No. 09-152Supreme Court, U.S.

- =0

OCT

7 - 2009

IN THE OFFICE OF THE CLERK

Supreme Court of the United States

RUSSELL BRUESEWITZ, ROBALEE BRUESEWITZ,

Parents and Natural Guardians of HANNAH BRUESEWITZ,a Minor Child and In Their Own Right,

Petitioners,U.

WYETH, INC. f/k/a WYETH LABORATORIES, WYETH-AYERSTLABORATORIES, WYETH LEDERLE, WYETH LEDERLE

VACCINES and LEDERLE LABORATORIES,

Respondents.

On Petition for a Writ of Certiorari to theUnited States Court of Appeals for the Third Circuit

BRIEF IN RESPONSE TO PETITIONFOR A WRIT OF CERTIORARI

Daniel J. Thomasch

Counsel of

Record Richard W.MarkE. Joshua Rosenkranz

John L. EwaldORRICK,HERRINGTON

& SUTCLIFFELLP 666 FifthAvenue

New York, New York 10103212-506-5000

Counsel for Respondents

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QUESTION PRESENTED

In the 1980s, the costs and risks of product

liability litigation drove several vaccine

manufacturers out of the market, causing shortages

of vaccines essential to public health programs.

Congress averted a public health crisis by enacting

the National Childhood Vaccine Injury Act of 1986.

The Act shielded vaccine manufacturers from

categories of tort litigation, directed federal agencies

to develop safer childhood vaccines, and established

a Vaccine Court to administer a no-fault remedy for

vaccine-related injuries. The Act's express

preemption provision states that "[n]o vaccine

manufacturer shall be liable in a civil action" if the

injury "resulted from side effects that were

unavoidable even though the vaccine was properly

prepared and was accompanied by proper directions

and warnings." 42 U.S.C. § 300aa-22(b)(1).

Does the Vaccine Act expressly preempt astate-law claim against a vaccine manufacturer basedon an allegation that the vaccine-related injury couldhave been avoided by a vaccine design allegedly saferthan the one approved by the U.S. Food and DrugAdministration for use nationwide?

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RULE 29.6 STATEMENT

Respondent Wyeth, Inc., improperly identified inthe caption as Respondents "Wyeth, Inc. f/k/aWyeth Laboratories, Wyeth-Ayerst Laboratories,Wyeth Lederle, Wyeth Lederle Vaccines and LederleLaboratories," states that Wyeth is a publiclytraded corporation. No publicly held corporationowns 10% or more of its outstanding shares.

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TABLE OF CONTENTS

Page

QUESTION PRESENTED........................................... i

RULE 29.6 STATEMENT. ......................................... ii

TABLE OF CONTENTS............................................ iii

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

iv

INTRODUCTION. ....................................................... 1

STATEMENT OF THE CASE................................... 3

In 1986, Congress Saw That

Vaccine Litigation Threatened

To Cause A

Public Health Crisis. ......................... 3

Policy Components Of The Vaccine Act...

5

DTP Vaccine. ......................................... 7

The Proceedings Below.........................

10

ARGUMENT. .................................................. 12

I. ON THE QUESTION PRESENTED,

THE THIRD CIRCUIT'S DECISIONDIRECTLY CONFLICTS WITH THEGEORGIA SUPREME COURT'SDECISION.. ................................................... 12

II.WYETH AGREES THAT THE

QUESTION PRESENTED IS ONE OFNATIONAL IMPORTANCE.. ....................... 15

III. THE THIRD CIRCUIT CORRECTLY

FOUND THAT THE VACCINE ACTEXPRESSLY PREEMPTS ALL

DESIGN DEFECT CLAIMS.......................... 27

CONCLUSION.........................................................

35

iv

TABLE OF AUTHORITIES

Page(s)

Cases

Am. Home Prods. Corp. v. Ferrari,129 S. Ct. 2786 (2009). .................................. 1

Am. Home Prods. Corp. v. Ferrari,668 S.E.2d 236 (Ga. 2008). ............... 1, 13, 14

Bates u. Dow Agrosciences LLC,544 U.S. 431 (2005). .............................. 28, 30

Blackmon v. Am. Home Prods. Corp.,328 F. Supp. 2d 659 (S.D. Tex. 2004)........... 13

Brown v. Superior Ct.,751 P.2d 470 (Ca. 1988). .............................. 34

Bruesewitz v. Sec'y of HHS,No. 95-0266V, 2002 WL 31965744 (Fed. Cl.Dec. 20, 2002). ............................................ 11

Cedillo v. Sec'y of HHS,No. 98-916V, 2009 WL 331968 (Fed. CLFeb. 12, 2009), sustained, No. 98-916V,2009 WL 2998429 (Fed. Cl. Aug. 6, 2009). ... 21

Cipollone v. Liggett Group, Inc.,505 U.S. 504 (1992). .................................... 30

City of Erie v. Pap's A.M.,529 U.S. 277 (2000). ................................... 15

District of Columbia v. Heller,128 S. Ct. 2783 (2008). ............................... 32

Hahn v. Richter,673 A.2d 888 (Pa. 1996). .............................. 34

Hazlehurst v. Sec'y of HHS,No. 03-654V, 2009 WL 332306 (Fed. Cl.Feb. 12, 2009), sustained, No. 03-654V,2009 WL 2371336 (Fed. Cl. July 24, 2009). . 21

Hurley v. Lederle Labs Div. Of

Am. Cyanamid Co.,863 F.2d 1173 (5th Cir. 1989). ..................... 14

Merrill Lynch, Pierce, Fenner & Smith Inc.v. Dabit,547 U.S. 71 (2006). ...................................... 27

Militrano v. Lederle Labs.,769 N.Y.S.2d 839 (Sup. Ct. 2003), aff'd,

810 N.Y.S.2d 506 (App. Div. 2006), leavedenied, 857 N.E.2d 1137 (N.Y. 2006). .......... 13

Pension Benefit Guar. Corp. v. LTV Corp.,496 U.S. 633 (1990). .................................... 32

Snyder v. Sec'y of HHS,No. 01-162V, 2009 WL 332044 (Fed. Cl.Feb. 12, 2009), sustained, No. 01-162V,2009 WL 2517755 (Fed. Cl. Aug. 11, 2009). . 21

Sykes v. Glaxo-SmithKline,484 F. Supp. 2d 289 (E.D. Pa. 2007). ........... 13

United States v. Price,361 U.S. 304 (1960). .................................... 32

White v. Wyeth Labs., Inc.,533 N.E.2d 748 (Ohio 1988). .......................... 9

Wright v. Aventis Pasteur, Inc.,No. 3861, 2008 WL 4144386 (Pa. Ct. Corn. Pl.Aug. 27, 2008), No. 336 EDA 2008 (Pa. Super.Ct. argued June 9, 2009) 13

129 S. Ct. 1187 (2009). ............................ 28

Statutes, Regulations, and Legislative History

21 U.S.C. § 301 et seq. .................................. 7

42 U.S.C. § 247d-6d. .............................. 25, 26

42 U.S.C. § 262. ..................................... 7

42 U.S.C. § 300aa-1 et seq. .......................... 1

42 U.S.C. § 300aa-1................................ 7

42 U.S.C. § 300aa-11.............................. 6

42 U.S.C. § 300aa-12.............................. 6

42 U.S.C. § 300aa-13.............................. 6

42 U.S.C. § 300aa-14.............................. 6, 25

42 U.S.C. § 300aa-15.............................. 6

42 U.S.C. § 300aa-21.............................. 6

42 U.S.C. § 300aa-22.............................. passim

42 U.S.C. § 300aa-23.............................. 18

42 U.S.C. § 300aa-27.............................6,7, 23

42 U.S.C. § 300aa-33.............................. 25

Omnibus Budget Reconciliation Act of1987, Pub. L. No. 100-203, 101 Stat.1330-221

32

Public Readiness and Emergency

Preparedness Act, Pub. L. No.109-148(2006). ...............................................

