1. Impact
1.1. AMERICAN HOME PRODUCTS CORP. et al. v. FERRARI et al.
1.1.1. In context and the congressional intent behind it ”still “shows that the Act does not preempt all design defect claims against vaccine manufacturers.” The Supreme Court of the United States has now conducted its own “full examination of §§ 300aa22 (b)(1) in context and the congressional intent behind it” and reached the opposite conclusion, which is binding on this Court
1.2. Sebelius v. Cloer
1.2.1. A person whose petition under the National Vaccine Injury Compensation Program is dismissed as untimely can recover fees and costs
1.2.2. According to the plain text of the Act, as long as the petition was filed in good faith and a reasonable basis, the petitioner is eligible for an award of attorney's fees. To limit the ability of good-faith petitioners to obtain assistance with attorney's fees would run counter to Congress' express goals in the fees provision of the Act.
2. Importance
2.1. Prevents a vaccine supply crisis (which is what caused the NCVIA act to begin with)
3. Influence
3.1. Promotes growth and development in the Pharmaceutical industry as it protects companies so long as they are compliant with the regulations and ethics.
3.2. Also promotes the growth or sustainability of medical equipment manufactures.
4. References:
4.1. Cross & Miller (2016) The legal environment of business.
4.2. Find Law (n.d) AMERICAN HOME PRODUCTS CORP. et al. v. FERRARI et al. https://caselaw.findlaw.com/ga-supreme-court/1569488.html
4.3. AMA Journal of Ethics NCVIA and the Supreme Court's Decision (2012) http://journalofethics.ama-assn.org/2012/01/hlaw1-1201.html
5. Facts
5.1. Parties
5.1.1. Bruesewitz Family
5.1.2. Wyeth, LLC
5.2. What Happened
5.2.1. Six month old Hannah Bruesewitz received DTP vaccine and began having seizures within 24 hours of the vaccine.
5.2.2. The parents, Russel and Robalee, filed claim under the National Childhood Vaccine Injury Act (NCVIA) to the U.S. Court of Federal Claims.
5.3. Procedural History
5.3.1. The parents, filed claim to the U.S. Court of Federal Claims which denied claims under NCVIA.
5.3.2. Family filed state court suit against Wyeth, LLC on the basis of "strict product liability." (1)
5.3.3. Suit moved to Federal District Court, court held claim was preempted by NCVIA, protecting manufactures from liability for "unavoidable side effects." (1)
5.3.4. The U.S. Court of Appeals for the Third Circuit affirmed the district court's judgement.
5.3.5. Bruesewitz family then appealed to the Supreme Court.
6. Issue
6.1. Can federal law (NCVIA) protect vaccine manufactures from product liability lawsuits for children who suffer from health problems or injury due to vaccines?
6.2. Should the preemption provision in NCVIA bar state law claims against vaccine manufactures?
7. Rule of Law
7.1. NCVIA enacted in 1986 that establishes a no-fault compensation program designed to reduce the financial liability of vaccine makers due to vaccine injury claims.
7.1.1. It is designed to work faster and with greater ease than the civil tort system.
7.1.2. A person or guardian may file a petition for compensation in the United States Court of Federal Claims.
8. Analysis/Application
8.1. Manufacturer, Wyeth, LCC defense is the NCVIA. The
8.1.1. NCVIA: "No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine"
8.2. The quid pro quo for this is designed to "stabilize the vaccine market... manufacturers are generally immunized from liability... if they have complied with all regulatory requirements..."
8.2.1. Act "expressly eliminates liability for a vaccines unavoidable, adverse side effects"
8.3. Bruesewitz family must prove:
8.3.1. Wyeth did not meet regulatory requirements
8.3.2. Wyeth has already determined the side affects unavoidable.
9. Conclusion
9.1. Supreme court affirmed the lower's court judgement.
9.1.1. The NCVIA preempted the Plaintiff's claim against Wyeth for compensation for the injury to their daughter caused by the DTP vaccine’s side effects.
9.2. The Court found that the NCVIA’s compensation program "strikes a balance between paying victims harmed by vaccines and protecting the vaccine industry from collapsing under the costs of tort liability." (1)
9.3. "The NCVIA act expressly eliminates liability for a vaccine's unavoidable , adverse side effects." (1)
9.3.1. "The Vaccine manufacturers fund from their sales an informal , efficient compensation program for vaccine injuries and in exchange they avoid the costly tort litigation."