed to rebut the
presumption. Noting that Wyeth had presented uncontested
evidence that TRI-IMMUNOL and its warnings had been
approved by the FDA, the District Court found that Wyeth was
entitled to § 22(b)(2)’s presumption of proper warning. Next,
the District Court noted that the Amended Complaint did not
allege fraud or wrongful withholding of information within the
reasons set forth in this section.
44
meaning of § 22(b)(2)(A).14 Thus, the only relevant question
was whether plaintiffs had presented clear and convincing
evidence that Wyeth had not exercised due care.
Plaintiffs presented a report of the Vaccine Adverse
Event Reporting System (“VAERS”)15 confirming that the lot of
TRI-IMMUNOL that included the dose administered to Hannah
Bruesewitz was associated with two deaths and more than thirty
injuries. They also presented the affidavit of Dr. Donald H.
Marks, who claimed that such a lot is sometimes called a “hot
lot.” Dr. Marks relied on a 1984 memorandum by an
epidemiologist at the Department of Health and Human Services
(“HHS”) regarding the “Investigation of Potential Hot Lots,”
which said that “potential hot fill lots of DTP vaccine” are “fill
lots that exceeded a threshold of ³2 deaths or ³2 convulsions or
14
The District Court acknowledged that the original
Complaint alleged that Wyeth had committed fraud or wrongful
withholding of information, but the Amended Complaint failed
to do so. Nevertheless, even if the Amended Complaint had
repeated this allegation, the District Court suggested that it
would not have survived application of Fed. R. Civ. P. 9(b),
which requires that allegations of fraud be pled with
particularity.
15
As the District Court explained, “VAERS is a database
created, pursuant to the Vaccine Act, by the FDA and the
Centers for Disease Control and Prevention to receive reports
about adverse events which may be associated with vaccines.”
45
³10 total reports.” The District Court, however, found it
significant that this memorandum identified such lots merely as
“potential” hot lots.
The memorandum also stated that “[i]n order to proceed
with an investigation by which we could differentiate reporting
bias from a higher rate of reactivity in specific fill lots we
needed information on the number of doses distributed and
which percent went to the public sector.” Thus, in order to
differentiate between a “hot lot” and a “potential hot lot,”
investigators must know not only the total number of incidents
but also the rate at which the incidents occurred. Because the
“[p]laintiffs have produced no evidence from which a trier of
fact could infer that the dose in question originated” in such a
lot, the District Court concluded that the plaintiffs had not
proven that Wyeth failed to exercise due care by distributing
doses from this lot.
Before this Court, the plaintiffs argue that the District
Court’s reasoning is flawed on two grounds: (1) Wyeth is not
entitled to a presumption of proper warning unless the side
effects of the vaccine are first shown to be unavoidable; because
they allege a safer vaccine design was available, they argue that
§ 22(b)(2) should not apply; and (2) Dr. Mark’s opinion raises
an issue of fact as to whether Hannah’s dose came from a “hot
lot.” We dismiss both arguments. The first argument must be
dismissed for the reasons discussed in Part III—the Vaccine Act
preempts design defect claims premised on the notion that the
manufacturer could have created a safer vaccine. The second
requires more discussion.
46
As stated above, a court may not grant summary
judgment so long as there exists a genuine issue of material fact.
Fed. R. Civ. P. 56(c); Kaucher v. County of Bucks, 455 F.3d
418, 423 (3d Cir. 2006). To determine whether a factual dispute
is genuine, “the court’s function is not to weigh the evidence or
to determine the truth of the matter, but only to determine
whether the evidence of record is such that a reasonable jury
could return a verdict for the nonmoving party.” Orsatti v. N.J.
State Police, 71 F.3d 480, 482 (3d Cir. 1995); see also
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The
“mere existence of a scintilla of evidence” in support of the
nonmoving party’s claim is insufficent. Anderson, 477 U.S. at
252. We will resolve all doubts and draw all reasonable
inferences in favor of the nonmoving party. Conoshenti v. Pub.
Serv. Elec. & Gas Co., 364 F.3d 135, 140 (3d Cir. 2004).
Dr. Marks identified the HHS memorandum as the basis
on which he drew his conclusions: “This memorandum provides
what I understood to be the official definition of a ‘Hot Lot’.” 16
16
Dr. Marks also approvingly cited to an older document
from the Food and Drug Administration. This document states:
In analyzing patterns of adverse event reporting,
the FDA considers more than just the number of
reports for a lot. More reports will be received
for a large lot than a small one, simply because
vaccine from the large lot will be given to more
children. Some lots contain as many as 700,000
47
As the District Court correctly noted, the memorandum clearly
states that the incident statistics, cited above, only establish
“potential hot lots.” It further states that investigators must
identify the number of doses administered to determine whether
a particular vaccine lot qualifies as a “hot lot.” 17 Because
doses, while others as few as 20,000 doses.
Similarly, more reports will be received for a lot
that has been in use for a long time than a lot in
use for a short time. Even among lots of similar
size and time in use, some lots will receive more
reports than others simply due to change. The
FDA continually looks for lots that have received
more serious reports tha[n] should be expected on
the basis of such factors as size, time in use, and
chance variation.
