562 U.S. 223 | SCOTUS | 2011
Lead Opinion
delivered the opinion of the Court.
We consider whether a pre-emption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA)
I
A
For the last 66 years, vaccines have been subject to the same federal premarket approval process as prescription drugs, and compensation for vaccine-related injuries has been left largely to the States.
Despite the large number of suits, there were many complaints that obtaining compensation for legitimate vaccine-inflicted injuries was too costly and difficult.
Fast, informal adjudication is made possible by the Act’s Vaccine Injury Table, which lists the vaccines covered under the Act; describes each vaccine’s compensable, adverse side effects; and indicates how soon after vaccination those side effects should first manifest themselves.
Successful claimants receive compensation for medical, rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity; pain and suffering; and $250,000 for vaccine-related deaths.
The quid pro quo for this, designed to stabilize the vaccine market, was the provision of significant tort-liability protections for vaccine manufacturers. The Act requires claimants to seek relief through the compensation program before filing suit for more than $1,000.
“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.”27
B
The vaccine at issue here is a DTP vaccine manufactured by Lederle Laboratories. It first received federal approval in 1948 and received supplemental approvals in 1953 and 1970. Respondent Wyeth purchased Lederle in 1994 and stopped manufacturing the vaccine in 1998.
Hannah Bruesewitz was born on October 20, 1991. Her pediatrician administered doses of the DTP vaccine according to the Center for Disease Control’s recommended childhood immunization schedule. Within 24 hours of her April 1992 vaccination, Hannah started to experience seizures.
In April 1995, Hannah’s parents, Russell and Robalee Bruesewitz, filed a vaccine injury petition in the United States Court of Federal Claims, alleging that Hannah suffered from on-Table residual seizure disorder and encephalopathy injuries.
Wyeth removed the suit to the United States District Court for the Eastern District of Pennsylvania, which granted Wyeth summary judgment on the strict-liability and negligence design-defect claims, holding that the Pennsylvania law providing those causes of action was pre-empted by 42 U.S.C. § 300aa-22(b)(1).
II
A
We set forth again the statutory text at issue:
“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.”34
The “even though” clause clarifies the word that precedes it. It delineates the preventative measures that a vaccine manufacturer must have taken for a side effect to be considered “unavoidable” under the statute. Provided that there
If a manufacturer could be held liable for failure to use a different design, the word “unavoidable” would do no work. A side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element. The language of the provision thus suggests that the design of the vaccine is a given, not subject to question in the tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design. Which plainly implies that the design itself is not open to question.
A further textual indication leads to the same conclusion. Produets-liability law establishes a classic and well known triumvirate of grounds for liability: defective manufacture, inadequate directions or warnings, and defective design.
B
The dissent’s principal textual argument is mistaken. We agree with its premise that “‘side effects that were unavoidable’ must refer to side effects caused by a vaccine’s design.”
Petitioners’ and the dissent’s textual argument also rests upon the proposition that the word “unavoidable” in § 300aa-22(b)(1) is a term of art that incorporates comment k to Restatement (Second) of Torts § 402A (1963-1964).
We have no need to consider the finer points of comment k. Whatever consistent judicial gloss that comment may have been given in 1986, there is no reason to believe that § 300aa-22(b)(1) was invoking it. The comment creates a special category of “unavoidably unsafe products,” while the statute refers to “side effects that were unavoidable.” That the latter uses the adjective “unavoidable” and the former the adverb “unavoidably” does not establish that Congress
The textual problems with petitioners’ interpretation do not end there. The phrase “even though” in the clause “even though the vaccine was properly prepared and [labeled]” is meant to signal the unexpected: unavoidable side effects persist despite best manufacturing and labeling practices.
Petitioners and the dissent contend that the interpretation we propose would render part of § 300aa-22(b)(1) superfluous: Congress could have more tersely and more clearly preempted design-defect claims by barring liability “if . . . the vaccine was properly prepared and was accompanied by proper directions and warnings.” The intervening passage (“the injury or death resulted from side effects that were unavoidable even though”) is unnecessary. True enough. But the rule against giving a portion of text an interpretation which renders it superfluous does not prescribe that a passage which could have been more terse does not mean what it says. The rule applies only if verbosity and prolixity can be eliminated by giving the offending passage, or the remainder of the text, a competing interpretation. That is not the ease here.
Ill
The structure of the NCVIA and of vaccine regulation in general reinforces what the text of § 300aa-22(b)(1) suggests. A vaccine’s license spells out the manufacturing method that must be followed and the directions and warnings that must accompany the product.
Design defects, in contrast, do not merit a single mention in the NCVIA or the FDA’s regulations. Indeed, the FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.
Jurors, of course, often decide similar questions with little guidance, and we do not suggest that the absence of guidance alone suggests pre-emption. But the lack of guidance for design defects combined with the extensive guidance for the two grounds of liability specifically mentioned in the Act strongly suggests that design defects were not mentioned because they are not a basis for liability.
The mandates contained in the Act lead to the same conclusion. Design-defect torts, broadly speaking, have two beneficial effects: (1) prompting the development of improved designs, and (2) providing compensation for inflicted injuries. The NCVIA provides other means for achieving both effects. We have already discussed the Act’s generous compensation scheme. And the Act provides many means of improving vaccine design. It directs the Secretary of Health and Human Services to promote “the development of childhood vaccines that result in fewer and less serious adverse reactions.”
These provisions for federal agency improvement of vaccine design, and for federally prescribed compensation, once again suggest that §300aa-22(b)(1)’s silence regarding design-defect liability was not inadvertent. It instead reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.
And finally, the Act’s structural quid pro quo leads to the same conclusion: The vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries;
The dissent believes the Act’s mandates are irrelevant because they do not spur innovation in precisely the same way as state-law tort systems.
IV
Since our interpretation of § 300aa-22(b)(1) is the only interpretation supported by the text and structure of the NCVIA, even those of us who believe legislative history is a legitimate tool of statutory interpretation have no need to resort to it. In any case, the dissent’s contention that it would contradict our conclusion is mistaken.
The dissent’s legislative history relies on the following syllogism: A 1986 House Committee Report states that § 300aa-22(b)(1) “sets forth the principle contained in Comment k of Section 402A of the Restatement of Torts (Second);”
Immediately after the language quoted by the dissent, the 1986 Report notes the difficulty a jury would have in faithfully assessing whether a feasible alternative design exists when an innocent “young child, often badly injured or killed,” is the plaintiff.
The dissent buries another unfavorable piece of legislative history. Because the 1986 Report believes that §300aa-22(b)(1) should incorporate “the principle in Comment K” and because the Act provides a generous no-fault compensation scheme, the 1986 Report counsels injured parties who cannot prove a manufacturing or labeling defect to “pursue recompense in the compensation system, not the tort system.”
