BRUESEWITZ v. WYETH INC.
Two hours after Hannah Bruesewitz received her six-month diphtheria, tetanus and pertussis vaccine in 1992, she started developing seizures and was hospitalized for weeks. Hannah has continued to suffer from residual seizure disorder that requires her to receive constant care, according to her parents. When their daughter was three-years-old, Russell and Robalee Bruesewitz filed a petition seeking compensation for her injuries. One month prior to the petition, new regulations eliminated Hannah's seizure disorder from the list of compensable injuries. The family's petition was denied. Three years later, in 1998, the drug company Wyeth withdrew the type of vaccine used in Hannah's inoculation from the market.
The Bruesewitzes filed a lawsuit against Wyeth in state court in Pennsylvania. They claimed the drug company failed to develop a safer vaccine and should be held accountable for preventable injuries caused by the vaccine's defective design. A federal judge dismissed the lawsuit, ruling that the National Childhood Vaccine Injury Act protected Wyeth from lawsuits over vaccine injury claims. The U.S. Court of Appeals for the 3rd Circuit affirmed.
- Brief of Vaccine Injured Petitioners
- Brief of Amici Curiae Kenneth W. Starr And Erwin Chemerinsky In Support of Petitioners Urging Reversal
- Brief Amici Curiae of the American Academy of Pediatrics And 21 Other Physician And Public Health Organizations In Support of Respondent
- Brief of Glaxosmithkline Llc, Merck Sharp & Dohme Corp. (formerly Known as Merck & Co., Inc.), And Sanofi Pasteur Inc. as Amici Curiae In Support of Respondent
- Brief of Washington Legal Foundation as Amicus Curiae In Support of Respondent
Can a federal law shield vaccine manufacturers from certain product liability lawsuits in state court that seek damages for serious health problems suffered by children?
Legal provision: National Childhood Vaccine Injury Act of 1986
Yes. The Supreme Court affirmed the lower court decision in an opinion by Justice Antonin Scalia. The majority reasoned that Congress had set up a special vaccine court as a way to provide compensation to injured children without driving drug manufacturers from the vaccine market. Justice Stephen Breyer filed a concurring opinion. Justice Sonia Sotomayor filed a dissenting opinion, joined by Justice Ruth Bader Ginsburg. Justice Elena Kagan took no part in consideration of the case.
SUPREME COURT OF THE UNITED STATES
RUSSELL BRUESEWITZ, et al., PETITIONERS v. WYETH LLC, fka WYETH, INC., fka WYETH LABORATORIES, et al.
on writ of certiorari to the united states court of appeals for the third circuit
[February 22, 2011]
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)[Footnote 1] bars state-law design-defect claims against vaccine manufacturers.
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.[Footnote 2] Under that regime, the elimination of communicable diseases through vaccination became “one of the greatest achievements” of public health in the 20th century.[Footnote 3] But in the 1970’s and 1980’s vaccines became, one might say, victims of their own success. They had been so effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases,[Footnote 4] and much more concerned with the risk of injury from the vaccines themselves.[Footnote 5]
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, by the mid-1980’s the suits numbered more than 200 each year.[Footnote 6] This destabilized the DTP vaccine market, causing two of the three domestic manufacturers to withdraw; and the remaining manufacturer, Lederle Laboratories, estimated that its potential tort liability exceeded its annual sales by a factor of 200.[Footnote 7] Vaccine shortages arose when Lederle had production problems in 1984.[Footnote 8]
Despite the large number of suits, there were many complaints that obtaining compensation for legitimate vaccine-inflicted injuries was too costly and difficult.[Footnote 9] A significant number of parents were already declining vaccination for their children,[Footnote 10] and concerns about compensation threatened to depress vaccination rates even further.[Footnote 11] This was a source of concern to public health officials, since vaccines are effective in preventing outbreaks of disease only if a large percentage of the population is vaccinated.[Footnote 12]
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 (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.[Footnote 13] A special master then makes an informal adjudication of the petition within (except for two limited exceptions) 240 days.[Footnote 14] The Court of Federal Claims must review objections to the special master’s decision and enter final judgment under a similarly tight statutory deadline.[Footnote 15] At that point, a claimant has two options: to accept the court’s judgment and forgo a traditional tort suit for damages, or to reject the judgment and seek tort relief from the vaccine manufacturer.[Footnote 16] 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.[Footnote 17] Claimants who show that a listed injury first manifested itself at the appropriate time are prima facie entitled to compensation.[Footnote 18] No showing of causation is necessary; the Secretary bears the burden of disproving causation.[Footnote 19] A claimant may also recover for unlisted side effects, and for listed side effects that occur at times other than those specified in the Table, but for those the claimant must prove causation.[Footnote 20] Unlike in tort suits, claimants under the Act are not required to show that the administered vaccine was defectively manufactured, labeled, or designed.
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.[Footnote 21] Attorney’s fees are provided, not only for successful cases, but even for unsuccessful claims that are not frivolous.[Footnote 22] These awards are paid out of a fund created by an excise tax on each vaccine dose.[Footnote 23]
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.[Footnote 24] Manufacturers are generally immunized from liability for failure to warn if they have complied with all regulatory requirements (including but not limited to warning requirements) and have given the warning either to the claimant or the claimant’s physician.[Footnote 25] They are immunized from liability for punitive damages absent failure to comply with regulatory requirements, “fraud,” “intentional and wrongful withholding of information,” or other “criminal or illegal activity.”[Footnote 26] And most relevant to the present case, the Act expressly eliminates liability for a vaccine’s unavoidable, adverse side effects:
“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.”[Footnote 27]
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.[Footnote 28] She suffered over 100 seizures during the next month, and her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.”[Footnote 29] Hannah, now a teenager, is still diagnosed with both conditions.
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.[Footnote 30] A Special Master denied their claims on various grounds, though they were awarded $126,800 in attorney’s fees and costs. The Bruesewitzes elected to reject the unfavorable judgment, and in October 2005 filed this lawsuit in Pennsylvania state court. Their complaint alleged (as relevant here) that defective design of Lederle’s DTP vaccine caused Hannah’s disabilities, and that Lederle was subject to strict liability, and liability for negligent design, under Pennsylvania common law.[Footnote 31]
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).[Footnote 32] The United States Court of Appeals for the Third Circuit affirmed.[Footnote 33] We granted certiorari. 559 U. S. ___ (2010).
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.”[Footnote 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 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 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.[Footnote 35]
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.[Footnote 36] If all three were intended to be preserved, it would be strange to mention specifically only two, and leave the third to implication. It would have been much easier (and much more natural) to provide that manufacturers would be liable for “defective manufacture, defective directions or warning, and defective design.” It seems that the statute fails to mention design-defect liability “by deliberate choice, not inadvertence.” Barnhart v. Peabody Coal Co., 537 U. S. 149, 168 (2003). Expressio unius, exclusio alterius.
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.”[Footnote 37] We do not comprehend, however, the second step of its reasoning, which is that the use of the conditional term “if ” in the introductory phrase “if the injury or death resulted from side effects that were unavoidable” “plainly implies that some side effects stemming from a vaccine’s design are ‘unavoidable,’ while others are avoidable.”[Footnote 38] That is not so. The “if ” clause makes total sense whether the design to which “unavoidable” refers is (as the dissent believes) any feasible design (making the side effects of the design used for the vaccine at issue avoidable), or (as we believe) the particular design used for the vaccine at issue (making its side effects unavoidable). Under the latter view, the condition established by the “if” clause is that the vaccine have been properly labeled and manufactured; and under the former, that it have been properly designed, labeled, and manufactured. Neither view renders the “if ” clause a nullity. Which of the two variants must be preferred is addressed by our textual analysis, and is in no way determined by the “if ” clause.
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).[Footnote 39] The Restatement generally holds a manufacturer strictly liable for harm to person or property caused by “any product in a defective condition unreasonably dangerous to the user.”[Footnote 40] Comment k exempts from this strict-liability rule “unavoidably unsafe products.” An unavoidably unsafe product is defined by a hodge-podge of criteria and a few examples, such as the Pasteur rabies vaccine and experimental pharmaceuticals. Despite this lack of clarity, petitioners seize upon one phrase in the comment k analysis, and assert that by 1986 a majority of courts had made this a sine qua non requirement for an “unavoidably unsafe product”: a case-specific showing that the product was “quite incapable of being made safer for [its] intended … use.”[Footnote 41]
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”;[Footnote 42] none attaches special significance to the term “unavoidable” standing alone.
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.[Footnote 43] But petitioners’ reading eliminates any opposition between the “even though” clause—called a concessive subordinate clause by grammarians—and the word “unavoidable.”[Footnote 44] Their reading makes preemption turn equally on unavoidability, proper preparation, and proper labeling. Thus, the dissent twice refers to the requirements of proper preparation and proper labeling as “two additional prerequisites” for preemption independent of unavoidability.[Footnote 45] The primary textual justification for the dissent’s position depends on that independence.[Footnote 46] But linking independent ideas is the job of a coordinating junction like “and,” not a subordinating junction like “even though.”[Footnote 47]
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.[Footnote 48] To be sure, petitioners’ and the dissent’s interpretation gives independent meaning to the intervening passage (the supposed meaning of comment k); but it does so only at the expense of rendering the remainder of the provision superfluous. Since a vaccine is not “quite incapable of being made safer for [its] intended use” if manufacturing defects could have been eliminated or better warnings provided, the entire “even though” clause is a useless appendage.[Footnote 49] It would suffice to say “if the injury or death resulted from side effects that were unavoidable”—full stop.
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.[Footnote 50] Manufacturers ordinarily must obtain the Food and Drug Administration’s (FDA) approval before modifying either.[Footnote 51] Deviations from the license thus provide objective evidence of manufacturing defects or inadequate warnings. Further objective evidence comes from the FDA’s regulations—more than 90 of them[Footnote 52]—that pervasively regulate the manufacturing process, down to the requirements for plumbing and ventilation systems at each manufacturing facility.[Footnote 53] Material noncompliance with any one of them, or with any other FDA regulation, could cost the manufacturer its regulatory-compliance defense.[Footnote 54]
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.[Footnote 55] And the decision is surely not an easy one. Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. Striking the right balance between safety and efficacy is especially difficult with respect to vaccines, which affect public as well as individual health. Yet the Act, which in every other respect micromanages manufacturers, is silent on how to evaluate competing designs. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution (an approval it takes years to obtain[Footnote 56])? Or does it suffice that a vaccine design has been approved in other countries? Or could there be liability for failure to use a design that exists only in a lab? Neither the Act nor the FDA regulations provide an answer, leaving the universe of alternative designs to be limited only by an expert’s imagination.
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 exten- sive 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.”[Footnote 57] It establishes a National Vaccine Program, whose Director is “to achieve optimal prevention of human infectious diseases … and to achieve optimal prevention against adverse reactions.”[Footnote 58] The Program is to set priorities for federal vaccine research, and to coordinate federal vaccine safety and efficacy testing.[Footnote 59] The Act requires vaccine manufacturers and health-care providers to report adverse side effects,[Footnote 60] and provides for monitoring of vaccine safety through a collaboration with eight managed-care organizations.[Footnote 61] And of course whenever the FDA concludes that a vaccine is unsafe, it may revoke the license.[Footnote 62]
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.[Footnote 63]
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;[Footnote 64] in exchange they avoid costly tort litigation and the occasional disproportionate jury verdict.[Footnote 65] But design-defect allegations are the most speculative and difficult type of products liability claim to litigate. Taxing vaccine manufacturers’ product to fund the compensation program, while leaving their liability for design defect virtually unaltered, would hardly coax manufacturers back into the market.
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.[Footnote 66] That is a novel suggestion. Although we previously have expressed doubt that Congress would quietly preempt product-liability claims without providing a federal substitute, see Medtronic, Inc. v. Lohr, 518 U. S. 470, 486–488 (1996) (plurality opinion), we have never suggested we would be skeptical of preemption unless the congressional substitute operated like the tort system. We decline to adopt that stance today. The dissent’s belief that the FDA and the National Vaccine Program cannot alone spur adequate vaccine innovation is probably questionable, but surely beside the point.
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);”[Footnote 67] in 1986 comment k was “commonly understood” to require a case-specific showing that “no feasible alternative design” existed; Congress therefore must have intended §300aa–22(b)(1) to require that showing.[Footnote 68] The syllogism ignores unhelpful statements in the Report and relies upon a term of art that did not exist in 1986.