Pub. Health Serv., Dep’t of Health & Human Servs., Vaccine
Adverse Event Reporting System (VAERS) 2.
17
Other authorities support this. For instance, according to
the Centers for Disease Control and Prevention:
Vaccine lots are not the same. The sizes of
vaccine lots might vary from several hundred
thousand doses to several million, and some are in
distribution much longer than others. Naturally a
larger lot or one that is in distribution longer will
be associated with more adverse events, simply by
chance. Also, more coincidental deaths are
48
plaintiffs have not offered any evidence on this point, Dr.
Marks’ assertions and conclusions are unsupported by the very
memorandum upon which he relies.
The plaintiffs also contend that the sheer number of
adverse events associated with this vaccine lot is sufficient to
establish “some evidence of a serious health problem no [matter]
how many doses, circumscribed by the concept of a batch, it
contains.” While this may be true, the plaintiffs’ burden is not
to produce “some evidence”—a mere scintilla—but evidence
sufficient for a reasonable jury to find in their favor. The HHS
memorandum states that investigators cannot conclude whether
a vaccine lot is a “hot lot” without evidence on the number of
doses administered. Thus, even drawing all inferences and
associated with vaccines given in infancy than
later in childhood, since the background death
rates for children are highest during the first year
of life. So knowing that lot A has been associated
with x number of adverse events while lot B has
been associated with y number would not
necessarily say anything about the relative safety
of the two lots, even if the vaccine did cause the
events.
Centers for Disease Control and Prevention, Some Common
Misconceptions About Vaccination and How to Respond to
Them,
http://www.cdc.gov/vaccines/vac-gen/6mishome.htm#Therear
ehot.
49
doubts in favor of the plaintiffs, there is insufficient evidence on
which a jury could conclude that Hannah’s vaccine came from
a “hot lot.” Accordingly, the District Court did not err in
granting summary judgment on the failure to warn claim.
V.
In their Amended Complaint, the plaintiffs alleged that
Wyeth’s “manufacturing process and inadequate quality control
resulted in recurrent problems with maintaining the appropriate
balance between neuron-toxins and endo-toxins in the pertussis
vaccine.” Plaintiffs also assert, as they do before this Court, that
they have a “classic manufacturing defect claim here: that the
vaccine lot used on Hannah Bruesewitz was tainted such that it
was associated with two deaths and more than 66 injuries, a
number and percentage far in excess of that for other lots.”
Under Pennsylvania law, a plaintiff alleging a manufacturing
defect based on a strict liability theory must show that: (1) “the
product was defective;” (2) “the defect was a proximate cause
of the plaintiff’s injuries;” and (3) the defect causing the injury
existed at the time the product left the seller’s hands.” Berkebile
v. Brantly Helicopter Corp., 337 A.2d 893, 898 (Pa. 1975).
The District Court held that plaintiffs had failed to
provide enough evidence of a manufacturing defect to meet their
burden for purposes of summary judgment. With regard to the
first claim, related to the balance of neuro- and endo-toxins, the
District Court concluded that “Plaintiffs have offered absolutely
no evidence to support this allegation . . . .” Moreover, the
District Court noted this claim was directly refuted by Wyeth,
which offered undisputed evidence that its pertussis vaccine did
50
not contain a neuro-toxin component and was not known to have
a neuro-toxic effect.
The District Court also considered the plaintiffs’ second
argument, which was essentially the same as the “hot lot” theory
discussed above. The plaintiffs argued to the District Court that
a “hot lot” can serve as circumstantial evidence of a
manufacturing defect. The District Court noted that this theory
is known as the “malfunction theory:”
The malfunction theory permits a plaintiff to
prove a defect in a product with evidence of the
occurrence of a malfunction and with evidence
eliminating abnormal use or reasonable,
secondary causes for the malfunction. The
plaintiff is relieved from demonstrating precisely
the defect yet it permits the trier-of-fact to infer
one existed from evidence of the malfunction, of
the absence of abnormal use and of the absence of
reasonable secondary causes.
Bruesewitz v. Wyeth, 508 F. Supp.2d 430, 450 (E.D. Pa. 2007)
(quoting Barnish v. KWI Bldg. Co., 916 A.2d 642, 646
(Pa. Super. Ct. 2007)).
As the District Court recognized, this theory has not been
applied to allegedly defective vaccines. Nevertheless, we need
not determine if and how this theory of liability would apply in
this case. Both before the District Court and this Court, the
plaintiffs predicated their argument for a manufacturing defect
on the fact that Hannah’s vaccine came from a “hot lot.” For the
51
reasons stated in Part IV, after drawing all reasonable inferences
in favor of the plaintiffs, we agree with the District Court’s
conclusion that the plaintiffs have not provided evidence from
which a jury could conclude that Hannah was administered a
vaccine from a “hot lot.” Because plaintiffs sole arguments to
this Court on the manufacturing defect issue require a finding of
a “hot lot,” we will also affirm the District Court’s judgment on
this claim.
VI.
We hold that the plaintiffs design defect claims are
expressly preempted by the Vaccine Act. We also conclude that
the plaintiffs have failed to establish either a manufacturing
defect or a warning defect claim under the Vaccine Act. For the
reasons discussed above, we will affirm the District Court’s
grant of summary judgment in favor of Wyeth.
52