Not to worry, the dissent retorts, a Committee Report by a later Congress “authoritatively]” vindicates its interpreta
It does not matter that § 300aa-22(b)(1) did not take effect until the later Congress passed the excise tax that funds the compensation scheme,
* * *
For the foregoing reasons, we hold that the National Childhood Vaccine Injury Act pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects. The judgment of the Court of Appeals is affirmed.
It is so ordered.
42 U. S. C. § 300aa-22(b)(1).
See P. Hutt, R. Merrill, & L. Grossman, Food and Drug Law 912-913, 1458 (3d ed. 2007).
Centers for Disease Control, Achievements in Public Health, 1900-1999: Impact of Vaccines Universally Recommended for Children, 48 Morbidity and Mortality Weekly Report 243, 247 (Apr. 2, 1999).
See Mortimer, Immunization Against Infectious Disease, 200 Science 902, 906 (1978).
See National Vaccine Advisory Committee, A Comprehensive Review of Federal Vaccine Safety Programs and Public Health Activities 2-3 (Dec. 2008) (hereinafter NVAC), http://www.hhs.gov/nvpo/nvac/documents/vaceine-safety-review.pdf (as visited Feb. 18, 2011, and available in Clerk of Court’s case file).
See Sing & Willian, Supplying Vaccines: An Overview of the Market and Regulatory Context, in Supplying Vaccines: An Economic Analysis of Critical Issues 45, 51-52 (M. Pauly, C, Robinson, S. Sepe, M. Sing, & M. Willian eds. 1996).
See id., at 52.
See Centers for Disease Control, Diphtheria-Tetanus-Pertussis Vaccine Shortage, 33 Morbidity and Mortality Weekly Report 695-696 (Dec. 14, 1984).
See Apolinsky & Van Detta, Rethinking Liability for Vaecine Injury, 19 Cornell J. L. & Pub. Pol’y 537, 550-551 (2010); T. Burke, Lawyers, Lawsuits, and Legal Rights: The Battle Over Litigation in American Society 146 (2002).
Mortimer, supra, at 906.
See Hagan, Vaccine Compensation Schemes, 45 Food Drug Cosm. L. J. 477, 479 (1990).
See R. Merrill, Introduction to Epidemiology 65-68 (5th ed. 2010).
See 42 U. S. C. §300aa-11(a)(1).
See § 300aa-12(d)(3).
See § 300aa-12(e), (g).
See § 300aa-21(a).
See § 300aa-14(a); 42 CFR §100.3 (2009) (current Vaccine Injury Table).
See 42 U. S. C. §§ 300aa-11(c)(1), 300aa-13(a)(1)(A).
See § 300aa-13(a)(1)(B).
See § 300aa-11(e)(1)(C)(ii).
See §300aa-15(a).
See § 300aa-15(e).
See § 300aa-15(i)(2); 26 U. S. C. §§4131, 9510.
See 42 U. S. C. §300aa-11(a)(2).
See § 300aa-22(b)(2), (c). The immunity does not apply if the plaintiff establishes by dear and convincing evidence that the manufacturer was negligent, or was guilty of fraud, intentional and wrongful withholding of information, or other unlawful activity. See §§300aa-22(b)(2), 300aa-23(d)(2).
§ 300aa-23(d)(2).
§ 300aa-22(b)(1).
See Bruesewitz v. Secretary of Dept. of Health and Human Servs., No. 95-0266V, 2002 WL 31965744, *3 (Ct. Cl., Dec. 20, 2002).
561 F. 3d 233, 236 (CA3 2009).
See Bruesewitz, supra, at *1.
See 561 F. 3d, at 237. The complaint also made claims based upon failure to warn and defective manufacture. These are no longer at issue.
See id., at 237-238.
Id., at 235.
42 U. S. C. § 300aa-22(b)(1).
The dissent advocates for another possibility: “[A] side effect is ‘unavoidable’ . . . where there is no feasible alternative design that would eliminate the side effect of the vaccine without compromising its cost and utility.” Post, at 263 (opinion of Sotomayor, J.). The dissent makes no effort to ground that position in the text of § 300aa-22(b)(1). We doubt that Congress would introduce such an amorphous test by implication when it otherwise micromanages vaccine manufacturers. See infra, at 238. We have no idea how much more expensive an alternative design can be before it “compromisfesj” a vaccine’s cost or how much efficacy an alternative design can sacrifice to improve safety. Neither does the dissent. And neither will the judges who must rule on motions to dismiss, motions for summary judgment, and motions for judgment as a matter of law. Which means that the test would probably have no real-world effect.
W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton on Law of Torts 695 (5th ed. 1984); Restatement (Third) of Torts §2 (1999).
Post, at 252.
Ibid.
See Brief for Petitioners 29.
Restatement §402A, at 347.
Id., Comment k, at 353; petitioners cite, inter alia, Kearl v. Lederle Labs., 172 Cal. App. 3d 812, 828-830, 218 Cal. Rptr. 453, 463-464 (1985); Belle Bonfils Mem. Blood Bank v. Hansen, 665 P. 2d 118, 122 (Colo. 1983).
Though it is not pertinent to our analysis, we point out that a large number of courts disagreed with that reading of comment k, and took it to say that manufacturers did not face strict liability for side effects of properly manufactured prescription drugs that were accompanied by adequate warnings. See, e. g., Brown v. Superior Court, 227 Cal. Rptr. 768, 772-775 (Cal. App. 1986) (officially depublished), aff’d 44 Cal. 3d 1049, 751 P. 2d 470 (1988); McKee v. Moore, 648 P. 2d 21, 23 (Okla. 1982); Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, 1303-1304 (Ala. 1984); Lindsay v. Ortho Pharmaceutical Corp., 637 F. 2d 87, 90-91 (CA2 1980) (applying N. Y. law); Wolfgruber v. Upjohn Co., 72 App. Div. 2d 59, 61, 423 N. Y. S. 2d 95, 96 (1979); Chambers v. G. D. Searle & Co., 441 F. Supp. 377, 380-381 (Md. 1975); Basko v. Sterling Drug, Inc., 416 F. 2d 417, 425 (CA2 1969) (applying Conn. law).
See, e. g., Johnson v. American Cyanamid Co., 239 Kan. 279, 285, 718 P. 2d 1318, 1323 (1986); Feldman v. Lederle Labs., 97 N. J. 429, 440, 446-447, 479 A. 2d 374, 380, 383-384 (1984); Belle Bonfils Mem. Blood Bank, supra, at 121-123; Cassisi v. Maytag Co., 396 So. 2d 1140, 1144, n. 4, 1146 (Fla. App. 1981); Racer v. Utterman, 629 S. W. 2d 387, 393 (Mo. App. 1981).