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.[Footnote 69] Eliminating that concern is why the Report’s authors “strongly believ[e] that Comment k is appropriate and necessary as the policy for civil actions seeking damages in tort.”[Footnote 70] The dissent’s interpretation of §300aa–22(b)(1) and its version of “the principle in Comment K” adopted by the 1986 Report leave that concern unaddressed.
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.”[Footnote 71] That counsel echoes our interpretation of §300aa–22(b)(1).
Not to worry, the dissent retorts, a Committee Report by a later Congress “authoritative[ly]” vindicates its interpretation.[Footnote 72] Post-enactment legislative history (a contradiction in terms) is not a legitimate tool of statutory interpretation. See Jones v. United States, 526 U. S. 227, 238 (1999); United States v. Mine Workers, 330 U. S. 258, 281–282 (1947). Real (pre-enactment) legislative history is persuasive to some because it is thought to shed light on what legislators understood an ambiguous statutory text to mean when they voted to enact it into law. See Exxon Mobil Corp. v. Allapattah Services, Inc., 545 U. S. 546, 568 (2005). But post-enactment legislative history by definition “could have had no effect on the congressional vote,” District of Columbia v. Heller, 554 U. S. 570, 605 (2008).
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,[Footnote 73] and that the supposedly dispositive Committee Report is attached to that funding legislation.[Footnote 74] Those who voted on the relevant statutory language were not necessarily the same persons who crafted the statements in the later Committee Report; or if they were did not necessarily have the same views at that earlier time; and no one voting at that earlier time could possibly have been informed by those later statements. Permitting the legislative history of subsequent funding legislation to alter the meaning of a statute would set a dangerous precedent. Many provisions of federal law depend on appropriations or include sunset provisions;[Footnote 75] they cannot be made the device for unenacted statutory revision.
That brings us to the second flaw in the dissent’s syllogism: Comment k did not have a “commonly understood meaning”[Footnote 76] in the mid-1980’s. Some courts thought it required a case-specific showing that a product was “unavoidably unsafe”; many others thought it categorically exempted certain types of products from strict liability.[Footnote 77] When “all (or nearly all) of the” relevant judicial decisions have given a term or concept a consistent judicial gloss, we presume Congress intended the term or concept to have that meaning when it incorporated it into a later-enacted statute. Merck & Co. v. Reynolds, 559 U. S. ___, ___ (2010) (Scalia, J., concurring in part and concurring in judgment) (slip op., at 5). The consistent gloss represents the public understanding of the term. We cannot make the same assumption when widespread disagreement exists among the lower courts. We must make do with giving the term its most plausible meaning using the traditional tools of statutory interpretation. That is what we have done today.
* * *
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.Footnote 1
42 U. S. C. §300aa–22(b)(1).Footnote 2
See P. Hutt, R. Merrill, & L. Grossman, Food and Drug Law 912–913, 1458 (3d ed. 2007).Footnote 3
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).Footnote 4
See Mortimer, Immunization Against Infectious Disease, 200 Science 902, 906 (1978).Footnote 5
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/vaccine-safety-review.pdf (as visited Feb. 18, 2011, and available in Clerk of Court’s case file).Footnote 6
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. William eds. 1996).Footnote 7
See id., at 52.Footnote 8
See Centers for Disease Control, Diptheria-Tetanus-Pertussis Vaccine Shortage, 33 Morbidity and Mortality Weekly Report 695–696 (Dec. 14, 1984).Footnote 9
See Apolinsky & Van Detta, Rethinking Liability for Vaccine 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).Footnote 10
Mortimer, supra, at 906.Footnote 11
See Hagan, 45 Food Drug Cosm. L. J. 477, 479 (1990).Footnote 12
See R. Merrill, Introduction to Epidemiology 65–68 (2010).Footnote 13
See 42 U. S. C. §300aa–11(a)(1).Footnote 14
See §300aa–12(d)(3).Footnote 15
See §300aa–12(e), (g).Footnote 16
See §300aa–21(a).Footnote 17
See §300aa–14(a); 42 CFR §100.3 (2009) (current Vaccine Injury Table).Footnote 18
See 42 U. S. C. §§300aa–11(c)(1), 300aa–13(a)(1)(A).Footnote 19
See §300aa–13(a)(1)(B).Footnote 20
See §300aa–11(c)(1)(C)(ii).Footnote 21
See §300aa–15(a).Footnote 22
See §300aa–15(e).Footnote 23
See §300aa–15(i)(2); 26 U. S. C. §§4131, 9510.Footnote 24
See 42 U. S. C. §300aa–11(a)(2).Footnote 25
See §300aa–22(b)(2), (c). The immunity does not apply if the plaintiff establishes by clear 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).Footnote 26
See Bruesewitz v. Secretary of Health and Human Servs., No. 95–0266V, 2002 WL 31965744, *3 (Ct. Cl., Dec. 20, 2002).Footnote 29
561 F. 3d 233, 236 (CA3 2009).Footnote 30
See id., at *1.Footnote 31
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.Footnote 32
See id., at 237–238.Footnote 33
Id., at 235.Footnote 34
42 U. S. C. §300aa–22(b)(1).Footnote 35
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 15 (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 13–14. We have no idea how much more expensive an alternative design can be before it “compromis[es]” 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.Footnote 36
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).Footnote 37
Post, at 3.Footnote 38
See Brief for Petitioners 29.Footnote 40
Restatement §402A, p. 347.Footnote 41
Id., Comment k, p. 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 Memorial 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 Pharm. 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 (D Md. 1975); Basko v. Sterling Drug, Inc., 416 F. 2d 417, 425 (CA2 1969) (applying Conn. law).Footnote 42
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 Memorial 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).Footnote 43
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 17, n. 14. “Even though” is a close cousin of the latter. See Webster’s New International Dictionary 709, 2631 (2d ed. 1957). The statement “the car 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.)Footnote 44
See W. Follett, Modern American Usage: A Guide 61 (1966).Footnote 45
Post, at 9, 17.Footnote 46
Post, at 3–5.Footnote 47
The dissent responds that these “additional prerequisites” act “in a concessive, subordinating fashion,” post, at 17, 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 concessive, subordinating role to play.Footnote 48
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).Footnote 49
That is true regardless of whether §300aa–22(b)(1) incorporates comment k. See Restatement §402A, Comment k, pp. 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”).Footnote 50
See 42 U. S. C. §262(a), ( j); 21 CFR §§601.2(a), 314.105(b) (2010).Footnote 51
See §601.12.Footnote 52
See §§211.1 et seq., 600.10–600.15, 600.21–600.22, 820.1 et seq.Footnote 53
See §§211.46, 211.48.Footnote 54
See 42 U. S. C. §300aa–22(b)(2).Footnote 55
Hutt, Merrill, & Grossman, Food and Drug Law, at 685, 891.Footnote 56
See Sing & William, Supplying Vaccines, at 66–67.Footnote 57
42 U. S. C. §300aa–27(a)(1).Footnote 58
See §§300aa–2(a)(1)–(3), 300aa–3.Footnote 60
See §300aa–25(b).Footnote 61
See NVAC 18–19.Footnote 62
See 21 CFR §601.5(b)(1)(vi) (2010).Footnote 63
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 26. 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.Footnote 64
See 42 U. S. C. §300aa–15(i)(2); Pub. L. 99–660, §323(a), 100 Stat. 3784. The dissent’s unsupported speculation that demand in the vaccine market is inelastic, see post, at 24, 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-economics scholars.Footnote 65
See 42 U. S. C. §§300aa–11(a)(2), 300aa–22.Footnote 66
See post, at 21–24.Footnote 67
H. R. Rep. No. 99–908, pt. 1, p. 25 (1986) (hereinafter 1986 Report).Footnote 68
Post, at 7–8.Footnote 69
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”).Footnote 70
Post, at 12. 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).Footnote 73
Pub. L. 99–960, §323(a), 100 Stat. 3784.Footnote 74
H. R. Rep. No. 100–391, pt. 1, p. 701 (1987).Footnote 75
See, e.g., Pub. L. 104–208, §§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).Footnote 76
Post, at 8.Footnote 77
See n. 39, supra; post, at 7–8, n. 5.
562 U. S. ____ (2011)
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562 U. S. ____ (2011)
SUPREME COURT OF THE UNITED STATES
RUSSELL BRUESEWITZ, et al., PETITIONERS v. WYETH LLC, fka WYETH, INC., fka WYETH LABORATORIES, et al.
on writ of certiorari to the united states court of appeals for the third circuit
[February 22, 2011]
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 other sources, including legislative history, statutory purpose, and the views of the federal administrative agency, here supported by expert medical opinion. Unlike the dissent, however, I believe these other sources reinforce the Court’s conclusion.
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 (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
“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. 24 (1986) (hereinafter H. R. Rep.).
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 (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; see ante, at 2–3. 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., 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://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); Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diptheria Toxoid and Acellular Pertussis Vaccines, 55 Morbidity and Mortality Weekly Report, No. RR–3, p. 2 (Mar. 24, 2006) (hereinafter Preventing Tetanus) (statistics for 1934–1943), http://www.cdc.gov/mmwr/PDF/rr/rr5503.pdf; U. S. Dept. of Health and Human Services, Centers for Disease Control and Prevention, Epidemiology and Prevention of Vaccine-Preventable Diseases 200 (11th ed. rev. May 2009). After vaccination became common, the number of annual cases of whooping cough declined from over 200,000 to about 2,300, and the number of deaths from about 4,000 to about 12. Preventing Tetanus 2; Childhood Immunizations, House Committee on Energy and Commerce, 99th Cong., 2d Sess., 10 (Comm. Print 1986) (hereinafter Childhood Immunizations).
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 Re- port (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; 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; 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. At the same time, Congress sought to provide generous compensation to those whom vaccines injured—as determined by an expert compensation program. Id., at 5, 24.
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 In- jury Table. 42 U. S. C. §300aa–14; ante, at 3–4; 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 3–4; §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 . . . caused Congress to intervene” by enacting this statute. AAP Brief 24 (internal quotation marks omitted).
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 (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’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 (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.
562 U. S. ____ (2011)
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562 U. S. ____ (2011)
SUPREME COURT OF THE UNITED STATES
RUSSELL BRUESEWITZ, et al., PETITIONERS v. WYETH LLC, fka WYETH, INC., fka WYETH LABORATORIES, et al.
on writ of certiorari to the united states court of appeals for the third circuit
[February 22, 2011]
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:
“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).[Footnote 1] The reference in the “even though” clause to a “properly prepared” vaccine “accompanied by proper directions and warnings” is an obvious reference to two such defects—manufacturing and labeling defects. The plain terms of the “even though” clause thus indicate that §22(b)(1) applies only where neither kind of defect is present. Because §22(b)(1) is invoked by vaccine manufacturers as a defense to tort liability, it follows that the “even though” clause requires a vaccine manufacturer in each civil action to demonstrate that its vaccine is free from manufacturing and labeling defects to fall within the liability exemption of §22(b)(1).[Footnote 2]
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 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 conditional “if ” clause in §22(b)(1) to denote a categorical exemption from liability. Cf. Erlenbaugh v. United States, 409 U. S. 239, 243 (1972) (“[A] legislative body generally uses a particular word with a consistent meaning in a given context”).
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.[Footnote 3]
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 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.[Footnote 4] As “[a]n outstanding example” of an “[u]navoidably unsafe” product, comment k cites “the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected”; “[s]ince 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.” Id., at 353. Comment k thus provides that “seller[s]” of “[u]navoidably unsafe” products are “not to be held to strict liability” provided that such products “are properly prepared and marketed, and proper warning is given.” Ibid.
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)(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.[Footnote 5] Given Congress’ expressed intent to codify the “principle in Comment K,” 1986 Report 26, the term “unavoidable” in §22(b)(1) is best understood as a term of art, which incorporates the commonly understood meaning of “unavoidably unsafe” products under comment k at the time of the Act’s enactment in 1986. See McDermott Int’l, Inc. v. Wilander, 498 U. S. 337, 342 (1991) (“[W]e assume that when a statute uses … a term [of art], Congress intended it to have its established meaning”); Morissette v. United States, 342 U. S. 246, 263 (1952) (same).[Footnote 6] Similarly, courts applying comment k had long required manufacturers invoking the defense to demonstrate that their products were not only “unavoidably unsafe” but also properly manufactured and labeled.[Footnote 7] By requiring “prope[r] prepar[ation]” and “proper directions and warnings” in §22(b)(1), Congress plainly intended to incorporate these additional comment k requirements.
