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THE SUPREME COURT OF THE UNITED STATES

FALL TERM, 2010

DOCKET NO. 01-01234

ROGER KENT AND ANITA KENT, PARENTS

AND NATURAL GUARDIANS OF ANNA

KENT, A MINOR CHILD, AND IN THEIR OWN

RIGHT,

Petitioner,

v.

INGEN LABORATORIES,

Respondent.

ON WRIT OF CERTIORARI TO THE COURT OF APPEALS

FOR THE TWELFTH CIRCUIT

Brief for Petitioner

Team #P31

Issue #1

Saurish Bhattacharjee (XXX) XXX-XXXX


Table of Contents

TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . . . . ii

QUESTIONS PRESENTED . . . . . . . . . . . . . . . . . . . . . 1

OPINIONS BELOW . . . . . . . . . . . . . . . . . . . . . . . . 1

CONSTITUTIONAL PROVISIONS AND RULES . . . . . . . . . . . . . 1

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . 2

STATEMENT OF THE CASE . . . . . . . . . . . . . . . . . . . . 4

ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

I. 22(B)(1) DOES NOT PREEMPT ALL VACCINE DESIGN DEFECT


CLAIMS BECAUSE A PRESUMPTION AGAINST PREEMPTION OPERATES IN
THE STATUTORY CONSTRUCTION OF FEDERAL LAWS. . . . . . . 6

A. The plain language and statutory framework of


22(b)(1) bolster the presumption against preemption of
all design defect claims. . . . . . . . . . . . . . 7

B. The structure and purpose of 22(b)(1) bolster the


presumption against preemption of all design defect
claims. . . . . . . . . . . . . . . . . . . . . . 12

II. SOUND PUBLIC POLICY DISFAVORS READING 22(B)(1) AS A


CATEGORICAL PREEMPTION OF ALL DESIGN DEFECT CLAIMS AGAINST
VACCINE MANUFACTURERS. . . . . . . . . . . . . . . . . 15

III. SUMMARY JUDGMENT IS INAPPROPRIATE IN THIS CASE BECAUSE A


GENUINE ISSUE OF MATERIAL FACT EXISTS AS TO WHETHER THE
SIDE EFFECTS OF INGENS WHOLE-CELL DPT VACCINE WERE
UNAVOIDABLE. . . . . . . . . . . . . . . . . . . . . . 16

CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . 17

i
Table of Authorities

Cases

American Home Products Corp. v. Ferrari, 284 Ga. 384


(Ga. 2008) . . . . . . . . . . . . . . 6,8,9,12,14,15,16,17

Bates v. Dow Agrosciences, LLC, 544 U.S. 431 (2005) . . . 6,7,15

Blackmon v. American Home Products Corp., 328 F. Supp. 2d 659


(S.D. Tex. 2004) . . . . . . . . . . . . . . . . . . . . 11

Feldman v. Lederle Laboratories, 479 A.2d 374


(N.J. 1984) . . . . . . . . . . . . . . . . . . . . . 14,15

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) . . . . . . 6,7,15

Schafer v. American Cyanamid Co., 20 F.3d 1


(1st Cir. 1994) . . . . . . . . . . . . . . . . . 10,11,12

United States v. Menasche, 348 U.S. 528 (1955) . . . . . . . 7,9

Wyeth v. Levine, 129 S. Ct. 1187 (2009) . . . . . . . . . . . 17

Constitutional Provisions

U.S. Const. art. VI, cl. 2 . . . . . . . . . . . . . . . . . . 6

Statutes

42 U.S.C. 300aa-11(a)(2)(A) . . . . . . . . . . . . . . 10,11

Legislative Material

H. Rep. No. 908 (1986), reprinted in


1986 U.S.C.C.A.N.6344 . . . . . . . . . . . . . 4,12,13,16

Treatises

Restatement 2d Torts 402A, comment k . . . . . . . . . 4,5,13

ii
iii
Questions Presented

Whether Section 22(b)(1) of the National Childhood Vaccine

Injury Act of 1986 which expressly preempts certain design

defect claims against manufacturers 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 preempts all vaccine design defect

claims, regardless whether the vaccines side effects were

unavoidable?

