When injury is unavoidable: The Vaccine act's limited preemption of design defect claims

Virginia Law Review

Volumn 96, Issue 1, 2010, Pages 199-239

  Shah, Nitin ^a  

^a NONE

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EID: 77952088684     PISSN: 00426601     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (270)

1. Gordon Shemin, Comment, Mercury Rising: The Omnibus Autism Proceeding and What Families Should Know Before Rushing Out of Vaccine Court, 58 Am. U. L. Rev. 459, 462-64 (2008).
2. See generally Autism General Order #1, In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a Similar Neurodevelopmental Disorder, Autism Master File (Fed. Cl. July 3, 2002), available at http://www.uscfc. uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf (establishing omnibus autism proceeding to deal with the rising number of claims concerning the autism-vaccine link); Shemin, supra, at 478-90 (2008) (discussing generally the history of the Omnibus Autism Proceeding).
3. See Autism Update-April 23, 2008, In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a Similar Neurodevelopmental Disorder, Autism Master File, 7 (Fed. Cl. Apr. 23, 2008), available at http://www.uscfc.uscourts.gov/sites/default/files/autism/autism-update-4-23-08. pdf.
4. See 42 U.S.C. §300aa-15 (2006). Where the vaccine does not result in death, damages in the National Vaccine Injury Compensation Program are limited to actual and reasonable projected unreimbursable medical and rehabilitation expenses.
5. People with such varying perspectives as Robert Kennedy, Jr., author David Kirby, and actor-celebrities Jim Carrey and Jenny McCarthy have all actively advocated the vaccine-autism link. Shemin, supra note 1, at 480 nn.108-09.
6. See, e.g., David Kirby, Evidence of Harm xi-xvi (2005);
7. Jim Carrey, The Judgment on Vaccines Is In, The Huffington Post, Apr. 22, 2009, available at http://www.huffingtonpost.com/jim-carrey/the-judgment-on- vaccines-b-189777.html;
8. Robert Kennedy, Jr., Deadly Immunity, Rolling Stone, June 20, 2005, available at http://www.rollingstone.com/politics/story/7395411/deadly-immunity;
9. Jeffrey Kluger, Jenny McCarthy on Autism and Vaccines, Time, Apr. 1, 2009, available at http://www.time.com/time/health/article/0,8599,1888718,00. html.
10. See Shemin, supra note 1, at 478-82 (discussing the lack of scientific support for the vaccine-autism theory and the volumes of evidence against such a causal connection); see also Institute of Medicine, Immunization Safety Review: Vaccines and Autism 1-7 (2004);
11. Study Finds Vaccine Preservative is Not Linked to Risks of Autism, N.Y. Times, Jan. 8, 2008, at A18 (citing California epidemiological study finding no link between receipt of thimerosal-containing vaccines and autism incidence).
12. -42 U.S.C. §§ 300aa-1 to 300aa-34 (2006).
13. Id. § 300aa-11(a).
14. Id. §300aa-21(a).
15. Id. § 300aa-22(b)(1).
16. See Bruesewitz v. Wyeth Inc., 561 F.3d 233, 235 (3d Cir. 2009) [hereinafter Bruesewitz II] (holding that the Vaccine Act preempted all design defect claims);
17. Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236, 237-238 (Ga. 2008) [hereinafter Ferrari II] (holding that the Vaccine Act does not preempt all state-law-based design defect claims, but rather only claims where the injurious side effects of the vaccine were unavoidable).
18. See Petition for Writ of Certiorari, Bruesewitz v. Wyeth Inc., 78 U.S.L.W. 3082, at i (U.S. Aug. 4, 2009) (No.09-152).
19. See Vaccine Injury Compensation: Hearing on H.R. 5810 Before the Subcomm. on Health and the Environment of the H. Comm. on Energy and Commerce, 98th Cong. 234 (1984) [hereinafter 1984 House Hearings] (statement of Robert J. Johnson, President, Lederle Labs. Div., Am. Cyanimid Co.) ("Against [a] record of unrivaled success in conquering diseases, we have a situation in this country where manufacturers are abandoning the vaccine business under an unprecedented onslaught of unpredictable litigation.");
20. see also Institute of Medicine, Vaccine Supply and Innovation 27-28 (1985) [hereinafter IOM1985 Report].
21. If the Secretary of Health and Human Services disputes the petitioner's entitlement to compensation, the matter is adjudicated before a special master of the U.S. Court of Federal Claims. 42 U.S.C. §300aa-12(e)(1) (2006).
22. Id. §300aa-11(a). This preemption provision also bars damages actions that are less than $1000. Id. Alternatively, petitioners may opt out of the Program 240 days after filing the petition if the special master assigned to the case has not yet reached a decision or 420 days after filing the petition if the court has failed to enter a judgment. Id. §300aa-21(b).
23. Id. §300aa-11(a)(2).
24. Id. § 300aa-21(a).
25. Id. If the petitioner chooses to appeal, then upon the completion of the appeals process, the special master will issue a judgment, which the petitioner will have ninety days to elect to accept or reject. Id.
26. Id. §§300aa-21 to 300aa-22. Critically, state limitations periods are stayed for the duration of time that the petition is in Vaccine Court, from the date of filing until the date of election. Id. § 300aa-16(c). This is why many petitioners who participated in the Omnibus Autism Proceeding will be free to file civil actions on a thimerosal-based theory of causation, even though thimerosal has not been present in most childhood vaccines since 2001.