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” for purposes of §22(b)(1) involves a specific inquiry in each case as to whether the vaccine “in the present state of human skill and knowledge cannot be made safe,” 1986 Report 26—i.e., whether a feasible alternative design existed that would have eliminated the adverse side effects of the vaccine without compromising its cost and utility. See Brief for Kenneth W. Starr et al. as Amici Curiae 14–15 (“If a particular plaintiff could show that her injury at issue was avoidable … through the use of a feasible alternative design for a specific vaccine, then she would satisfy the plain language of the statute, because she would have demonstrated that the side effects were not unavoidable”). Finally, the Report confirms that the “even though” clause is properly read to establish two additional prerequisites—proper manufacturing and proper labeling—to qualify for §22(b)(1)’s liability exemption.[Footnote 8]
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. In 1987, Congress passed legislation to fund the compensation program. The House Energy and Commerce Committee Report[Footnote 9] accompanying that legislation specifically stated that “the codification of Comment (k) of The Restatement (Second) of Torts was not intended to decide as a matter of law the circumstances in which a vaccine should be deemed unavoidably unsafe.” Id., at 691. The Committee noted that “[a]n amendment to establish … that a manufacturer’s failure to develop [a] safer vaccine was not grounds for liability was rejected by the Committee during its original consideration of the Act.” Ibid. In light of that rejection, the Committee emphasized that “there should be no misunderstanding that the Act undertook to decide as a matter of law whether vaccines were unavoidably unsafe or not,” and that “[t]his question is left to the courts to determine in accordance with applicable law.” Ibid.
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 (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).[Footnote 10] Congress in 1987 had a number of options before it, including adopting an entirely different compensation scheme, as the Reagan administration was proposing;[Footnote 11] establishing different limitations on tort liability, including eliminating design defect liability, as pharmaceutical industry leaders were advocating;[Footnote 12] or not funding the compensation program at all, which would have effectively nullified the relevant portions of the Act. Because the tort reforms in the 1986 Act, including §22(b)(1), had no operative legal effect unless and until Congress provided funding for the compensation program, the views of the Congress that enacted that funding legislation are a proper and, indeed, authoritative guide to the meaning of §22(b)(1). Those views, as reflected in the 1987 Report, provide unequivocal confirmation of petitioners’ reading of §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 vio-lence 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 7. 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 3. 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 7, 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;[Footnote 13] removing that bacteria or virus might remove the “harmful element,” but it would also necessarily render the vaccine inert. As explained above, the legislative history of the Vaccine Act and the cases interpreting comment k make clear that a side effect is “unavoidable” for purposes of §22(b)(1) only where there is no feasible alternative design that would eliminate the side effect of the vaccine without compromising its cost and utility. See supra, at 7. The majority’s premise—that side effects stemming from a vaccine’s design are always avoidable—is thus belied by the statutory text and legislative history of §22(b)(1). And because its starting premise is invalid, its conclusion—that the design of a vaccine is not subject to challenge in a tort action—is also necessarily invalid.
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 be superfluous, void, or insignificant” (internal quotation marks omitted)).
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 pre-emption of all state” design defect claims, the fact “[t]hat Congress added the remainder of the provision” is strong evidence of its intent not to pre-empt design defect claims categorically. Bates, 544 U. S., at 449; see also American Home Prods. Corp. v. Ferrari, 284 Ga. 384, 393, 668 S. E. 2d 236, 242 (2008) (“ ‘If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly’ ” (quoting Bates, 544 U. S., at 449)), cert. pending, No. 08–1120.
Strikingly, the majority concedes that its interpretation renders 13 words of the statute entirely superfluous. See ante, at 12 (“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.[Footnote 14]
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 8. 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 to preserve design defect claims in §22(b)(1). Indeed, Congress’ principal aim in enacting §22(b)(1) was not to preserve manufacturing and labeling claims (those, too, were already preserved by §22(a)), but rather, to federalize comment k-type protection for “unavoidably unsafe” vaccines. The “even though” clause simply functions to limit the applicability of that defense. The lack of express language in §22(b)(1) specifically preserving design defect claims thus cannot fairly be understood as impliedly (and categorically) pre-empting such traditional state tort claims, which had already been preserved by §22(a).[Footnote 15]
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 8 (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,[Footnote 16] while many others had not addressed the applicability of comment k specifically to vaccines or applied comment k to civil actions proceeding on a theory other than strict liability (e.g., negligence[Footnote 17]). A statute that simply stated that vaccine manufacturers would be liable for “defective design” would be silent as to the availability of a comment k-type defense for “unavoidably unsafe” vaccines, and thus would not have fully achieved Congress’ aim of extending greater liability protection to vaccine manufacturers by providing comment k-type protection in all civil actions as a matter of federal law.
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 13. 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.”[Footnote 18] Ibid. And yet it is undisputed that prior to the Act, vaccine manufacturers had long been subject to liability under state tort law for defective vaccine design. That the Vaccine Act did not itself set forth a comprehensive regulatory scheme with respect to design defects is thus best understood to mean not that Congress suddenly decided to change course sub silentio and pre-empt a longstanding, traditional category of state tort law, but rather, that Congress intended to leave the status quo alone (except, of course, with respect to those aspects of state tort law that the Act expressly altered). See 1987 Report 691 (“It is not the Committee’s intention to preclude court actions under applicable law. The Committee’s intent at the time of considering the Act … was … to leave otherwise applicable law unaffected, except as expressly altered by the Act”).
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 14, 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.[Footnote 19] Rather, the function of ensuring that vaccines are optimally designed in light of existing science and technology has traditionally been left to the States through the imposition of damages for design defects. Cf. Bates, 544 U. S., at 451 (“ ‘[T]he specter of damage actions may provide manufacturers with added dynamic incentives to continue to keep abreast of all possible injuries stemming from use of their product[s] so as to forestall such actions through product improvement’ ”); Wyeth v. Levine, 555 U. S. ___, ___ (2009) (slip op., at 22–23) (noting that the FDA has “traditionally regarded state law as a complementary form of drug regulation” as “[s]tate tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly”).[Footnote 20] The importance of the States’ traditional regulatory role is only underscored by the unique features of the vaccine market, in which there are “only one or two manufacturers for a majority of the vaccines listed on the routine childhood immunization schedule.” Brief for Respondent 55. The normal competitive forces that spur innovation and improvements to existing product lines in other markets thus operate with less force in the vaccine market, particularly for vaccines that have already been released and marketed to the public. Absent a clear statutory mandate to the contrary, there is no reason to think that Congress intended in the vaccine context to eliminate the traditional incentive and deterrence functions served by state tort liability in favor of a federal regulatory scheme providing only carrots and no sticks.[Footnote 21] See Levine, 555 U. S., at ___ (slip op., at 18) (“The case for federal pre-emption is particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest, and has nonetheless decided to stand by both concepts and to tolerate whatever tension there is between them.” (internal quotation marks and alteration omitted)).
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.[Footnote 22] Through that program, Congress relieved vaccine manufacturers of the burden of compensating victims of vaccine-related injuries in the vast majority of cases[Footnote 23]—an extremely significant economic benefit that “functionally creat[es] a valuable insurance policy for vaccine-related injuries.” Reply Brief for Petitioners 10. The structure and legislative history, moreover, point clearly to Congress’ intention to divert would-be tort claimants into the compensation program, rather than eliminate a longstanding category of traditional tort claims. See 1986 Report 13 (“The Committee anticipates that the speed of the compensation program, the low transaction costs of the system, the no-fault nature of the required findings, and the relative certainty and generosity of the system’s awards will divert a significant number of potential plaintiffs from litigation”). Indeed, although complete pre-emption of tort claims would have eliminated the principal source of the “unpredictability” in the vaccine market, Congress specifically chose not to pre-empt state tort claims categorically. See 42 U. S. C. §300aa–22(a) (providing as a “[g]eneral rule” that “State law shall apply to a civil action brought for damages for a vaccine-related injury or death”). That decision reflects Congress’ recognition that court actions are essential because they provide injured persons with significant procedural tools—including, most importantly, civil discovery—that are not available in administrative proceedings under the compensation program. See §§300aa–12(d)(2)(E), (d)(3). Congress thus clearly believed there was still an important function to be played by state tort law.
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 15.[Footnote 24] To be sure, reasonable minds can disagree about the wisdom of having juries weigh the relative costs and benefits of a particular vaccine design. But whatever the merits of the majority’s policy preference, the decision to bar all design defect claims against vaccine manufacturers is one that Congress must make, not this Court.[Footnote 25] By construing §22(b)(1) to pre-empt all design defect claims against vaccine manufacturers for covered vaccines, the majority’s decision leaves a regulatory vacuum in which no one—neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements. This concern is especially acute with respect to vaccines that have already been released and marketed to the public. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins. Nothing in the text, structure, or legislative history remotely suggests that Congress intended that result.
I respectfully dissent.Footnote 1
W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton on Law of Torts 695 (5th ed. 1984).Footnote 2
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))).Footnote 3
This leaves the question of what precisely §22(b)(1) means by “unavoidable” side effects, which I address in the next section.Footnote 4
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 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.Footnote 5
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) (“unavoidability” 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) (“[A]pplicability 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–, 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 case-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 7–8, 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.Footnote 6
The majority refuses to recognize that “unavoidable” is a term of art derived from comment k, suggesting that “ ‘[u]navoidable’ is hardly a rarely used word.” Ante, at 10. 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.Footnote 7
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).Footnote 8
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 1–2 (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 review vaccines for optimal vaccine design, see infra, at 20–22, and n. 19, and thus it seems highly unlikely that Congress intended to eliminate the traditional mechanism for such review (i.e., design defect liability), particularly given its express retention of state tort law in the Vaccine Act, see 42 U. S. C. §300aa–22(a). In any event, to the extent there is ambiguity as to how precisely Congress intended the “principle in Comment K” to apply to the covered vaccines, that ambiguity is explicitly resolved in petitioners’ favor by the 1987 House Energy and Commerce Committee Report, H. R. Rep. No. 100–391, pt. 1, pp. 690–691 (hereinafter 1987 Report). See infra this page and 11–12.Footnote 9
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 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.Footnote 10
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 18. 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.Footnote 11
See 1987 Report 700 (describing the administration’s alternative proposal).Footnote 12
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 provisions of the 1986 Act should be amended to assure that manufacturers will not be found liable in the tort system if they have fully complied with applicable government regulations. In particular, manufacturers should not face liability under a ‘design defect’ theory in cases where plaintiffs challenge the decisions of public health authorities and federal regulators that the licensed vaccines are the best available way to protect children from deadly diseases” (statement of Robert B. Johnson, President, Lederle Laboratories Division, American Cyanamid Co.)).Footnote 13
See American Academy of Pediatrics, Questions and Answers about Vaccine Ingredients (Oct. 2008), http://www.aap.org/immunization/ families/faq/Vaccineingredients.pdf (all Internet materials as visited Feb. 18, 2011, and available in Clerk of Court’s case file).Footnote 14
In this manner, the “even though” clause functions in a “concessive subordinat[ing]” fashion, ante, at 11, in accord with normal grammatical usage. According to the majority, however, the “even though” clause “clarifies the word that precedes it” by “delineat[ing]” the conditions that make a side effect “unavoidable” under the statute. Ante, at 7. The majority’s interpretation hardly treats the clause as “concessive,” and indeed strains the meaning of “even though.” In the majority’s view, proper manufacturing and labeling are the sole prerequisites that render a vaccine’s side effects unavoidable. Thus, an injurious side effect is unavoidable because the vaccine was properly prepared and labeled, not “even though” it was. The two conjunctions are not equivalent: The sentence “I am happy even though it is raining” can hardly be read to mean that “I am happy because it is raining.” In any event, the more fundamental point is that petitioners’ interpretation actually gives meaning to the words “even though,” whereas the majority concedes that its interpretation effectively reads those words entirely out of the statute. See supra this page.Footnote 15
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. ___, ___ (2008) (slip op., at 5) (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)).Footnote 16
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 necessary 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.Footnote 17
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”).Footnote 18
See 42 U. S. C. §262(a)(2)(C)(i)(I) (“The Secretary shall approve a biologics license application … on the basis of a demonstration that … the biological product that is the subject of the application is safe, pure, and potent”).Footnote 19
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 biologics 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 biologics 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 biologics licenses, moreover, and thus has no authority to require a manufacturer to adopt a different vaccine design.Footnote 20
Indeed, we observed in Levine that the FDA is perpetually understaffed and underfunded, see 555 U. S., at ___, n. 11 (slip op., at 22, 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. Soto, 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 ___ (slip op., at 23).Footnote 21
The majority mischaracterizes my position as expressing a general “skeptic[ism] of preemption unless the congressional substitute operate[s] like the tort system.” Ante, at 16. 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’ pre-emptive 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 liability where, as here, Congress specifically included an express saving clause preserving state law, there is a long history of state-law regulation of vaccine design, and pre-emption of state law would leave an important regulatory function—i.e., ensuring optimal vaccine design—entirely unaddressed by the congressional substitute.Footnote 22
The majority’s suggestion that “vaccine manufacturers fund from their sales” the compensation program is misleading. Ante, at 15. 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 of the excise tax has an impact on the number of vaccines sold by the vaccine manufacturer. The majority points to no evidence that the excise tax—which ordinarily amounts to 75 cents per dose, 26 U. S. C. §4131(b)—has any impact whatsoever on the demand for vaccines.Footnote 23
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, foregoing any tort remedies against vaccine manufacturers”); S. Plotkin, W. Orenstein, & P. Offit, Vaccines 1673 (5th ed. 2008) (noting that “[v]irtually all … petitioners, even those who were not awarded compensation” under the compensation program, choose to accept the program’s determination).Footnote 24
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 5.Footnote 25
Respondent notes that there are some 5,000 petitions alleging a causal link between certain vaccines 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 underlies many of the policy arguments in respondent’s brief and appears to underlie the majority and concurring opinions in this case. In the absence of any empirical data, however, the prospect of an onslaught of autism-related tort litigation by claimants denied relief by the Vaccine Court seems wholly speculative. As an initial matter, the special masters in the autism cases have thus far uniformly rejected the alleged causal link between vaccines and autism. See Brief for American Academy of Pediatrics et al. as Amici Curiae 20–21, n. 4 (collecting cases). To be sure, those rulings do not necessarily mean that no such causal link exists, cf. Brief for United States as Amicus Curiae 29 (noting that injuries have been added to the Vaccine Injury Table for existing vaccines), or that claimants will not ultimately be able to prove such a link in a state tort action, particularly with the added tool of civil discovery. But these rulings do highlight the substantial hurdles to recovery a claimant faces. See Schafer v. American Cyanamid Co., 20 F. 3d 1, 5 (CA1 1994) (“[A] petitioner to whom the Vaccine Court gives nothing may see no point in trying to overcome tort law’s yet more serious obstacles to recovery”). Trial courts, moreover, have considerable experience in efficiently handling and disposing of meritless products liability claims, and decades of tort litigation (including for design defect) in the prescription-drug context have not led to shortages in prescription drugs. Despite the doomsday predictions of respondent and the various amici cited by the concurrence, ante, at 6–7, the possibility of a torrent of meritless lawsuits bankrupting manufacturers and causing vaccine shortages seems remote at best. More fundamentally, whatever the merits of these policy arguments, the issue in this case is what Congress has decided, and as to that question, the text, structure, and legislative history compel the conclusion that Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines. The majority’s policy-driven decision to the contrary usurps Congress’ role and deprives such vaccine-injured children of a key remedy that Congress intended them to have.
