1. Background
1.1. Facts
1.1.1. Parties
1.1.1.1. Petitioner: Russell Bruesewitz, et al.
1.1.1.2. Respondent: Wyeth, Inc., Wyeth Laboratories, et al.
1.1.2. What Happened
1.1.2.1. Family Version
1.1.2.1.1. They claimed that the drug company, Wyeth, failed to develop a safer vaccine and should be held accountable for preventable injuries caused by the vaccine's defective design.
1.1.2.1.2. They claimed that Wyeth was subject to strict liability and liability for negligent design under Pennsylvania common law.
1.1.2.2. Pharmaceutical Company Version
1.1.2.2.1. The vaccine at issue 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.
1.2. Procedural History
1.2.1. The Bruesewitzes' petitioned the vaccine court on Hannah's behalf but were denied an award, although they were awarded $126,800 in attorney's fees and costs.
1.2.1.1. The VICP is a no-fault program to compensate individuals who experience adverse reactions to vaccination and to protect vaccine manufacturers from certain types of liability to ensure a sufficient production of vaccine.
1.2.1.1.1. The VICP allows claimants to petition a vaccine court for an award paid from a fund created by excise taxes on vaccines.
1.2.1.1.2. The vaccine court will issue an award if the adverse reaction is listed on the Vaccine Injury Table, which lists compensable injuries by vaccine type, without the petitioner needing to prove causation or fault.
1.2.1.1.3. The claimant may decide whether to accept or reject the vaccine court’s judgment or file a state tort claim against the manufacturer, unless the claim is preempted by NCVIA.
1.2.2. In October of 2005, The Bruesewitzes' filed a lawsuit against Wyeth in the State Court of Pennsylvania.
1.2.2.1. The Bruesewitzes rejected the vaccine court’s ruling, and filed a state claim stating that the vaccine manufactured by Lederle Laboratories (later purchased by Wyeth) had a defective design that caused their daughter’s disabilities.
1.2.3. Wyeth had the lawsuit removed to the United States District Court for the Eastern District of Pennsylvania and asked for a summary judgement.
1.2.4. The District Court dismissed the Bruesewitzes' claim against Wyeth: Ruling that the National Childhood Vaccine Injury Act protected Wyeth from lawsuits over vaccine injury claims.
1.2.4.1. No vaccine manufacturer is 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.
1.2.5. On March 8, 2010 the U.S. Court of Appeals granted the Bruesewitzes' an appeal
1.2.6. On February 22, 2011 the U.S. Court of Appeals for the 3rd Circuit, in a six-to-two decision, affirmed the decision made by the District Court.
2. Critique
2.1. Issue Before The Courts
2.1.1. The Interpretation of Vaccine Legislation
2.1.1.1. “No vaccine manufacturer shall be liable 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."
2.1.2. Strict Liability
2.1.2.1. Company documents, identified through discovery refered to increased adverse reactions with Tri-Immunol, although not residual seizure disorder specifically, as compared with a vaccine with an acellular pertussis component (DTaP).
2.1.2.1.1. In other documents, company representatives concluded that pursuing a “better pertussis component” was “not worth it for the total market.”
2.1.2.1.2. The DTaP vaccine is now standard in the United States, and Wyeth removed Tri-Immunol from the market in 1998 .
2.2. Analysis
2.2.1. Definition
2.2.1.1. Strict Liability
2.2.1.1.1. A tort law: Liability that does not depend on actual negligence or intent to harm.
2.2.1.1.2. A manufacturer is responsible for any damages caused by its products, irrespective of the level of care it exercised.
2.2.2. Arguement
2.2.2.1. Vaccines are in a unique position as the components that make them effective may also cause serious adverse effects.
2.2.2.2. Vaccines are considered "unavoidably unsafe products” and therefore, according to legislation are exempted from strict liability as long as consumers are adequately warned about their risks.
2.2.2.2.1. Legislation is used to assure that products such as vaccines remain on the market, since they make a vital contribution to public health.
2.2.2.3. The safety profile of vaccines are regulated by the Food and Drug Administration (FDA)..
2.2.3. Courts Take
2.2.3.1. According to the National Childhood Vaccine Injury Act (NCVIA) of 1986, vaccine makers are immune from lawsuits charging that the design of a vaccine is defective.
2.3. Decision
2.3.1. Vaccine makers are immune from lawsuits charging that the design of a vaccine is defective.
2.3.1.1. Federal Preemption of state laws and reliance on regulation set forth by the FDA.
2.3.2. No injury occurred
2.4. Rule of Law
2.4.1. Strict Liability
2.4.1.1. Application
2.4.1.1.1. The way in which the legislation was interpreted had the potential to defeat the purpose of the vaccine court and potentially jeopardize market stability and vaccine availability.
2.4.1.2. Conclusion
2.4.1.2.1. Vaccine makers are immune from lawsuits charging that the design of a vaccine is defective.
3. Assigned Questions
3.1. The impact of the decision
3.1.1. Additional Cases
3.1.1.1. National Collegiate Athletic Association v. Christopher Christie
3.1.1.1.1. A lawsuit that was brought forth by Athletic leagues in regards to New Jersey legislation that legalized and regulated sports gambling at New Jersey racetracks and casinos for individuals age twenty-one and older.
3.1.1.1.2. The court determined that New Jersey legislation was invalid, under the Supremacy Clause of the United States Constitution, as preempted by PASPA.
3.1.1.2. Eric Rooney v The City of Philadelphia
3.1.1.2.1. A negligence lawsuit that was brought forth in regards to the city's maintenance of the city's sewage system.
3.2. Why would a business professional care about the decision/ how has the decision changed the way business operates
3.2.1. This case was an important win for pharmaceutical companies in regards to their ability to make and produce vaccines without the threat of being sued over vaccine injury.
3.2.2. A businessman can look at the vaccine market as a stable investment due to this type of ruling. There is a decreased ability to bring a successful lawsuit against a vaccine makers.
3.3. Two current business practices that have been influenced by the case
3.3.1. Tighter control over vaccine production by the FDA in regards to vaccine improvement and monitoring.
3.3.2. Decrease ability for lawyers to bring forth cases that claim that a vaccines defective design causes autism.
3.3.3. An increase in the number of people in the anti-vaccine movement leading to recent measles outbreaks in the U.S.