25

viWyeth v. Levine,

viii

National Vaccine Injury CompensationProgram Revision of the Vaccine Injury

Table, 60 Fed. Reg. 7678 (Feb. 8, 1995). . 11

Pandemic Influenza Vaccines—Amendment,

74 Fed. Reg. 30294-01 (June 25, 2009).... 25

H.R. Rep. No. 99-908 (1986), as reprinted in1986 U.S.C.C.A.N. 6344..................... passim

Staff of Subcomm. on Health and the

Environment, 99th Cong., ChildhoodImmunizations (Sept. 1986) 4, 16, 17, 23

Miscellaneous

American Academy of Pediatrics,Committee on Infectious Diseases, TheRelationshipBetween Pertussis Vaccine and Central

Nervous System Sequelae: Continuing

Assessment, 97 Pediatrics 279 (1996)......... 8

CDC, Questions & Answers-2009 H1N1

Influenza Vaccine,http://www.cdc.gov/h1n1flu/ vaccination/public/vaccination_ga_pub.htm(last updated Oct. 5, 2009)....................... 24

CDC, Pertussis Vaccination: AcellularPertussis Vaccine for Reinforcing andBooster Use, 41 MMWR 1 (Feb. 7, 1992). . 10

CDC, Recommended ImmunizationSchedules for Persons Aged 0-18

viii

Years—UnitedStates, 2008, 57 MMWR Q1 (Jan.11, 2008).24

viii

CDC, Recommendation of the ImmunizationPractices Advisory Committee NewRecommended Schedule for ActiveImmunization of Normal Infants andChildren, 35 MMWR 577 (Sept.19, 1986). ... 24

Geoffrey Evans, Update on Vaccine Liability in theUnited States 42 Clinical Infectious D i s e a s e sS 1 3 0 ( 2 0 0 6 ) 1 6 , 1 7

FDA/CBER, Thimerosal in Vaccines,http://www.fda.gov/CBER/vaccine/thimeros al.htm (last updated Aug. 31, 2009). .. 18, 20

FDA, VAERS Overview,http://www.fda.gov/BiologicsBlood Vaccines/SafetyAvailability/ReportaProble m/VaccineAdverseEvents/Overview/default

.htm (last updated July 10, 2009). ............ 21

HHS, HRSA Awards Contract to StudyAdverse Events in Childhood Vaccines(Oct. 23, 2008), http://archive.hrsa.gov/newsroom/releases/2008/vaccinestudy.htm1.7

HRSA, Countermeasures Injury CompensationProgram—Covered Countermeasures,http://www.hrsa.gov/countermeasurescomp /countermeasures.htm (last visitedOct. 7,

2009). ....................................................... 26

HRSA, National Vaccine Injury Compensation ProgramS ta t i s t i c s R e p o r t (S e p . 1 4 , 2009 ) ,http://www.hrsa.gov/vaccinecompensation/s t a t i s t i c s _ r e p o r t . h t m . 1 7

ix

Immunization Safety Review Committee,Board on Health Promotion andDisease Prevention, Institute ofMedicine,

Immunization Safety Review: Vaccines andAutism (2004)20

Institute of Medicine, DTP Vaccine andChronic Nervous System Dysfunction: A

New Analysis (1994).................................... 8

SafeMinds, Vaccines and Autism,http://www.safeminds.org/mercury/vaccines-and-

autism.html (last visited Oct. 7, 2009). ...... 22

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INTRODUCTION

Respondents ("Wyeth") agree with Petitioners("plaintiffs") that the Court should grant certiorari inthis case to resolve a crucial public health issueupon which the lower courts are split. Twenty-fiveyears ago, a deluge of cases asserting claims justlike this one drove vaccine manufacturers from themarket and threatened the nation's supply ofchildhood vaccines. Congress stabilized the marketby enacting the National Childhood Vaccine InjuryAct of 1986, 42 U.S.C. § 300aa-1 et seq. (the"Vaccine Act" or "Act"), which created a new,no-fault compensation program for vaccine-relatedinjuries and included an express preemptionprovision (Section 22) that limits the scope ofdamage claims that can be advanced againstvaccine manufacturers. The question presented bythe petition is whether Section 22 categoricallypreempts all design defect claims, which werecentral to the 1980s litigation crisis.

In answering that question in the affirmative, theUnited States Court of Appeals for the Third Circuitexpressly—and correctly—rejected the conclusion ofthe Georgia Supreme Court in American HomeProducts Corp. v. Ferrari, 668 S.E.2d 236 (Ga. 2008).1

The Georgia Supreme Court held that

I The vaccine manufacturer defendants in Ferrari petitionedfor a writ of certiorari, which petition is pending. No. 08-1120.This Court called for the views of the United States on thepetition, American Home Products Corp. u. Ferrari, 129 S. Ct.2786 (2009), but the Solicitor General has not yet filed her briefin response to the invitation.

Section 22 does not preclude design defect claimsunless the manufacturer demonstrates, case bycase, that there was no safer design that could haveavoided the injury.

The Court should not wait for another case totake up the question of which interpretation ofSection 22 is correct. The stability of the nation'schildhood vaccine supply remains precarious.Determining which state law claims Section 22allows against vaccine manufacturers will affect thedevelopment and supply of vaccines. If theconflicting interpretations of the Georgia SupremeCourt and the Third Circuit are left unresolved,vaccine manufacturers will face the potentiallydevastating prospect of thousands of lawsuitschallenging the design of their FDA-approvedvaccines in courts across the country.Approximately 5,000 petitions—all premised on theclaim that a child's autism was caused byvaccines—are pending in the federal no-faultvaccine compensation program ("Vaccine Court").Regardless of how the Vaccine Court decides thosepetitions, every claimant has the potential to rejectthe judgment and elect to file a civil action fordamages.

Apart from the need to review the questionpresented, however, Wyeth disagrees with almosteverything else in plaintiffs' petition. Plaintiffs injectimplied preemption issues into their petition; butthose issues have no relevance to the questionpresented here of express preemption under theVaccine Act. Wyeth also disagrees with plaintiffsthat the Third Circuit erred in its ultimate result.The Third Circuit—joining every court to address

the issue outside Georgia—correctly decided that theVaccine Act categorically preempts all design defectclaims. The court properly rejected plaintiffs'construction of the statute—which would permitu n f e t t e r e d l i t i g a t i o n aga in s t vac c i n emanufacturers—as antithetical to Congress's primaryaim of ensuring a stable supply of childhood vaccines.

Because a litigation deluge would threaten thesupply of childhood vaccines, the Court should grantcertiorari in this case and verify whichinterpretation of the express preemption provision iscorrect, the Third Circuit's or the Georgia SupremeCourt's.

STATEMENT OF THE CASE

In 1986, Congress Saw That Vaccine LitigationThreatened To Cause A Public Health Crisis

The petition's discussion of the Vaccine Act isincomplete. Plaintiffs write as if Congress intended forthe Vaccine Act to compensate allegedlyvaccine-injured individuals and nothing more. But theVaccine Act's new approach to compensation forvaccine-related injuries is only one part of a multi-faceted public health program Congress created.

Congress recognized in 1986 that "[v]accination ofchildren against deadly, disabling, but preventableinfectious diseases has been one of the mostspectacularly effective public health initiatives thiscountry has ever undertaken." H.R. Rep. No. 99-908,at 4 (1986), as reprinted in 1986 U.S.C.C.A.N. 6344,6345. For example, pertussis (or whooping cough) isa serious, highly communicable respiratory disease.