The dissent’s assertion that we treat “even though” as a synonym for “because” misses the subtle distinction between “because” and “despite.” See post, at 265, n. 14. “Even though” is a close eousin of the latter. See Webster’s New International Dictionary 709, 2631 (2d ed. 1957). The statement “the ear accident was unavoidable despite his quick reflexes” indicates that quick reflexes could not avoid the accident, and leaves open two unstated possibilities: (1) that other, unstated means of avoiding the accident besides quick reflexes existed, but came up short as well; or (2) that quick reflexes were the only possible way to avoid the accident. Our interpretation of § 300aa-22(b)(1) explains why we think Congress meant the latter in this context. (Incidentally, the statement “the car accident was unavoidable because of his quick reflexes” makes no sense.)
See W. Follett, Modern American Usage: A Guide 61 (1966).
Post, at 258, 265.
Post, at 251-253.
The dissent responds that these “additional prerequisites” act “in a concessive, subordinating fashion,” post, at 265, n. 14 (internal quotation marks and brackets omitted). But that is no more true of the dissent's conjunctive interpretation of the present text than it is of all provisions that set forth additional requirements — meaning that we could eliminate “even though” from our English lexicon, its function being entirely performed by “and.” No, we think “even though” has a distinctive conces-sive, subordinating role to play.
Because the dissent has a superfluity problem of its own, its reliance on Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), is misplaced. See id., at 449 (adopting an interpretation that was “the only one that makes sense of each phrase” in the relevant statute).
That is true regardless of whether §300aa-22(b)(1) incorporates comment k. See Restatement § 402A, Comment k, at 353, 354 (noting that “unavoidably unsafe products” are exempt from strict liability “with the qualification that they are properly prepared and marketed, and proper warning is given”).
See 42 U. S. C. §262(a), (j); 21 CFR §§ 601.2(a), 314.105(b) (2010).
See §601.12.
See §§211.1 et seq., 600.10-600.15, 600.21-600.22, 820.1 et seq.
See §§211.46, 211.48.
See 42 U. S. C. §300aa-22(b)(2).
Hutt, Merrill, & Grossman, Food and Drug Law, at 685, 891.
See Sing & Willian, Supplying Vaccines, at 66-67.
42 U. S. C. § 300aa-27(a)(1).
§300aa-1.
See §§300aa-2(a)(1)-(3), 300aa-3.
See §300aa-25(b).
See NVAC 18-19.
See 21 CFR §601.5(b)(1)(vi) (2010).
The dissent quotes just part of this sentence, to make it appear that we believe complex epidemiological judgments ought to be assigned in that fashion. See post, at 274. We do not state our preference, but merely note that it is Congress’s expressed preference — and in order to preclude the argument that it is absurd to think Congress enacted such a thing, we assert that the choice is reasonable and express some of the reasons why. Leaving it to the jury may (or may not) be reasonable as well; we express no view.
See 42 U. S. C. § 300aa-15(i)(2); § 323(a), 100 Stat. 3784. The dissent’s unsupported speculation that demand in the vaccine market is inelastic, see post, at 272-273, n. 22, sheds no light on whether Congress regarded the tax as a quid pro quo, most Members of Congress being neither professional economists nor law-and-eeonomies scholars.
See 42 U. S. C. §§300aa-11(a)(2), 300aa-22.
See post, at 269-272.
H. R. Rep. No. 99-908, pt. 1, p. 25 (1986) (hereinafter 1986 Report).
Post, at 255-257.
1986 Report, at 26; see ibid. (“[E]ven if the defendant manufacturer may have made as safe a vaccine as anyone reasonably could expect, a court or jury undoubtedly will find it difficult to rule in favor of the ‘innocent’ manufacturer if the equally ‘innocent’ child has to bear the risk of loss with no other possibility of recompense”).
Ibid.
Ibid.
Post, at 261. This is a courageous adverb since we have previously held that the only authoritative source of statutory meaning is the text that has passed through the Article I process. See Exxon Mobil Corp. v. Allapattah Services, Inc., 545 U. S. 546, 568 (2005).
§ 323(a), 100 Stat. 3784.
H. R. Rep. No. 100-391, pt. 1, p. 701 (1987).
See, e.g., §§401, 403(a), 110 Stat. 3009-655 to 3009-656, 3009-659 to 3009-662, as amended, note following 8 U. S. C. § 1324a (2006 ed., Supp. III) (E-Verify program expires Sept. 30, 2012).
Post, at 257.
See n. 39, supra; post, at 256, n. 5.
Concurrence Opinion
concurring.
I join the Court’s judgment and opinion. In my view, the Court has the better of the purely textual argument. But the textual question considered alone is a close one. Hence,
I
House Committee Report No. 99-908 contains an “authoritative” account of Congress’ intent in drafting the preemption clause of the National Childhood Vaccine Injury Act of 1986 (NCVIA or Act). See Garcia v. United States, 469 U. S. 70, 76 (1984) (“[T]he authoritative source for finding the Legislature’s intent lies in the Committee Reports on the bill”). That Report says that “if” vaceine-injured persons
“cannot demonstrate under applicable law either that a vaccine was improperly prepared or that it was accompanied by improper directions or inadequate warnings [they] should pursue recompense in the compensation system, not the tort system.” H. R. Rep. No. 99-908, pt. 1, p. 26 (1986) (hereinafter H. R. Rep. or Report).
The Report lists two specific kinds of tort suits that the clause does not pre-empt (suits based on improper manufacturing and improper labeling), while going on to state that compensation for other tort claims, e. g., design-defect claims, lies in “the [NCVIA’s no-fault] compensation system, not the tort system.” Ibid.