27. See generally id. §§ 300aa-22 to 300aa-23.
28. Id. § 300aa-22(b), (c), (e).
29. The other two listed exceptions to the general preservation of state law rights of action contained in §300aa-22(a) are Subsections (c) and (e). Subsection (c) protects manufacturers from liability for failure to directly warn of potential dangers, thus adopting the so-called "learned intermediary doctrine." Id.§ 300aa-22(c). Subsection (e) preempts any efforts to override the saving clause of Subsection (a) in that it prevents states from establishing or enforcing any law that "prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccinerelated injury or death if such civil action is not barred by this part." Id. §300aa-22(e). In addition, § 23(d)(2) shields manufacturers from punitive damages in cases where they complied with all material requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, unless there is a showing of fraud or other criminal misconduct notwithstanding that material compliance. Id. §300aa-23(d)(2).
30. Id. §300aa-22(b).
31. -21 U.S.C. §§301-399 (2006).
32. -42 U.S.C. §§201-300ii-4 (2006).
33. -42 U.S.C. §300aa-22(b) (2006). In full, the subsection reads:
34. (b) Unavoidable adverse side effects; warnings
35. No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1,1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
36. For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows-
37. (A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa-23(d)(2) of this title, or (B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
38. Id.
39. See Bruesewitz II, 561 F.3d 233, 235 (3d Cir. 2009);
40. Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289, 301-03 (E.D. Pa. 2007);
41. Blackmon v. Am. Home Prods. Corp., 328 F. Supp. 2d 659, 662-66 (S.D. Tex. 2004);
42. Militrano v. Lederle Labs., 810 N.Y.S.2d 506, 508 (N.Y. App. Div. 2006);
43. Wright v. Aventis Pasteur, Inc., No.3861, 2008 Phila. Ct. Com. Pl. LEXIS 221, at *20-21 (Pa. Ct. Com. Pl. Aug. 27,2008).
44. See Sykes, 484 F. Supp. 2d at 292;
45. Blackmon, 328 F. Supp. 2d at 661-62;
46. Wright, 2008 Phila. Ct. Com. Pl. LEXIS 221, at *3.
47. See Bruesewitz v. Wyeth, Inc., 508 F. Supp. 2d 430, 434-35 (E.D. Pa. 2007);
48. Militrano, 810 N.Y.S.2d at 507. It is worth noting that this question did not even arise until nearly two decades after the enactment of the Vaccine Act. This is in large part a testament to the success of the Program in satisfying potential plaintiffs with plausible claims for compensation. It also demonstrates the uniqueness of (a) the nearcomplete absence of scientific support for the thimerosal theory, so as to create a likelihood of dismissal in even the no-fault Program, and (b) the strength of either the conviction or monetary interests of the proponents of the theory, or both. See Sharon Begley, Anatomy of a Scare, Newsweek, Mar. 2, 2009, at 42, 44-47.
49. Bruesewitz II, 561 F.3d at 235. The analysis of the Third Circuit closely tracks that of the various trial courts mentioned above that found full preemption.
50. Id. at 243.
51. Id. at 245.
52. Id. at 246.
53. Id.
54. Id. at 247-48 (citing H. Rep. No. 99-908, at 25-26 (1986)). Comment k states that manufacturers are not liable for certain inherently dangerous products when injury was unavoidable, so long as the product was properly prepared and accompanied by proper directions and warnings. Restatement (Second) of Torts § 402A cmt. k (1965) ("Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous."). The language regarding preparation, directions, and warnings seems to be employed to disclaim any effect on liability for defective manufacture or failure to warn. Id. See infra Section IV.B for a more comprehensive examination of integration of Comment k.
55. Bruesewitz II, 561 F.3d at 248-249
56. Id. at 248 (quoting H. Rep. No. 99-908, at 26 (1986)).
57. Id.
58. -668 S.E.2d 236 (Ga. 2008).
59. Id. at 237.
60. Ferrari v. Am. Home Prods. Corp., 650 S.E.2d 585,590 (Ga. Ct. App. 2007) [hereinafter Ferrari I].
61. Bates v. Dow Agrosciences LLC, 544 U.S. 443 (2005).
62. Ferrari I, 650 S.E.2d at 590.
63. Ferrari II, 668 S.E.2d at 238. Bates can, however, be fairly read to compel application of an interpretation disfavoring preemption where that interpretation is more textually plausible than, or even as textually plausible as, an alternative reading favoring broader preemptive scope. See infra Section II.A. But the Court of Appeals in Ferrari I made no judgment as to which of the two possible readings of § 22(b) was more plausible; it held only that both were plausible. Accordingly, the Supreme Court of Georgia was probably right to repudiate the intermediate court's analysis. The relative plausibility of the two interpretations of § 22(b) is discussed infra Section III.A; the application of the presumption against preemption to § 22(b) is discussed in greater detail infra Section III.C.
64. Ferrari II, 668 S.E.2d at 239.
65. Id. at 240.
66. Id. This issue is discussed in greater detail infra Section III.A.
67. Id. at 240-41. The Ferrari II court's interpretation of the legislative history is discussed infra Section IV.A.
68. Id. at 242.
69. Some commentators view this tendency as a deliberate attempt by Congress to evade hard choices between competing interest groups on preemption questions. See James A. Henderson, Jr. & Aaron D. Twerski, Products Liability: Problems and Process 424 (5th ed. 2004) ("Congress quite clearly has sought to placate both industry and consumers by speaking out of both sides of its mouth.");
70. Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach, 76 Geo. Wash. L. Rev. 449, 450 (2008) ("To be sure, with the stroke of a pen Congress could definitively determine when its product regulations displace state common law. Instead, Congress repeatedly punts....");
71. see also Caleb Nelson, Preemption, 86 Va. L. Rev. 225, 302 n.235 (2000) ("When members of Congress focus on a particular issue but fail to reach a collective decision about how to resolve it, they sometimes compromise by enacting intentionally ambiguous language that transfers the issue to the courts.").
72. For a critique of the court's use of the plain meaning doctrine in other preemption cases, see Michael Gadeberg, Presumptuous Preemption: How "Plain Meaning" Trumped Congressional Intent in Engine Manufacturers Assoc, v. South Coast Air Quality Management District, 32 Ecology L.Q. 453, 478-80 (2005).
