131 S.Ct. 1068 Supreme Court of the United States Russell BRUESEWITZ, et al., Petitioners, v. ...

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131 S.Ct. 1068 Supreme Court of the United States Russell BRUESEWITZ, et al., Petitioners, v. WYETH LLC, fka Wyeth, Inc., fka Wyeth Laboratories, et al. No. 09–152. Argued Oct. 12, 2010. Decided Feb. 22, 2011. by Mind Map: 131 S.Ct. 1068  Supreme Court of the United States  Russell BRUESEWITZ, et al., Petitioners,  v.  WYETH LLC, fka Wyeth, Inc., fka Wyeth Laboratories, et al.  No. 09–152.  Argued Oct. 12, 2010.  Decided Feb. 22, 2011.

1. Facts

1.1. Parties

1.1.1. WYETH LLC, fka Wyeth, Inc., fka Wyeth Laboratories, et al.

1.1.1.1. 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.

1.1.1.1.1. Kathleen M. Sullivan, New York, NY, for Respondents. Benjamin J. Horwich, for United States as amicus curiae, by special leave of the Court, supporting the Respondents. John Eddie Williams, John T. Boundas, Williams Kherkher, Hart Boundas, LLP, Houston, Texas, Collyn A. Peddie, Houston, Texas, David C. Frederick, Derek T. Ho, Brendan J. Crimmins, Janie N. Kucera, Kellogg, Huber, Hansen, Todd, Evans & Figel, P.L.L.C., Washington, D.C., Petitioners. Daniel J. Thomasch, Richard W. Mark, E. Joshua Rosenkranz, Lauren J. Elliot, John L. Ewald, Orrick, Herrington & Sutcliffe LLP, New York, NY, Kathleen M. Sullivan, Faith E. Gay, Sanford I. Weisburst, William B. Adams, Quinn Emanuel Urquhart & Sullivan, LLP, New York, NY, for Respondent.

1.1.2. Russell BRUESEWITZ, et al., Petitioners,

1.1.2.1. Parents of minor who allegedly suffered series of seizures and resulting developmental delay after receiving dose of diphtheria-tetanus-pertussis (DTP) vaccine brought products liability action against vaccine manufacturer after rejecting judgment of the United States Court of Federal Claims. Manufacturer filed motion for summary judgment.

1.1.2.1.1. David C. Frederick, Washington, DC, for Petitioners

1.1.3. The Supreme Court

1.1.3.1. Justice Breyer filed concurring opinion. Justice Sotomayor, joined by Justice Ginsburg, filed dissenting opinion. Justice Kagan took no part in consideration or decision of the case.

1.2. The What

1.2.1. Affirmed: The Supreme Court, Justice Scalia, held that National Childhood Vaccine Injury Act (NCVIA) preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.

1.3. Procedural History

1.3.1. The National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) created a no-fault compensation program to stabilize a vaccine market adversely affected by an increase in vaccine-related tort litigation and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too costly and difficult. The Act provides that a party alleging a vaccine-related injury may file a petition for compensation in the Court of Federal Claims, naming the Health and Human Services Secretary as the respondent; that the court must resolve the case by a specified deadline; and that the claimant can then decide whether to accept the court's judgment or reject it and seek tort relief from the vaccine manufacturer. Awards are paid out of a fund created by an excise tax on each vaccine dose. As a quid pro quo, manufacturers enjoy significant tort-liability protections. Most importantly, the Act eliminates manufacturer liability for a vaccine's unavoidable, adverse side effects.

1.3.2. Held: The NCVIA preempts all design-defect claims against vaccine manufacturers **1071 brought by plaintiffs seeking compensation for injury or death caused by a vaccine's side effects. Pp. 1075 – 1082

1.3.2.1. Hannah Bruesewitz's parents filed a vaccine-injury petition in the Court of Federal Claims, claiming that Hannah became disabled after receiving a diphtheria, tetanus, and pertussis (DTP) vaccine manufactured by Lederle Laboratories (now owned by respondent Wyeth). After that court denied their claim, they elected to reject the unfavorable judgment and filed suit in Pennsylvania state court, alleging, inter alia, that the 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.