The strongest contrary argument rests upon the Report’s earlier description of the statute as “set[ting] forth the principle contained in Comment k” (of the Restatement Second of Torts’ strict liability section, 402A) that “a vaccine manufacturer should not be liable for injuries or deaths resulting from unavoidable side effects.” Id., at 25 (emphasis added). But the appearance of the word “unavoidable” in this last-mentioned sentence cannot provide petitioners with much help. That is because nothing in the Report suggests that
II
The legislative history describes the statute more generally as trying to protect the lives of children, in part by ending “the instability and unpredictability of the childhood vaccine market.” H. R. Rep., at 7; see ante, at 227-228. As the Report makes clear, routine vaccination is “one of the most spectacularly effective public health initiatives this country has ever undertaken.” H. R. Rep., at 4. Before the development of routine whooping cough vaccination, for example, “nearly all children” in the United States caught the disease and more than 4,000 people died annually, most of them infants. U. S. Dept, of Health and Human Services, Centers for Disease Control and Prevention, What Would Happen if We Stopped Vaccinations? http.7/www.cdc.gov/vaccines/ vac-gen/whatifstop.htm (all Internet materials as visited Feb. 17, 2011, and available in Clerk of Court’s case file);
But these gains are fragile; “[t]he causative agents for these preventable childhood illnesses are ever present in the environment, waiting for the opportunity to attack the unprotected individual.” Hearing on S. 827 before the Senate Committee on Labor and Human Resources, 99th Cong., 1st Sess., pt. 2, pp. 20-21 (1985) (hereinafter Hearings) (testimony of the American Academy of Pediatrics); see California Dept, of Public Health, Pertussis Report (Jan. 7, 2011), www.cdph.ca.gov/programs/immunize/Documents/ PertussisReport2011-01-07.pdf (In 2010,8,383 people in California caught whooping cough, and 10 infants died). Even a brief period when vaccination programs are disrupted can lead to children’s deaths. Hearings 20-21; see Gangarosa et al., Impact of Anti-Vaccine Movements on Pertussis Control: The Untold Story, 351 Lancet 356-361 (Jan. 31, 1998) (when vaccination programs are disrupted, the number of cases of whooping cough skyrockets, increasing by orders of magnitude).
In considering the NCVIA, Congress found that a sharp increase in tort suits brought against whooping cough and other vaccine manufacturers between 1980 and 1985 had
Given these broad general purposes, to read the preemption clause as preserving design-defeet suits seems anomalous. The Department of Health and Human Services (HHS) decides when a vaccine is safe enough to be licensed and which licensed vaccines, with which associated injuries, should be placed on the Vaccine Injury Table. 42 U. S. C. § 800aa-14; ante, at 228; A Comprehensive Review of Federal Vaccine Safety Programs and Public Health Activities 13-15, 32-34 (Dec. 2008), http://www.hhs.gov/nvpo/nvac/ documents/vaccine-safety-review.pdf. A special master in the Act’s compensation program determines whether someone has suffered an injury listed on the Injury Table and, if not, whether the vaccine nonetheless caused the injury. Ante, at 228; §300aa-13. To allow a jury in effect to second-guess those determinations is to substitute less expert for more expert judgment, thereby threatening manufacturers with liability (indeed, strict liability) in instances where any conflict between experts and nonexperts is likely
Ill
The United States, reflecting the views of HHS, urges the Court to read the Act as I and the majority would do. It notes that the compensation program’s listed vaccines have survived rigorous administrative safety review. It says that to read the Act as permitting design-defect lawsuits could lead to a recurrence of “exactly the crisis that precipitated the Act,” namely, withdrawals of vaccines or vaccine manufacturers from the market, “disserv[ing] the Act’s central purposes,” and hampering the ability of the agency’s “expert regulators, in conjunction with the medical community, [to] control the availability and withdrawal of a given vaccine.” Brief for United States as Amicus Curiae 30, 31.
The United States is supported in this claim by leading public health organizations, including the American Academy of Pediatrics, the American Academy of Family Physicians, the American College of Preventive Medicine, the American Public Health Association, the American Medical Association, the March of Dimes Foundation, the Pediatric Infectious Diseases Society, and 15 other similar organizations. Brief for American Academy of Pediatrics et al. as Amici
I would give significant weight to the views of HHS. The law charges HHS with responsibility for overseeing vaccine production and safety. It is “likely to have a thorough understanding” of the complicated and technical subject matter of immunization policy, and it is comparatively more “qualified to comprehend the likely impact of state requirements.” Geier v. American Honda Motor Co., 529 U. S. 861, 883 (2000) (internal quotation marks omitted); see Medtronic, Inc. v. Lohr, 518 U. S. 470, 506 (1996) (Breyer, J., concurring in part and concurring in judgment) (the agency is in the best position to determine “whether (or the extent to which) state requirements may interfere with federal objectives”). HHS’ position is particularly persuasive here because expert public health organizations support its views and the matter concerns a medical and scientific question of great importance: how best to save the lives of children. See Skidmore v. Swift & Co., 323 U. S. 134 (1944).
In sum, congressional reports and history, the statute’s basic purpose as revealed by that history, and the views of the expert agency along with those of relevant medical and scientific associations, all support the Court’s conclusions. I consequently agree with the Court.
Dissenting Opinion
dissenting.
Vaccine manufacturers have long been subject to a legal duty, rooted in basic principles of products liability law, to improve the designs of their vaccines in light of advances in science and technology. Until today, that duty was enforceable through a traditional state-law tort action for defective design. In holding that § 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act), 42 U. S. C. § 300aa-22(b)(l), pre-empts all design defect claims for injuries stemming from vaccines covered under the Act, the Court imposes its own bare policy preference over the considered judgment of Congress. In doing so, the Court excises 13 words from the statutory text, misconstrues the Act's legislative history, and disturbs the careful balance Congress struck between compensating vaccine-injured children and stabilizing the childhood vaccine market. Its decision leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products. Because nothing in the text, structure, or legislative history of the Vaccine Act remotely suggests that Congress intended such a result, I respectfully dissent.
I
A
Section 22 of the Vaccine Act provides “ [standards of responsibility” to govern civil actions against vaccine manufacturers. 42 U. S. C. § 300aa-22. Section 22(a) sets forth the “[gjeneral rule” that “State law shall apply to a civil action brought for damages for a vaccine-related injury or death.” § 300aa-22(a). This baseline rule that state law applies is subject to three narrow exceptions, one of which, § 22(b)(1), is at issue in this case. Section 22(b)(1) provides:
*251 “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.” § 300aa-22(b)(1).
The provision contains two key clauses: “if the injury or death resulted from side effects that were unavoidable” (the “if” clause), and “even though the vaccine was properly prepared and was accompanied by proper directions and warnings” (the “even though” clause).
Blackletter products liability law generally recognizes three different types of product defects: design defects, manufacturing defects, and labeling defects (e.g., failure to warn).
Given that the “even though” clause requires the absence of manufacturing and labeling defects, the “if” clause’s reference to “side effects that were unavoidable” must refer to
Congress’ use of conditional “if” clauses in two other provisions of the Vaccine Act supports the conclusion that § 22(b)(1) requires an inquiry in each case in which a manufacturer seeks to invoke the provision’s exception to state tort liability. In § 22(b)(2), Congress created a presumption that, for purposes of § 22(b)(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” federal labeling requirements. 42 U. S. C. § 300aa-22(b)(2). Similarly, in § 23(d)(2), Congress created an exemption from punitive damages “[i]f . . . the manufacturer shows that it complied, in all material respects,” with applicable federal laws, unless it engages in “fraud,” “intentional and wrongful withholding of information” from federal regulators, or “other criminal or illegal activity.” §300aa-23(d)(2). It would be highly anomalous for Congress to use a conditional “if” clause in §§ 22(b)(2) and 23(d)(2) to require a specific inquiry in each case while using the same
Indeed, when Congress intends to pre-empt design defect claims categorically, it does so using categorical (e. g., “all”) and/or declarative language (e. g., “shall”), rather than a conditional term (“if”). For example, in a related context, Congress has authorized the Secretary of Health and Human Services to designate a vaccine designed to prevent a pandemic or epidemic as a “covered countermeasure.” 42 U. S. C. §§247d-6d(b), (i)(1), (i)(7)(A)(i). With respect to such “covered countermeasure[s],” Congress provided that subject to certain exceptions, “a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure,” §247d-6d(a)(1) (emphasis added), including specifically claims relating to “the design” of the countermeasure, § 247d-6d(a)(2)(B).
