In October 2010, the Supreme Court heard oral arguments for Bruesewitz v. Wyeth , a case which involves the scope of the National Childhood Vaccine Injury Act. The issue before the Court was whether 42 U.S.C. Section 300aa-22(b)(1) of the act precludes all vaccine design defect claims even if the vaccine's side effects were avoidable, in other words whether the section preempts vaccine design defect claims categorically, or whether the vaccine manufacturer has to show on a case-by-case basis that the side effects could not have been avoided by some alternatively designed vaccine. On February 22, 2011, the Supreme Court issued its decision in Bruesewitz , affirming, by a vote of 6-2, the decision of the U.S. Court of Appeals for the Third Circuit that the federal law preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by the vaccine's side effects. This report provides an overview of the structure of the Vaccine Act and the relevant facts of the Bruesewitz case. It then examines the lower court decisions before reviewing the Supreme Court decision. Finally, it discusses the decision's potential effect on preemption jurisprudence as well as on the existing Vaccine Act litigation. The National Childhood Vaccine Injury Act (Vaccine Act) was enacted in 1986 and established a national vaccine program to "achieve optimal prevention of human infectious diseases through immunization and ... against adverse reaction to vaccines." Under the Vaccine Act, the National Vaccine Injury Compensation Program (Compensation Program) was established to handle claims against drug manufacturers for vaccine-related injuries and deaths. The Compensation Program has two parts. Part A creates a mandatory forum for the administration of claims by requiring individuals who seek compensation, including the injured party's legal representative, to file a petition in the United States Court of Federal Claims (Vaccine Court). A petitioner is entitled to recover if the affected person (1) received a vaccine covered by the Vaccine Act; (2) suffered a "covered" injury ; and (3) it cannot be shown by a preponderance of the evidence that the injuries or death were not caused by the vaccine. A petitioner who suffers an off-Table, or non-covered, injury may still recover compensation by proving affirmatively that the vaccine caused the injury. Part B permits a petitioner to decline the result of the Vaccine Court and pursue a civil suit in state or federal district court only after a final judgment is issued by the Vaccine Court. Any subsequent civil action is governed by state law, including the applicable statute of limitations, which is stayed pending the outcome of the suit filed in the Vaccine Court. However, Section 300aa-22 places limitations on subsequent civil actions, and it is this section that is at issue in Bruesewitz v. Wyeth . In this case, the plaintiffs/petitioners were the parents of Hannah Bruesewitz. They filed a claim with the Vaccine Court in April 1995, seeking compensation on behalf of their daughter, who suffered from several seizures shortly after receiving the third of five recommended doses of the diphtheria-pertussis-tetanus (DPT) vaccine on April 1, 1992. Hannah was subsequently diagnosed as having residual seizure disorder and developmental delay, for which she will likely require medical care for the remainder of her life. The DPT vaccine that Hannah received was marketed by Wyeth (and its predecessors) under the trade name TRI-IMMUNOL and approved in 1948. TRI-IMMUNOL contained whole, inactivated pertussis cells ("whole-cell") that effectively reduced pertussis infections and associated deaths, but it was linked to a variety of adverse events. In December 1991, the FDA approved Wyeth's application for an alternative DPT vaccine, known as ACEL-IMUNE. ACEL-IMUNE does not contain the "whole-cell" component, and is reportedly less likely to cause adverse events. The FDA initially approved Wyeth's ACEL-IMUNE for use in the fourth and fifth doses of the DPT vaccine, but did not approve its use in the first three doses of the DPT vaccine until December 1996. Thus, for her third dose Hannah received the TRI-IMMUNOL vaccine because there were no non-whole-cell vaccines commercially available at the time. Wyeth, the defendant/respondent, voluntarily discontinued manufacturing TRI-IMMUNOL in 1998. Although the plaintiffs filed their complaint with the Vaccine Court, alleging that Hannah suffered covered injuries, the Vaccine Court held a hearing in July 2002 and concluded in December 2002 that Hannah's injuries were off-Table injuries and that the petitioners had not proved causation in fact. On February 14, 2003, the plaintiffs did not accept the Vaccine Court's judgment to dismiss the claim with prejudice, and subsequently brought suit in the Philadelphia County Court of Common Pleas in October 2005. Wyeth removed the action on the basis of diversity jurisdiction to the United States District Court for the Eastern District of Pennsylvania. In federal district court, the plaintiffs sued for damages to Hannah Bruesewitz, costs, punitive