1. Rule of law
1.1. National Childhood Vaccine Injury Act (1986)
1.2. Product Liability Law
1.2.1. Liability of manufacturer to defective products-intentional act
1.3. Pennsylvania common law
1.4. Negligence Act
1.4.1. Not deliberate but present unlawful acts
2. Analysis/ Application
2.1. Presentation of the Rule by Defendant and Plaintiffs
2.1.1. Plaintiffs.
2.1.1.1. Special attention was given to the interpretation of the word "unavoidable" interpreting it as if a manufacturer was liable for producing vaccines with serious side effects, the production of harmful vaccines would be avoidable.Therefore,manufacturer's immunity to liability causes negligence to produce a safer vaccine and failure to warn for side effects.
2.1.1.1.1. Even though products liability law includes defective manufacture, inadequate directions and warnings and defective design,NCVIA acknowledges only the first two and excludes the last one.Therefore, Defendant is liable for causing side effects caused by design defects which are not covered by the Act's liability
2.1.2. Defendant
2.1.2.1. Defedant claimed all actions are legally covered by NCVIA.Wyeth used comment k-Restatement of Torts:" vaccine manufacturers are exempt from strict liability rules" to prove its liability immunity
2.1.2.1.1. Textual wrongful interpretations is an act of Plaintiffs' lack of evidence.For example the word "unavoidable" cannot be used by itself but only in conjunction with others and in this case it refers to the side effects of the vaccine
2.2. Court Reasoning and Interpretation
2.2.1. The NCVIA served :1) as a protection of the public from disease outbreaks and 2) as a market stabilizer avoiding exceccsive vaccine related tort litigation and vaccine shortage since manufacturers could not afford to stay in the market
2.2.1.1. The " no fault compensation program"acted quickly to vaccine related victims.
2.2.1.1.1. "The Court relied heavily on the following text of the Vaccine Act:"no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine related injury or health associated with the administration of a vaccine after October 1st, 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"
2.2.2. Justice Sotomayor and Ginsburg had dissenting opinions based on the textual arguments of the word "unavoidable".Additionally it was noted that a careful balance has to be established between the injured children's' compensations and manufacturers' obligation to technological and scientific improvements
3. Impact
3.1. Sebelius v. Cloer,569 US (2013)Dr. Cloer, a student at the time, received a Hepatitis B immunization in 1997.Gradually after she developed symptoms of MS and she finally diagnosed in 2003. She became aware of a possible link between MS and Hepatitis B vaccine.
3.1.1. She then filed a claim at the Court of Claims but it was rejected with the reason of being untimely.The claimant then filed for attorney's fees and costs. The Supreme Court ordered that legal costs will be awarded even tough petition is untimely if it is filed in good faith and there is a reasonable basis for the claim
3.2. Mut. Pharma. Co.v.Barlett, 570 US (2013).Karen Barlett filed a complaint against Mutual Pharmaceutical for suffering severe health complications after given an inflammatory pain reliever for shoulder pain. The patient was prescribed Clinoril,but was given a generic form of the pill.
3.2.1. Barlett sued Mut. Pharm for failure to warn and design defects.Supreme Court preempt generic drug defect design under precedent law.
4. Influence
4.1. Vaccine steady supply has enabled increased vaccination.Today vaccination of students, health care professionals and employees in other fields is mandatory.Vaccinations are also covered by most insurance plans in the effort to reduce risk of more serious disease
4.2. An excise tax of $0.75 per vaccine is collected to a central fund for the compensation of vaccine related injured individuals
5. Facts
5.1. Parties
5.1.1. Bruesewitz (plaintiff) v. Wyeth LLC, FKA Wyeth, Inc (defendant)
5.2. What happened
5.2.1. In 1986 Congress enacted the National Childhood Vaccine Injury Act.The Act shields vaccines manufacturers against civil liability claims seeking compensation for health injuries attributed to the vaccines already approved by the FDA. Manufacturers' immunity holds if proven that injuries could not have been prevented through a safer design
5.2.1.1. Patients who suffered injuries due to vaccination may file claims for compensation at the no fault Court of Federal Claims
5.2.1.1.1. If the vaccine is listed under causing reactions in the past-listed on the Table- the Court will issue an award to the claimant
5.2.1.1.2. If the vaccine is not listed the court will issue an award if the claimant proves the vaccine caused the injury
5.3. Procedural history
5.3.1. In 1995 the Bruesewitzs filed a petition in the Court of Federal Claims seeking compensation as provided by the National Childhood Vaccine Injury Act. The vaccine was included in the list of vaccines that had caused complications in the past
5.3.1.1. A Special Master denied the Plaintiffs' claims but awarded them $126,00 in legal expenses
5.3.1.1.1. The Plaintiffs' rejected the court's decision
6. Issue
6.1. Are accusations for negligence and deliberate actions for defective vaccine design and lack of warning protected by the Vaccine Act?Will the Supreme Court grant Wyeth immunity under the Act?
6.1.1. Will this prevent vaccine manufacturers from exiting the market due high compensation costs?
6.1.2. Will this decision attribute in market stabilization and avert vaccine shortages seen in 1980 due to tort liability threats?
6.1.3. Will vaccine manufacturers' liability immunity prevent the them from vaccine improvements efforts?
6.1.4. What are the ethical considerations of this decision?
6.2. Or the Supreme Court will impose vaccine manufacturers to litigation?
6.2.1. What economic implications this decision may have at the market?Can vaccine manufacturers afford to be in the market after paying for compensations. Is there a possibility of vaccine shortage?
6.2.2. Does this decision protect public health?What are the possible implications?
7. Conclusion
7.1. Under the vaccine Act Defendant is not liable for design defects and negligence claims.(Court affirmed 6-2)
8. Importance
8.1. The holding of Brusewitz v. Wyeth has legal and public health ramifications
8.1.1. Vaccine manufacturers' immunity to liability renders arguments such as the significance of public fear for dangerous side effects after vaccine administration.Historic and recent pandemic, such the H1N1 in 2009, prove that vaccine health benefits in public health outweigh complications of single incidents
8.1.2. Alternatively,vaccine manufacturers' immunity to liability may alter improvements in vaccine manufacturing which also affects public health.A warning does not guarantee safety and a health care professional should wander after all how a no fault court is appropriate in deciding health issues?