The plain text and structure of the Vaccine Act thus compel the conclusion that § 22(b)(1) pre-empts some — but not all — design defect claims. Contrary to the majority’s and respondent’s categorical reading, petitioners correctly contend that, where a plaintiff has proved that she has suffered an injury resulting from a side effect caused by a vaccine’s design, a vaccine manufacturer may invoke § 22(b)(1)’s liability exemption only if it demonstrates that the side effect stemming from the particular vaccine’s design is “unavoidable,” and that the vaccine is otherwise free from manufacturing and labeling defects.
The legislative history confirms petitioners’ interpretation of § 22(b)(1) and sheds further light on its pre-emptive scope. The House Energy and Commerce Committee Report accompanying the Vaccine Act, H. R. Rep. No. 99-908, pt. 1 (1986) (hereinafter 1986 Report), explains in relevant part:
“Subsection (b) — Unavoidable Adverse Side Effects; Direct Warnings. — This provision sets forth the principle contained in Comment k of Section 402A of the Restatement of Torts (Second) that a vaccine manufacturer should not be liable for injuries or deaths resulting from unavoidable side effects even though the vaccine was properly prepared and accompanied by proper directions and warnings.
“The Committee has set forth Comment K in this bill because it intends that the principle in Comment K regarding 'unavoidably unsafe’ products, i. e., those products which in the present state of human skill and knowledge cannot be made safe, apply to the vaccines covered in the bill and that such products not be the subject of liability in the tort system.” Id., at 25-26.
The 1986 Report expressly adopts comment k of §402A of the Restatement of Torts (Second) (1963-1964) (hereinafter Restatement), which provides that “unavoidably unsafe” products — i. e., those that “in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use” — are not defective.
As the 1986 Report explains, Congress intended that the “principle in Comment K regarding ‘unavoidably unsafe’ products” apply to the vaccines covered in the bill. 1986 Report 26. That intent, in turn, is manifested in the plain text of § 22(b)(1) — in particular, Congress’ use of the word “unavoidable,” as well as the phrases “properly prepared” and “accompanied by proper directions and warnings,” which were taken nearly verbatim from comment k. 42 U. S. C. § 300aa-22(b)(l); see Restatement 353-354 (“Such a[n unavoidably unsafe] product, properly prepared, and accompa
The 1986 Report thus confirms petitioners' interpretation of § 22(b)(1). The 1986 Report makes clear that “side effects that were unavoidable” in § 22(b)(1) refers to side effects stemming from a vaccine's design that were “unavoidable.” By explaining what Congress meant by the term “unavoid
To he sure, postenactment legislative history created by a subsequent Congress is ordinarily a hazardous basis from which to infer the intent of the enacting Congress. See Sullivan v. Finkelstein, 496 U. S. 617, 631-632 (1990) (Scalia, J., concurring in part). But unlike ordinary postenactment legislative history, which is justifiably given little or no weight, the 1987 Report reflects the intent of the Congress that enacted the funding legislation necessary to give operative effect to the principal provisions of the Vaccine Act, including § 22(b)(1).
In sum, the text, structure, and legislative history of the Vaccine Act are fully consistent with petitioners’ reading of § 22(b)(1). Accordingly, I believe § 22(b)(1) exempts vaccine manufacturers from tort liability only upon a showing by the manufacturer in each case that the vaccine was properly manufactured and labeled, and that the side effects stemming from the vaccine’s design could not have been prevented by a feasible alternative design that would have eliminated the adverse side effects without compromising the vaccine’s cost and utility.
II
In contrast to the interpretation of § 22(b)(1) set forth above, the majority’s interpretation does considerable violence to the statutory text, misconstrues the legislative history, and draws the wrong conclusions from the structure of the Vaceine Act and the broader federal scheme regulating vaccines.
As a textual matter, the majority’s interpretation of § 22(b)(1) is fundamentally flawed in three central respects. First, the majority’s categorical reading rests on a faulty and untenable premise. Second, its reading functionally excises 13 words from the statutory text, including the key term “unavoidable.” And third, the majority entirely ignores the Vaccine Act’s default rule preserving state tort law.
To begin, the majority states that “[a] side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element.” Ante, at 232. From that premise, the majority concludes that the statute must mean that “the design of the vaccine is a given, not subject to question in the tort action,” because construing the statute otherwise would render § 22(b)(1) a nullity. Ibid. A tort claimant, according to the majority, will always be able to point to a differently designed vaccine not containing the “harmful element,” and if that were sufficient to show that a vaccine’s side effects were not “unavoidable,” the statute would pre-empt nothing.
The starting premise of the majority’s interpretation, however, is fatally flawed. Although in the most literal sense, as the majority notes, a side effect can always be avoided “by use of a differently designed vaccine not containing the harmful element,” ibid., this interpretation of “unavoidable” would effectively read the term out of the statute, and Congress could not have intended that result. Indeed, § 22(b)(1) specifically uses the conditional phrase “if the injury or death resulted from side effects that were unavoidable,” which plainly indicates that Congress contemplated that there would be some instances in which a vaccine’s side effects are “unavoidable” and other instances in which they are not. See supra, at 252. The majority’s premise that a vaccine’s side effects can always be “avoid[ed] by use of a differently designed vaccine not containing the harmful element,” ante, at 232, entirely ignores the fact that removing the “harmful
The majority’s reading suffers from an even more fundamental defect. If Congress intended to exempt vaccine manufacturers categorically from all design defect liability, it more logically would have provided: “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 vaccine was properly prepared and was accompanied by proper directions and warnings.” There would have been no need for Congress to include the additional 13 words “the injury or death resulted from side effects that were unavoidable even though.” See TRW Inc. v. Andrews, 534 U. S. 19, 31 (2001) (noting “cardinal principle of statutory construction that a statute ought, upon the whole, to be so construed that, if it can be prevented, no clause, sentence, or word shall
In Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), this Court considered an analogous situation where an express pre-emption provision stated that certain States “ ‘shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.’” Id., at 436 (quoting 7 U. S. C. § 136v(b) (2000 ed.)). The Bates Court stated:
“Conspicuously absent from the submissions by [respondent] and the United States is any plausible alternative interpretation of ‘in addition to or different from’ that would give that phrase meaning. Instead, they appear to favor reading those words out of the statute, which would leave the following: ‘Such State shall not impose or continue in effect any requirements for labeling or packaging.’ This amputated version of [the statute] would no doubt have clearly and succinctly commanded the pre-emption of all state requirements concerning labeling. That Congress added the remainder of the provision is evidence of its intent to draw a distinction between state labeling requirements that are pre-empted and those that are not.” 544 U. S., at 448-449.