Opinions Below

111 F.4th 111 (12th Cir. 2009)

Constitutional Provisions and Rules

U.S. Const. art. VI, cl. 2

42 U.S.C. 300aa-22(b)(1)

1
Introduction

22(b)(1) of the National Childhood Vaccine Injury Act of

1986, 42 U.S.C. 300aa-1 et seq., expressly precludes design

defect claims against vaccine manufacturers for unavoidable

side effects caused by vaccines covered under the statute.

Respondent InGen Laboratories claims that all design defect

claims against vaccine manufacturers are preempted under

22(b)(1). Since the canons of statutory construction, sound

public policy, and the specific facts of this case militate

against preemption of all design defect claims under 22(b)(1),

Petitioners Roger and Anita Kent, on behalf of their daughter

Anna Kent, request that this Court reverse the Twelfth Circuit.

First, there is a presumption against preemption of state-

law causes of action by federal law. The plain language of

22(b)(1) only operates to preempt design defect claims based

upon side effects which are unavoidable despite proper

manufacturing and labeling. This implies that design defect

claims predicated upon avoidable side effects despite proper

manufacturing and labeling are not preempted by 22(b)(1). The

fact that 22(b)(1) sits in a statutory framework which allows

petitioners to reject the judgment of the Vaccine Court in order

to pursue civil actions against vaccine manufacturers only adds

to the presumption against preemption. Furthermore, the

structure and purpose of the Vaccine Act as a whole disfavor

2
preemption of all design defect claims under 22(b)(1).

Preemption of all design defect claims would reduce compensation

for vaccine-injury victims, in direct contravention of

Congresss clear and manifest purpose to provide sufficient

compensation for such victims under the Vaccine Act.

Categorical preemption also runs afoul of Congresss intent to

codify 402A, comment k, of the Second Restatement of Torts,

which has historically been interpreted as requiring a case-by-

case analysis of the unavoidably unsafe characteristics of a

product. The structure and purpose of the Vaccine Act thus

strengthen the presumption against preemption of all state

design defect claims under 22(b)(1).

Second, allowing 22(b)(1) to create tort immunity from

design defect claims for vaccine manufacturers undermines a

strong state interest in compensating the victims of defectively

manufactured products. This runs contrary to sound public

policy, thereby disfavoring a categorical preemption of design

defect claims under 22(b)(1). Finally, because a genuine

issue of material fact exists as to whether Respondent InGen had

a feasible alternative design of the DPT vaccine available,

summary judgment cannot be granted in favor of Respondent. The

existence of such a feasible alternative design suggests that

Anna Kents injuries were not unavoidable and thus not

preempted under 22(b)(1).

3
Statement of the Case

Congress enacted the National Childhood Vaccine Injury Act

of 1986 (Vaccine Act), 42 U.S.C. 300aa-1 et seq., in order

to ensure that all children who are injured by vaccines have

access to sufficient compensation for their injuries. H. Rep.

No. 908, at 3 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6346.

To that end, Congress established a comprehensive compensation

system under the Vaccine Act as an appealing alternative to the

tort system. Id. at 6367. An individual may elect to reject a

judgment and award made under the compensation program created

by the Vaccine Act, and instead file a civil action for damages

relating to a vaccine injury just as he or she may have done

prior to the enactment of the legislation. Id. at 6344.

Congress created an express preemption of a narrow class of

design defect claims under 300aa-22(b)(1) of the Vaccine Act,

which establishes that a vaccine manufacturer is not 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 even though the vaccine was properly

prepared and was accompanied by proper directions and warnings.

In using the term unavoidable in 22(b)(1), Congress intended

to codify 402A, comment k, of the Second Restatement of Torts.

1986 U.S.C.C.A.N. at 6367. Comment k bars strict liability for:

Unavoidably unsafe products . . . which, in the present state

4
of human knowledge are quite incapable of being made safe for

their intended and ordinary use. Restatement 2d Torts 402A,

comment k.

Anna Kent received the third dose in the five dose series

for the diphtheria-pertussis-tetanus (DPT) vaccine on April 1,

1992. (R. at 4). Anna suffered a series of seizures following

the administration of the vaccine, and doctors subsequently

diagnosed her with residual seizure disorder and developmental

delay. (R. at 4). Annas DPT vaccine was manufactured by

Respondent InGen Laboratories, and was made with a whole-cell

pertussis component. (R. at 4). An acellular pertussis

vaccine, which is less likely to cause adverse side effects than

a whole-cell formula of the vaccine, was eventually approved

by the FDA for use during the first three doses in 1996. (R. at

4, 35). InGen was in possession of an acellular pertussis

formula, which it purchased from Eli Lilly, a manufacturer which

withdrew from the vaccine market in 1974. (R. at 35).

