1. Conclusion
1.1. Affirmed lower court's decision
1.2. Yes, the NCVIA prevents design based defect lawsuits against manufacturers
2. Impact
2.1. Holmes v. Merck & Co, No. 08-16557
2.1.1. 1-year old son died after receiving MMR vaccine; design defect liability based on Bruesewitz v. Wyeth decision
2.2. Payne v. Tri-State CareFlight, No. CIV 14-1044 JB/KBM
2.2.1. Flight paramedic, nurse and pilot seeking unpaid compensation
2.2.2. Used Bruesewitz v. Wyeth for preemption discussion
2.3. Raymo v. Secretary of Health and Human Services, No. 11–654V
2.3.1. Daughter paralyzed from vaccines
2.3.2. Attempting to get attorney's fees covered, referenced Bruesewitz v. Wyeth
3. Importance
3.1. This case enforced the protections given to vaccine manufacturers under NCVIA; they could continue to produce vaccines for the market place without fear of liability cases
4. Influence
4.1. This case had significant impacts on other cases pending, particularly those related to autism and vaccines; the outcome of this case suggest that autism potentially caused by vaccines would not be able to rely on design defect arguments
4.2. The NCVIA set up an entire compensation program based on vaccine taxes
4.3. Would be an influential if I was a producer of some type of safety product- in this case, the harm the product is preventing is deemed to be of higher value than the harmful side effects it creates
5. Facts
5.1. Parties
5.1.1. Russell and Robalee Bruesewitz (parents of daughter injured by vaccine)
5.1.2. Wyeth, LLC (owner of company that created the vaccine)
5.2. What Happened
5.2.1. 1992: Hannah started having seizures 2 hours after getting vaccines (3: diphtheria, tetanus, and pertussis) administered at 6 months old
5.2.1.1. 100 seizures in the month following vaccine administration (which was done correctly)
5.2.1.2. It was not an isolated event: Hannah continues to suffer from 'residual seizure disorder' and 'developmental delay'
5.2.2. 1998: That particular vaccine used was pulled from the market
5.3. Procedural History
5.3.1. The Bruesewitzes first filed a petition in 1995 in the Court of Federal Claims, which was denied
5.3.1.1. Bruesewitzes rejected the judgement
5.3.2. 2005: Bruesewitzes then filed in Pennsylvania
5.3.2.1. Claims were based on defect liability, under PA Common Law
5.3.3. Wyeth moved the case to US District Court for Eastern District of PA, which gave summary judgement
5.3.4. US Court of Appeals for the 3rd Circuit affirmed
5.3.5. Went to US Supreme Court
6. Issue
6.1. Does the National Childhood Vaccine Injury Act of 1986 prevent design based defect lawsuits against vaccine manufacturers?
7. Rule of Law
7.1. National Childhood Vaccine Injury Act of 1986
7.1.1. Liability (is design defect applicable?)
8. Analysis/Application
8.1. Vaccines are only useful at preventing a disease if most people receive them (therefore, there's a public interest in ensuring vaccine development and production is not limited by lawsuit fear or costs)
8.1.1. Concerns about vaccine side effects had people opting out (they were no longer afraid of diseases the vaccine prevented)
8.1.2. Lawsuits from injury where making production of vaccines non-profitable to companies
8.1.2.1. This led to a vaccine shortage
8.1.2.1.1. Therefore the NCVIA was created
8.2. The NCVIA allows vaccines to have different liability criteria than products-liability law
8.2.1. Criteria 1: "defective manufacture"
8.2.2. Criteria 2: "inadequate directions or warnings"
8.2.3. the NCVIA (or FDA) does not allow for the questioning of the design of the vaccine
8.3. Design-defect torts are useful for two things: improving design, and compensation for injury. Both are invalid when relating to vaccines for the following (bracketed out) reasons
8.3.1. Improvement: the National Vaccine Program and FDA are already focused on this all the time
8.3.2. Compensation: In order to protect vaccine manufacturers, the NCVIA sets up a system to deal with vaccine-injury related compensation
8.3.2.1. Vaccines were taxed to create a pool of money for compensation
8.3.2.2. Suit went through Court of Federal Claims
8.3.2.3. Applicable vaccines, side effects, timelines, and compensation were clearly listed
8.3.2.3.1. No need to show causation, just timing, for vaccines and side effects listed
8.3.2.3.2. Non-listed vaccines and side effects were eligible, however causation must be proven
8.3.2.4. The decision (made in 240 days) could either be accepted by the plaintiff, or reject judgement and seek tort relief
8.4. The NCVIA really protects vaccine manufacturers from liability of their products- even in the cases of death
8.4.1. They could literally kill you with their product and you [your remaining family members] can't question the design of the vaccine in court
8.4.2. As a federal act, this overrules any state laws