4

In 1934, there were 265,269 reported cases ofpertussis and 7,518 deaths. See Staff of Subcomm.on Health and the Environment, 99th Cong.,Childhood Immunizations 9-10 (Sept. 1986)("Subcomm. Rep."). After 40 years of widespreaduse of the whole-cell pertussis vaccine, theincidence of pertussis dropped to 2,276 reportedcases in 1984 and only 12 deaths. Id. Congressenacted the Vaccine Act when the burden ofvaccine litigation costs threatened to underminethe spectacular public health gains brought aboutby nationwide vaccination.

In the 1980s, vaccine manufacturers faced aproliferation of product liability claims involvingchildhood vaccines. Most of these cases were likethis one, involving claims that the diphtheria,tetanus, and pertussis ("DTP") vaccine wasdefectively designed because there was anunlicensed, allegedly safer, alternative vaccine inexistence that would have prevented the samediseases. The result of that litigation explosion,according to Congress, was a vaccine market sounstable and unpredictable" as to threaten the"

supply of vaccines necessary to carry out childhoodimmunization programs. See 1986 U.S.C.C.A.N. at6346. Observing that litigation had already drivenmanufacturers from the market, Congressconcluded that the "withdrawal of even a single[additional] manufacturer would present the veryreal possibility of vaccine shortages, and, in turn,increasing numbers of unimmunized children, and,perhaps, a resurgence of preventable diseases." Id.at 6348. Congress addressed the public healthcrisis with the Vaccine Act.

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Policy Components Of The Vaccine Act

The objective of universal vaccination to combatinfectious disease and promote the common publichealth requires a stable supply of safe and effectivevaccines. Through the Vaccine Act, Congresssought: (1) to keep vaccine manufacturers in themarket; (2) to provide fair compensation to the fewwho suffer adverse side effects from vaccination;and (3) to have improved vaccines developed. Thekey to achieving these goals was to create acomprehensive, national vaccine policy—fromdeveloping safer vaccines, to a new paradigm forproviding compensation and litigating injuryclaims.

Keeping vaccine manufacturers in themarket. The element of the statutory scheme thatprotects vaccine manufacturers from the sort ofburdensome litigation that Congress found haddriven manufacturers out of the market is Section22(b)(1). It provides, in full:

No vaccine manufacturer shall be liable in acivil action for damages arising from avaccine-related injury or death associatedwith the administration of a vaccine afterOctober 1, 1988, if the injury or deathresulted from side effects that wereunavoidable even though the vaccine wasproperly prepared and was accompanied byproper directions and warnings.

42 U.S.C. § 300aa-22(b)(1). Neither party interpretsSection 22 to preclude any and all state tort claims.The parties agree that the Vaccine Act permitsclaims against a manufacturer for injuries causedby a vaccine not manufactured according to itsFDA-

6

approved formula (i.e., not "properly prepared") ornot accompanied by proper directions andwarnings for use. The question presented by thepetition is whether Section 22 leaves open thepossibility of other claims for damages, specificallydesign defect claims, which were central to thelitigation in the 1980s.

Before filing a civil action, a person seekingdamages for a vaccine-related injury must file apetition for compensation in the Vaccine Court,which is an adjunct to the Court of Federal Claims.42 U.S.C. §§ 300aa-11(a)(2), 12(c), 21(a).Compensation claims are decided on a no-faultbasis. Id. §§ 300aa-13, 14, 15(i). A Vaccine Courtclaimant does not need to prove that the injurycould have been avoided through a safer design orthat the vaccine was otherwise defective—as tortlaw would require—but only that there is a causallink between the administered vaccine and theinjury. See id. § 300aa-13. After receiving ajudgment in Vaccine Court, the claimant can eitheraccept the judgment or reject it and file a civilaction, subject to several substantive andprocedural constraints. See 42 U.S.C. § 300aa-21.

The National Vaccine Program. The VaccineAct established a National Vaccine Program ("NVP")to promote the development of improved, safervaccines for use in immunization programsnationwide. 42 U.S.C. § 300aa-27(a)(1). Throughthis program, nearly a dozen federal agencies,including the Food and Drug Administration("FDA"), work together "to achieve optimalprevention of human infectious diseases throughimmunization and to achieve optimal prevention

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against adverse reactions to vaccines." 42 U.S.C. §300aa-1. Congress established a "[m]andate forsafer childhood vaccines" and assigned theSecretary of the Department of Health & HumanServices ("HHS") with the responsibility to"assure improvements in . . . licensing,manufacturing, processing, testing, labeling,warning, . . . and research on vaccines, in order toreduce the risks of adverse reactions to vaccines."42 U.S.C. § 300aa27(a)(1), (2).

The Vaccine Act left in place the laws andregulations that make the FDA responsible forregulating the formulation, production, andlabeling of childhood vaccines, which are biologicalproducts subject to the Federal Food, Drug, andCosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., andthe Public Health Service Act, 42 U.S.C. § 262.Such oversight is done through the FDA's Centerfor Biologics Evaluation and Research ("CBER"),which was created in 1988, the same year theVaccine Act became effective. CBER is entirelydistinct from those aspects of the FDA that regulatedrugs and devices. Following FDA licensure, amanufacturer cannot change the vaccine formulaor the labeling without FDA approval. See 21 C.F.R.§§ 601.2, 601.12.

DTP Vaccine

Wyeth disputes almost all of the factualassertions in plaintiffs' Statement of the Case.Those assertions that purport to have citationalsupport largely do not cite to the record below, butrather to statements made in decisions fromcompletely unrelated cases. There is no need to

8

catalog all of those inaccuracies here because theyare not relevant to the pure question of lawpresented by the petition. But Wyeth will addressthe most misleading of the statements about theregulatory history of the DTP vaccine at issue and

purported safer alternative vaccines.2

The pertussis component in TRI-IMMUNOL®, theDTP vaccine at issue, consists of a suspension ofwhole, killed pertussis cells. A. 1035a, ¶ 6; 866a,3

116. Plaintiffs argue that Wyeth should havemarketed a "safer alternative vaccine[ ]," i.e., anentirely different vaccine to prevent the samediseases that TRI-IMMUNOL® addresses. Pet. at 3.Plaintiffs contend that the "safer alternativevaccine[ ]" was either: (1) an acellular pertussisvaccine, which contained selected components ofthe

Wyeth denies that the DTP vaccine caused the minor plaintiff's2

injuries, a position which is consistent with the views ofnumerous medical organizations and agencies that haverejected plaintiffs' causation theory. See, e.g., American Academyof Pediatrics, Committee on Infectious Diseases, The RelationshipBetween Pertussis Vaccine and Central Nervous System Sequelae:Continuing Assessment, 97 Pediatrics 279 (1996); Institute ofMedicine, DTP Vaccine and Chronic Nervous System Dysfunction:A New Analysis (1994). Causation, however, was not at issue inplaintiffs' appeal to the Third Circuit and is not before thisCourt on the petition.

3

Citations to A.

are to the Appendix filed below.

Plaintiffs admitted a number of facts in the district courtsummary judgment briefing. In this section, when two citationsto the Appendix follow a sentence, they refer respectively to therelevant paragraph in Wyeth's statements of undisputed factand plaintiffs' response admitting that the paragraph is notdisputed.

9

pertussis cell; or (2) the Tri-Solgen vaccine, whichwas a "fractionated cell" vaccine that containedpart of the pertussis bacterium, but unlikeacellular vaccines, was neither characterized(identifying the parts of the cell) nor purified(utilizing only specific parts of the cell).

Indisputably, at the time of the minor plaintiff'simmunization in April 1992, the only DTP vaccinesthat were licensed for immunizing infants used a"whole cell" pertussis vaccine component. A.1036a, ¶ 12; 867a, ¶ 12. The FDA did not licensefor infants a DTP vaccine containing an acellularpertussis component until mid-1996, more thanfour years after the immunization of the minorplaintiff. A. 1036a, ¶ 9; 867a, ¶ 9.

