Justice SCALIA delivered the opinion of the Court.
We consider whether a preemption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA)
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.
Much of the concern centered around vaccines against diphtheria, tetanus, and pertussis (DTP), which were blamed for children's disabilities and developmental delays. This led to a massive increase in vaccine-related tort litigation. Whereas between 1978 and 1981 only nine product-liability suits were filed against DTP manufacturers,
Despite the large number of suits, there were many complaints that obtaining compensation for legitimate vaccine-inflicted injuries was too costly and difficult.
To stabilize the vaccine market and facilitate compensation, Congress enacted the NCVIA in 1986. The Act establishes a no-fault compensation program "designed to work faster and with greater ease than the civil tort system." Shalala v. Whitecotton, 514 U.S. 268, 269, 115 S.Ct. 1477, 131 L.Ed.2d 374 (1995). A person injured by a vaccine, or his legal guardian, may file a petition for compensation in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent.
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 tortliability protections for vaccine manufacturers. The Act requires claimants to seek relief through the compensation program before filing suit for more than $1,000.
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.
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 preempted by 42 U.S.C. § 300aa-22(b)(1).
We set forth again the statutory text at issue:
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 was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore preempted.
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
A further textual indication leads to the same conclusion. Products-liability law establishes a classic and well known triumvirate of grounds for liability: defective manufacture, inadequate directions or warnings, and defective design.
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
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 had comment k in mind. "Unavoidable" is hardly a rarely used word. Even the cases petitioners cite as putting a definitive gloss on comment k use the precise phrase "unavoidably unsafe product";
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 case here.
The structure of the NCVIA and of vaccine regulation in general reinforces
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 preemption. 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.
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 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 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 "authoritative[ly]" vindicates its interpretation.
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,
That brings us to the second flaw in the dissent's syllogism: Comment k did not have a "commonly understood meaning"
* * *
For the foregoing reasons, we hold that the National Childhood Vaccine Injury Act preempts 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.
Justice KAGAN took no part in the consideration or decision of this case.
Justice BREYER, 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, like the dissent, I would look to
House Committee Report 99-908 contains an "authoritative" account of Congress' intent in drafting the pre-emption clause of the National Childhood Vaccine Injury Act of 1986 (NCVIA or Act). See Garcia v. United States, 469 U.S. 70, 76, 105 S.Ct. 479, 83 L.Ed.2d 472 (1984) ("[T]he authoritative source for finding the Legislature's intent lies in the Committee Reports on the bill"). That Report says that, "if" vaccine-injured persons
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 23, U.S.Code Cong. & Admin.News, 1986, at p. 6364 (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 the statute means the word "unavoidable" to summon up an otherwise unmentioned third exception encompassing suits based on design defects. Nor can the Report's reference to comment k fill the gap. The Report itself refers, not to comment k's details, but only to its "principle," namely, that vaccine manufacturers should not be held liable for unavoidable injuries. It says nothing at all about who—judge, jury, or federal safety agency—should decide whether a safer vaccine could have been designed. Indeed, at the time Congress wrote this Report, different state courts had come to very different conclusions about that matter. See Cupp, Rethinking Conscious Design Liability for Prescription Drugs: The Restatement (Third) Standard Versus a Negligence Approach, 63 Geo. Wash. L.Rev. 76, 79 (1994-1995) ("[C]ourts [had] adopted a broad range of conflicting interpretations" of comment k). Neither the word "unavoidable" nor the phrase "the principle of Comment k" tells us which courts' view Congress intended to adopt. Silence cannot tell us to follow those States where juries decided the design-defect question.
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, U.S.Code Cong. & Admin.News, 1986, at p. 6348; see ante, at 1072-1073. As the Committee Report makes clear, routine vaccination is "one of the most spectacularly effective public health initiatives this country has ever undertaken." H.R. Rep.,
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., 2d 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 "prompted manufacturers to question their continued participation in the vaccine market." H.R. Rep., at 4, U.S.Code Cong. & Admin.News, 1986, at p. 6345; Childhood Immunizations 85-86. Indeed, two whooping cough vaccine manufacturers withdrew from the market, and other vaccine manufacturers, "fac[ing] great difficulty in obtaining [product liability] insurance," told Congress that they were considering "a similar course of action." H.R. Rep., at 4, U.S.Code Cong. & Admin.News, 1986, at p. 6345; Childhood Immunizations 68-70. The Committee Report explains that, since there were only one or two manufacturers of many childhood vaccines, "[t]he loss of any of the existing manufacturers of childhood vaccines. . . could create a genuine public health hazard"; it "would present the very real possibility of vaccine shortages, and, in turn, increasing numbers of unimmunized children, and, perhaps, a resurgence of preventable diseases." H.R. Rep., at 5, U.S.Code Cong. & Admin.News, 1986, at p. 6346. At the same time, Congress sought to provide generous compensation to those whom vaccines injured—as determined by an expert compensation program. Id., at
Given these broad general purposes, to read the pre-emption clause as preserving design-defect 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. § 300aa-14; ante, at 1073-1074; 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 1073-1074; § 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 to be particularly severe—instances where Congress intended the contrary. That is because potential tort plaintiffs are unlikely to bring suit unless the specialized compensation program has determined that they are not entitled to compensation (say, because it concludes that the vaccine did not cause the injury). Brief for United States as Amicus Curiae 28 ("99.8% of successful Compensation Program claimants have accepted their awards, foregoing any tort remedies against vaccine manufacturers"). It is difficult to reconcile these potential conflicts and the resulting tort liabilities with a statute that seeks to diminish manufacturers' product liability while simultaneously augmenting the role of experts in making compensation decisions.