73. Gadeberg argues that the Court was too quick to apply the plain meaning doctrine in the case-Engine Manufacturers Association v. South Coast Air Quality Management District, 541 U.S. 246, 252 (2004)-because another provision of the Clean Air Act rendered the preemption provision at issue ambiguous.
74. Id. at 480-482
75. -505 U.S. 504, 519-520 (1992).
76. Id. at 521. The Court was at least partly driven by a desire to give some meaning to "requirements" that went beyond the meaning of "standards" from the 1965 act, reasoning that Congress must have had something in mind in changing the wording.
77. Id. at 521 & n.19.
78. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1008 (2008);
79. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 443 (2005);
80. Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996).
81. -128 S. Ct. at 1010.
82. -21 U.S.C. §360k(a) (2006).
83. Riegel, 128 S. Ct. at 1014-1016 (Ginsburg, J., dissenting).
84. Id. at 1007-1009
85. Id. at 1009 ("The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification.").
86. Id. at 1008.
87. Id. ("Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments."). This comment evinces concern for the ex ante effects of Court rulings. The Court's prior decisions on the meaning of "requirements" would have had no bearing on Congress' intent in using the word in the MDA, which was enacted in 1976, well before the Court first found "requirements" to include common law claims in Cipollone. Although the initial determination-originating in Cipollone-that use of the term "requirements" bars common law claims is at least somewhat arbitrary, Justice Scalia's rule does succeed in giving order to the analysis going forward.
88. See Caleb Nelson, What is Textualism?, 91 Va. L. Rev. 347, 391 (2005) (discussing Justice Scalia's support for rule-based interpretive approaches in order to "help courts discern Congress's likely intent not because they reflect careful study of what Congress does on its own, but simply because members of Congress know that the courts use them").
89. See infra Section ILB.
90. See Riegel, 128 S. Ct. at 1013;
91. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 448-49 (2005);
92. Medtronic, Inc. v. Lohr, 518 U.S. 470, 496-97 (1996).
93. See, e.g., Bates, 544 U.S. at 448-519
94. -128 S. Ct. at 1008-09;
95. see also supra note 60.
96. See Nelson, Preemption, supra note 49, at 292 (discussing the "various forms" that the presumption against preemption has taken).
97. -544 U.S. 431 (2005).
98. Id. at 436 (quoting 7 U.S.C. §136v(b) (2006)).
99. Id. at 447-518
100. Id. at 449. In fact, it found Dow's reading implausible, thus mooting the presumption in this instance (since the Court would not adopt an implausible reading of a statute, presumption or not). But in the critical passage in which the Court reaffirmed and defined the scope of the presumption, it proceeded on the assumption that Dow's reading was plausible.
101. Id. ("Even if Dow had offered us a plausible alternative reading of §136v(b)-indeed, even if its alternative were just as plausible as our reading of that text-we would nevertheless have a duty to accept the reading that disfavors pre-emption.").
102. Id. The negative inference, however, was that the presumption would not be sufficient for a less plausible interpretation disfavoring preemption to be chosen over a more plausible interpretation favoring preemption.
103. In his opinion, Justice Stevens did cite legislative history in support of his narrower preemptive reading. Id. at 452 n.26. However, the rule he articulated concerning application of the presumption-prior to any mention of the legislative history of the relevant statute-indicates that it was based upon a reading of the statutory text itself, not upon reference to any extra-statutory interpretive aids.
104. See id. at 449 (referring to application of the presumption to a competing "reading of that [statute's] text").
105. -128 S. Ct. 999, 1010 (2008).
106. Id.
107. -129 S. Ct. 538, 543 (2008).
108. Id. at 547.
109. -129 S. Ct. 1187,1194-95 (2009) ("[Particularly in those [cases] in which Congress has 'legislated ... in a field which the States have traditionally occupied,'... we 'start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.'" (quoting Lohr, 518 U.S. at 485)).
110. Id. at 1229-1230 (Alito, J., dissenting).
111. -129 S. Ct. at 557-558
112. Id. at 557-58. At the same time, as support for the proposition that the presumption is dead or dying, Justice Thomas cited its absence from Justice Scalia's majority's opinion in Riegel. But in that case, eight Justices-including Justice Stevens, author of the majority opinions in Bates and Good-agreed that the language of the preemptive provision was clear, meaning that the reading favoring preemption was the only plausible textual interpretation. Only if the presumption against preemption were so strong as to require courts to override a statute's plain meaning would it be apposite in such circumstances. The Court has never suggested that it is.
113. This argument is different from what Einer Elhauge calls the "preferenceeliciting" rationale for the presumption against preemption. That argument relies on the claim that Congress is more likely to overturn a Court ruling disfavoring preemption than one favoring preemption. See Roderick Hills, Against Preemption: How Federalism Can Improve the National Legislative Process, Univ. of Mich. Pub. Law Working Paper No. 27, at 22 (2003) ("[W]here a statute is ambiguous, the court ought to interpret the preemptive force of federal statutes to burden interest groups favoring preemption, on the assumption that these pro-preemption groups- overwhelmingly, business and industry groups-are more capable of promoting a vigorous debate in Congress than their opponents.").
114. See generally Einer Elhauge, Statutory Default Rules: How to Interpret Unclear Legislation 151-55 (2008);
115. Einer Elhauge, Preference-Eliciting Statutory Default Rules, 102 Colum. L. Rev. 2162, 2164-2168 (2002). What empirical data exist, however, show that Congress hardly ever responds to the Court's preemption decisions, no matter which way it decides.