Nevertheless, plaintiffs argue that Wyeth shouldhave marketed the Tri-Solgen vaccine (which waswithdrawn in the 1970s by its manufacturer EliLilly) instead of the FDA-approved TRI-IMMUNOL® vaccine. The FDA, however, concludedthat the Tri-Solgen design was inferior to that ofTRI-IMMUNOL®. In 1982, Wyeth Laboratoriessought approval to market a vaccine based on theTri-Solgen design, but the FDA rejected the licenseapplication, expressing "the need for several designimprovements." White v. Wyeth Labs., Inc., 533 N.E.2d748, 753 (Ohio 1988).

Plaintiffs also argue that the FDA did not licensean acellular vaccine for infants simply becauseWyeth failed to seek FDA approval for such avaccine. That is false. The delay in licensing theacellular vaccine for infants in the United Stateswas the product of the FDA's appropriate insistencethat

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all such vaccines be proven through clinical trialsto be as efficacious as the existing whole-cellvaccine. CDC, Pertussis Vaccination: AcellularPertussis Vaccine for Reinforcing and Booster Use, 41MMWR 1 (Feb. 7, 1992). That requirement tookyears to fulfill in the United States. A. 1036a, ¶ 9;867a, ¶ 9. Japan did not have a similarrequirement, and in the face of a pertussis epidemicin 1981, the Japanese government permittedacellular pertussis vaccines to go to market with noefficacy testing and only limited clinical studies ofimmunogenicity and safety. CDC, PertussisVaccination: Acellular Pertussis Vaccine forReinforcing and Booster Use, 41(RR-1) MMWR 1(Feb. 7, 1992). Indeed, having neither required norreceived clinical trial data to show that acellularvaccines were efficacious, regulatory authoritiesin Japan limited administration of acellularpertussis vaccines to children with more developedimmune systems, i.e., children two years of age andolder. Id.

The Proceedings Below

On April 3, 1995, plaintiffs filed a Vaccine Courtpetition seeking compensation for injuries theminor plaintiff allegedly suffered as the result of aDTP vaccination administered in April 1992. Afteran evidentiary hearing, the Vaccine Court rendereda judgment dismissing plaintiffs' petition withprejudice for failing to establish that the DTPvaccine caused the minor plaintiff's injuries. 4

4

Plaintiffs correctly assert that residual seizure disorderassociated with DTP vaccine was removed from the VaccineInjury Table in 1995, thus placing on plaintiffs the burden of

11

Bruesewitz v. Sec'y of HHS, No. 95-0266V, 2002 WL31965744 (Fed. Cl. Dec. 20, 2002). Plaintiffs didnot appeal that judgment to the Court of FederalClaims or the Federal Circuit; instead, they electedto reject the judgment of the Vaccine Court and topursue civil litigation.

After Wyeth moved for summary judgment, thedistrict court, sua sponte, invited the FDA and HHSto submit an amicus brief. A-112. Plaintiffs aresimply wrong that HHS and FDA responded to theinvitation by stating that in this case there was "nopreemption of all design defect claims." Pet. at 13.Instead, the two agencies chose not to take aposition on the preemptive scope of the Vaccine Actat that time. The FDA and HHS responded by letterto the district court that they did not then have anofficial view on the preemption issue because theagencies are not parties to civil actions commencedafter a claimant has properly exhausted theadministrative compensation process, and do notadminister provisions that govern such civil actions.A-107-09.

proof as to medical causation. What plaintiffs fail to mention,however, is that HHS removed residual seizure disorder fromthe Table because it determined there was no "medical evidenceto support" the presumption. National Vaccine InjuryCompensation Program Revision of the Vaccine Injury Table,60 Fed. Reg. 7678, 7691 (Feb. 8, 1995) (emphasis added). Evenwith the condition removed from the Table, plaintiffs still wereable to argue in Vaccine Court that the DTP vaccine in-factcaused the minor plaintiff's injuries. All of plaintiffs' causationtheories were rejected by the special master. Bruesewitz, 2002WL 31965744, at *12-*17.

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After "extensive discovery," the district courtgranted summary judgment to Wyeth on plaintiffs'entire complaint. A-54-56. The district court held,inter alia, that Section 22(b)(1) of the Vaccine Actexpressly preempted plaintiffs' design defect claims.A-87.

The Third Circuit affirmed the district court'sjudgment. The Third Circuit concluded that thestatutory text, structure, and legislative history ofSection 22 showed "a 'clear and manifest'expression of congressional intent" to preemptdesign defect claims. A-30. In so ruling, the ThirdCircuit considered and explicitly rejected theGeorgia Supreme Court's analysis, stating that itdid "not consider the Ferrari Court's reading [ofSection 22] to be compelling." A-28. The courtfound that "[e]ach of the objectives [of the VaccineAct] extolled by the Commerce Report would beundermined if design defect claims were permittedunder the statute," leading to the "very problemswhich led to instability in the vaccine market andwhich caused Congress to intervene through thepassage of the Vaccine Act." A-36.

ARGUMENT

I. ON THE QUESTION PRESENTED, THETHIRD CIRCUIT'S DECISION DIRECTLYC O N F L I C T S W I T H T H E G E O R G I ASUPREME COURT'S DECISION.

Wyeth agrees with plaintiffs that there is a clearand irreconcilable conflict between a state's highestcourt (the Georgia Supreme Court) and a federalcourt of appeals (the Third Circuit) on whether theVaccine Act expressly preempts all design defect

13

claims. The Third Circuit's holding that the VaccineAct expressly preempts all design defect claims isconsistent with all others on the issue outside ofGeorgia. See Militrano u. Lederle Labs., 769 N.Y.S.2d839, 845-46 (Sup. Ct. 2003), aff'd, 810 N.Y.S.2d 506(App. Div. 2006), leave denied, 857 N.E.2d 1137(N.Y. 2006) (table); Sykes v. GlaxoSmithKline, 484 F.Supp. 2d 289, 299-303 (E.D. Pa. 2007); Blackmon v.Am. Home Prods. Corp., 328 F. Supp. 2d 659,664-66 (S.D. Tex. 2004); Wright v. Aventis Pasteur,Inc., No. 3861, 2008 WL 4144386 (Pa. Ct. Corn. Pl.Aug. 27, 2008), No. 336 EDA 2008 (Pa. Super. Ct.argued June 9, 2009). These courts have concludedthat the Vaccine Act expressly preempts all liabilityof vaccine manufacturers unless the claimed injurycould have been avoided by proper preparation ofthe administered vaccine or by including properdirections and warnings with the administeredvaccine.

The Georgia Supreme Court reached the oppositeconclusion when it held that the Vaccine Act'spreemption clause "clearly does not preempt alldes ign de fect c la ims aga inst vacc inemanufacturers," "but instead provides that a vaccinemanufacturer cannot be held liable for defectivedesign if it is determined, on a case-by-case basis,that the injurious side effects of the particularvaccine were unavoidable." Am. Home Prods. Corp.v. Ferrari, 668 S.E.2d 236, 238, 242 (Ga. 2008). 5

The uncertainty for vaccine manufacturers created by the5

split between the Georgia Supreme Court and the Third Circuiton the question presented is reason enough to grant review.

14

Wyeth also agrees with plaintiffs that the criticalissue should not be left to percolate any further.Recent events in the Ferrari trial court onlyunderscore the urgent need for this Court to reviewthis question. The petition for a writ of certiorari inFerrari (No. 08-1120) is still pending before thisCourt. On June 8, 2009, the Court called for theviews of the United States on the petition. Beforethe Solicitor General filed her brief, the respondents(plaintiffs below) filed a voluntary notice ofdismissal without prejudice in the trial court.