ORAL ARGUMENT OF DAVID C. FREDERICK ON BEHALF OF THE PETITIONERS
Chief Justice John G. Roberts: We will hear argument this afternoon in Case 09-152, Bruesewitz v. Wyeth.
Mr. Frederick: Thank you, Mr. Chief Justice, and may it please the Court:
This case involves a vaccine designed in the 1940s that was administered to Hannah Bruesewitz in 1992, some 30 years after scientists discovered a safer way to design the pertussis component of the DTP vaccine.
The Third Circuit held that the Bruesewitzes could not pursue a design defect claim under State law invoking the preemption principle in claiming that the Vaccine Act of 1986 preempted the Bruesewitz's State law claim.
That holding is in error for three reasons.
First, the court overlooked the numerous provisions of the Act protecting manufacturers from liability, but it did not expressly preempt design defect claims.
Second, the court misconstrued the word 22(b)(1)'s Federal law defense.
And third, the court adopted a policy that exposes children to unnecessary safety risks.
With respect to the first reason, in the 1986 Act Congress created a program, the vaccine program, that was funded by surcharges on the vaccines that users used, and out of that fund designed a program to pay compensation to persons who were injured by vaccine-related acts.
Congress also provided a mechanism for exhaustion through the vaccine court program before a person claiming injury could pursue a State law cause of action.
In creating Federal law defenses to the State law that was designed to govern such actions, Congress established certain defenses, but all of those defenses apply on a case-by-case basis.
There are no absolute provisions that preclude a State law claim.
The Third Circuit misunderstood that basic principle.
The defenses that the Vaccine Act created for manufacturers includes such things as a regulatory compliance defense for failure to warrant claims, a learned intermediary doctrine that is instituted at a national level, the imposition of comment k--
Chief Justice John G. Roberts: What is -- I'm sorry, Mr. Frederick.
What's the point that you are trying to make?
That because there are a whole bunch of provisions designed to help manufacturers, that this one can't possibly also be designed to help manufacturers?
Mr. Frederick: --My point is that when one looks at the specific language of 22(b)(1) against the backdrop of these other provisions, it's clear what Congress was intending was to enact a national defense, but not to displace State law completely.
And the question presented is whether, on a case-by-case basis, the design defect claims that had been brought by the Bruesewitzes are displaced as a matter of law.
Chief Justice John G. Roberts: I would have thought the argument would go the other way: That because they set up a compensation scheme, that was a good sign that they didn't want to allow State law claims.
Mr. Frederick: And if one looks, Mr. Chief Justice, at sections 21, 22, and 23 of the Act, what 21 provides is that the Claimant can elect not to accept the vaccine court judgment.
Section 22 provides the standards of responsibility, and section 23 provides the mechanisms for trial of the State law claim.
And 23(e) provides that the evidence of the vaccine table and what happens in the vaccine court shall not be admissible in the State law claim.
Justice Samuel Alito: Section 22(b)(1) refers to side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
If the term "unavoidable" was intended to carry its ordinary meaning, what need was there for the rest of that language:
"Even though the vaccine was properly prepared and was accompanied by proper directions and warnings? "
If it was improperly prepared or didn't have the proper directions and warnings, then the side effects are avoidable.
So that language is surplus, isn't it, if "unavoidable" really means unavoidable?
Mr. Frederick: What Congress was intending to do, Justice Alito, was, with the word "unavoidable", to use a word that had a settled meaning in the common law.
And that settled meaning referred to the design of the product in light of the current state of scientific knowledge.
That grew directly from comment k, the section 402A of the restatement of torts.
And in comment k, which tracked the structure of the restatement provision itself, the general rule for the restatement was strict liability for dangerous products, quote,
"although the drug is properly manufactured or properly warned against. "
Justice Samuel Alito: But isn't it true that at the time, there was a distinct minority view that you could not recover for design defects for vaccines?
Mr. Frederick: There certainly was a debate.
The majority view, however, was to adopt comment k as a defense to strict liability claims on a case-by-case basis.
And the cases that we've set forth, I think, illustrate that, even the cases that the other side cites.
Several of them had been overruled by the time the 1986 act took effect and there was a decided shift in favor in the case-by-case application of comment k.
And in the 1987 report, Congress made very clear it intended to preserve that case-by-case approach.
That is set forth at page 50 of our brief, Justice Alito.
So when one looks at both the words that Congress used in 22(b)(1), the debates that occurred, and the committee reports that explained what Congress is intending here, we believe the intent is unmistakably clear to adopt comment k as a defense to--
Justice Antonin Scalia: But you haven't really answered Justice Alito's question as to why the later language is not surplus.
If indeed it bears the technical meaning you say that it -- that it bears, that later language is surplus.
Mr. Frederick: --It is not surplus if one reads comment k and understands what the drafters there were intending to get at, which was: If, based on current scientific knowledge, the risks are unavoidably unsafe, meaning there is no way in science we can design a safer product, there will be a defense to a claim of strict liability unless or provided that the product is properly manufactured and warned against.
This was a proviso that was intended to ensure that the focus be kept on the unavoidable, unsafe aspects of the design of the vaccine.
Now, the other side's view takes other words of 22(b)(1) and renders them surplusage.
And I am looking now at page 19A of our reply brief, where we set forth the statutory language, if you want to follow along here.
What the other side's view is that after the word 1, 1988 -- I am at page 19A of the reply brief, the addendum.
Under their view, all of the words that follow the word "if" and through "even though" becomes surplusage, because under their reading the manufacturer is relieved of all liability if, quote,
"the vaccine was properly prepared and was accompanied by proper directions and warnings. "
and renders the entire concept of unavoidability surplusage.
So our view is that what these--
Justice Antonin Scalia: Say that again.
I don't follow it.
Tell me that again.
Mr. Frederick: --Under their -- Justice Scalia, looking at (b)(1) on page 19A following the date October 1, 1988.
Justice Antonin Scalia: Right.
Mr. Frederick: Under their view, after the word "if", the phrase
"the injury or death resulted from side effects that were unavoidable even though. "
is surplusage, because in their view of the statute Congress created a complete exoneration from liability if the vaccine was properly prepared and was accompanied by proper warnings.
They took the concept of unavoidability completely out of the statute.
And the word "unavoidable" had a settled meaning.
There were numerous cases that had construed that meaning in light of the 20-year history of Restatement section 402A.
Justice Ruth Bader Ginsburg: I take it that the government is urging that FDA approval.
Mr. Frederick: --Justice Ginsburg, that position is incorrect.
And there is empirical evidence indicating that the manufacturers, Lederle's Mr. Johnson, testified that the problem with the '86 version of the statute was that it allowed for design defects to go forward.
And he urged there to be a regulatory compliance defense.
Chief Justice John G. Roberts: So you are asking us to interpret this statute in light of his testimony at a hearing?
Mr. Frederick: What I'm saying is that Congress had choices, and one of the choices was to adopt a regulatory compliance defense for design defect claims, and it chose not to do that.
Chief Justice John G. Roberts: It seems to me the language supports the reading Justice Ginsburg has just suggested, or the government has just suggested, with the use of the word "the".
It says the effects of the vaccine were unavoidable, even though the vaccine was properly prepared.
Your position is, well -- the question is whether it was unavoidable if you could have prepared a different vaccine.
But this says
"unavoidable, even though the vaccine was properly. "
Mr. Frederick: Right.
And it is preceded by the word Mr. Chief Justice.
And if suggests--
Chief Justice John G. Roberts: I don't see the word "if".
Mr. Frederick: --It's right after the date, 1988.
If -- if the injury resulted from side effects.
So it is looking on a case-by-case basis in that context, whether the vaccine created the injury or side effect that is being complained of.
Justice Antonin Scalia: Mr. Frederick, I have this problem with -- with your interpretation.
As -- as has been said, the government interprets "unavoidable" to mean unavoidable with respect to the vaccine that has been approved.
If it doesn't mean that, if it simply means unavoidable with some other vaccine, you could always avoid them if you have a vaccine that is significantly less effective.
I mean, what other vaccine are you comparing it with?
Mr. Frederick: Justice Scalia, let me try to clear this up in this way.
All of these vaccines are approved by the FDA.
And the question is whether you give a presumption of design correctness for all time based on the FDA's approval of that vaccine.
This vaccine was approved in--
Justice Antonin Scalia: I understand that, but the plaintiff comes in and says, Look, you could have eliminated this, this, and this, and these side effects would not occur.
Of course the vaccine would only be effective in 75 % of the cases, but nonetheless, it was avoidable.
Mr. Frederick: --And that's why the concept of unavoidability as a defense always rested on the current State of scientific knowledge.
In the 1960s, Lederle signed--
Justice Antonin Scalia: Well, that doesn't answer my question.
I acknowledge it rests on current scientific knowledge, but current scientific knowledge would enable you to design a drug that does not have these side effects even though it's significantly less effective, and there is no criterion as to how much less effective it has to be to qualify and so forth, whereas the government's interpretation of the word ties it to a -- to a particular vaccine.
Mr. Frederick: --Justice Scalia, the way these cases were construed, and we have cited them in our reply brief, the standard was whether or not it was as safe as a feasible alternative but was -- sorry, as efficacious but safer as a feasible alternative.
That's how the courts -- the State court--
Justice Antonin Scalia: It has to be just as effective?
Mr. Frederick: --It has to be efficacious.
Justice Antonin Scalia: Just as effective?
Mr. Frederick: Sure.