116. See Note, New Evidence on the Presumption Against Preemption: An Empirical Study of Congressional Responses to Supreme Court Preemption Decisions, 120 Harv. L. Rev. 1604, 1605 (2007). Thus, if the goal is eliciting preferences, the presumption has not been effective. Instead, I argue that a consistently-applied presumption would make it more difficult ex ante for Congress to appease interest groups favoring preemption with intentionally ambiguous statutory language, since those parties would know that courts would apply the presumption against them. The inability to satisfy those groups with ambiguous language could make Congress more willing to decide the preemption question one way or the other in the first instance.
117. See, e.g., Dole Food Co. v. Patrickson, 538 U.S. 468, 476-77 (2003);
118. Mertens v. Hewitt Assoes., 508 U.S. 248, 258 (1993).
119. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 448-449 (2005).
120. Id. at 448.
121. If one construes "properly prepared" to allow claims whenever vaccines were not prepared in accordance with the FDA-approved design specifications, then a finished product that deviates from that approved design could be deemed improperly prepared and a suit therefore would be allowed. This would be true whether the deviation was a result of an unapproved change in design or a defect in the manufacturing process. In any event, this plausible reading does not change the answer to the question here, which is whether vaccine manufacturers can ever be held liable for defective design when the vaccine conformed to FDA-approved specifications.
122. This alternative mirrors the Court's finding in Bates that if Congress had intended to bar parallel requirements, it could have left the "in addition to or different from" language out of the provision, resulting in an "amputated version" that "would no doubt have clearly and succinctly commanded the pre-emption of all state require- ments concerning labeling." Bates, 544 U.S. at 449. Alternatively, the drafters of §22(b) could have kept the phrase "that were unavoidable," and also stated that all side effects that resulted from products covered by the Vaccine Act were to be considered unavoidable for purposes of §22(b). Either approach would have given operative effect to each word of the provision and would have served to bar all design defect claims outright.
123. -328 F. Supp. 2d 659 (S.D. Tex. 2004).
124. -484 F. Supp. 2d 289 (E.D. Pa. 2004). In Bruesewitz II, the Third Circuit did not make a serious effort to explain the language of §22(b), instead noting that "it is always possible to construct through hindsight an alternate structure for a statute with alternative wording that would render it more clear."
125. Bruesewitz II, 561 F.3d 233,246 (3d Cir. 2009).
126. Blackmon, 328 F. Supp. 2d at 664 (emphasis added).
127. Id.
128. Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289, 300 (E.D. Pa. 2007).
129. None of the five courts proposed an alternate reading of §22(b) that gives operative effect to "that were unavoidable." Even if a court found some claim besides failure-to-warn, defective manufacture, and defective design that the clause purportedly preserved, it is hard to imagine that the court could draw a distinction that would have the clause preserve that other claim but not defective design claims where the injury was avoidable.
130. United States v. Nordic Village, Inc., 503 U.S. 30, 36 (1992).
131. This interpretation would not give rise to manufacturing defect or failure-to-warn liability despite proper preparation and proper directions and warnings where the injury was nevertheless avoidable. Definitionally, improper preparation is a requisite element to a finding of defective manufacture, and improper direction or warning is a requisite element to a finding of failure-to-warn liability. Accordingly, the word "unavoidable" only modifies actions for claims other than defective manufacture and failure to warn: it would allow recovery only where the injury was avoidable, for example, through use of a safer feasible design.
132. While I have argued that the language of §22(b) must be read in a very strained manner to bar all design defect claims, it must be admitted that if Congress meant to establish a requirement of avoidability for design defect recovery, it had clearer ways to say that, too. It could have simply said that design defect claims are only barred where the injury was unavoidable, or that such claims are not barred where the injury was avoidable. But because the "that were unavoidable" clause does not modify manufacturing and warning defect claims, see supra note 91, mentioning the specific claims to which the clause did apply would have been unnecessary, though not unhelpful.
133. See Bruesewitz II, 561 F.3d at 235 (3d Cir. 2009).
134. See infra Section III.A.
135. Those opportunities arise 240 days from filing a petition for Program compensation, 420 days from filing, and upon rejection of the Program's judgment at the end of proceedings. 42 U.S.C. § 300aa-21(b) (2006);
136. see supra note 14 and accompanying text.
137. -42 U.S.C. §300aa-22(a), (e) (2006).
138. By only prohibiting actions where the injury occurs despite proper preparation, §22(b) implicitly preserves all claims where the injury occurs due to improper preparation. 42 U.S.C. §300aa-22(b) (2006).
139. Section 22(b) creates a presumption that covered vaccines are accompanied by proper directions and warnings where the manufacturer complied with the requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. That presumption may be rebutted by a showing (a) that the manufacturer engaged in fraud or intentional misconduct with regard to information relating to the safety and effectiveness of the vaccine, or (b) by clear and convincing evidence that the manufacturer was negligent despite conforming to the statutory requirements. 42 U.S.C. § 300aa-22(b)(2) (2006). Section 22(c) protects manufacturers from liability for failure to warn directly through adoption of the so-called learned intermediary doctrine.
140. Id. § 300aa-22(c).
141. In Sykes v. Glaxo-SmithKline, the trial judge found that allowing a case-by-case determination of avoidability would frustrate the purpose of the Vaccine Act to keep these cases out of the courts. 484 F. Supp. 2d 289, 301-302 (E.D. Pa. 2007). But considering the Vaccine Act's general preservation of state law tort claims, this argument would seem to prove too much.
142. See Robinson v. Shell Oil Co., 519 U.S. 337, 340 (1997);
143. see also Riegel v. Medtronic Inc., 128 S. Ct. 999, 1009 (2008) (declining to consider agency interpretation where "statute itself speaks clearly to the point at issue");
144. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 448-49 (2005) (citing manufacturer's failure to offer a plausible alternative reading of the statutory provision).
145. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 493-494 (1996).
146. Id. at 493.
147. -128 S. Ct. at 1007.