1.3.2.1.1. Wyeth removed the suit to the Federal District Court. It granted Wyeth summary judgment, holding that the relevant Pennsylvania law was preempted by 42 U.S.C. § 300aa–22(b)(1), which provides that “[n]o 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.” The Third Circuit affirmed.

1.3.3. Section 300aa–22(b)(1)'s text suggests that a vaccine's design is not open to question in a tort action. If a manufacturer could be held liable for failure to use a different design, the “even though” clause would do no work. A vaccine side effect could always have been avoidable by use of a different vaccine not containing the harmful element. The language of the provision thus suggests the design is not subject to question in a tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design. This conclusion is supported by the fact that, although products-liability law establishes three grounds for liability—defective manufacture, inadequate directions or warnings, and defective design—the Act mentions only manufacture and warnings. It thus seems that the Act's failure to mention design-defect liability is “by deliberate choice, not inadvertence.” Barnhart v. Peabody Coal Co., 537 U.S. 149, 168, 123 S.Ct. 748, 154 L.Ed.2d 653. P. 1076.

1.3.4. 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.30 A Special Master denied their claims on various grounds, though they were awarded $126,800 in attorney's *231 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.31

1.3.4.1. 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).32 The United States Court of Appeals for the Third Circuit affirmed.33 We granted certiorari. 559 U.S. ––––, 130 S.Ct. 1734, 176 L.Ed.2d 211 (2010).

1.4. Summary

1.4.1. Courts in the words of justice Scalia, " We consider whether a preemption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA)1 bars state-law design-defect claims against vaccine manufacturers."

1.4.2. Without disregard and with legal protection, there was found no ability to sue.

2. Issue

2.1. 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.”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.”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.

3. Rule of Law

3.1. “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”34

4. Analysis/Applcation

4.1. 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 *232 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.

4.2. 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 **1076 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.35

4.3. 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.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 *233 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, 123 S.Ct. 748, 154 L.Ed.2d 653 (2003). Expressio unius, exclusio alterius. B

5. Conclusion

5.1. 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. 562 U.S. 223, 243, 131 S.Ct. 1068, 1082

5.1.1. "(1) any inn, hotel, motel, or other establishment which provides lodging to transient guests, other than an establishment located within a building which contains not more than five rooms for rent or hire and which is actually occupied by the proprietor of such establishment as his residence;

5.2. The Court affirmed the lower court's judgment.

5.2.1. The Manufacturer and the Vaccine itself are not liable for the damages due to existing protections

6. Impact

6.1. The legislative history describes the statute more generally as trying to protect the lives of children, in part by ending “the instability and unpredictability of the childhood vaccine market.” H.R. Rep., at 7, U.S.Code Cong. & Admin.News, 1986, at p. 6348; see ante, at 1072 – 1073. As the Committee Report makes clear, routine vaccination is “one of the most spectacularly effective public health initiatives this country has ever undertaken.” H.R. Rep., **1084 at 4, U.S.Code Cong. & Admin.News, 1986, at p. 6345.

6.2. 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 *247 “prompted manufacturers to question their continued participation in the vaccine market.” H.R. Rep., at 4, U.S.Code Cong. & Admin.News, 1986, at p. 6345; Childhood Immunizations 85–86.

7. Importance

7.1. “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.

7.2. This ruling strengthened the rules in place allowing manufacturers of vaccines to operate (within limits) in a manner that will provide the maximum immunity and good for the populace in an area deemed critical (TTD Shots in this case)by the Health and Human Services Department.

8. Influence

8.1. Congressional Power

8.2. Congress enacted the National Childhood Vaccine Injury Act (NCVIA) to stabilize the vaccine market and facilitate compensation. National Childhood Vaccine Injury Act of 1986, § 301 et seq., 42 U.S.C.A. § 300aa–1 et seq.

8.3. , Smith ex rel. Smith v. Wyeth Labs., Inc., No. Civ. A 84–2002, 1986 WL 720792, *5 (S.D.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”),

8.4. Brown v. Superior Ct., 44 Cal.3d 1049, 245 Cal.Rptr. 412, 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”);