This nonprejudicial withdrawal (the Ferrariplaintiffs are free to refile their case at any time)does not eliminate the public health problem theFerrari decision created. As the Georgia SupremeCourt said: its decision is—and will remain—thelaw of Georgia "at least until the Supreme Court ofthe United States has spoken on the issue." Ferrari,668 S.E.2d at 243. The vaccine manufacturerdefendants petitioned this Court to review Ferraribecause the Georgia Supreme Court's decision laysthe foundation to renew the very litigation crisisand subsequent threat to the vaccine supply that

The additional case law plaintiffs cite does nothing toilluminate the question. Not one of the more than 30 casescited in pages 17-20 of the petition squarely addresses thequestion of whether Section 22 of the Vaccine Act expresslypreempts all design defect claims. For example, many of thosedecisions address implied field and conflict preemptionarguments arising under the FDCA concerning claims that arose

before the effective date of the Vaccine Act, October 1, 1988.See, e.g., Hurley v. Lederle Labs Div. Of Am. Cyanamid Co., 863F.2d 1173 (5th Cir. 1989).

15

Congress sought to avert with the Vaccine Act. Thatthreat is addressed in Point II, infra. It is alsodescribed in depth in the Ferrari petition, the replybrief, and in the amicus brief submitted in supportof the Ferrari petitioners by the American Academyof Pediatrics and 10 other physician and publichealth organizations.

The Ferrari plaintiffs' strategic maneuvering doesraise the issue as to whether Ferrari, although stilla viable case for review, is now the best vehicle toaddress and resolve the question presented.Because the dismissal was without prejudice, theFerrari plaintiffs can refile at any time, and a livecontroversy therefore remains. See City of Erie v.Pap's A.M., 529 U.S. 277, 288 (2000). The Ferrariplaintiffs' nonprejudicial dismissal could beconsidered an attempt to "manipulate the Court'sjurisdiction to insulate a favorable decision fromreview." Id. However, given the Ferrari plaintiffs'present intent not to litigate, Wyeth acknowledgesthat the Court may view this case as a moresuitable vehicle to resolve the question identicallypresented here and in Ferrari. In that event, Wyethrequests that the Court hold the Ferrari petitionpending the Court's granting of certiorari in, andthe disposition of, this case.

II. WYETH AGREES THAT THE QUESTIONPRESENTED IS ONE OF NATIONALIMPORTANCE.

Wyeth agrees with plaintiffs that whether theVaccine Act expressly preempts all design defectclaims is a crucial question of national importance.The parties are in agreement that Congress enacted

16

the Vaccine Act to ensure that there would be astable supply of safe and effective vaccines todayand in the future. But the parties (or, looked atanother way, the Third Circuit and the GeorgiaSupreme Court) are diametrically opposed as towhat Section 22 means. Plaintiffs assert thatlitigation against vaccine manufacturers over designdefect claims will lead to a stable vaccine supply andimproved vaccines, and Congress wrote Section 22to allow that. The Third Circuit rejected thatargument. This sharp disagreement over howCongress intended to ensure the continuedavailability of essential childhood vaccines isprecisely the type of issue that this Court shouldresolve now.

The threat to the vaccine supply. Plaintiffs'remarkable assertion that the Third Circuit's rulingprecluding litigation over design defect claimssomehow "disrupted a stable vaccine supply for allchildren" (Pet. at 4) defies common sense and isprovided without any explanation or citation. To thecontrary, the pre-Vaccine Act history of thechildhood vaccine market demonstrates, and therelevant legislative history reflects, that Congressappreciated that litigation disrupts the vaccinemarket. That reality was a driving force for thepassage of the Vaccine Act, the creation of a VaccineCourt, and the preemption of all but a narrow rangeof liability theories in post-Vaccine Court cases.

Between 1980 and 1985, 299 lawsuits were filedagainst vaccine manufacturers seeking damages forinjuries alleged to be caused by vaccines. Subcomm.Rep. at 85; see also Geoffrey Evans, Update onVaccine Liability in the United States, 42 ClinicalInfectious Diseases 5130, S134 (2006). Nearly two-

17

thirds of those lawsuits, like this case, claimedinjury from an allegedly defective DTP vaccine.Subcomm. Rep. at 86. This onslaught of litigationled to a precarious vaccine supply and causedCongress to find that "the withdrawal of even asingle manufacturer" could lead to vaccine shortagesand the resurgence of preventable infectiousdiseases. 1986 U.S.C.C.A.N. at 6348.

The Vaccine Act—through the no-faultcompensation program and the preemption ofcertain tort claims—fundamentally changed thelitigation status quo. In just two decades, thecompensation fund has awarded more than $1.8billion to over 2,200 families and individuals. HHS,HRSA Awards Contract to Study Adverse Events inC h i ld h o o d V a c c i n e s ( O c t . 2 3 , 2 0 0 8 ) ,http://archive. hrsa. gov/newsroo m/releases/2008/vaccine study. htm. Additionally,litigation against manufacturers of DTP and othervaccines slowed dramatically after the law tookeffect in 1988. See id.; Evans, supra, at S134. Thepost-Vaccine Act litigation that has been filed todate has been less costly. No case governed by theVaccine Act against a vaccine manufacturer hasproceeded to trial in the two decades since theVaccine Act became effective.

Today, a new litigation threat to the nation'svaccine supply exists. Approximately 5,000 petitionsare currently pending in the "Omnibus AutismProceeding" in Vaccine Court. HRSA, National VaccineInjury Compensation Program Statistics Report (Sep. 14,2 0 0 9 , h t t p : / / w w w . h r s a . g o v /vaccinecompensation/statistics_report.htm. Whilethe omnibus proceeding will decide for all of thepending cases whether there is a causal linkbetween

18

childhood vaccines and autism, that ruling will haveno preclusive effect outside of Vaccine Court. 42U.S.C. § 300aa-23(e). Each claimant may elect to filea civil action after proceeding through VaccineCourt. Over 350 civil actions have been filed againstvaccine manufacturers in various courts withallegations that childhood vaccines caused therecipient to develop autism.

The potential deluge of post-Vaccine Courtlitigation could lead to the same dangerous situationthat existed in the mid-1980s. The number ofchildhood vaccine manufacturers has not increasedsince the enactment of the Vaccine Act. In theUnited States market today, as in 1986, there is stilljust one manufacturer for the polio vaccine, one forMMR, and two for the DTP vaccine. Compare 1986U.S.C.C.A.N. at 6348, with FDA/CBER, Thimerosal inVaccines, http ://www.fda. gov/CBER/vaccine/thimerosal.htm (last updated Aug. 31, 2009). Thus,what Congress said in 1986 is true today: "The lossof any of the existing manufacturers of childhoodvaccines at this time could create a genuine publichealth hazard." 1986 U.S.C.C.A.N. at 6348.

Plaintiffs and their amici argue that the VaccineAct permits individuals who have exhausted theVaccine Court remedy to elect to file civil actionsasserting all the same sorts of claims that couldhave been asserted before the Act changed nationalpolicy. Indeed, plaintiffs argue that the Vaccine Actmade it easier to sue vaccine manufacturers byrequiring all states to allow design defect claimsagainst manufacturers even if the state's commonlaw does not recognize the theory. See Pet. at 36-37.Plaintiffs' amici postulate that the finished Vaccine

Act was a "compromise" (Amicus Br. at 4), but undertheir and plaintiffs' interpretation of the Act, this"compromise" resulted in a new no-faultcompensation scheme, but no change at all to therules governing civil actions or lessening of litigationrisks that vaccine manufacturers faced.