148. Id. at 1004-1005
149. Id. at 1007, 1011.
150. Prior to the Court's ruling in Wyeth v. Levine, 129 S. Ct. 1187 (2009), one plausibly could have interpreted Riegel to require examination of the scope and emphasis of the relevant regulatory scheme in determining the reach of the preemptive provision against state tort claims, regardless of whether Congress actually intended to import regulatory findings into the statute. Such a rule would be consistent with the "tort as regulation" approach advanced by various scholars.
151. See Sharkey, supra note 49, at 474-75, 479-80 (suggesting that agency determinations affecting preemptive scope may be entitled to deference of their own force);
152. see also Thomas W. Merrill, Preemption and Institutional Choice, 102 Nw. U. L. Rev. 727, 755 (2008) (identifying regulatory nature of state common law);
153. Peter H. Schuck, FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot, 13 Roger Williams U. L. Rev. 73, 75-76 (2008) (recognizing the competing compensatory and regulatory aims of tort law).
154. -42 U.S.C. § 262(2006).
155. See id. §262(a)(2)(C) (requiring that approved biologies be "safe, pure, and potent");
156. see also 21 CFR § 601.2 (2009) (describing detailed requirements for biologies licensing applications).
157. As an interpretive matter, this reading still suffers from the same defect as the Blackmon-Sykes reading if one reads "properly prepared" to include all claims in which the vaccine was prepared in accordance with FDA-approved design specifications.
158. -128 S. Ct. at 1006-1007
159. See id. at 1006. This framework has not been seriously disputed; the real question arises when certain federal regulations and state law claims fit into the three categories.
160. Wyeth v. Levine, 129 S. Ct. 1187, 1194 (2009). The Court also noted: "[A]gencies have no special authority to pronounce on pre-emption absent delegation by Congress ...."
161. Id. at 1201 (emphasis added).
162. It is at least theoretically possible that design defect claims would nevertheless be impliedly preempted as an obstacle to federal regulation in the field. See generally Geier v. Am. Honda Motor Co., 529 U.S. 861, 864-65, 868 (2000) (finding implied preemption despite inapplicability of express preemption clause). After the Court's recent decision in Wyeth v. Levine, however, it is extremely unlikely that a court would find obstacle preemption here. Applying Levine by analogy, the only conflict between federal regulation of vaccines and state tort liability is the degree to which Congress intended the Vaccine Act remedy to be exclusive. Section 22 addresses the scope of this conflict precisely, and so there would be no argument that the conflict extends beyond that contemplated by the express preemption provisions.
163. See Levine, 129 S. Ct. at 1199-1201 (narrowly construing the scope of obstacle preemption).
164. There are two arguably regulatory components in the Vaccine Act. The first part, codified at 42 U.S.C. §§300aa-l to 300aa-6 (2006), establishes the National Vaccine Advisory Committee, charged with issuing a report and recommending ways to encourage the availability of a safe and adequate vaccine supply. The Committee lacked the power to issue any new regulations or otherwise bind manufacturers. More substantially, the Vaccine Act also created new requirements for manufacturers to maintain records with regard to the testing and manufacture of vaccines, with civil sanctions for noncompliance. 42 U.S.C. §300aa-28 (2006).
165. See supra notes 96-101 and accompanying text.
166. See 21 U.S.C. § 360k(a) (2006).
167. See generally 21 U.S.C. § 360e-f (2006). The Medical Device Amendment authorized FDA to regulate medical devices for the first time.
168. -42 U.S.C. § 300aa-22(b)(2) (2006). The presumption is rebutted upon a showing that the manufacturer engaged in fraud or misconduct, or upon a showing of clear and convincing evidence that the manufacturer was nevertheless negligent. Id. at 300aa22(b)(2)(A)-(B).
169. Id. §300aa-23(d)(2).
170. See supra Section I.A.
171. Bates v. Dow Agroscience LLC, 544 U.S. 431, 449 (2005).
172. Id. at 448.
173. Id. at 448-449
174. See, e.g., Bruesewitz v. Wyeth Inc., No.07-3794, at 32 (3d Cir. Mar. 27, 2009);
175. Bruesewitz v. Wyeth, Inc., 508 F. Supp. 2d 430, 438 (E.D. Pa. 2007);
176. Sykes v. GlaxoSmithKline, 484 F. Supp. 2d 289, 297 (E.D. Pa. 2007);
177. Blackmon v. Am. Home Prods. Corp., 328 F. Supp. 2d 659, 663 (S.D. Tex. 2004).
178. In 1984, two of the three U.S. marketers of the diphtheria-tetanus- pertussis (DTP) vaccine pulled out of the market, citing the high cost of litigation related to the products. See 1984 House Hearings, supra note 12 (statement of Robert B. Johnson, President, Lederle Labs. Div., Am. Cyanimid Co.);
179. IOM 1985 Report, supra note 12, at 27-28 (1985). During the same time period, the price per dose of required childhood vaccines increased dramatically, a development for which manufacturers blamed high litigation costs. See 1984 House Hearings, supra note 12, at 239 (statement of Robert B. Johnson).
180. See supra notes 96-101 and accompanying text.
181. National Childhood Vaccine-Injury Compensation Act, H.R. 5810, 98th Cong. §§2101(a)-(b), 2101(d)(1)-(2) (1984).
182. National Childhood Vaccine Injury Compensation Act of 1986, H.R. 5184, 99th Cong. §2111 (a)(1)-(2) (1986).
183. H.R. 5184 §2122(b). The only material difference between §2122(b) of H.R. 5184 and §22(b) of the Vaccine Act was that §2122(b) did not create a presumption of proper warning where the manufacturer complied with regulatory requirements. Id.