Petitioners Roger and Anita Kent, parents and natural

guardians of Anna Kent, initially filed a claim with the Vaccine

Court in April 1995. (R. at 4). Petitioners rejected the

Vaccine Courts adverse judgment, and subsequently filed a tort

suit in Tahoma state court, alleging design defect. (R. at 4).

Respondent removed the action on the basis of diversity to the

Northern District of Tahoma and filed for summary judgment. (R.

5
at 5). The District Court concluded that Petitioners claim was

expressly preempted by 300aa-22(b)(1) of the Vaccine Act. (R.

at 5). The Twelfth Circuit affirmed, upholding the District

Courts decision both on the grounds of preemption under

22(b)(1) and on the facts of the case. (R. at 7).

Argument

I. 22(B)(1) DOES NOT PREEMPT ALL VACCINE DESIGN DEFECT


CLAIMS BECAUSE A PRESUMPTION AGAINST PREEMPTION OPERATES IN
THE STATUTORY CONSTRUCTION OF FEDERAL LAWS.

The Supremacy Clause of the United States Constitution

states that federal law is the supreme law of the land. U.S.

Const., art. VI, cl. 2. As such, federal law can sometimes

preempt state law, preventing it from having effect. (R. at 5).

The Supreme Court has recognized that because the States are

independent sovereigns in our federal system . . . Congress does

not cavalierly pre-empt state-law causes of action. Medtronic,

Inc. v. Lohr, 518 U.S. 470, 485 (1996). Under this presumption

against preemption, the Supreme Court does not read a federal

act as superseding the historic police powers of the States

unless this is the clear and manifest purpose of Congress.

Id. at 485. See Bates v. Dow Agrosciences, LLC, 544 U.S. 431,

449 (2005) (upholding design defect action against pesticide

manufacturer under the presumption against preemption); see

also American Home Products Corporation v. Ferrari, 284 Ga. 384,

6
393 (Ga. 2008) (upholding design defect action against vaccine

manufacturer under the presumption against preemption).

22(b)(1) expressly preempts design defect claims against

vaccine manufacturers predicated upon unavoidable side

effects. In cases of express preemption, the Court must

identify the domain expressly pre-empted by the language of a

statute. Medtronic, 518 U.S. at 484. (quoting Cipollone v.

Liggett Group, 505 U.S. 504, 517 (1992)). This domain is

discerned from: (i) the plain language of the pre-emption

statute and the statutory framework surrounding it, and (ii) the

structure and purpose of the statute as a whole, as revealed

through the reviewing courts reasoned understanding of the way

in which Congress intended the statute and its surrounding

regulatory scheme to affect business, consumers, and the law.

Id. at 486.

a. The plain language and statutory framework of 22(b)(1)


bolster the presumption against preemption of all design
defect claims.

A preeminent canon of construction imposes upon an

interpreting court the duty to give effect, if possible, to

every clause and word of a statute . . . rather than to

emasculate an entire section. United States v. Menasche, 348

U.S. 528, 538-39 (1955) (quoting Inhabitants of Montclair Tp. v.

Ramsdell, 107 U.S. 147 (1883)); see also Bates, 544 U.S. at 449

(Our reading is at once the only one that makes sense of each

7
phrase in 136v(b) and the one favored by our canons of

interpretation.).

In accordance with this canon of construction, the Court

must first give force to the conditional if in 22(b)(1): a

vaccine manufacturer is not 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 . . . . 42 U.S.C. 300aa-22(b)(1) (emphasis

added). The conditional nature of this clause contemplates the

occurrence of side effects which are avoidable, and for which a

vaccine manufacturer may be civilly liable. Ferrari, 284 Ga.

at 390. Given the presence of the conditional if in

22(b)(1), the plain language of the statute suggests that there

must be certain avoidable side effects. Design defect claims

alleging such avoidable side effects must not be preempted by

the text of the Vaccine Act.

