2009 Decisions

Opinions of the United

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Precedential or Non-Precedential: Precedential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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1

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

____________________
2

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
3

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
4

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
The Vaccine Act created the “Vaccine Injury Table.” 42 1

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

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
The party also has the option of appealing the Court of 2

Federal Claims’ judgment to the United States Court of Appeals

for the Federal Circuit. 42 U.S.C. § 300aa-12(f). 

6

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. 42 U.S.C. § 300aa-21. 

2

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.
The National Health Institute first issued a product 3

license for TRI-IMMUNOL in 1948 to American Cyanamid

Company (“Cyanamid”). Lederle Laboratories, an

unincorporated division of Cyanamid, produced TRIIMMUNOL. In 1994, American Home Products Corporation

(“AHPC”) acquired Cyanamid. In March 2002, AHPC changed

its name to Wyeth. 

7

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 (“Wyeth”) 3

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. ACELIMUNE 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
The acellular pertussis vaccine contains pertussis toxin 4

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

Immuni z a ti on Pr a c tices, O cto b er 9 , 1992,

http://www.cdc.gov/mmwr/preview/mmwrhtml/00048610.htm.

8

and is less likely to cause adverse events. The FDA initially 4

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 emergency room visits, six

hospitalizations, and two deaths. Hannah’s physician later
Effective March 10, 1995, approximately one month 5

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

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,
10

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. § 300aa22(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
11

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
12

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
13

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
14

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
15

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
16

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
The plaintiffs argue that the District Court’s decision 6

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

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.” Accordingly, we must consider 6
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

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:
19

(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 vaccinerelated 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
20

(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 vaccinerelated 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
21

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). 
22

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. 
23

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.”);
24

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
25

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 . . . .”). 
26

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
27

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
28

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
See, e.g., Davis v. Wyeth Labs., Inc., 399 F.2d 121, 128 7

(9th Cir. 1968); Lewis v. Baker, 413 P.2d 400, 404 (Or. 1966)

(overruled in part on other grounds). 

29

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. The Ferrari Court’s 7

construction of § 300aa-22 could create an awkward dichotomy

in the case law of these states—their courts would be required
In Wyeth v. Levine, S. Ct. , No. 06-1249, 2009 WL 8

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

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. Our construction, however, does not indicate 8
approval of a drug’s design and alteration. 

31

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
32

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
The Georgia Supreme Court took this reference to mean 9

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-bycase 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-bycase analysis was necessary . . . others concluded that

33

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
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. 

Comment k states the following: 10

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 isit 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

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. Id. 10
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

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
36

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
37

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
38

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-bycase 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
Information pertaining to Congressional passage of the 11

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. 

The Energy and Commerce Committee retains a 12

transcript of this hearing, but this transcript was not available to

us. 

39

amendments to the legislation. Because the Budget Committee 11

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. Third, “the views of a subsequent 12

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
40

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.
41

The Background Report also explained thatJapan 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
42

“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
The parties disagree as to whether Section 22(b)(2) is a 13

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

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
reasons set forth in this section. 

44

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
The District Court acknowledged that the original 14

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.

As the District Court explained, “VAERS is a database 15

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

meaning of § 22(b)(2)(A). Thus, the only relevant question 14

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”) confirming that the lot of 15

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 2 deaths or 2 convulsions or
46

10 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. 
Dr. Marks also approvingly cited to an older document 16

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 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
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. 

Other authorities support this. For instance, according to 17

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

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.” Because 17
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

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
50

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
51

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
52

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.