184. Id. §2122(c). The two exceptions were for claims alleging (a) breach of express manufacturer warranty and (b) material deviations from the manufacturer's design specifications or performance standards. Id. at §2122(c)(2)(A)-(B). The provision would seem to have required a showing of negligence for all claims except those alleging breach of express warranty and defective manufacture. This language posed a bar that extended beyond that created by the relevant part of §22(b). While the requirement of fault stiffened the burden for would-be plaintiffs, it did not moot the language of §22(b) altogether: in the absence of a safer feasible alternative design, the " that were unavoidable" clause would disallow defective design liability even if a jury found negligent design.
185. See National Childhood Vaccine Injury Compensation Act of 1985: Hearing on S. 827 Before the S. Comm. on Labor and Human Resources, 99th Cong. 14-16 (1985) (statement of Martin H. Smith, M.D., President, Am. Acad, of Pediatrics) (describing and expressing support for amendment proposed by Sen. Christopher Dodd of Connecticut, which would have granted immunity to manufacturers if the " vaccine were tested, manufactured, distributed, and labeled in accordance with Food and Drug Administration requirements" ).
186. This conclusion is weakened by the fact that the rejected immunity provisions would have barred claims other than design claims, so it could plausibly be argued that they were not intended to have any effect on design defect liability. The rejected House proposal would have also barred failure-to-warn claims in the absence of negligence, and the rejected Senate proposal would have given manufacturers a regulatory compliance defense for all possible tort claims. But the proposals do suggest that when Congress intended to impose sweeping limitations on state law claims, it did so with stronger and clearer language than that employed in §22(b). Because that stronger language is absent from the Act as passed, the language ultimately adopted should not be read to do the same amount of work as-or more work than-the rejected proposals.
187. See Chris Collins & John Hanchette, Writers of Compensation Bills Switch Public and Private Roles, in The Vaccine Machine 22,22 (1984). According to Collins and Hanchette, the 1984 version of the bill was co-written by Stephan E. Lawton, a lobbyist for AAP, and Jeffrey H. Schwartz, the leader of a parental advocacy group. Id.
188. Vaccine Injury Compensation: Hearing on H.R. 1780, H.R. 4777, and H.R. 5184 Before the Subcomm. on Health and the Environment of the H. Comm. on Energy and Commerce, 99th Cong. 132 (1986) (statement of Martin H. Smith, M.D., President, Am. Acad, of Pediatrics).
189. Id. at 134. AAP's discussion of recovery due to " adverse reactions" suggests that it was most concerned about injuries that occurred even though the vaccine was properly prepared. See id.
190. Id. at 237-38 (statement of Robert B. Johnson, President, Lederle Labs. Div., Am. Cyanamid Co.). Johnson referred to the bill's inability to eliminate tort claims where juries find that " the vaccines [manufacturers] sell are not as good as some alternative product, even though our vaccines have been approved by the Government as safe and effective." Id. at 238.
191. Id. at 229 (statement of John E. Lyons, Executive Vice President, Merck & Co., Inc.).
192. H.R. Rep. No.99-908, pt. 1, at 26 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6367.
193. See Bruesewitz II, 561 F.3d 233, 250-51 (3d Cir. 2009);
194. Bruesewitz v. Wyeth, Inc., 508 F. Supp. 2d 430, 442, 445 (E.D. Pa. 2007);
195. Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289, 300 (E.D. Pa. 2007);
196. Blackmon v. Am. Home Prods. Corp., 328 F. Supp. 2d 659, 664-65 (S.D. Tex. 2004);
197. Militrano v. Lederle Labs., 810 N.Y.S.2d 506, 508 (N.Y. App. Div. 2006);
198. Wright v. Avenus Pasteur, Inc., No.3861, 2008 WL 4144386 (Pa. Ct. Com. Pl. Aug. 27, 2008).
199. H.R. Rep. No.99-908, pt. 1, at 25-26 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6366-6367
200. See infra Section IV.B.
201. H.R. Rep. No.99-908, pt. 1, at 26 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6367.
202. Ferrari II, 668 S.E.2d 236, 240-241 (Ga. 2008).
203. If the committee had really wanted to demonstrate the optional nature of the advice to go through the program where there was no defect in preparation or warnings, the committee could have said " may" instead of " should." Alternatively, while in the course of discussing the claims alleging improper preparation and improper directions and warnings that §22(b) implicitly recognizes, the report could also have recognized claims where injury was otherwise avoidable.
204. See supra notes 134-145 and accompanying text.
205. -132 Cong. Rec. 30,760 (1986). Representative Waxman gave the same example in an op-ed piece published a week earlier in The Washington Post. See Henry A. Waxman, When a Vaccine Injures a Child: A No-Fault Way to Compensate, Wash. Post, Oct. 9,1986, at A27. A claim of " inadequate research" most likely falls into the category of defective design. It suggests a claim that exists even though the vaccine was prepared in accordance with design specifications and contained directions and warnings that accord with FDA requirements, because research into the vaccine's possible designs did not adequately consider avoidable safety risks.
206. See generally An- notation, Burden of Proving Feasibility of Alternative Safe Design in Products Liability Action Based on Defective Design, 78 A.L.R.4th
207. Kristin Cordier Karnezis, Annotation, Products Liability: Modern Cases Determining Whether Product is Defectively Designed, 96 A.L.R.3d 22, 35 (2009). An inadequate research claim could plausibly fall into the category of failure-to-warn-but such a claim would clearly be barred by the regulatory compliance defense provision for failure-to-warn claims under §22(b).
208. H.R. Rep. No.100-391, at 691 (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1, 2313-365. The report continued: " The Committee stresses that there should be no misunderstanding that the Act undertook to decide as a matter of law whether vaccines were unavoidably unsafe or not. This question is left to the courts to determine in accordance with applicable law." Id. The report also noted that the committee had considered, and rejected, an amendment to the Vaccine Act to shield a manufacturer from liability for failure to " develop [a] safer vaccine." Id.