As with the statutory interpretation rejected by this Court in Bates, the majority’s interpretation of § 22(b)(1) functionally excises 13 words out of the statute, including the key term “unavoidable.” See Duncan v. Walker, 533 U. S. 167, 174 (2001) (“We are especially unwilling” to treat a statutory term as surplusage “when the term occupies so pivotal a place in the statutory scheme”). Although the resulting “amputated version” of the statutory provision “would no doubt have clearly and succinctly commanded the preemption of all state” design defect claims, the fact “[t]hat
Strikingly, the majority concedes that its interpretation renders 13 words of the statute entirely superfluous. See ante, at 236 (“The intervening passage (‘the injury or death resulted from side effects that were unavoidable even though’) is unnecessary. True enough”). Nevertheless, the majority contends that “the rule against giving a portion of text an interpretation which renders it superfluous ... applies only if verbosity and prolixity can be eliminated by giving the offending passage, or the remainder of the text, a competing interpretation.” Ibid. According to the majority, petitioners’ reading of § 22(b)(1) renders the “even though” clause superfluous because, to reach petitioners’ desired outcome, “[i]t would suffice to say ‘if the injury or death resulted from side effects that were unavoidable’ — full stop.” Ante, at 237. As explained above, however, the “even though” clause establishes two additional prerequisites— proper manufacturing and proper labeling — to qualify for § 22(b)(l)’s exemption from liability. Contrary to the majority’s contention, then, the “even though” clause serves an important function by limiting the scope of the pre-emption afforded by the preceding “if” clause.
The majority also suggests that if Congress wished to preserve design defect claims, it could have simply provided that manufacturers would be liable for “defective manufacture, defective directions or warning, and defective design.” Ante, at 233 (internal quotation marks omitted). Putting aside the fact that § 22(a) already preserves design defect claims (to the extent § 22(b)(1) does not apply), the majority’s proposed solution would not have fully effectuated Congress’ intent. As the legislative history makes clear, Congress used the term “unavoidable” to effectuate its intent that the “principle in Comment K regarding 'unavoidably unsafe’ products ... apply to the vaccines covered in the bill.” 1986 Report 26; see also 1987 Report 691. At the time of the Vaccine Act’s enactment in 1986, at least one State had expressly rejected comment k,
B
The majority’s structural arguments fare no better than its textual ones. The principal thrust of the majority’s position is that, since nothing in the Vaccine Act or the FDA's regulations governing vaccines expressly mentions design defects, Congress must have intended to remove issues concerning the design of FDA-licensed vaccines from the tort system. Ante, at 237. The flaw in that reasoning, of course, is that the FDA’s silence on design defects existed long before the Vaccine Act was enacted. Indeed, the majority itself concedes that the “FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.”
The majority also suggests that Congress necessarily intended to pre-empt design defect claims since the aim of such tort suits is to promote the development of improved designs and provide compensation for injured individuals, and the Vaccine Act “provides other means for achieving both effects” — most notably through the no-fault compensation program and the National Vaccine Program. Ante, at 238-239, and nn. 57-60 (citing 42 U. S. C. §§ 300aa-l, 300aa-2(a)(1)-(3), 300aa-3, 300aa-25(b), 300aa-27(a)(1)). But the majority’s position elides a significant difference between state tort law and the federal regulatory scheme. Although the Vaccine Act charges the Secretary of Health and Human Services with the obligation to “promote the development of childhood vaccines” and “make or assure improvements in .,. vaccines, and research on vaccines,” § 300aa-27(a), neither the Act nor any other provision of federal law places a legal duty on vaccine manufacturers to improve the design of their vaccines to account for scientific and technological advances. Indeed, the FDA does not condition approval of a vaccine on it being the most optimally designed among reasonably available alternatives, nor does it (or any other federal entity) ensure that licensed vaccines keep pace with technological and sci
Ill
In enacting the Vaccine Act, Congress established a carefully wrought federal scheme that balances the competing interests of vaccine-injured persons and vaccine manufacturers. As the legislative history indicates, the Act addressed “two overriding concerns”: “(a) the inadequacy — from both the perspective of vaccine-injured persons as well as vaccine manufacturers — of the current approach to compensating those who have been damaged by a vaccine; and (b) the instability and unpredictability of the childhood vaccine market.” 1986 Report 7. When viewed in the context of the Vaccine Act as a whole, § 22(b)(1) is just one part of a broader statutory scheme that balances the need for compensating vaccine-injured children with added liability protections for vaccine manufacturers to ensure a stable childhood vaccine market.
The principal innovation of the Act was the creation of the no-fault compensation program — a scheme funded entirely through an excise tax on vaccines.
Instead of eliminating design defect liability entirely, Congress enacted numerous measures to reduce manufacturers’ liability exposure, including a limited regulatory compliance presumption of adequate warnings, see §300aa-22(b)(2), elimination of claims based on failure to provide direct warnings to patients, § 300aa-22(e), a heightened standard for punitive damages, § 300aa-23(d)(2), and, of course, immunity from damages for “unavoidable” side effects, §300aa-22(b)(1). Considered in light of the Vaccine Act as a whole, §22(b)(l)’s exemption from liability for unavoidably unsafe vaccines is just one part of a broader statutory scheme that reflects Congress’ careful balance between providing adequate compensation for vaccine-injured children and conferring substantial benefits on vaccine manufacturers to ensure a stable and predictable childhood vaccine supply.
The majority’s decision today disturbs that careful balance based on a bare policy preference that it is better “to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.” Ante, at 239.
I respectfully dissent.
W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton on Law of Torts 695 (5th ed. 1984).
See Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 255 (1984); Brown v. Earthboard Sports USA, Inc., 481 F. 3d 901, 912 (CA6 2007) (“ ‘[F]ederal preemption is an affirmative defense upon which the defendants bear the burden of proof’ ” (quoting Fifth Third Bank v. CSX Corp., 415 F. 3d 741, 745 (CA7 2005))).
This leaves the question of what precisely § 22(b)(1) means by “unavoidable” side effects, which I address in the next section.
Comment k provides as follows:
“Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk*255 which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.” Restatement 353-354.