I will concede that point.
The problem here was that an efficacious design existed as of the 1960s and the internal documents indicated that Lederle--
Justice Sonia Sotomayor: You keep saying that.
But didn't I understand correctly that that drug was withdrawn from the Japanese market in which it had originally been--
Mr. Frederick: --No.
Let me clarify.
There are two theories by which there was a design defect claim.
One concerned a product by Eli Lilly called Tri-Solgen.
That was a split cell vaccine that was developed and sold in the 1960s.
It was demonstrated to have far less serious effects for encephalopathy and other residual seizure disorders and problems.
Justice Sonia Sotomayor: --Was it proven that it was as effective?
Mr. Frederick: Yes, it was, and it had 65 % of the market.
Justice Ruth Bader Ginsburg: And could it be used for all five -- there are five inoculations in this series.
Mr. Frederick: That's correct.
Justice Ruth Bader Ginsburg: And only one of them was not approved for the first three.
Mr. Frederick: That's the second one for Justice Sotomayor.
This was an acellular technique that had been studied in the United States in the 1950s and eventually was developed by the Japanese in the 1980s.
That acellular technique was eventually approved by the FDA in the mid-1990s and is now common in all of the three-part VDAP vaccines that are currently on the market.
Our point is that the scientists literally knew about that acellular technique.
They were beginning to do tests, but they didn't aggressively do it for economic reasons.
And that has never been--
Justice Ruth Bader Ginsburg: If there is a safer alternative, it must be pursued regardless of cost?
Mr. Frederick: --No, there is a reasonableness standard.
The standard of due care that State law and tort has always had is: What does a reasonable manufacturer do in the same or similar circumstances?
But that is a question, ultimately, of fact, whether or not the economics--
Justice Anthony Kennedy: In a question of fact in a case-by-case determination in every State, the manufacturers would probably be worse off under your approach than if they didn't have the law at all, because the law seems to at least qualify section -- comment k.
Mr. Frederick: --Justice Kennedy, that was the whole design of the vaccine program, because if you channelled most claims into something that the manufacturers didn't have to defend against or pay the judgments of, the thought was that the vast, vast majority of people would never go to State court.
And it would only be in those rare circumstances like the problem we have here where the vaccine court awards nothing that the Bruesewitzes even had to go to State court.
Had they filed their claim a month earlier when residual seizure disorder was still on the vaccine table, we wouldn't be here.
Justice Ruth Bader Ginsburg: Why was it taken off?
Mr. Frederick: There was a debate in the scientific community.
The Institute of Medicine believed that residual seizure disorder was medically proved to be a causative factor from the pertussis component of the DTP.
There was a disagreement of -- by folks in the Secretary of Health and Human Services as to whether or not that was sufficient to justify legal cause.
Justice Ruth Bader Ginsburg: And so didn't the special master find what -- in the compensation proceeding that causation had not been proved?
Mr. Frederick: Yes.
And it was a proceeding, Justice Ginsburg, that had allowed for no discovery against the drug manufacturer.
Justice Ruth Bader Ginsburg: Well, you -- you say that in court you could prove causation, because you had discovery, although you couldn't prove it before the special master because discovery was very limited?
Mr. Frederick: That's our submission.
And that was the design that Congress intended.
That's why what happens in the vaccine court under section 23(e), as a matter of law, is inadmissible in a subsequent State court action.
Justice Stephen G. Breyer: And can you -- maybe this is a good point, but I would like to know what your response is.
I'm not asking you in either a hostile nor friendly way.
The -- assume for the moment that the language, I cannot find clear one way or the other.
So I think it's ambiguous.
At that point, what is your response, on that assumption that this brief on the other side from the American Academy of Pediatrics and 21 other physician and public health organizations -- what the pediatricians here say is that, if you win, we're turning this over to judges and juries instead of the FDA and other specialized agencies, that the result could well be driving certain vaccines from the market, and basically, a lot of children will die.
And that -- that's their claim.
And I think that their legal argument there is that wasn't Congress's purpose.
Congress's purpose was the contrary.
So leaving the language out of it, I would like you to respond to what I would call that purpose-related, fact-related argument by these particular people.
Mr. Frederick: If I may, let me make two points, Justice Breyer, the legal point and the policy point.
The legal point is: This Court's cases make clear that there is a clear statement principle.
Before Congress is presumed to have displaced State law, it must act with a clear statement.
And that is true in the Eleventh Amendment context as well as the preemption context.
So if you conclude there is ambiguity, we should win--
Justice Stephen G. Breyer: Well, there is another case on that where we are going to have to go into -- which is, does that mean every bit of it has to be clear?
Does it mean the intent has to be clear?
That's a complicated area.
But I will put that aside for the moment.
Mr. Frederick: --Here, 22(a) answers that question as a matter of law, because it says the State law provides the general rule.
Justice Stephen G. Breyer: Right.
Mr. Frederick: Now, that's the legal point.
The policy point is that by channelling the vast majority -- and the SG's brief says 99 percent of the people who go through vaccine court accept the judgment of the vaccine court.
And on the First Circuit, the Schaefer decision -- which you wrote, Justice Breyer -- said that even in the instances in which people lose in the vaccine court, they may regard the hurdles and obstacles of the State court process to be so great that they don't bother to try.
It's difficult to win these kinds of cases in State court--
Justice Sonia Sotomayor: Explain why.
Mr. Frederick: --Because proving causation and proving the availability, based on science, of an alternative design is not something that is a relatively easy thing to do.
Justice Stephen G. Breyer: --But that's -- that's why I asked the question.
Frankly, if I see the Academy of Pediatrics telling me one thing, and I in an earlier case wrote the other thing, I do tend to think I could have been wrong.
And that's -- that's why I am asking you: Is that the best you can find on the other side, namely something I once wrote in a case?
Or are there other -- are there other things?
Mr. Frederick: It happened in the moment to come to mind, Justice Breyer.
The point that I want to make is that the threat of liability is only a realistic one if there is a threat that there's actually going to be payment at the end.
And Plaintiffs do not bring cases to lose; they bring cases if they have a reasonable prospect of winning based on what the evidence would show a design defect to be.
And so when Congress set up this system and it exonerated the vaccine makers of 99 percent of all cases that are going to go through this system claiming defects or problems, if you ask manufacturers around the country that you get a special defense against punitive damages, you get a regulatory compliance defense for failure to warn, you have to have a trifurcated proceeding, and you are not going to have to pay damages or defend the actions 99 percent of the time, most manufacturers in the United States would take that bargain.
And so the question--
Chief Justice John G. Roberts: It would depend, I suppose, on what they thought the judgments were going to be in the 1 percent of the time.
Mr. Frederick: --And--
Chief Justice John G. Roberts: It doesn't take too many $60 million verdicts to make you come out on the other side of your calculus.
Mr. Frederick: --And that's why, going back to the wording of the statute, Mr. Chief Justice, in section 23, where Congress said for someone who had elected not to accept the judgment in 21, you get to go to State court and try to prove your claim.
Justice Ruth Bader Ginsburg: Anyone could go to the State -- I mean, somebody who won in the vaccine court could go to court on the argument that the amount was insufficient, the amount of compensation.
There is -- there is no foreclosure of anyone to come to court; is that right?
Mr. Frederick: That's correct.
But you have to fight through the defenses that Congress erected in 22(b)(1), (b)(2), and (c), which are quite difficult defenses--
Justice Samuel Alito: What would happen if a drug manufacturer sought FDA approval of an alternative vaccine and the injury occurred during the period while that was under consideration by the FDA?
That's -- that's just too bad?
Mr. Frederick: --A harder case, but not one that couldn't be proved under State law.
The negligence inquiry would look into whether or not a reasonable manufacturer would have tried earlier and more aggressively to obtain FDA approval.
Here, we think we can meet that standard, because we had a drug that was on the market, the split cells Tri-Solgen, that was proved to be safer and just as efficacious, and it had been on the market until Wyeth took it off, after Wyeth concluded that when it purchased the rights from Eli Lilly it couldn't manufacture the vaccine Tri-Solgen in a way that it would get it the profit stream that it wanted--
Justice Ruth Bader Ginsburg: In the -- when it was -- when Tri-Solgen was owned by Lilly and you said that it was approved and marketed, was that one available for all five inoculations?
Mr. Frederick: --Yes.
Yes, Justice Ginsburg.
That was used for all through the series for children's vaccination for DTP.
And the problem here with the other side's approach, fundamentally, is that not only does it render part of 22(b)(1) surplusage, and not only does it ignore the many benefits that manufacturers got, but at the end of the day it allows for an exoneration from liability, even for manufacturers who know there is a safer design available.
And that fundamentally is something Congress never would have imagined, that manufacturers would invoke an immunity from suit, even when they knew--
Justice Anthony Kennedy: Does the secretary -- does the secretary have the authority to -- to withdraw certification on the ground that it is no longer safe, fair, and potent?
Mr. Frederick: --Yes, Justice Kennedy.
Justice Anthony Kennedy: You are assuming that the manufacturer knows something that the secretary doesn't?
Mr. Frederick: --No.
Our submission, Justice Kennedy, is that for many vaccines there is no safer alternative, and there could be no design defect claim.
But for those instances in which there is a safer alternative, the burden under State law is for the manufacturer to act reasonably in pursuing the safer design, if that is available.
It's not -- there is no provision in the FDA regulations or under statute for the FDA to engage in a comparative safety analysis.
Chief Justice John G. Roberts: If the language--
Justice Sonia Sotomayor: Is there any provision in the regulations that require a manufacturer to withdraw a drug earlier than when the FDA tells them to?
Mr. Frederick: Not that I'm aware of.
Justice Sonia Sotomayor: So this immunity would come along until they go to the FDA and say, Well, we've gotten enough incidents to prove--
Mr. Frederick: That's correct.
And this very vaccine, Justice Sotomayor, was taken off the market in 1998.
And the product that Wyeth used as the substitute for it says in its package insert, this is a safer vaccine than the Tri-Immunol that we have taken off the market.
Chief Justice John G. Roberts: --But I'm not sure that in most cases you are going to be able to tell immediately -- you are marketing one vaccine and something else is being tested or about to be approved, or it's on the market -- that that's safer.
Particularly since you have to look not only at -- whatever -- injury and mortality rates, but also efficaciousness -- or efficiency, I guess -- in terms of the vaccine.
So you don't know right away.
Somebody comes in and says, Here's a different vaccine; your vaccine causes one death every 10,000 doses, or whatever it is.
And the other says, This is better; it's one death every 12,000 doses.
You say, Well, but ours is more efficient in stopping the vaccine.
Well, how much more efficient?
Well, it depends on the judgment of a jury.
Mr. Frederick: And the manufacturers win that case, probably, Mr. Chief Justice.
Justice Anthony Kennedy: But -- but you assume that there is no clause or burden to the manufacturers who defend these suits to assess settlement offers.
This is a -- this is a tremendous expense.
Mr. Frederick: Only if you accept the--
Justice Anthony Kennedy: It -- it may well be that the manufacturer has to settle a meritorious case; we all know that.
Mr. Frederick: --Yes.
But, Justice Kennedy, that's after an exhaustive process through which they have gone through the vaccine program and the person is dissatisfied with the remedy that's provided.
So in these vast majority of cases, unlike drug cases where there is no channeling mechanism, here the vaccine fund is designed to take care of the vast, vast, vast majority of those kinds of claims.
And it's only in those rare circumstances where there would be a State lawsuit.
If I could reserve the balance of my time.
Chief Justice John G. Roberts: Thank you, Mr. Frederick.
ORAL ARGUMENT OF KATHLEEN M. SULLIVAN ON BEHALF OF THE RESPONDENTS
Ms Sullivan: Mr. Chief Justice, and may it please the Court:
Congress enacted the National Childhood Vaccine Injury Act against the backdrop of a wave of tort litigation that threatened to drive manufacturers out of the business of providing the vaccine--
Justice Sonia Sotomayor: So why didn't they make the vaccine court exclusive?
There is plenty of administrative systems that make -- preclude State law actions altogether and place you in administrative proceedings.
So if their intent was to drive out State lawsuits, why not do that?
Ms Sullivan: --Because, Justice Sotomayor, the kind of lawsuits that caused Congress concern were the very kind of lawsuits that are expressly preempted by 22(b)(1), and that is design defect claims, which have the exact problem that was just being discussed.
For a design defect claim, as Justice Scalia pointed out, the challenge that is brought to the vaccine that was approved by the FDA can be challenged as less safe than some alternative vaccine, bounded only by the imagination of the experts.
