Source: https://www.reminger.com/insights-525.html
Timestamp: 2019-04-20 00:54:37+00:00

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The Supreme Court of the United States entered the vaccine debate in 1905 when it decided Jacobson v. Massachusetts, holding that a “well-ordered society” must be able to enforce “reasonable regulations” in responding to “an epidemic disease which threatens the safety of its members.” The Court—in an opinion authored by Justice John Marshall Harlan—upheld the authority of states to enforce compulsory vaccination laws, reasoning that the freedom of the individual must sometimes be subordinated to the common welfare.3 Today, all 50 states have laws requiring the vaccination of school children for many diseases, although exceptions are allowed for medical as well as religious reasons.
Recently, in response to the alleged “revived anti-vaccination movement,” many political leaders and health care experts publicly encouraged parents to have their children vaccinated. While concerns about unvaccinated children are seemingly heightened, another side of the vaccination issue has not attracted the same level of media scrutiny: what happens when someone claims that a vaccine caused injury? With all the recent headlines involving vaccinations, it might be beneficial for the products liability practitioner to know the answer to that question. As this article explains, the answer is somewhat complicated because of the “National Childhood Vaccine Injury Act,” (the “NCVIA”) and the United States Supreme Court’s response to the NCVIA in Bruesewitz, et al. v. Wyeth LLC, et al.4 Thanks to the NCVIA and Bruesewitz, answering the question of what happens when a vaccine allegedly causes injury now involves determining when state tort law is preempted by the NCVIA.
II. THE NATIONAL CHILDHOOD VACCINE INJURY ACT.
Responding to these issues, Congress established the National Vaccine Injury Compensation Program in the Department of Health and Human Services. The goal of the program was to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals determined to be injured by certain vaccines. The program established a no-fault alternative to the traditional tort system for resolving vaccine injury claims and was “designed to work faster and with greater ease than the civil tort system.”8 Determining that the administration of vaccines was too important to national health to allow it to be rendered financially impossible by tort law, Congress passed the National Childhood Vaccine Injury Act (“NCVIA”) in 1986 in order to keep manufacturers of vaccines in the market while still providing compensation for vaccine related injuries.
2. Brief overview of the process under the NCVIA.
The NCVIA is intended to provide fast, informal adjudication, which is made possible partly by the Vaccine Injury Table. The Table lists the vaccines the NCVIA covers, describes each vaccine’s compensable adverse side effects, and indicates how soon after the vaccination those side effects typically manifest themselves.10 Claimants who show that a listed injury first manifested itself at the appropriate time are prima facie entitled to compensation without needing to show causation. It is also possible for a claimant to recover for unlisted side effects as well as for side effects that occur at times other than those specified in the Table. In those situations, however, the claimant must prove causation.11 Unlike in tort suits, claimants under the NCVIA do not need to show that the vaccine was defectively manufactured, labeled, or designed in order to recover.
3. The relationship between NCVIA and state tort law.
Disagreements over the extent of the protection provided by subsection (b) is what led to the Supreme Court’s decision in Bruesewitz, et al. v. Wyeth LLC.
The majority opinion found further support for its conclusion from the structure and regulations of the NCVIA. The regulations accompanying the NCVIA require a vaccine’s license to disclose the manufacturing method that must be followed as well as the directions and warnings that must supplement the product.23 If a product deviates from the license, that deviation provides objective evidence of manufacturing defects or inadequate warnings, and manufacturers must obtain the Food and Drug Administration’s approval before modifying either the manufacturing method or the directions and warnings. More than 90 Food and Drug Administration regulations regulate the manufacturing process.
Justice Sotomayor’s principal disagreement with the majority centers on the meaning of the word “unavoidable” in 42 U.S.C. § 300aa- 22(b)(1). She would interpret the word “unavoidable” as a term of art incorporating comment k of the Restatement (Second) of Torts § 402A (1963-1964). The Restatement generally holds manufacturers strictly liable for harm caused to person or property when that harm is caused by “any product in a defective condition unreasonably dangerous to the user.” 27 Under comment k, “unavoidably unsafe products” are exempted from the strict liability rule. Justice Sotomayor argues that Congress was referring to comment k of the Restatement by using the word “unavoidable,” and therefore had no intention of preempting state law design defect claims.
Regarding the question of what can be done about the unvaccinated child—the question so prominent in the news media today—this article is of no use. However, this article hopefully provides the products liability practitioner with some guidance in answering the question of what happens when an individual claims that a vaccine has caused some sort of injury. The NCVIA establishes an elaborate system for vaccine related claims to be adjudicated, and most claims must start in the United States Court of Federal Claims. Because of the NCVIA and Bruesewitz, all state tort law design defect claims are preempted.
1See the Centers for Disease Control and Prevention, “History of Vaccine Safety,” http://www.cdc.gov/ vaccinesafety/vaccine_monitoring/history.html (last accessed 3/19/15).
2 See “The Return of the Vaccine Wars,” by David Oshinsky.
Sing & William, 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).
Vaccine Injury, 19 Cornell J.L. & Pub. Pol’y 537, 550- 51 (2010).
8Shalala v. Whitecotton, 514 U.S. 268, 269 (1995). 9See 42 U.S.C. § 300aa.
42 U.S.C. § 300aa-14(a); 42 CFR § 100.3 (current Vaccine Injury Table).
11 42 U.S.C. § 300aa-11(c)(1)(C)(ii).
13See 42 U.S.C. § 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.
Court, they are not addressed here.
17 Bruesewitz v. Wyeth LLC, 131 S.Ct. 1068 (2011).
19 42 U.S.C. § 300aa-22(b)(1).
Bruesewitz, 131 S.Ct. at 1075 (emphasis in original).
22 Id. (emphasis in original).
Bruesewitz, 131 S.Ct. at 1079. 25 Id.
26 Id. citing 42 U.S.C. § 300aa-27(a)(1).
27 Restatement (Second) § 402A, p. 347. 28 Bruesewitz, 131 S.Ct. at 1077.

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