The Twelfth Circuits Majority opinion below claims that

any side effect resulting from a vaccine that is properly

prepared and accompanied by proper directions and warnings is

automatically unavoidable. (R. at 6). This argument is

predicated upon a total failure to give effect to each word of

22(b)(1) which reads, in pertinent part: unavoidable even

though the vaccine was properly prepared and was accompanied by

proper directions and warnings (emphasis added). The words

8
even though are used to distinguish avoidable side effects due

to improper manufacture or labeling from unavoidable side

effects that occur despite proper manufacture and labeling. If

the words even though are to be given any effect, then the

Majoritys conflation of the word unavoidable with the phrases

properly prepared and accompanied by proper directions and

warnings must be erroneous. Additionally:

In order to bar all liability for defective design and to


permit liability only for manufacturing and warning
defects, Congress could have easily . . . made the bar to
civil liability conditional on proper preparations and
warnings, so that subsection (b) (1) would simply state
that a vaccine manufacturer is not civilly liable if the
vaccine was properly prepared and was accompanied by proper
directions and warnings.

Ferrari, 284 Ga. at 390. The word unavoidable must be doing

some work that the phrases properly prepared and accompanied

by proper directions are not, or else it is redundant.

The Majoritys reading of 22(b)(1) deprives the words

if, unavoidable, and even though of any effect, and thus

emasculate[s] an entire section of the statute. Menasche, 348

U.S. at 539. Giving effect to each phrase and word, it is clear

that the plain language of 22(b)(1) does not preempt all

design defect claims against vaccine manufacturers. The plain

language of 22(b)(1) only preempts claims predicated upon side

effects that are unavoidable despite proper manufacturing and

labeling. By negative implication, 22(b)(1) does not preempt

9
claims based upon side effects that are avoidable despite proper

manufacturing and labeling.

In reviewing the statutory framework in which 22(b)(1)

sits, one must note the Vaccine Acts requirement that a person

injured directly by a vaccine first bring a Vaccine Court

proceeding under 300aa-11(a)(2)(A). Schafer v. American

Cyanamid Co., 20 F.3d 1,3 (1st Cir. 1994). Then, the Vaccine

Act gives that person, under 300-aa21(a) and 300aa-

11(a)(2)(A)(i), the choice either to accept the Vaccine Courts

judgment, thereby forgoing his tort rights, or to reject the

judgment and retain his tort rights. Id. at 3. By positive

implication, the Vaccine Act expressly reserves state courts a

role for review of design defect and other tort claims, once a

petitioner has rejected the judgment of the Vaccine Court.

In Schafer, plaintiffs initially petitioned the Vaccine

Court for compensation of injuries suffered from the

administration of a polio vaccine. Schafer, 20 F.3d at 3. One

of the plaintiffs accepted the award of the Vaccine Court, while

co-plaintiffs withdrew their petitions and pursued an action

seeking damages under Massachusetts tort law. Id. Faced with

the question of whether the Vaccine Act barred co-plaintiffs

civil lawsuit, the court held that co-plaintiffs were entitled

to bring a civil action for damages since they had not

themselves accepted an award by the Vaccine Court. Id. at 3, 7.

10
By contrast, in Blackmon v. American Home Products Corp.,

plaintiffs never initially petitioned the Vaccine Court, but

instead immediately filed a state court action against the

defendant, alleging design defect for the use of thimerosal in

polio vaccines. 328 F. Supp. 2d 659, 662 (S.D. Tex. 2004).

Defendants removed the case to federal court, which held that

plaintiffs design defect claim was preempted by the Vaccine

Act. Id. at 666.

Anna Kents case is easily distinguishable from that of the

plaintiffs in Blackmon, who did not initially file a petition in

the Vaccine Court, as required by 300aa-11(a)(2)(A). This

crucial procedural dissimilarity suggests that the holding in

Blackmon is not applicable to the current case. Instead, like

the plaintiffs in Schafer, Annas parents initially filed a

claim with the Vaccine Court, alleging that Anna suffered

residual seizure disorder and encephalopathy caused by InGens

DPT vaccine. (R. at 4). Once the Vaccine Court rendered an

adverse judgment, Annas parents rejected the Vaccine Courts

judgment and filed a tort suit in Tahoma state court, alleging

design defect. (R. at 8). The state court is authorized, under

300aa-22(a), to review Annas design defect claim. As such,

Annas design defect claim is not preempted by 22(b)(1), so

long as the side-effects Anna suffered from the administration

of InGens DPT vaccine were not unavoidable.