damages, and other legal equitable relief. They alleged four counts against Wyeth: Count I alleged that Wyeth negligently failed to produce a safer vaccine despite knowledge of the existence and feasibility of such safer alternatives; Count II alleged that Wyeth negligently failed to warn of the actual dangers associated with the particular batch of DPT vaccine administered to Hannah; Count III asserted strict liability for design defect , in the existence or feasibility of safer alternative designs for the vaccine rendered the vaccine administered to Hannah defective and unreasonably dangerous; and Count IV asserted strict liability for manufacturing defect , in that, in addition to the unreasonable danger due to the alleged design defect, the particular dose of vaccine administered to Hannah contained a manufacturing defect that made it "extra-hazardous." The district court granted Wyeth's motion for summary judgment, concluding that Counts I and III (design defect claims) were preempted by the Vaccine Act and that the plaintiffs failed to raise any genuine issue of material fact as to Counts II and IV (failure to warn and manufacturing defect claims, respectively). The United States Court of Appeals for the Third Circuit (Third Circuit) affirmed the federal district court's decision. On appeal, the Third Circuit addressed three questions presented by the Bruesewitzes: (1) whether Section 22(b)(1) acts as a complete bar to design defect claims; (2) whether the plaintiffs met their burden under Section 22(b)(2) of the Vaccine Act to show that the defendants failed to provide an adequate warning of the alleged dangers of the vaccine; and (3) whether the plaintiffs provided sufficient evidence of a manufacturing defect to survive the defendant's motion for summary judgment. The federal district court agreed with the conclusion and reasoning of three other court decisions that held that the Vaccine Act preempts design defect claims. In holding that the Vaccine Act categorically preempts all design defect claims, it drew four conclusions. First, it held that vaccine manufacturers would not be protected from lawsuits if case-by-case inquiries were permitted. Second, the establishment of a no-fault remedies compensation program suggests that it was Congress's intention to provide manufacturers with immunity, allowing them to improve the safety of their products through the innovation of safer alternative designs. Third, the compensation scheme reflects a balance Congress struck "between the policy of widespread distribution of childhood vaccines and the need to compensate those injured affecting that policy." Lastly, the Vaccine Act preempts state law determinations of whether a vaccine is unavoidably unsafe, because "an FDA-approved vaccine design includes the side-effects of that vaccine, and is therefore, by statutory definition, the unavoidably unsafe product subject to" immunity under the liability principles of the Restatement (Second) of Torts Section 402A comment k. The Third Circuit upheld the district court's decision, but stated that further analysis was warranted. In particular, the court found Sections 22(a) and (b) to contain express preemption language because, like other provisions in federal law, it "conveys a clear intent to override state law civil action claims in particular, defined circumstances." The court of appeals stated that whether the plaintiffs' claims fell within the scope of preemption "hinge[d] on the word 'unavoidable.'" The plaintiffs argued that it "expressly precludes only those state tort claims involving vaccines with side effects first shown to be 'unavoidable,'" and that "avoidability must first be determined on a case-by-case basis." The defendant, on the other hand, argued that the language "preempts all claims arising from allegations of design defect." The court resolved to look at the language, structure, and legislative history of the act to ascertain the scope of preemption created by Section 22(b), concluding that it could not make such a determination from the statutory text alone. The Court of Appeals found that the Report from the House Committee on Energy and Commerce (Commerce Report) supported the conclusion that the Vaccine Act preempts all design defect claims. In the court's analysis, most importantly, the Commerce Report "stated in precise and certain terms that its reference to comment k and the language of 22(b) results in immunity for liability for all design defects, whether liability rests on theories of strict liability or negligence" (emphasis in the original). According to the court, any reading of the provision to permit state courts to make case-by-case determinations would exacerbate the "very problems which led to instability in the vaccine market and which caused Congress to intervene." The court acknowledged but did not find reliable a subsequent Report from the House Committee on the Budget (Budget Report) which implicates that whether vaccines are unavoidably unsafe "is [a question] left to the courts to determine in accordance with applicable law."