209. The Georgia Supreme Court considered the language of the 1987 report in deciding Ferrari II. 668 S.E.2d at 241. In Bruesewitz II, however, the Third Circuit declined to accord any weight to the 1987 report because it apparently believed that the comments came not from the House Energy and Commerce Committee, which had jurisdiction over the Vaccine Act, but from the House Budget Committee, which did not. Bruesewitz II, 561 F.3d 233, 250 (3d Cir. 2009). Indeed, as the Third Circuit notes, the comments were part of a Budget Committee report on the Omnibus Budget Reconciliation Act of 1987, Pub. L. No. 100-203 (1987). Id. at 249;
210. H. R. Rep. No. 100-391, at 1 (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1, 2313-2. But the comments in question were within a title containing official recommendations reported from the Committee on Energy and Commerce, and accompanied by an official letter of transmittal from that committee's chairman, Representative John D. Dingell of Michigan. H.R. Rep. No. 100-391, at 377-79 (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1, 2313-197 to 2313-199. The Bruesewitz court apparently failed to notice this important fact.
211. See District of Columbia v. Heller, 128 S. Ct. 2783, 2837 n.28 (2008);
212. Doe v. Chao, 540 U.S. 614, 626-27 (2004).
213. The Supreme Court has given weight to subsequent history when it concerns a bill, ultimately enacted, that is closely related to the original law that is the subject of the dispute. See Whitman v. Am. Trucking Ass'ns, 531 U.S. 457, 492 (2001) (Breyer, J., concurring);
214. FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 137-39 (2000).
215. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1009 (2008) (" The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification." );
216. see also Exxon Mobil Corp. v. Allapattah Servs., Inc., 545 U.S. 546, 567-71 (2005);
217. Burlington N. R.R. Co. v. Okla. Tax Comm'n, 481 U.S. 454, 461 (1987). In Exxon Mobil, 545 U.S. at 567-68, a House committee report indicated that the statute in question, 28 U.S.C. § 1367, was not intended to modify the requirement, established in Zahn v. International Paper Company, 414 U.S. 291, 301 (1973), that each plaintiff in a diversity suit must individually satisfy the amount-in-controversy requirement of the statute creating diversity jurisdiction, 28 U.S.C. §1332. Noting language in a working paper by a subcommittee of the Federal Court Study Committee suggesting that §1367 might overrule Zahn, the Court found that, taken as a whole, the legislative history of §1367 was " far murkier than selective quotation from the House Report would suggest." Id. at 569-570 It declined to give weight to the House report because it did not " accord[] with the best reading of the statute's text." Id. at 571. The situation here is quite analogous.
218. See H.R. Rep. No.100-391, at 691 (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1, 2313-365;
219. H.R. Rep. No. 99-908, pt. 1, at 25-26 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6366-6367
220. Restatement (Second) of Torts §402A cmt. k (1965).
221. Id.
222. Id. (internal punctuation omitted).
223. The language that such products are " especially common in the field of drugs" is some indication that the drafters of Comment k intended for at least a product-byproduct approach, not a fully categorical approach. Likewise, the language concerning proper preparation, directions, and warnings can also be read to require a case-bycase determination of the defense's applicability.
224. For a history of Comment k's drafting, see Joseph A. Page, Generic Product Risks: The Case Against Comment k and for Strict Tort Liability, 58 N.Y.U. L. Rev. 853, 864-72 (1983). According to Page, upon the failure of the drafting committee to reach a consensus on prescription drug exemption from inherent risk liability, what resulted was a comment that " failed to delineate in any meaningful way either the breadth of its coverage or its purpose." Id. at 866.
225. Am. L. Prods. Liab. 3d §17:36 (1987). That section also notes: " Comment k is not intended to provide all ethical drugs with blanket immunity from strict liability design defect claims, but rather courts must decide the applicability of the doctrine on a caseby-case basis after considering evidence related to the various factors set forth in Comment k." Id.
226. Restatement (Second) of Torts §402A cmt. k (1965);
227. see Joanne Rhoton Galbreath, Annotation, Products Liability: What is an " Unavoidably Unsafe" Product, 70 A.L.R. 4th 16, 41-47 (1989);
228. Am. L. Prods. Liab. 3d §17:47 (1987) (" Most courts have stated that there is no justification for giving all prescription drug manufacturers blanket immunity from strict liability under Comment k, and that whether a particular drug is unavoidably unsafe should be determined on a case-by-case basis." ). The Georgia Supreme Court found similarly in Ferrari II: " Only a few jurisdictions have held that any prescription drug is deemed unavoidably unsafe and, thus, that strict liability for defective design is barred." 668 S.E.2d 236,239 (Ga. 2008). A minority of courts has interpreted Comment k to offer blanket immunity from strict liability claims for prescription drug makers.
229. See, e.g., Hackett v. G.D. Searle & Co., 246 F. Supp. 2d 591, 595 (W.D. Tex. 2002) (applying Texas law);
230. Fellows v. USV Pharm. Corp., 502 F. Supp. 297, 300 (D. Md. 1980) (applying Maryland law);
231. Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, 1304 (Ala. 1984);
232. Brown v. Superior Court, 751 P.2d 470, 476-77 (Cal. 1988);
233. Grundberg v. Upjohn Co., 813 P.2d 89, 95 (Utah 1991). It is important to note that many of these minority states, including California and Texas, did not adopt a blanket immunity rule for prescription drugs until after enactment of the Vaccine Act. Thus, that subsequent adoption of a broader reading of Comment k could not have informed § 22(b)'s drafters' understanding of Comment k. Other courts that have spoken on the issue have adopted the case-by-case approach to applying Comment k. See, e.g., Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 657 (1st Cir. 1981) (applying New Hampshire law);
234. Singer v. Sterling Drug, Inc., 461 F.2d 288, 290-91 (7th Cir. 1972) (applying Indiana law);
235. Amore v. G.D. Searle & Co., 748 F. Supp. 845, 853-54 (S.D. Fla. 1990) (applying Florida law);
236. Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1301 (D. Minn. 1988) (applying Minnesota law);
237. Graham v. Wyeth Labs., 666 F. Supp. 1483, 1497 (D. Kan. 1987) (applying Kansas law);
238. Bryant v. Hoffman-LaRoche, Inc., 585 S.E.2d 723, 728 (Ga. Ct. App. 2003);
239. Toner v. Lederle Labs., 732 P.2d 297, 306 (Idaho 1987);
240. Pollard v. Ashby, 793 S.W.2d 394,400 (Mo. Ct. App. 1990);
241. Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 840 (Neb. 2000);