It was those design defect claims that were the problem.
Justice Sonia Sotomayor: So, how -- couldn't they have taken care of that with Daubert?
I mean, won't most of these cases get resolved on a motion for summary judgment?
Ms Sullivan: --Not design defect claims, Your Honor.
Just to go back to 1986 and what the crisis was.
As the 1986 House report makes clear, the manufacturers were being driven out of the vaccine business, imperiling the nation's design -- vaccine supply by design defect claims that did survive summary judgment.
And that did lead to the danger, as Justice Kennedy pointed out, of settlements.
The key point about protection--
Justice Sonia Sotomayor: Point me to the FDA regulations or law where the FDA, in giving a license to or permitting a new vaccine, actually looks at whether that vaccine is the most efficacious way with the least serious harm to the population.
Is there a regulation that requires that judgment by them before they issue permission to market?
Ms Sullivan: --There is not, Justice Sotomayor.
What the FDA is empowered by regulation to decide under the Food, Drug, and Cosmetic Act is whether the vaccine is safe and efficacious.
Justice Sonia Sotomayor: All right.
What is the motivation?
If there is no -- there's no approval mechanism for the FDA to look at that issue, what is the motivation for manufacturers to voluntarily remove a drug that is causing harm to the public before the FDA acts?
If they are completely immune under your reading of this preemption statute, what motivates them to act more quickly?
Ms Sullivan: --The Act itself.
But section 27 of the Act -- let me just go back and describe what Congress did in 1986.
It said, We have a crisis, and it created three things to solve the crisis: A preemption provision that said, Let's end the design defect claims that are causing the problem.
Justice Ruth Bader Ginsburg: Ms. Sullivan -- Ms. Sullivan, if Congress had wanted to do that, they could have said simply that no vaccine manufacturer may be held civilly liable if the vaccine is properly prepared and accompanied by proper directions and adequate warnings.
That would have been the simplest statement.
Congress didn't make that statement.
They were asked to amend the statute to make that statement, and they didn't.
I mean, if you wanted to make it clear that there is no design defect liability, then say that: No civil liability unless inadequately -- improperly prepared, improper directions, or warnings.
What they -- the language that they used is certainly, to say the least, confusing.
This unavoidable -- these side effects that were unavoidable.
Well, why did they need to put that in there if what they were concerned with was to cut out liability for design defects?
Ms Sullivan: --Justice Ginsburg, let's go back to the text and put -- read the two clauses together.
And our main point here is, as Justice Alito and Justice Scalia have already pointed out, the Petitioners render the "even though" clause surplusage.
We read the two clauses together.
And let's read them together against the backdrop of the three kinds of product liability claims that could be brought: Design defect, manufacturing defect, and failure to warn.
The -- the statute references two out of the three.
And we -- we believe that -- and the Government believes that the reason that was done was to say that the third omitted kind of claim, design defect claims, were preempted.
The two that were allowed -- and, Justice Sotomayor, this is what makes it different from straight pure administrative schemes -- this does preempt defect claims, the omitted claim.
It allows manufacturing defect claims and it allows warning claims subject to the presumption in 22(b)(2).
Justice Anthony Kennedy: Under your view, when does the manufacturer have to come forward and acknowledge that there is a defect in the design?
Mr. Frederick: Well, Justice Kennedy, the manufacturer is subject to ongoing reporting requirements under section 28 of the statute.
And I think that if you think there is ambiguity in the text, as Justice Breyer suggests, we can go to the structure of the statute.
And let me just mention a number of features of the statute--
Justice Sonia Sotomayor: Could you please just answer that question?
What is the motivation for the manufacturer to either continue the testing of their product and voluntarily stopping it if a better design has been found by someone else or even an inducement for them to find a better design if a competitor comes around?
Because I don't see why they should stop until they have caused as many injuries as they need to before the FDA says stop.
Ms Sullivan: --Well, Justice--
Justice Sonia Sotomayor: What is the inducement for them to do it voluntarily?
Ms Sullivan: --Yes.
First of all, Justice Sotomayor, Justice Kennedy is correct, the FDA can order removal from the market.
Justice Sonia Sotomayor: I am not asking about the FDA.
Ms Sullivan: But the reason why--
Justice Sonia Sotomayor: I said the manufacturers' motivations.
Ms Sullivan: --And -- and, Justice Sotomayor, the reason why the FDA has never had to use that nuclear option is that it -- it works closely with manufacturers long before it needs to be used, and that's because of the rest of the structure of the Act.
I would like to focus on what Congress did in 1986 in addition to--
Chief Justice John G. Roberts: Before you get to that, I think your answer to Justice Sotomayor's question is: Nothing; the manufacturers have no reason to take the vaccine off the market until the FDA tells them to.
Ms Sullivan: --That's not correct, Your Honor.
So the -- section 27.
Section 27 distinguishes vaccines from other drugs.
Section 27 says that the Secretary of Health and Human Services shall -- shall have an affirmative mandate to promote safer vaccines and to reduce the number of side effects.
And the Vaccine Act didn't just eliminate design defects--
Justice Anthony Kennedy: But if the manufacturer is slow or remiss or negligent or willful in not giving the information to the Government, there is nothing the injured person can do.
There is still complete preemption, under your view?
Ms Sullivan: --Of design defect claims, Justice Kennedy, but not of warning claims.
And it will -- there are grave consequences if a manufacturer withholds knowledge of adverse effects from the FDA.
Justice Sonia Sotomayor: Does the victim of that withholding have a private cause of action?
I don't see anything in this that would give them--
Ms Sullivan: --There is not a freestanding cause of action.
But if you look at 22(b)(2), you see that the manufacturer will lose his -- lose its presumption that its warnings were correct.
It will be subject to warnings suits in State court if it withholds information from the FDA without the benefit of the presumption.
Justice Ruth Bader Ginsburg: The warning--
Ms Sullivan: And if you look at--
Justice Ruth Bader Ginsburg: --The warning -- the warning claims, the manufacturing claims, those are always avoidable.
Ms Sullivan: --Always avoidable.
Exactly, Your Honor.
Justice Ruth Bader Ginsburg: But -- so what can be -- the only thing that can be unavoidable is the design defect.
Ms Sullivan: That's exactly right, Your Honor.
And that's how the text makes sense.
To go back to the text, the text says there are two kinds of avoidable side effects: Side effects that come from improper preparation -- well, of course the manufacturer can avoid those; it can prepare the vaccine better without contaminants -- and it can avoid warning defects by changing the warning.
Justice Anthony Kennedy: The warning doesn't have to say,
"Warning: We could make something better if we wanted to. "
Ms Sullivan: It does not.
That's correct, Your Honor.
And that's because--
Justice Sonia Sotomayor: --Or there is something better on the market than this that won't cause that.
Ms Sullivan: --But look.
Mr. Frederick has told a story that perhaps has misled the Court into thinking there was a safer vaccine in the 1980s.
There was not.
And just to be -- just to tell the story of a success in the way that FDA worked with the scientific community and the national Government worked with manufacturers to produce a safer vaccine, it was the Federal--
Justice Ruth Bader Ginsburg: Well, can you -- can we be concrete and concentrate on this Tri-Solgen, which, according to Mr. Frederick--
Ms Sullivan: --Yes.
Justice Ruth Bader Ginsburg: --Eli was producing, and it was available for all five inoculations.
And then Wyeth bought it, and then--
Ms Sullivan: Justice Ginsburg, Tri-Solgen was a split cell vaccine.
It was manufactured and produced by Lily in the 60s and withdrawn in the 70s.
But Mr. Frederick was incorrect that the Government ever deemed it as effective and safer than the wholesale vaccine, Tri-Immunol, that was administered in this case.
If I could refer Your Honor to page 19 of the Respondent's brief, we cite to 50 -- Federal Register 51051 and 52.
That's where the FDA specifically determined that Tri-Solgen was not safer, was not safer, than Tri-Immunol with respect to seizure disorders or other severe effects.
It simply may have involved less local effects like fevers and rashes.
So there was never any government determination that Tri-Solgen was safer.
In fact, Tri-Solgen came off the market.
Because the section 27 worked, the Federal Government worked to promote safer vaccines--
Justice Stephen G. Breyer: How does it do that?
Look, I think a difficulty I have is this.
Imagine vaccine X saves 10,000 lives, but inevitably 20 children will be killed.
Time period one.
Five years passes.
The manufacturer now realizes he could save three of those five people.
Is there anything in the law that requires him to tell the FDA that that is so?
Ms Sullivan: --There is not anything that requires him to tell the FDA that is so--
Justice Stephen G. Breyer: All right.
If there is nothing that requires him to tell the FDA what comes along, what I think your opponent is saying is at that moment, it is no longer an unavoidable harm and there is nothing in this statute that says that unavoidable harms -- that avoidable harms are taken away from the courts.
So what is your response to that?
He's saying all the unavoidable ones are taken away, but not the avoidable ones.
And now we have an example of where they, ok.
So what is your response to that?
Ms Sullivan: --That "unavoidable" in the statute is a term of art.
And to the extent that comment k is relevant at all, Mr. Frederick says,
"Oh, Congress was adopting comment k, the majority view. "
Well, first, there was not a majority view.
Justice Stephen G. Breyer: If you want to read it especially to mean unavoidable and avoidable.
Let's assume you are right about that, or let's assume it is at least ambiguous.
If that's so, then what is your response to the question I raised before, that is: That he says that if you allow judges and juries to decide only the question of avoidability, there will not be the harms that the childhood pediatricians thought there would be, because most people will go to the courts -- to the vaccine court anyway.
There are very few such cases, and there will not be enough liability to drive manufacturers from the market.
You heard him respond to that.
What is your response to that?
Ms Sullivan: First, there will be enough liability to drive manufacturers from the market.
Let me correct some things that Mr. Frederick said that were not true.
The vaccine court, 99 percent of those who receive monetary judgments in vaccine court, the administrative no fault system, do accept their award, but what Congress was concerned about was those who lose in the administrative system and then go take their second bite at the apple in State court, whereas, as has been mentioned, they are not bound by any findings in the vaccine court.
Justice Stephen G. Breyer: That's a minor point, but I thought if you went into the vaccine court you had to sign something saying you weren't going to go into a tort case.
I'm wrong about that?
Ms Sullivan: --No.
You go into a vaccine court and there is an exhaustion requirement.
22(b)(1) must add something to the exhaustion requirement.
We say it adds an exemption preemption provision, but you can elect at the end to take the judgement or not.
Those who get money in vaccine court, 99 percent take it.
What we are worried about is the 64 percent who lose in vaccine court.
Justice Sonia Sotomayor: What do those 64 percent do now?
What is the percentage of those people who actually go into court now?
Ms Sullivan: I can't answer that, Your Honor.
Justice Sonia Sotomayor: Is that because whatever the percentage is, proving causation is never easy--
Ms Sullivan: That's true, Your Honor.
Justice Sonia Sotomayor: --for non-listed--
Ms Sullivan: But there are 5,000 claimants in vaccine court now who claim there is a relationship between the mumps, measles, and rubella vaccine and autism.
They have lost all six test cases and when the individual cases are resolved, that is 5,000 potential claimants in State court.
Congress was worried about episodic waves of fear about vaccines leading to future litigation.
They took care of existing Claimants with vaccine injuries back in 1986 with the compensation system.
The reason they put in 22(b)(1) was to prevent future litigation in State court where manufacturers could be driven from the market by the fear of liability that had in 1986 involved the withdrawal of insurance, the escalation of insurance costs, the withdrawal of one manufacturer from the vaccine market.
And today there are very few vaccine manufacturers and the risk of the vaccine supply on which the nation's protection from contagious disease depends, it depends upon the existence of that stable supply of vaccines--
Justice Ruth Bader Ginsburg: --If Congress were so clear, as you are describing it, then why didn't it adopt the provision that said failure to develop a safer vaccine would not be grounds for liability?
Ms Sullivan: --Your Honor, Justice Ginsburg, I think you have to look to the rest of the structure of the Acts to see what Congress did here.
It did three things.
It made vaccines quite different from other drugs.
And this is not a situation where the FDA has to monitor 11,000 drugs, of which it wouldn't even care if they came off the market.
The government doesn't care if--
Justice Ruth Bader Ginsburg: But it also was directed to vaccines.
Ms Sullivan: --That's right--
Justice Ruth Bader Ginsburg: The failure to develop a safer vaccine would not be grounds for liability, and Congress didn't enact that.