See, e. g., Smith ex rel. Smith v. Wyeth Labs., Inc., No. Civ. A 84-2002, 1986 WL 720792, *5 (SD W. Va., Aug. 21, 1986) (“[A] prescription drug is not ‘unavoidably unsafe’ when its dangers can be eliminated through design changes that do not unduly affect its cost or utility”); Kearl v. Lederle Labs., 172 Cal. App. 3d 812, 830, 218 Cal. Rptr. 453, 464 (1985) (“unavoid-ability” turns on “(i) whether the product was designed to minimize — to the extent scientifically knowable at the time it was distributed — the risk inherent in the product, and (ii) the availability ... of any alternative product that would have as effectively accomplished the full intended purpose of the subject product”), disapproved in part by Brown v. Superior Ct., 44 Cal. 3d 1049, 751 P. 2d 470 (1988); Belle Bonfils Memorial Blood Bank v. Hansen, 665 P. 2d 118, 122 (Colo. 1983) (“[Ajpplieability of comment k . . . depends upon the co-existence of several factors,” including that “the product’s benefits must not be achievable in another manner; and the risk must be unavoidable under the present state of knowledge”); see also 1 L. Frumer & M. Friedman, Products Liability §§ 8.07[1]-[2], pp. 8-277 to 8-278 (2010) (comment k applies “only to defects in design,” and there “must be no feasible alternative design which on balance accomplishes the subject product’s purpose with a lesser risk” (internal quotation marks omitted)). To be sure, a number of courts at the time of the Vaccine Act’s enactment had interpreted comment k to preclude design defect claims categorically for certain kinds of products, see Hill v. Searle Labs., 884 F. 2d 1064, 1068 (CA8 1989) (collecting cases), but as indicated by the sources cited above, the courts that had construed comment k to apply on a ease-specific basis generally agreed on the basic elements of what constituted an “unavoidably unsafe” product. See also n. 8, infra. The majority’s suggestion that “judges who must rule on motions to dismiss, motions for summary judgment, and motions for judgment as a matter of law” are incapable of adjudicating claims alleging “unavoidable” side effects, ante, at 232, n. 35, is thus belied by the experience of the many courts that had adjudicated such claims for years by the time of the Vaccine Act’s enactment.
The majority refuses to reeognize that “unavoidable” is a term of art derived from comment k, suggesting that “ ‘[unavoidable’ is hardly a rarely used word.” Ante, at 235. In fact, however, “unavoidable” is an extremely rare word in the relevant context. It appears exactly once (i. e., in § 300aa-22(b)(1)) in the entirety of Title 42 of the U. S. Code (“Public Health and Welfare”), which governs, inter alia, Social Security, see 42 U. S. C. § 301 et seq., Medicare, see § 1395 et seq., and several other of the Federal Government’s largest entitlement programs. The singular rarity in which Congress used the term supports the conclusion that “unavoidable” is a term of art.
See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F. 2d 652, 657 (CA1 1981); Needham v. White Labs., Inc., 639 F. 2d 394, 402 (CA7 1981); Reyes v. Wyeth Labs., 498 F. 2d 1264, 1274-1275 (CA5 1974); Davis v. Wyeth Labs., 399 F. 2d 121, 127-129 (CA9 1968); Feldman v. Lederle Labs., 97 N. J. 429, 448, 479 A. 2d 374, 384 (1984); see also Toner v. Lederle Labs., 112 Idaho 328, 336, 732 P. 2d 297, 305 (1987).
Respondent suggests an alternative reading of the 1986 Report. According to respondent, “the principle in Comment K” is simply that of nonliability for “unavoidably unsafe” products, and thus Congress’ stated intent in the 1986 Report to apply the “principle in Comment K” to “the vaccines covered in the bill” means that Congress viewed the covered vaccines as a class to be ‘“unavoidably unsafe.’” 1986 Report 25-26; Brief for Respondent 42. The concurrence makes a similar argument. Ante, at 244-245 (opinion of Breyer, J.). This interpretation finds some support in the 1986 Report, which states that “if [injured individuals] cannot demonstrate under applicable law either that a vaccine was improperly prepared or that it was accompanied by improper directions or inadequate warnings [they] should pursue recompense in the compensation system, not the tort system.” 1986 Report 26. It also finds some support in the pre-Vaccine Act case law, which reflected considerable disagreement in the courts over “whether comment k applies to pharmaceutical products across the board or only on a case-by-case basis.” Ausness, Unavoidably Unsafe Products and Strict Products Liability: What Liability Rule Should Be Applied to the Sellers of Pharmaceutical Products? 78 Ky. L. J. 705, 708, and n. 11 (1989-1990) (collecting cases). This interpretation, however, is undermined by the fact that Congress has never directed the Food and Drug Administration (FDA) or any other federal agency to re
The Third Circuit’s opinion below expressed uncertainty as to whether the 1987 Report was authored by the House Budget Committee or the House Energy and Commerce Committee. See 561 F. 3d 233, 250 (2009). As petitioners explain, although the Budget Committee compiled and issued the Report, the Energy and Commerce Committee wrote and approved the relevant language. Title IV of the 1987 Report, entitled “Committee on Energy and Commerce,” comprises “two Committee Prints approved by the Committee on Energy and Commerce for inclusion in the forthcoming reconciliation bill.” 1987 Report 377, 380.
The majority suggests that the 1987 legislation creating the funding mechanism is akin to appropriations legislation and that giving weight to the legislative history of such legislation “would set a dangerous precedent.” Ante, at 242. The difference, of course, is that appropriations legislation ordinarily funds congressional enactments that already have operative legal effect; in contrast, operation of the tort reforms in the 1986 Act, including § 22(b)(1), was expressly conditioned on the enactment of a separate tax to fund the compensation program. See § 323(a), 100 Stat. 3784. Accordingly, this Court’s general reluctance to view appropriations legislation as modifying substantive legislation, see, e. g., TVA v. Hill, 437 U. S. 153, 190 (1978), has no bearing here.
See 1987 Report 700 (describing the administration’s alternative proposal).
See, e. g., Hearings on Funding of the Childhood Vaccine Program before the Subcommittee on Select Revenue Measures of the House Committee on Ways and Means, 100th Cong., 1st Sess., 85 (1987) (“[T]he liability
See American Academy of Pediatrics, Questions and Answers About Vaccine Ingredients (Oct. 2008), http://www.aap.org/immunization/families/ faq/Vaceineingredients.pdf (all Internet materials as visited Feb. 18, 2011, and available in Clerk of Court's case file).