Plaintiffs' view of the Vaccine Act flies in the faceof Congress's clearly expressed intent. Congresserected two barriers to reduce lawsuits and thuskeep manufacturers in the market: (1) it created ano-fault compensation system; and (2) it preemptedall tort claims except manufacturing defect claimsand certain failure-to-warn claims. Plaintiffs'interpretation of Section 22 renders both barriersessentially meaningless. Without the categoricalpreemption of vaccine design claims as intended byCongress, Vaccine Court could be reduced to just acheckpoint plaintiffs pass through on their way tocivil court. Making it easier for plaintiffs to suevaccine manufacturers would do nothing to ensurea stable vaccine supply because it would not lessenthe litigation burden on vaccine manufacturers.That is not what Congress intended.

Regardless of Congress's intent with the VaccineAct, amici argue that a civil remedy for design defectclaims should be available because the "vaccinecourt has failed." Amicus Br. at 15. The premise ofamici's argument is erroneous; Vaccine Court hasnot failed. The entire amicus brief, and much ofplaintiffs', rests on the assumption that most, if notall, vaccine-related injury claims are valid. In fact,many of the claims asserted by claimants lack any

20

scientific basis whatsoever and thus denial ofrecovery in those actions is not a sign of failure.6

The vaccine/autism allegations at issue in theOmnibus Autism Proceeding are a case in point.Every government public health agency andreputable scientific body to address thequestion—including the FDA—has rejectedallegations that childhood vaccines cause autism.See, e.g.,

F D A / C B E R , T h i m e r o s a l i n V a c c in e s ,http://www.fda.gov/cber/vaccine/thimerosal.htm.

(last updated Aug. 31, 2009) (stating that FDA"conducted a comprehensive review of the use ofthimerosal in childhood vaccines," and concludingthat there was "no evidence of harm from the use ofthimerosal as a vaccine preservative, other thanlocal hypersensitivity reactions").

The most notable of the scientific reviews wasthe report of a panel of world-renowned expertsappointed by the National Academy of Science'sInstitute of Medicine, which decisively declared that"the evidence favors rejection of a causalrelationship between thimerosal containingvaccines and autism." Immunization Safety ReviewCommittee, Board on Health Promotion andDisease Prevention, Institute of Medicine,Immunization Safety Review: Vaccines and Autism 7(2004) (emphasis in original).

6

Even if one assumed that amici's criticisms of the Vaccine

Act are valid (which they are not), that the no-faultcompensation program has failed in the eyes of certain parentsis not a reason to ignore the language of the statute or theintent of the Congress that passed it.

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In February, the Vaccine Court issued opinionsin three test cases considering claimants' theorythat the Measles-Mump-Rubella ("MMR") vaccine, incombination with thimerosal-containing vaccines,could cause autism. In each case, the SpecialMaster found that the claimant had utterly failed toprove causation. All three of those decisions by theSpecial Masters were recently affirmed by the Courtof Federal Claims.? Decisions by the SpecialMasters are soon expected on the three test casesc o n s i d e r i n g c l a i m a n t s ' t h e o r y t h a tthimerosal-containing vaccines alone cause autism.

While the allegations in the Omnibus AutismProceeding represent the current litigation threat tovaccine manufacturers, there is little reason todoubt that vaccines will continue to be blamed fora host of unrelated conditions. As the FDA hasstated, vaccines are commonly accused of causinga wide variety of illnesses that happen to manifestthemselves in early childhood at the time whenchildren are also receiving vaccines. FDA, VAERSO v e r v i e w ,http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProble m/VaccineAdverse Events/Overview/default.htm (last updated July10, 2009). For example, one of plaintiffs' amici,

See Cedillo v. Sec'y of HHS, No. 98-916V, 2009 WL 331968(Fed. Cl. Feb. 12, 2009), sustained, No. 98-916V, 2009 WL

2998429 (Fed. Cl. Aug. 6, 2009); Hazlehurst v. Sec'y of HHS, No.03-654V, 2009 WL 332306 (Fed. Cl. Feb. 12, 2009), sustained,No. 03-654V, 2009 WL 2371336 (Fed. Cl. July 24, 2009);Snyder v. Sec'y of HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl.Feb. 12, 2009), sustained, No. 01-162V, 2009 WL 2517755 (Fed.Cl. Aug. 11, 2009).

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SafeMinds, has blamed essentially every majorcomponent of vaccines for causing autism,including "aluminum adjuvant,

mercury preservative,endotoxins, and viral or bacterial antigens."SafeMinds, Vaccines and Autism, http://www. safeminds .or g/mercury/vaccines-and- autism.html

(last visited Oct. 7, 2009). It is a short step fromsuch allegations to design defect litigation claims.

As long as vaccines are on the market, they willbe blamed for one disease or another, regardless ofwhether those claims have any scientific merit. Bypreempting design claims, Congress intended toprevent meritless claims from ever being filedagainst manufacturers. But plaintiffs' Section 22interpretation provides no such disincentive. Itleaves the courthouse door wide open forapproximately 5,000 claimants who—if plaintiffs'amici is to be believed—think they have a betterchance for recovery before a jury than the VaccineCourt special masters. Amicus Br. at 13. The stakesfor public health are high, and the Court should notleave the Vaccine Act preemption question foranother day.

The threat to vaccine development. Plaintiffsalso contend that the Third Circuit's interpretationof Section 22 destroys the manufacturers' incentiveto create new and improved vaccines. Pet. at 28.This too is incorrect and was not the determinationmade by Congress in 1986.

In passing the Act, Congress recognized the needto spur the development of new vaccines and theimprovement of existing ones. Congress determinedthat the development and evaluation of new and

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improved vaccines to protect the population as awhole required a comprehensive and collaborativeprogram among scientists in public health agencies,industry, and academic institutions. See 1986U.S.C.C.A.N. at 6352. But Congress recognized thatthe high costs of, and potential liability from,product liability litigation involving existingvaccines threatened the development of newvaccines. 1986 U.S.C.C.A.N. at 6345; Subcomm.Rep. at 72. Thus, Congress limited the tort claimsthat could be brought against manufacturers byenacting Section 22.

The scope of the protection afforded to vaccinemanufacturers by Section 22 relates directly to thepolicy decisions Congress made in creating theNational Vaccine Program. To the extent that statetort law traditionally provides an incentive formanufacturers to develop safer products, Congressaddressed that policy goal by establishing aNational Vaccine Program to research and developimproved, safer vaccines. For example, Section 27of the Act mandates that HHS "promote thedevelopment of childhood vaccines that result infewer and less serious adverse reactions than thosevaccines on the market on December 22, 1987, andpromote the refinement of such vaccines." 42U.S.C. § 300aa27(a)(1). There is no comparableprogram for prescription drugs or medical devices.For vaccines, product improvement andreevaluation to reduce risk and improve safety isnot left solely to the marketplace and theself-interest of the private sector; nor is it to beindirectly prompted by the threat of jury verdictsover allegedly "unsafe" vaccine designs. Under theNational Vaccine

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Program, safer vaccines are to be actively pursuedin the public interest, and the limited exceptions toSection 22(b)'s preemptive scope do not provide any"after-the-fact" evaluation role to juries.

Freed from the crush of product liabilitylitigation, vaccine manufacturers, in conjunctionwith the various expert federal agencies, have hadgreat success in developing new and improvedvaccines. Since 1986, the collaboration has yieldedseven new vaccines now on the routine childhoodimmunization schedule: hepatitis B; varicella;pneumococcal disease; influenza; hepatitis A;meningococcal disease; and rotavirus. CompareCDC, Recommendation of the Immunization PracticesAdvisory Committee New Recommended Schedulefor Active Immunization of Normal Infants andChildren, 35 MMWR 577 (Sep. 19, 1986), withCDC, Recommended Immunization Schedules forPersons Aged 0-18 Years—United States, 2008, 57MMWR Q1 (Jan. 11, 2008).