242. Feldman v. Lederle Labs., 479 A.2d 374, 383 (N.J. 1984);
243. White v. Wyeth Labs., 533 N.E.2d 748, 752 (Ohio 1988);
244. Senn v. Merrell-Dow Pharms., 751 P.2d 215, 218 n.4 (Or. 1988);
245. Castrignano v. E.R. Squibb & Sons, 546 A.2d 775, 781 (RI. 1988).
246. See Nat'l Archives & Records Admin, v. Favish, 541 U.S. 157, 168-69 (2004) (assuming that Congress legislated with understanding of background common law norm of allowing families control over images of deceased kin in enacting the Freedom of Information Act);
247. Meyer v. Holley, 537 U.S. 280, 285 (2003) (construing implied federal housing discrimination cause of action to include vicarious liability claim because of assumption that Congress creates tort actions " against a legal background of ordinary tort-related ... rules and consequently intends its legislation to incorporate those rules" ).
248. See cases cited, supra note 159.
249. See cases cited, supra note 159;
250. see also United States v. Texas, 507 U.S. 529, 534 (1993) (" In order to abrogate a common-law principle, the statute must speak directly to the question addressed by the common law." (internal quotation marks omitted)).
251. See sources cited, supra notes 93-102 and accompanying text.
252. -42 U.S.C. §300aa-22(b)(1) (2006);
253. see also Ferrari II, 668 S.E.2d at 240 (Ga. 2008).
254. See Daniel A. Cantor, Comment, Striking a Balance Between Product Availability and Product Safety: Lessons From the Vaccine Act, 44 Am. U. L. Rev. 1853, 1859-60 (1995) (noting difficulties plaintiffs face in proving design defects in state law actions and arguing that the Program offers an attractive alternative);
255. Deny Ridgway, No-Fault Vaccine Insurance: Lessons from the National Vaccine Injury Compensation Program, 24 J. Health Pol. Pol'y & L. 59, 78-79 (1999) (concluding that the Program has been effective at incentivizing would-be plaintiffs-and their lawyers-to accept Vaccine Court judgments rather than risk losing in civil court).
256. But see Katherine E. Strong, Proving Causation Under the Vaccine Injury Act: A New Approach For a New Day, 75 Geo. Wash. L. Rev. 426, 446-58 (2007) (arguing that the preponderance standard imposed on Program petitioners is too strict and advocating an easier benefit-of-the-doubt standard to help the Program achieve its goals of keeping claims out of the tort system).
257. Virtually all petitioners who receive a favorable judgment in the Program elect to accept that judgment rather than reject it and file civil suit. See Office of Management and Budget, Detailed Information on the Vaccine Injury Compensation Program Assessment (2005), available at http://www.whitehouse.gov/ omb/expectmore/detail/10003807.2005.html (showing that, in 2004, not a single petitioner rejected a favorable Program judgment and pursued a civil remedy, and further showing comparable data for prior years).
258. -42 U.S.C. §300aa-15(e) (2006).
259. See Ridgway, supra note 165, at 78 (suggesting that Program payment of attorney fees while petition is pending in Vaccine Court gives attorneys little incentive to convince petitioners to file civil suit against manufacturers).
260. See Shemin, supra note 1, at 482-90. The Vaccine Act does not contemplate the self-styled " omnibus proceeding" that the special masters designed to consolidate autism claims into a series of test cases. Shemin argues that the special masters have interpreted their powers a little too creatively, leading to concerns that trial courts may not recognize participation in the Omnibus Autism Proceeding as constituting the requisite exhaustion of the Vaccine Act remedy. Id. at 491-499
261. See id. at 512 (noting that the Vaccine Court's eight special masters " may be illequipped to process the remaining 4900 autism claims in a timely fashion" ).
262. Nonautism Program petition volume has remained remarkably stable since 1992. Except for 1999, in which 410 nonautism petitions were filed, nonautism petition volume has fluctuated between 84 and 242 per year, with 163 filed in 2008, the most recent year for which data have been finalized. See Health Resources and Services Administration, U.S. Department of Health and Human Services, National Vaccine Injury Compensation Program: Statistics Report (Oct. 20, 2009), available at http://www.hrsa.gov/Vaccinecompensation/Docs/ StatisticsReport.pdf.
263. See Begley, supra note 28, at 45-46;
264. sources cited, supra note 4 and accompanying text.
265. Defendant-manufacturers have already had success, in early thimerosal cases, with the argument that the plaintiffs' expert witnesses and scientific theory are not credible. Three federal district courts applying the rule of Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993),
266. and one state court applying Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), denied plaintiffs the ability to present their theory of causation because of scientific implausibility and, accordingly, dismissed the actions before trial.
267. See Redfoot v. B.F. Ascher & Co., 2007 WL 1593239, at 18-19 (N.D. CaI. June 1, 2007);
268. Doe v. Ortho-Clinical Diagnostics, 440 F. Supp. 2d 465, 475-76, 478-79 (M.D.N.C. 2006);
269. Easter v. Aventis Pasteur, Inc., 358 F. Supp. 2d 574 (E.D. Tex. 2005) ;
270. Blackwell v. Sigma Aldrich, Inc., No. 24-C-04-004829, at 23 (Baltimore, Md., City Cir. Ct. Dec. 21, 2007).