Ms Sullivan: --Your Honor, Congress enacted a preemption provision that we think it was in the four corners of the provision of 22(b)(1), "preempts design defects".
It has a carveout for the two kinds of suits that are allowed, manufacturer and warning defects.
The clear holding of the rest of the text is that design defect claims are precluded.
Compensation makes sure that people who do have injuries from vaccines are taken care of.
The rest of the structure of the Act injects the Federal Government into driving the vaccine development process in a way that it does not for other drugs.
Congress wants people to take vaccines.
It wants us to inoculate all our children.
It wants us to have compensation to ensure people who are injured that they can get some money to take care of their children's disabilities.
But Congress wanted to make sure that it was driving, that the Federal Government, the FDA, the Centers For Disease Control, together with the AMA, together with task forces, were driving research to make safer vaccines.
Justice Sonia Sotomayor: --You are making an assumption that has a flawed premise, which is that their only concern was protecting the manufacturers.
Ms Sullivan: Not at all, Your Honor.
Justice Sonia Sotomayor: It couldn't have been.
Ms Sullivan: They compensate the victims.
Justice Sonia Sotomayor: Not only do they compensate victims, but they permitted victims to go into State court.
Ms Sullivan: For manufacturing and warning claims.
For manufacturing and warning claims.
Justice Sonia Sotomayor: No, no, no.
That's your assumption.
My point is that if we are talking about what the purpose was, you can't assume that--
Ms Sullivan: Two purposes: Compensation and the protection of the vaccine supply.
Justice Sotomayor, the clearest way that I--
Justice Sonia Sotomayor: --So what you are suggesting is there is no compensation for an injury that was avoidable in its normal sense, which is--
Ms Sullivan: --No--
Justice Sonia Sotomayor: --If this drug had not been sold and another drug had been used the person would have avoided their injury.
Ms Sullivan: --Well, there is no such drug here.
Acellular vaccine was not approved by the FDA for use in infants under two until 1996.
It was approved for children over two in 1991.
That's because in this country, we require clinical studies that weren't required in Japan a decade earlier to make sure that--
Justice Sonia Sotomayor: It sounds to me that you're going to win on non-summary judgment.
I don't see -- I do understand the cost of litigation.
It can be very, very onerous.
So I'm not trying to minimize it, but I do think that there's a whole lot of hurdles in place before a plaintiff wins on one of these claims.
Ms Sullivan: --Justice Sotomayor, manufacturing claims and warning claims are susceptible to summary judgment.
Design defect claims are not in the same way.
You are shadowboxing against an infinite number of theories about how there could have been a safer vaccine.
But the clearest way I can say why Mr. Frederick's interpretation can't be right is: If you concede at least one purpose was to protect manufacturers, to protect the vaccine supply, in addition to compensating the victims, Mr. Frederick's reading of 22(b)(1) does not serve that purpose.
He reads 22(b)(1) to leave manufacturers in the exact same place after the Act that they were before.
Go to State court.
Try to show that there was--
Justice Ruth Bader Ginsburg: They set up this whole compensation scheme where everybody agrees -- I mean, the manufacturers got this compensation scheme which took most of the cases out of State court.
So to say they were left just like they were before, before they were exposed to all these claims -- now it's only to a very small part of them.
Ms Sullivan: --That's not quite right, Justice Ginsburg.
The Act allows all losers in vaccine court to go to State court.
There are 5,000--
Justice Ruth Bader Ginsburg: Yes, yes.
I got that answer from Mr. Frederick before.
But most of them don't, because it's cheaper, faster, and working well.
Ms Sullivan: --For vaccine court winners, that's true.
For vaccine court losers, the fear was that these lawsuits would drive manufacturers out of the market, even if the manufacturers could win in the end.
For a preemption provision to do any work, it needs to attach at the beginning of the claim.
22(e), for example, refers to bringing an action.
22(b)(1), to do any work to protect manufacturers, has to attach to prevent the cause of action from being brought.
Justice Anthony Kennedy: I'm still not clear -- I'm still not clear what answer you gave to Justice Ginsburg's question, saying: Why didn't Congress put this out in plain words: There should be no liability for design?
Is the answer sloppy drafting?
Are you reluctant to give that answer?
Ms Sullivan: Well, Justice Kennedy, it could have been drafted a different way and it would have meant the same thing.
We think the best way to read the two clauses together "unavoidable", "even though", is to refer to what comment k meant.
Now, comment k used the term "unavoidable".
We know Congress was thinking about the term unavoidable.
We know that because in the 1986 House report the congressional committee say we would like to enact the principle of comment k.
Well, what is the principle of comment k?
The principle of comment k is there are so products so useful that we want them to stay on the market without design defect liability.
They can only be sued for manufacturing or warning defects.
Those are the only two kinds of suits you can bring.
In our view, comment k was Congress's denomination of vaccines as comment -- sorry, 22.1 was the denomination of--
Chief Justice John G. Roberts: Thank you, Ms. Sullivan.
Ms Sullivan: --as a comment k product.
Chief Justice John G. Roberts: Mr. Horwich.
ORAL ARGUMENT OF BENJAMIN J. HORWICH, FOR UNITED STATES, AS AMICUS CURIAE, SUPPORTING THE RESPONDENTS
Mr. Horwich: Mr. Chief Justice, and may it please the Court:
I think the Court finds itself actually three-quarters of the way through the argument without actually hearing about the most important federal agency that is involved with this, which is arguably not the Food and Drug Administration but the Centers for Disease Control and Prevention.
And so with respect to the question about what is it that is governing whether the -- whether the -- the -- a given vaccine is subject to the Act and what are the incentives and who is actually making the decision and who is trying to determine if there's something better that's out there that we should be pursuing -- that is the mission of the Centers for Disease Control and Prevention.
That is why Congress took the original table -- the vaccines that are on the original table in this statute were taken from CDC's recommendations that reflect CDC's expert scientific judgment, based on the input from the medical and scientific community, of what vaccines do we have that are the ones we should use to protect the public health?
Justice Stephen G. Breyer: Do they get the information from the manufacturers?
And -- I mean, would they find out if in fact there had been a change--
Mr. Horwich: Well--
Justice Stephen G. Breyer: --and it was now -- there is a safer alternative?
Mr. Horwich: --Well, let me -- let me give -- kind of -- let me answer that in -- in two ways.
The -- the first is that the -- the nature of vaccine research is not something that manufacturers do in a cloistered laboratory somewhere.
So it's actually very unlikely to imagine that a manufacturer somehow comes uniquely into possession of this knowledge.
I mean in fact, the Federal Government spends billions of dollars doing vaccine research that government scientists themselves perform.
The government sets the agenda for what are our targets for development.
The -- the research agenda to pursue the acellular pertussis vaccine was something driven by the Federal Government.
Federal Government made a choice and said we -- we don't want manufacturers and our scientists pursuing the -- the Tri-Solgen approach and trying to improve that.
We don't understand that vaccine very well.
We know the ultimate target needs to be the development of an acellular vaccine, and so that's the research path that -- to go on--
Justice Stephen G. Breyer: Suppose then that in -- suppose I look into this, which I will do, the CDC and what they do.
And suppose I become convinced you are completely right, that this is a government agency that is top of this and the chances of something going wrong are very small and they will figure it all out, together with the manufacturers.
Suppose I conclude that.
What do I do about this word unavoidable?
Mr. Horwich: --Well I think--
Justice Stephen G. Breyer: Now I can't say that the word unavoidable -- it's pretty hard to say that that word unavoidable means avoidable; and I am in fact -- like to look to the purposes of this statute, that if something says "day" I can't say it means "night".
And so -- so what -- what is it about this word that allows us to say that it's avoidable?
Mr. Horwich: --Well, I think the answer to that actually came in a question that Justice Ginsburg posed to Mr. Frederick, which is that unavoidable is being used in the sense of okay; what are the vaccines that FDA has approved that CDC has recommended for routine administration to children, and that are the -- and that are the ones that the Federal Government has determined are appropriate therefore to protect the public health?
And given that that is the state of affairs that we are in, was this injury--
Justice Stephen G. Breyer: To show that -- remember they only want to say, because of special circumstances this is an avoidable -- this is an avoidable injury.
I think I am right on that.
And -- and so the best place to look in your opinion, for me to look, to show that this word unavoidable includes that avoidable claim, is where?
Mr. Horwich: --I think the way to understand it is -- is to see that as the -- as the committee report -- as the '86 committee report says, that what Congress is trying to convey in using the word unavoidable is it is -- it is respecting the principle of comment k, which is the principle that socially beneficial products that nonetheless have these adverse effects ought to be on the market and we ought not to allow tort law to push them off the market, which is exactly what--
Justice Sonia Sotomayor: Excuse me -- going back to the point you just started with--
Mr. Horwich: --Yes.
Justice Sonia Sotomayor: --which was is this -- is the Control -- Disease Center, is it making a judgment before it approves a drug for licensing, that it's the most efficacious drug on market?
Mr. Horwich: CDC does not issue a license.
Justice Sonia Sotomayor: No--
Mr. Horwich: But the way the statute works is that the statute only covers, in its present form, the way -- I'm referring now to the present version of the provision in the statute that explains how vaccines become subject to the Act, because not all vaccines are.
The provision is in 14(e) of the Act, which I believe may not be reproduced in any of the papers, but it basically says that two things have to happen.
One is that before the vaccine becomes subject to either the compensation program or the preemption provision -- is that CDC has to recommend it for routine administration.
And that is a judgment that CDC makes with the advice of the Advisory Committee on Immunization Practices.
Justice Sonia Sotomayor: --Where do I look at that?
At what documents do I look at to make a judgment that in fact, CDC is doing what I ask, that it is looking at the question of whether this is the most efficacious drug with the least adverse effects?
Is that a judgment it's making?
Mr. Horwich: Yes.
Justice Sonia Sotomayor: We know the FDA is not.
Are you representing to us right now that CDC makes that judgment?
Mr. Horwich: CDC makes that judgment and announces it in a reasoned, published announcement in its official journal which is the Morbidity and Mortality Weekly Report.
And so for every drug -- or excuse me, for every vaccine that it recommends for routine administration, it publishes a notice in its journal explaining, this is -- these are the products that we are recommending for routine use, this is the -- the studies, this is the development of them, this is our basis for this determination.
Justice Sonia Sotomayor: That would include comparisons to other drugs on the market?
Mr. Horwich: --Well, it -- there often won't be other drugs actually on the market to compare it to, but there will be -- there will be a vast body of scientific literature that again is not exclusively within the manufacturers' control, because it has been produced by the Federal Government, by other countries' public health agencies, by academic scientists, that CDC will reference or its advisory committee will have incorporated in its recommendation.
Chief Justice John G. Roberts: So it doesn't make a determination that the one that they are listing in their morbidity report is better than one that's out there?
This is a situation where there were two of them out there.
Mr. Horwich: Well, there -- there were not two out there, Mr. Chief Justice.
At the time of this there was -- there were two forms of the -- out there -- I'm sorry, if I can ask at what time you are referring to?
Chief Justice John G. Roberts: Well, the comparison between the vaccine that caused the harm and the one that Mr. Frederick's client says was more efficacious and therefore the harms were avoidable.
Mr. Horwich: Right, and I'm not--
Chief Justice John G. Roberts: There must be a situation where the Centers for Disease Control approve, alert people to the fact that there is a particular vaccine that they think manufacturers should -- should produce, and there is another vaccine addressed to the same disease already on the market.
That's never the case?
They must improve the vaccine--
Mr. Horwich: --Yes, certainly.
Chief Justice John G. Roberts: --or we wouldn't have this case.
Mr. Horwich: Certainly they do.
And I mean, the Federal Government--
Chief Justice John G. Roberts: When they publish that information in their weekly report, do they compare it both with respect to losses or mortality and with respect to efficiency, with -- to the other vaccines on the market.
Mr. Horwich: --Yes.
Let me give you an excellent example of that which is probably familiar to the Court, that there are two types polio vaccines.
There is the Sabin vaccine, with is associated with certain very rare but severe side effects but which is extremely efficacious at protecting a population, and then there is the Salk vaccine, which is not associated with those same side effects, but is not as effective at protecting the population.
Now CDC made a determination and this was a determination in effect from the 1960s through the 1990s, that the Sabin vaccine -- the one that is, quote, unquote, "less safe", was the appropriate one for use because it better served the public health.
Now as polio -- now this is a dynamic process that CDC is continually engaged in, and so as polio approached global eradication and you are not as concerned about actual control of disease running in the community, CDC transitioned its recommendation to the Salk vaccine.