11
b. The structure and purpose of 22(b)(1) bolster the
presumption against preemption of all design defect
claims.

Congress has expressly stated that the purpose behind the

passage of the Vaccine Act is to ensure that all children who

are injured by vaccines have access to sufficient compensation

for their injuries. H. Rep. No. 908, at 3 (1986), reprinted in

1986 U.S.C.C.A.N. 6344, 6346. To that end, it is clear that

Congress intended the Vaccine Acts compensation system to

operate as an alternative, and not as a replacement, to the

traditional tort compensation system. Id. at 6367; see Ferrari,

284 Ga. at 392 (in the committees opinion, if a vaccine-

injured person does not have a claim for manufacturing or

warning defect, he should find the compensation system appealing

even though he is authorized to attempt to prove the existence

of a safer design in the tort system.); see also Schafer, 20

F.3d at 3 (the Act modifies, but does not eliminate, the

traditional tort system, which Congress understood to provide

important incentives for the safe manufacture and distribution

of vaccines.). A categorical preemption of design defect

claims under 22(b)(1) would lead to decreased compensation for

vaccine-injury victims. Such a result is incontrovertibly at

odds with Congresss clear and manifest purpose for augmenting

the traditional tort system through passage of the Vaccine Act,

i.e. sufficient compensation for vaccine-injury victims.

12
As Congress has unequivocally indicated, an individual may

elect to reject a judgment and award made under the [Vaccine

Acts] compensation program and file a civil action for

damages relating to a vaccine injury just as he or she may have

done prior to the enactment of the legislation. 1986

U.S.C.C.A.N. at 6344. It is clear that prior to the enactment

of the Vaccine Act, a plaintiff could bring a lawsuit alleging

design defect against a vaccine manufacturer. Following the

logic of Congresss above proposition, it must be the case that

22(b)(1) is not intended to preempt the very same design

defect claims a plaintiff could levy prior to the enactment of

the Vaccine Act. See Bates, 544 U.S. at 449 (The long history

of tort litigation against manufacturers . . . adds force to the

basic presumption against pre-emption.).

Congress has also stated that 22(b)(1) is intended to

codify 402A, comment k, of the Second Restatement of Torts.

1986 U.S.C.C.A.N. at 6367. Comment k bars strict liability

for: Unavoidably unsafe products which, in the present state of

human knowledge are quite incapable of being made safe for their

intended and ordinary use. Restatement 2d Torts 402A,

comment k. Congress specifically intends that the principle in

Comment K regarding unavoidably unsafe products . . . apply to

those vaccines covered in the bill. . . . 1986 U.S.C.C.A.N. at

6367. The word unavoidably, as it is used in comment k, is a

13
term of art, one that has a specific and nuanced legal meaning.

An established rule of statutory construction states that when a

statute uses a term of art, Congress intends for that term to

have its established meaning. McDermott International, Inc. v.

Wilander, 498 U.S. 337, 342 (1991).

Historically, [m]ost of the states . . . that have

adopted Comment k have applied it in a more limited fashion and

on a case-by-case basis. Ferrari, 284 Ga. at 389 (citing

Bryant v. Hoffman-La Roche, 262 Ga. App. 401, 404 (2003)); see

also Feldman v. Lederle Laboratories, 479 A.2d 374, 383 (N.J.

1984) (holding that whether a drug is unavoidably unsafe under

comment k should be determined on a case-by-case basis). Thus,

under the established meaning of comment k, unavoidability is

determined by a fact-intensive inquiry on a case-by-case basis.

If Congress intended for the word unavoidable to have its

established meaning, then the unavoidability of vaccine side

effects must be determined on a case-by-case basis. Ferrari,

284 Ga. at 386. To deem a vaccine unavoidably unsafe, the trier

of fact must decide whether the challenged vaccine is the only

design available in the present state of human knowledge. Id.

This suggests that summary judgment is inappropriate in

determinations of unavoidability under 300aa-22(b)(1), since

unavoidability is a question of fact for a jury to determine.

