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
- § 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
- The plain language and statutory framework of § 22(b)(1) bolster the presumption against preemption of all design defect claims...... 7
- The structure and purpose of § 22(b)(1) bolster the presumption against preemption of all design defect claims...... 12
- SOUND PUBLIC POLICY DISFAVORS READING § 22(B)(1) AS A CATEGORICAL PREEMPTION OF ALL DESIGN DEFECT CLAIMS AGAINST VACCINE MANUFACTURERS...... 15
- SUMMARY JUDGMENT IS INAPPROPRIATE IN THIS CASE BECAUSE A GENUINE ISSUE OF MATERIAL FACT EXISTS AS TO WHETHER THE SIDE EFFECTS OF INGEN’S “WHOLE-CELL” DPT VACCINE WERE UNAVOIDABLE...... 16
CONCLUSION ...... 17
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
1
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 vaccine’s 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)
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 Laboratoriesclaims 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 alldesign 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 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 Congress’s clear and manifest purpose to provide sufficient compensation for such victims under the Vaccine Act. Categorical preemption also runs afoul of Congress’s 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, becausea 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 Kent’s injuries were not “unavoidable” and thus not preempted under § 22(b)(1).
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 ofa 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 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). Anna’s 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). InGenwas 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 Court’s 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. 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 Court’s decision both on the grounds of preemption under § 22(b)(1) and on the facts of the case. (R. at 7).
Argument
- § 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. SeeBates v. Dow Agrosciences, LLC, 544 U.S. 431, 449 (2005) (upholding design defect actionagainst pesticide manufacturer under the presumption against preemption); see alsoAmerican Home Products Corporation v. Ferrari, 284 Ga. 384, 393 (Ga. 2008) (upholding design defect actionagainst 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 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. Id.at 486.
- 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) (quotingInhabitants of Montclair Tp. v. Ramsdell, 107 U.S. 147 (1883)); see alsoBates, 544 U.S. at 449 (“Our reading is at once the only one that makes sense of each 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 Circuit’s Majority opinion belowclaims 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 “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 Majority’s 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 Majority’s 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 preemptall 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 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 Act’s 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 Court’s judgment, thereby forgoinghis 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.
By contrast, in Blackmon v. American Home Products Corp., plaintiffs never initiallypetitioned the Vaccine Court, but instead immediately filed a state court action againstthe defendant, alleging design defect forthe 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 Kent’s 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, Anna’s parents initially filed a claim with the Vaccine Court, alleging that Anna suffered residual seizure disorder and encephalopathy caused byInGen’s DPT vaccine. (R. at 4). Once the Vaccine Court rendered an adverse judgment, Anna’s parents rejected the Vaccine Court’s 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 Anna’s design defect claim. As such, Anna’s design defect claim is notpreempted by §22(b)(1), so long as the side-effects Anna suffered from the administration of InGen’s DPT vaccine were not “unavoidable.”
- 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 in1986 U.S.C.C.A.N. 6344, 6346. To that end, it is clear that Congress intended the Vaccine Act’s compensation system to operate as an “alternative,” and not as a replacement, to the traditional tort compensation system. Id. at 6367; seeFerrari, 284 Ga. at 392 (“in the committee’s 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 alsoSchafer, 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 Congress’s clear and manifest purpose for augmenting the traditional tort system through passage of the Vaccine Act, i.e. “sufficient compensation” for vaccine-injury victims.
As Congress has unequivocally indicated, an individual may “elect to reject a judgment and award made under the [Vaccine Act’s] 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 Congress’s above proposition, it must be the case that § 22(b)(1) is not intended to preemptthe very same design defect claims a plaintiff could levy prior to the enactment of the Vaccine Act. SeeBates, 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 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).