So I -- I think that answers the question that the CDC is making determinations in this regard in a comparative way; and I think it would be extraordinary then to have juries -- to have -- to imagine that Congress set up a system in which juries would effectively be second-guessing decisions like that, because CDC has made--
Chief Justice John G. Roberts: It has not only given that information; it has also said in its weekly report that this is the one we want you to make.
Mr. Horwich: --Yes, now.
Justice Stephen G. Breyer: They are not lawyers; they are scientists.
Mr. Horwich: Correct.
Justice Stephen G. Breyer: So they may not use these exact words, but you are saying whatever word they use, what they have is an ongoing process to say this is the best vaccine available; is that right?
Mr. Horwich: Yes.
And part of the on going process, as we described in our brief, is a unique system of monitoring and following up when there are adverse events.
So that we gave the example of the--
Justice Stephen G. Breyer: The committees have manufacturers on them and Government scientists and university people and others?
Mr. Horwich: --I'm sorry?
Justice Stephen G. Breyer: The committees have manufacturers and Government scientists and university professors and others?
Mr. Horwich: My understanding is actually the manufacturers are -- are -- are relatively less represented on these -- on these committees.
In a sense that the manufacturers are sometimes doing the manufacturing, but a lot of the research agenda is really driven by the Federal Government.
Chief Justice John G. Roberts: Thank you, counsel.
Justice Ruth Bader Ginsburg: Mr. Horwich, would you -- would you explain one feature of this, it was the allegation that there were an unusual number of adverse reactions to the particular lot that this child's third vaccine came from, and that those adverse reactions were not disclosed to the doctors.
And the doctors -- the child's doctor said if I had known about the unusual number of adverse reactions, I never would have used this vaccine.
Is there any actionable claim for that, for not disclosing that there were a number of adverse -- an unusual number of adverse reactions to this particular lot.
Mr. Horwich: If -- if I may?
Chief Justice John G. Roberts: Sure.
Mr. Horwich: Yes, absolutely there is, because that claim is either in the nature of a labeling claim or in the nature of a manufacturing defect claim.
And the -- the district court here and the court of appeals both treated that question not under preemption but on the facts, summary judgment in this case was granted purely on the absence of a disputed issue of material fact--
Chief Justice John G. Roberts: Thank you, counsel.
Mr. Horwich: --with respect to those claims.
Chief Justice John G. Roberts: Mr. Frederick, take five minutes.
REBUTTAL ARGUMENT OF DAVID C. FREDERICK ON BEHALF OF THE PETITIONERS
Mr. Frederick: Thank you.
The only law cited by the Government today was section 14 of the Vaccine Act.
It is not reproduced in the materials, but it is -- the title of section 14 is a vaccine injury table.
It's about recommendations that the CDC makes as to which vaccines will be on the vaccine table, so that when the person goes through vaccine court process, you can look and determine whether or not on a no-fault basis the vaccine is listed on the table or not listed on the table--
Justice Samuel Alito: May I ask you this question about something that Mr. Horwich said?
Under your understanding of this scheme, if a -- a person suffered a very serious injury as a result of the Sabin vaccine during the period when the CDC recommended that over the Salk vaccine, would the -- would that injured person have a claim for design defect if the person could -- could produce experts who said the CDC was wrong, that they should never have made this recommendation?
Mr. Frederick: --It's not that the CDC would be wrong, Justice Alito.
There is a difference between strict liability and a no-fault arrangement and where negligence would be asserted that a reasonable manufacturer would have come forward with information about a safer design.
So what Congress explicitly rejected and they voted this down in the Energy and Commerce Committee was a regulatory compliance defense solely on the basis that the FDA had approved at the time--
Justice Samuel Alito: Well, this may be -- this may be what Congress wanted and may be the better policy, but your answer to my question is that--
Mr. Frederick: --Yes.
Justice Samuel Alito: --that would permit a lay jury relying on experts produced in court, the CDC got this wrong, the Salk vaccine was really the better one.
Mr. Frederick: Yes, yes, that would be a viable design defect claim.
And let me give you an example right out of the Joint Appendix in this case.
In 1965 Lederle's researchers determine that Lily, the Tri-Solgen, had a 245 of the Joint Appendix.
That was in 1967.
Eight years later the internal scientists at Lederle wrote a memo to the head of Lederle and said we recommend that we approach Lily for its pertussis vaccine process and/or continue to bid on foreign contracts for this product line with the intent of increasing volume.
They had made the determination they were not capable internally of doing a safer design and they knew that for eight years and they nonetheless kept the wholesale pertussis in its market and the documents in this case indicate they did it for economic reasons.
And the whole idea behind having design defect claims is to put manufacturers to the duty of putting out safest possible products in light of what the science holds.
The CDC -- there are no regulations that the Government cites in its brief or today saying that the CDC does the kind of comparative analysis for safety that is provided under State law design defect claims.
Justice Stephen G. Breyer: Their argument is that the CDC will do it better than juries.
That's what I heard him say.
Mr. Frederick: And, Justice Breyer, there are now six DTaP vaccines on the market that CDC doesn't distinguish between them, but if it comes to pass that the science would indicate that one of them was woefully not as safe, and here, their argument is that the vaccine industry is going to go out of business.
This vaccine that's at issue in this case was taken off the market in 1998.
Chief Justice John G. Roberts: I thought Mr. Horwich told me that the CDC does compare new vaccines to the ones that are out in the market?
Mr. Frederick: He cited no law.
Chief Justice John G. Roberts: You think he was incorrect in that assertion.
We can go back and look at these weekly reports and they are either going to say this is better than the one that's out there or they are not.
Mr. Frederick: Yes.
And if you compare that to what Congress wrote in the statute, our submission is that Congress's words in section 22 take precedence.
Chief Justice John G. Roberts: I'm just trying to find out what your position is on that.
Do they compare it to existing vaccines or not?
Mr. Frederick: We found no law that gives the CDC the authority--
Chief Justice John G. Roberts: I'm not asking about law, I'm asking matter of fact.
Mr. Frederick: --Whether, I'm not.
Chief Justice John G. Roberts: You open up the weekly report.
Mr. Frederick: I'm sorry, Mr. Chief Justice.
Chief Justice John G. Roberts: When you open up the weekly report and it says this new vaccine is better vaccine than the one that is out there or not?
Mr. Frederick: I'm not aware that the CDC does the kind of granular comparisons that would go to the level of safety that is at issue in this kind of case.
And that's what's important here.
We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury to vaccines that we compel children to take.
And the whole idea behind Congress's scheme was to balance having vaccine supply available with providing a generous form of compensation to those persons who would be injured.
Chief Justice John G. Roberts: Thank you, counsel.
The case is submitted.
Unidentified Justice: The Honorable Court is now adjourned until tomorrow at 10 a.m..
Justice Antonin Scalia: This case is here on writ of certiorari to the United States Court of Appeals for the Third Circuit.
Hannah Bruesewitz was born on October 20th, 1991.
About six months later, the pediatrician administered doses of the diphtheria-tetanus and pertussis vaccines so-called the DTP vaccine.
Within 24 hours, Hannah started to experience seizures.
Her doctors eventually diagnosed her with -- with something called residual seizure disorder and developed mental delay.
Hannah now, a teenager, is still diagnosed with both conditions.
Her parents filed a vaccine injury claim with the National Vaccine Injury Program in 1995.
That no-fault program created by the National Childhood Vaccine Injury Act of 1986, which is a legislation of that issue here, was part of a congressional effort to stabilize a vaccine industry that had almost been destroyed by an increase in vaccine related tort litigation.
At one point, only a single domestic manufacturer continued to produce the DTP vaccine, and to facilitate compensation to claimants who found pursuing legitimate vaccines inflicted injuries too costly and too difficult.
Under the Act, the claimants are not required to show that the administered vaccine was defectively manufactured, labeled or designed.
And for the most common and first side effects, no showing of causation is even necessary if the injury first manifested itself at the express -- at the expected time after vaccination.
Compensation awards are paid out of a fund created by an excise tax levied against vaccine manufacturers.
The quid pro quo for the compensation program was the enactment of significant tort liability protections for manufacturers.
Most relevant to the present case, 42 U.S.C. Section -- never mind, eliminates -- it goes on and on -- eliminates manufacturer liability "In a civil action for damages arising from a vaccine related injury or death if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
A Special Master denied the Bruesewitz's claim under the no-fault program, so they then filed this federal lawsuit -- or this lawsuit.
As relevant here, they alleged that defective vaccine design caused Hannah's injuries in violation of Pennsylvania common law.
After Wyeth removed this suit from Pennsylvania State Court to Federal Court, the District Court held that the section in question preempted the Pennsylvania common law and the Court of Appeals for the Third Circuit affirmed.
We agree with the Court of Appeals at the National Childhood Vaccine Injury Act preempts all design defect claims against vaccine manufacturers.
To repeat state law, liability is expressly preempted "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."
If a manufacture could be held for a failure to use a different design, the word "unavoidable" in this passage would do no work.
A side effect could always be avoided by designing the vaccine to omit the harmful element.
It might be must -- much less effective but it would not cause harm.
The language of the provision does suggests that the design of the vaccine is a given, not subject to question in a tort action.
The expressio unius common leads to the same conclusion.
Products liability law establishes a well-known triumvirate of grounds for liability, defective manufacturer, inadequate directions or warning and defective design.
The text of the statute explicitly lists the first two grounds for liability as types of avoidable injury.
If all three were intended to be preserved, it would be strange to live the third defective design to implication.
Petitions contrary textual argument presumes that the word "unavoidable" in the statutory section is a term of art that incorporates comment K to the Restatement Second of Torts, Section 402 (a) which they contend was commonly understood to require a case specific showing that a design was as safe as possible.
There is no textual reason to believe that the statute was invoking comment K.
The statute uses the word unavoidable hardly a rare word, while comment K and the relevant judicial decisions use the precise raise unavoidably, unsafe product.
Moreover, we presume that Congress intended to adopt judicial interpretations of a relevant term in a later enacted statute only when all or nearly all of the relevant judicial decisions have given that term a consistent judicial gloss.
Comment K, however, did not have a commonly understood meaning in -- in the mid of 1980s.
Some Courts thought it required a case specific showing while many others thought that it categorically exempted certain classes of products such as prescription drugs from strict liability, design defect claims.
Petitioner's reading of the statute also treats proper preparation and proper labeling as additional prerequisites independent of avoidability.
That is to say, in addition to the requirement of unavoidability by whatever means including redesign, on petitioner's reading, the proper manufacture and proper labeling are further requirements.
That makes the statutory section bad English, linking independent ideas unavoidability, proper manufacture and proper labeling is the job of a coordinating conjunction like and not a subordinating conjunction like even though.
The structure of the Act and the vaccine regulation in general reenforces what the text suggests.
A vaccine's FTA license and over 90 FDA regulations pervasively regulate a vaccine's manufacturing method and the contents of its labeling, designed the vaccine contrast do not merit a single mention in the Act or the FDA's regulations.
The lack of guidance to manufacturers for designed defects combined with the extensive guidance for the two -- two grounds of liability specifically mentioned in the statute strongly suggest that design effects were not mentioned because they are not a basis for liability.
A mandates contained in the Act lead to the same conclusion, designed defect towards broadly speaking have two beneficial effects.
Number one, they prompt the development of improved designs and number two; they provide compensation for injuries.
The NCBIA provides other means for achieving both effects.
I've already mentioned the generous compensation program and the Act also contains numerous provisions "to achieve optimal prevention against adverse reactions," and to actively monitor the FDA approved vaccines.
These provisions once again suggest that the statute summons regarding the design defect liability reflects a sensible choice to live complex epidemiological judgments about vaccine design to federal officials rather than the juries.
The final evidence is the structural quid pro quo of the Act.
Vaccine manufacturers fund from their sales and informal efficient compensation program.
In exchange, they avoid cause of litigation and the occasional disproportionate jury verdict.
The Congress enacted this deal to coax manufacturers back into the vaccine market but design defect allegations are the most speculative and difficult type of products liability claim to litigate, taxing vaccine manufacturer's product to fund the compensation program while living their liability for design defects virtually unaltered would be an odd way to make vaccine manufacturer more attractive.
The judgement of the Court of Appeals is affirmed.
Justice Breyer has filed a concurring opinion.
Justice Sotomayor has filed a dissenting opinion in which Justice Ginsburg joins.
Justice Kagan took no part in the consideration or decision of the case.