Id. If the side effects of a vaccine were avoidable by a

14
feasible alternative design, liability is not completely barred

under 22(b)(1). Id. at 390. Anna Kent need only prove that

there was a feasible alternative design for the whole cell DPT

vaccine to avoid preemption of her claim under 22(b)(1).

II. SOUND PUBLIC POLICY DISFAVORS READING 22(B)(1) AS A


CATEGORICAL PREEMPTION OF ALL DESIGN DEFECT CLAIMS AGAINST
VACCINE MANUFACTURERS.

There is a strong state interest in compensating those who

are injured by a manufacturers defective products. Feldman,

479 A.2d at 394. Preempting all design defect claims under

22(b)(1) results in tort immunity for vaccine manufacturers,

which undermines the strong state interest in compensating those

injured by defective vaccines. Ferrari, 284 Ga. at 394. In the

absence of a clear and manifest congressional purpose to achieve

such a result, the Court must reject a reading of 22(b)(1)

that grants vaccine manufacturers tort immunity from design

defect claims. Id. See Bates, 544 U.S. at 450 (rejecting

reading of statute that would create tort immunity for pesticide

manufacturers); see also Medtronic, 518 U.S. at 487

(characterizing a statutory interpretation that would grant

complete immunity from design defect liability to an entire

industry as perverse).

The tort immunity heralded by a categorical preemption of

design defect claims under 22(b)(1) would frustrate Congresss

clear and manifest purpose of augmenting compensation of

15
vaccine-injury victims. 1986 U.S.C.C.A.N. at 6346. Since

Congress cannot have intended to promote two countervailing

purposes, the clear and manifest purpose of augmenting

compensation for vaccine-injury victims must prevail. As such,

sound public policy militates against reading 22(b)(1) as

preempting all design defect claims under the Vaccine Act.

III. SUMMARY JUDGMENT IS INAPPROPRIATE IN THIS CASE BECAUSE A


GENUINE ISSUE OF MATERIAL FACT EXISTS AS TO WHETHER THE
SIDE EFFECTS OF INGENS WHOLE-CELL DPT VACCINE WERE
UNAVOIDABLE

Summary judgment should never be granted unless the movant

has proven 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. To deem a vaccines side effects

unavoidable despite proper manufacturing and labeling, the trier

of fact must determine whether the challenged vaccine is the

only design available in the present state of human knowledge.

Ferrari, 284 Ga. at 386. If the side effects were avoidable by

a feasible alternative design, then the vaccine is not the only

design available in the present state of human knowledge, and

thus the vaccines side effects are not unavoidable. Id.

There is a genuine issue of material fact as to whether the

side effects that Anna Kent suffered were avoidable by a

feasible alternative design to the whole-cell DPT vaccine. An

acellular pertussis vaccine is less likely to cause adverse

16
advents than a whole-cell formula of the vaccine. (R. at 4).

It is stipulated that Respondent InGen was in possession of an

acellular pertussis formula, which it purchased from a

manufacturer which withdrew from the vaccine market in 1974.

(R. at 35). Given these stipulations, a genuine issue of

material fact exists as to whether the acellular pertussis

formula could have received FDA approval sooner than 1996, and

thus been available for use during Annas third dose of the DPT

vaccine in 1992. cf. Wyeth v. Levine, 129 S. Ct. 1187, 1198

(2009) (absent clear evidence that the FDA would not have

approved a change to [defendants drug] label, we will not

conclude that it was impossible for [defendant] to comply with

both federal and state [labeling] requirements.). A reasonable

jury could conclude that a feasible alternative design to the

whole-cell DPT vaccine existed at the time Anna received her

third dose. The unavoidability of the side effects of the

whole-cell DPT vaccine in Anna Kents case is thus a question

of fact for a jury to determine. Ferrari, 284 Ga. at 386.

Conclusion

For the foregoing reasons, the Petitioners, Roger Kent and

Anita Kent, respectfully request that the Supreme Court reverse

the decision of the Twelfth Circuit and hold that 42 U.S.C.

300aa-22(b)(1) does not preempt Petitioners design defect claim

against Respondent InGen Laboratories.

17
Respectfully Submitted,

_______________________

Saurish Bhattacharjee
Attorney for Petitioner

18