For vaccine manufacturers, the combination ofsubstantial protection from tort liability andgovernment collaboration has led to recentsuccesses outside of the Vaccine Act context. TheH1N1 vaccine is a prime example. Multiple publichealth agencies, working with the manufacturers,have collaborated to design a new vaccine in recordtime to protect the population against the novelinfluenza A (H1N1) (commonly referred to as "swineflu") pandemic. CDC, Questions & Answers-2009H I N I I n f l u e n z a V a c c i n e ,http://www.cdc.gov/hlnlflu/

vaccination/public/vaccination_qa_pub.htm(lastupdated Oct. 5, 2009).

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Pursuant to the Public Readiness andEmergency Preparedness Act ("PREP Act"), Pub. L.No. 109-148 (2006), Kathleen Sebelius, Secretary ofHHS, granted nearly complete legal immunity to themanufacturers of the H1N1 vaccines. PandemicInfluenza Vaccines—Amendment, 74 Fed. Reg.30294-01 (June 25, 2009); 42 U.S.C. § 247d-6d.The PREP Act does provide one very limitedexception to immunity if the "death or seriousphysical injury [was] proximately caused by willfulmisconduct" by a company or person covered by theAct. 42 U.S.C. § 247d-6d(d). Contrary to plaintiffs'argument that immunity from design defect claimswould "destroy incentives" to make new andimproved vaccines, the H1N1 vaccine experiencedemonstrates that limiting tort liability can result inunprecedented vaccine development.

Plaintiffs also argue that the PREP Act supportstheir interpretation of Section 22 because "[t]herewould have been no need to make vaccines alreadycovered by the Act subject to such legislation ifCongress had already created an exclusive remedyfor vaccine-related injuries." Pet. at 23. Thisargument fails for at least two reasons.

First, there is no overlap between the vaccinessubject to the PREP Act and those covered by theVaccine Act. Section 22 applies only to vaccinescovered by the Act, which are those vaccinesrecommended for routine administration tochildren. See 42 U.S.C. §§ 300aa-14(e), 22(b), 33(5).The H1N1 vaccine and the other vaccines coveredby the

26

PREP Act are those that the Secretary of HHS has8

deemed necessary to respond to public healthemergencies; these vaccines are not for routineadministration to children.

Second, the PREP Act grants nearly completelegal immunity to manufacturers of the H1N1vaccine. By contrast, the Vaccine Act strikes acareful balance between the compensation ofvaccine-injured persons and the limitation of claimsthat can be brought against vaccine manufacturersin a civil action. Individuals alleging injury from avaccine covered by the Vaccine Act could seekcompensation if the injury was caused by amanufacturing defect or inadequate warnings, butas to vaccines covered by the PREP Act, no suchclaims may be asserted. The PREP Act thereforedemonstrates that Congress felt it necessary toprovide vaccine manufacturers with even greaterprotections from tort liability than is provided in theVaccine Act.9

The countermeasures currently covered by declarations8

issued by the Secretary of HHS are: H1N1, H5N1, H2, H6, H7,and H9 pandemic influenza vaccines; anthrax; botulism;smallpox, and acute radiation syndrome. See HRSA,

Countermeasures Injury Compensation Program—CoveredC o u n t e r m e a s u r e s ,h t t p : / / w w w . h r s a . g o v i c o u n t e r m e a s u r e s c o m p /countermeasures.htm. (last visited Oct. 7, 2009).

Subsection (h) of section 247d-6d states that nothing in the9

section "shall be construed to affect the National VaccineInjury Compensation Program under title XIX of this chapter."42 U.S.C. § 247d-6d(h). This rule of constructiondemonstrates that Congress was aware of the Vaccine Actwhen it enacted PREP and that it intended for the differentprograms to occupy two distinct regimes.

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III. THE THIRD CIRCUIT CORRECTLYFOUND THAT THE VACCINE ACTEXPRESSLY PREEMPTS ALL DESIGNDEFECT CLAIMS.

The Third Circuit correctly held that Section22(b) of the Vaccine Act categorically preempts alldesign defect claims. While plaintiffs agree that thiswas the Third Circuit's holding (Pet. at 15-16), theycontend that the court "relied heavily upon the`complete' or field preemption principles." Pet. at18. The Third Circuit did no such thing. The courtrelied on the text of Section 22, the legislativehistory of the Act, and the structure of the VaccineAct to reach its decision that the statute expresslypreempts design defect claims. A-42. What plaintiffsactually are criticizing is the court's use of theVaccine Act's structure to support itsinterpretation of Section 22's text. That use is acommon and accepted statutory interpretationtechnique when construing an express preemptionprovision. See Merrill Lynch, Pierce, Fenner & SmithInc. v. Dabit, 547 U.S. 71 (2006) (relying on thestructure, the purpose, and the legislative history ofthe federal statute to support the conclusion thatthe statute expressly preempts state law).

The Third Circuit, consistent with this Court'sprecedent, properly began its analysis with thepresumption against preemption.rn A-15-16. The

a) The petition's description of the presumption againstpreemption—an incomplete quotation from Bates v. Dow

Agrosciences LLC—is inaccurate. Pet. at 32. This Court has

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court found that the presumption was overcomebecause Congress clearly intended to preempt alldesign defect claims. A-42.

Citing to Wyeth v. Levine, plaintiffs contend thatthe case for preemption here is 'particularly weak[because] Congress had indicated its awareness ofthe operation of state law in a field of federalinterest, and has nonetheless decided to stand byboth concepts and to tolerate whatever tensionthere [is] between them."' Pet. at 32 (quoting Wyethv. Levine, 129 S. Ct. 1187, 1200 (2009)). Plaintiffs'attempt to analogize this case to Levine isunavailing; the two cases present starkly differentsituations. The quoted excerpt from Levine waspreceded by the statement that "[i]f Congressthought state-law suits posed an obstacle to itsobjectives, it surely would have enacted an expresspre-emption provision at some point during theFDCA's 70-year history." Id. While Congress did notenact an express preemption provision forprescription drugs, it did, of course, enact onespecifically for vaccines precisely because of thethreat that state-law tort suits posed to the vaccinesupply and, consequently, to public health.

stated that it has a duty to accept a reading of a statute thatdisfavors preemption if that reading is equally or moreplausible than the reading that favors preemption. Bates, 544U.S. 431, 449 (2005). The Court has never ruled, however, thata merely plausible reading that results in no preemption mustbe followed over a more plausible reading that preempts statelaw.

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The Language Of Section 22(b) PreemptsDesign Defect Claims. After addressing thepresumption against preemption, the Third Circuitturned to the text of Section 22. Plaintiffs arguethat the Third Circuit's interpretation omits theconditional phrase 'if the injury or death resultedfrom side effects that were unavoidable."' Pet. at 29.This is incorrect. Reading the provision as a whole,the word "unavoidable" is modified by the 15 wordsthat follow, so that vaccine manufacturers areimmune from all civil liability except where theinjury could have been avoided in either of twoways that Congress specified: (1) by properpreparation; or (2) by providing proper directionsand warnings. There are no other exceptions to thebroad scope of preemption in Section 22(b).Plaintiffs misread Section 22(b) as preemptive onlywhere the alleged injury or death resulted from sideeffects that are proved to have been unavoidableunder any circumstances. That construction simplyreads out of the statute the words that follow"unavoidable."

Plaintiffs' reading also ignores how the phrase"the vaccine" is used after "unavoidable." Theprovision states that a manufacturer is not liable ifthe injury "resulted from side effects that wereunavoidable even though the vaccine was properlyprepared and was accompanied by properdirections and warnings." 42 U.S.C. §300aa-22(b)(1) (emphasis added). Here, plaintiffsare alleging that the side effects could have beenavoided if Wyeth marketed a "safer alternativevaccine[ ]" (Pet. at 3) that would have been designedto protect against the same diseases. However,allegations that a differently designed (purportedlysafer) vaccine

30

would have avoided the plaintiff's injury are thetype of claims that Congress intended to preempt."[T]he vaccine" in Section 22 refers to the vaccineadministered to the child, not a different vaccinethat theoretically could have been designed,manufactured, tested, licensed, approved, and thengiven to the child.