In this manner, the “even though” clause functions in a “concessive subordinat[ing]” fashion, ante, at 235, in accord with normal grammatical usage. According to the majority, however, the “even though” clause “clarifies the word that precedes it” by “delineating] ” the conditions that make a side effect “unavoidable” under the statute. Ante, at 231. The majority’s interpretation hardly treats the clause as “concessive,” and indeed
This Court, moreover, has long operated on “the assumption that the historic police powers of the States are not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Altria Group, Inc. v. Good, 555 U. S. 70, 77 (2008) (internal quotation marks and alteration omitted). Given the long history of state regulation of vaccines, see Brief for Petitioners 3-6, the presumption provides an additional reason not to read § 22(b)(1) as pre-empting all design defect claims, especially given Congress’ inclusion of an express saving clause in the same statutory section, see 42 U. S. C. § 300aa-22(a), and its use of the conditional “if” clause in defining the pre-emptive scope of the provision. See Bates v. Dow Agrosciences LLC, 544 U. S. 431, 449 (2005) (“In areas of traditional state regulation, we assume that a federal statute has not supplanted state law unless Congress has made such an intention clear and manifest” (internal quotation marks omitted)).
See Collins v. Eli Lilly Co., 116 Wis. 2d 166, 197, 342 N. W. 2d 37, 52 (1984) (“We conclude that the rule embodied in comment k is too restrictive and, therefore, not commensurate with strict products liability law in Wisconsin”). Collins did, however, “recognize that in some exigent circumstances it may be neeessary to place a drug on the market before adequate testing can be done.” Ibid. It thus adopted a narrower defense (based on “exigent circumstances”) than that recognized in other jurisdictions that had expressly adopted comment k.
See, e. g., Kearl, 172 Cal. App. 3d, at 831, n. 15, 218 Cal. Rptr., at 465, n. 15 (“[T)he unavoidably dangerous product doctrine merely exempts the product from a strict liability design defect analysis; a plaintiff remains free to pursue his design defect theory on the basis of negligence”); Toner, 112 Idaho, at 340, 732 P. 2d, at 309-310 (“The authorities universally agree that where a product is deemed unavoidably unsafe, the plaintiff is deprived of the advantage of a strict liability cause of action, but may proceed under a negligence cause of action”).
See 42 U. S. C. §262(a)(2)(C)(i)(I) (“The Secretary shall approve a bio-logies license application ... on the basis of a demonstration that . . . the biological product that is the subject of the application is safe, pure, and potent”).
See, e.g., Hurley v. Lederle Labs., 863 F. 2d 1173, 1177 (CA5 1988) (“[T]he FDA is a passive agency: it considers whether to approve vaccine designs only if and when manufacturers come forward with a proposal”); Jones v. Lederle Labs., 695 F. Supp. 700, 711 (EDNY 1988) (“[T]he agency takes the drugs and manufacturers as it finds them. While its goal is to oversee inoculation with the best possible vaccine, it is limited to reviewing only those drugs submitted by various manufacturers, regardless of their flaws”). Although the FDA has authority under existing regulations to revoke a manufacturer’s biologies licenses, that authority can be exercised only where (as relevant here) “[t]he licensed product is not safe and effective for all of its intended uses.” 21 CFR §601.5(b)(1)(vi) (2010); see § 600.3(p) (defining “safety” as “relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time”). The regulation does not authorize the FDA to revoke a biologies license for a manufacturer’s failure to adopt an optimal vaccine design in light of existing science and technology. See Conk, Is There a Design Defect in the Restatement (Third) of Torts: Products Liability? 109 Yale L. J. 1087, 1128-1129 (1999-2000) (“The FDA does not claim to review products for optimal design.... FDA review thus asks less of drug . . . manufacturers than the common law of products liability asks of other kinds of manufacturers”). At oral argument, counsel for amicus United States stated that the Centers for Disease Control and Prevention (CDC) routinely performs comparative analyses of vaccines that are already on the market. See Tr. of Oral Arg. 44-45; id., at 52-53 (describing CDC’s comparison of Sabin and Salk polio vaccines). Neither the United States nor any of the parties, however, has represented that CDC examines whether a safer alternative vaccine could have been designed given practical and scientific limits, the central inquiry in a state tort law action for design defect. CDC does not issue biologies licenses, moreover, and thus has no authority to require a manufacturer to adopt a different vaccine design.
Indeed, we observed in Levine that the FDA is perpetually understaffed and underfunded, see 555 U. S., at 578, n. 11, and the agency has been criticized in the past for its slow response in failing to withdraw or warn about potentially dangerous products, see, e. g., L. Leveton, H. Sox, & M. Stoto, Institute of Medicine, HIV and the Blood Supply: An Analysis of Crisis Decisionmaking (1995) (criticizing FDA response to transmission of AIDS through blood supply). These practical shortcomings reinforce the conclusion that “state law offers an additional, and important, layer of consumer protection that complements FDA regulation.” Levine, 555 U. S., at 579.
The majority mischaraeterizes my position as expressing a general “skeptictism] of pre-emption unless the congressional substitute operate[s] like the tort system.” Ante, at 240. Congress could, of course, adopt a regulatory regime that operates differently from state tort systems, and such a difference is not necessarily a reason to question Congress’ preemptive intent. In the specific context of the Vaccine Act, however, the relevant point is that this Court should not lightly assume that Congress intended sub silentio to displace a longstanding species of state tort liabil
The majority’s suggestion that “vaccine manufacturers fund from their sales” the compensation program is misleading. Ante, at 239. Although the manufacturers nominally pay the tax, the amount of the tax is specifically included in the vaccine price charged to purchasers. See CDC Vaccine Price List (Feb. 15, 2011), http://www.cdc.gov/vaccines/programs/vfc/ cdc-vac-price-list.htm. Accordingly, the only way the vaccine manufacturers can be said to actually “fund” the compensation program is if the cost
See Brief for United States as Amicus Curiae 28 (“Department of Justice records indicate that 99.8% of successful Compensation Program claimants have accepted their awards, forgoing any tort remedies against vaccine manufacturers”); S. Plotkin, W. Orenstein, & P. Offit, Vaccines 1673 (5th ed. 2008) (noting that “[virtually all .. . petitioners, even those who were not awarded compensation” under the compensation program, choose to accept the program's determination).
Justice Breyer's separate concurrence is even more explicitly policy driven, reflecting his own preference for the “more expert judgment” of federal agencies over the “less expert” judgment of juries. Ante, at 247.
Respondent notes that there are some 5,000 petitions alleging a causal link between certain vaeeines and autism spectrum disorders that are currently pending in an omnibus proceeding in the Court of Federal Claims (Vaccine Court). Brief for Respondent 56-57. According to respondent, a ruling that § 22(b)(1) does not pre-empt design defect claims could unleash a “crushing wave” of tort litigation that would bankrupt vaccine manufacturers and deplete vaccine supply. Id., at 28. This concern un