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 Curiae (hereinafter AAP Brief). The American Academy of Pediatrics has also supported the retention of vaccine manufacturer tort liability (provided that federal law structured state-law liability conditions in ways that would take proper account of federal agency views about safety). Hearings 14-15. But it nonetheless tells us here, in respect to the specific question before us, that the petitioners' interpretation of the Act would undermine its basic purposes by threatening to "halt the future production and development of childhood vaccines in this country," i.e., by "threaten[ing] a resurgence of the very problems which . . .
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., Inc., 529 U.S. 861, 883, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000) (internal quotation marks omitted); see Medtronic, Inc. v. Lohr, 518 U.S. 470, 506, 116 S.Ct. 2240, 135 L.Ed.2d 700 (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's 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, 65 S.Ct. 161, 89 S.Ct. 124 (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.
Justice SOTOMAYOR, with whom Justice GINSBURG joins, 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)(1), 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.
Section 22 of the Vaccine Act provides "[s]tandards of responsibility" to govern civil actions against vaccine manufacturers. 42 U.S.C. § 300aa-22. Section 22(a) sets forth the "[g]eneral 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:
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 side effects caused by something other than manufacturing and labeling defects. The only remaining kind of product defect recognized under traditional products liability law is a design defect. Thus, "side effects that were unavoidable" must refer to side effects caused by a vaccine's design that were "unavoidable." Because § 22(b)(1) uses the conditional term "if," moreover, the text plainly implies that some side effects stemming from a vaccine's design are "unavoidable," while others are avoidable. See Webster's Third New International Dictionary 1124 (2002) ("if" means "in the event that," "so long as," or "on condition that"). Accordingly, because the "if" clause (like the "even though" clause) sets forth a condition to invoke § 22(b)(1)'s defense to tort liability, Congress must also have intended a vaccine manufacturer to demonstrate in each civil action that the particular side effects of a vaccine's design were "unavoidable."
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
Indeed, when Congress intends to preempt 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), U.S.Code Cong. & Admin.News, 1986, p. 6344 (hereinafter 1986 Report), explains in relevant part:
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, U.S.Code Cong. & Admin.News, 1986, at p. 6367. 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)(1); see Restatement 353-354 ("Such a[n unavoidably unsafe] product, properly prepared, and accompanied by proper directions and warning, is not defective"). By the time of the Vaccine Act's enactment in 1986, numerous state and federal courts had interpreted comment k to mean that a product is "unavoidably unsafe" when, given proper manufacture and labeling, no feasible alternative design would reduce the safety risks without compromising the product's cost and utility.
The 1986 Report thus confirms petitioners' interpretation of § 22(b)(1). The 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 "unavoidable," moreover, the Report also confirms that whether a side effect is "unavoidable"
In addition to the 1986 Report, one other piece of the Act's legislative history provides further confirmation of the petitioners' textual reading of § 22(b)(1). When Congress enacted the Vaccine Act in 1986, it did not initially include a source of payment for the no-fault compensation program the Act established. The Act thus "made the compensation program and accompanying tort reforms contingent on the enactment of a tax to provide funding for the compensation." 1987 Report 690, U.S.Code Cong. & Admin.News, 1987, at p. 2313-690. In 1987, Congress passed legislation to fund the compensation program. The House Energy and Commerce Committee Report
To be 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, 110 S.Ct. 2658, 110 L.Ed.2d 563 (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.
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 Vaccine 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 1075. 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 1087. 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 1075, entirely ignores the fact that removing the "harmful element" will often result in a less effective (or entirely ineffective) vaccine. A vaccine, by its nature, ordinarily employs a killed or weakened form of a bacteria or virus to stimulate antibody production;
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, 122 S.Ct. 441, 151 L.Ed.2d 339 (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 be superfluous, void, or insignificant" (internal quotation marks omitted)).
In Bates v. Dow Agrosciences LLC, 544 U.S. 431, 125 S.Ct. 1788, 161 L.Ed.2d 687 (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, 125 S.Ct. 1788 (quoting 7 U.S.C. § 136v(b) (2000 ed.)). The Bates Court stated:
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, 121 S.Ct. 2120, 150 L.Ed.2d 251 (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
Strikingly, the majority concedes that its interpretation renders 13 words of the statute entirely superfluous. See ante, at 1078 ("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." Ibid. As explained above, however, the "even though" clause establishes two additional prerequisites—proper manufacturing and proper labeling—to qualify for § 22(b)(1)'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's only other textual argument is based on the expressio unius, exclusio alterius canon. According to the majority, because blackletter products liability law generally recognizes three different types of product defects, "[i]f all three were intended to be preserved, it would be strange [for Congress] to mention specifically only two"—namely, manufacturing and labeling defects in the "even though" clause—"and leave the third to implication." Ante, at 1076. The majority's argument, however, ignores that the default rule under the Vaccine Act is that state law is preserved. As explained above, § 22(a) expressly provides that the "[g]eneral rule" is that "State law shall apply to a civil action brought for damages for a vaccine-related injury or death." 42 U.S.C. § 300aa-22(a). Because § 22(a) already preserves state-law design defect claims (to the extent the exemption in § 22(b)(1) does not apply), there was no need for Congress separately and expressly
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 1076 (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, U.S.Code Cong. & Admin.News, 1986, at p. 6367; 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,
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 1078-1079. 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 1079-1080, and nn. 57-60 (citing 42 U.S.C. §§ 300aa-1, 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 scientific advances.
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, U.S.Code Cong. & Admin.News, 1986, at p. 6348. 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(c), 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)(1)'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 1080.
I respectfully dissent.
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, 245 Cal.Rptr. 412, 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 Pharm. Corp., 637 F.2d 87, 90-91 (C.A.2 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 (D.Md.1975); Basko v. Sterling Drug, Inc., 416 F.2d 417, 425 (C.A.2 1969) (applying Conn. law).
"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 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.