In criticizing the Third Circuit's ruling, plaintiffsalso assert that the absence of language in Section22(b) explicitly identifying "design defect" claimssupports their interpretation of the statute becauseCongress could have included such unequivocallanguage. Pet. at 31. Plaintiffs' criticism of statutorydrafting misses the mark. Congress chose languageto bar all claims—not just those explicitly labeled"design defect"—except for manufacturing defectand failure-to-warn claims.

In this respect, the Vaccine Act's preemptionclause is unique among the express preemptionprovisions that this Court has examined in the pasttwo decades in the context of common law tortclaims. Unlike the provisions at issue inCipollone / Altria, Lohrl Riegel, and Bates, whichprecluded general state law "requirements orprohibitions," the Vaccine Act's express preemptionprovision is aimed at tort claims. The sweepingterms of the provision—"no vaccine manufacturershall be liable in a civil action for damages"—avoidsthe type of claim-by-claim preemption inquiry thatwas necessary in interpreting the preemptionprovisions in Cipollone or Bates. See Bates, 544 U.S.at 443-54; Cipollone v. Liggett Group, Inc., 505 U.S.504, 524-530 (1992). The language preempts all

31

claims, however pleaded, except for the twoCongress specified. See 42 U.S.C. § 300aa-22(b).

The Authoritative Legislative HistoryReflects Congress's Intention To Bar Design DefectClaims. The Third Circuit also correctly found thatthe Committee Report on the bill supports theinterpretation that the Vaccine Act preempts alldesign defect claims. The court found that theCommittee Report "explicitly stated that injuredindividuals could only seek redress in the state tortsystem for certain manufacturing defect andwarning claims." A-35-36. Specifically, theCommittee Report explains:

Given the existence of the compensationsystem in [the Vaccine Act], the Committeestrongly believes that Comment k isappropriate and necessary as the policy forcivil actions seeking damages in tort.Vaccine-injured persons will now have anappealing alternative to the tort system.Accordingly, if they cannot demonstrateunder applicable law either that a vaccinewas improperly prepared or that it wasaccompanied by improper directions orinadequate warnings [they] should pursuerecompense in the compensation system, not the tortsystem.

1986 U.S.C.C.A.N. at 6367 (emphasis added).

The Third Circuit properly rejected plaintiffs'reliance on "legislative history" from a subsequentCongress. Plaintiffs argue that a Committee Reportthat accompanied certain amendments made to theVaccine Act in 1987 (relating to the funding of the

32

Act) constitutes evidence of Congress's intent in1986, when it adopted Section 22. That material isnot entitled to consideration, much less reliance: itis not competent legislative history of the provisionat issue in this case. See Pension Benefit Guar. Corp. v.LTV Corp., 496 U.S. 633, 650 (1990) (quoting UnitedStates v. Price, 361 U.S. 304, 313 (1960))("subsequent legislative history is a 'hazardous basisfor inferring the intent of an earlier' Congress"). Thefunding of the Act via the 1987 amendments did notconcern in any way the Section 22 limitations onliability of vaccine manufacturers in civil actions andso do not provide any guidance on the intent behindthe enacted law. The only modification the 1987amendments made to Section 22 was to replace thewords "effective date of this subpart" with "effectivedate of this part." Omnibus Budget ReconciliationAct of 1987, Pub. L. No. 100-203, 101 Stat.1330-221.

Plaintiffs contend that this Court's decision inDistrict of Columbia v. Heller, 128 S. Ct. 2783, 2805(2008), supports their argument that thepost-enactment legislative statements should havebeen given weight by the Third Circuit. Pet. at 35. Infact, the decision demonstrates that the ThirdCircuit correctly rejected the post-enactmentstatements. In Heller, the Court distinguishedbetween two types of statements. The Court foundthat "the examination of . . . sources to determinethe public understanding of a legal text in the periodafter its enactment . . . is a critical tool ofconstitutional interpretation." Id. (emphasis inoriginal). But the Court rejected precisely the type ofpost-enactment legislative statements plaintiffs relyon here. "Postenactment legislative history,' adeprecatory contradiction in

33

terms, refers to statements of those who drafted orvoted for the law that are made after its enactmentand hence could have had no effect on thecongressional vote." Id. That is exactly the casehere. The statements made in 1987 could have hadno effect on the Congress that enacted the languageof Section 22 in 1986.

Plaintiffs' Construction Of Section 22 IsContrary To The Structure Of The Vaccine Act.The Third Circuit was also correct in finding thatthe construction of Section 22 adopted by theGeorgia Supreme Court was contrary to thestructure of the Vaccine Act. As stated by the ThirdCircuit, the Georgia Supreme Court's construction"does not bar any design defect claims," but rathersubjects all such claims to the evaluation of thecourt. A-29. In other words, plaintiffs' reading ofSection 22(b) would not provide protection to avaccine manufacturer unless and until themanufacturer made a showing at trial that no safervaccine design was feasible. That would makeSection 22(b) pointless. If read as plaintiffs propose,Section 22 would protect vaccine manufacturersonly from a non-existent risk, because no state in1986 imposed (or today imposes) design defectliability on vaccine manufacturers for injuries thatcould not have been avoided under anyc i r c u m s ta n ce s . Fu r the rm o re , v a c c in emanufacturers would only gain this "protection" ineach case after incurring the substantial cost oflitigating design defect claims to a jury verdict,which would be inconsistent with Congress's goal ofreducing manufacturers' litigation costs.

Finally, the petition contends that Congressintended to create the 'awkward dichotomy"' that

34

plaintiffs' construction of Section 22 would entail.Pet. at 36 (quoting A-30). Some states, such asPennsylvania and California, have concluded thatstrict liability is inapplicable to design defect claimsinvolving prescription drugs. See Hahn v. Richter, 673A.2d 888, 889-90 (Pa. 1996); Brown v. Superior Ct.,751 P.2d 470 (Ca. 1988). The Third Circuit foundthat plaintiffs' construction would "create anawkward dichotomy" in such states by requiringcourts to "engage in case-by-case analysis of allstrict liability and negligent design defect claimsbrought under the Vaccine Act, while barring strictliability design defect claims against prescriptiondrug manufacturers." A-30. There is certainly no

evidence that Congress intended vaccinemanufacturers to be subjected to greater litigationrisk than drug manufacturers.

Plaintiffs attempt to counter this point byarguing that Congress has treated prescriptiondrugs and medical devices differently by includingan express preemption provision for medicaldevices, but not for prescription drugs. Pet. at 36.Plaintiffs' argument misses the Third Circuit'spoint. Congress wrote the Vaccine Act in responseto a litigation crisis that threatened the supply ofvaccines necessary to promote public health. TheVaccine Act overhauled the legal system andrules for compensating vaccine-related injurieswith the intent, among others, to protectmanufacturers from the type of litigation that hadput them under such pressure in the 1980s. Therewas absolutely no intent on the part of Congress toopen additional pathways for civil suits againstvaccine

35

manufacturers, or to make such suits easier forplaintiffs to pursue.

CONCLUSION

The Court should grant the petition for a writ ofcertiorari in this case on the question as presentedby Respondents and affirm the judgment of theUnited States Court of Appeals for the Third Circuit.

Respectfully submitted,

Daniel J. ThomaschCounsel of RecordRichard W. Mark

E. Joshua RosenkranzJohn L. Ewald

ORRICK,HERRINGTON &SUTCLIFFE LLP

666 Fifth Avenue

New Yoxk, NY 10103212-506-5000

Counsel For Respondents

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