1. Impact
1.1. Sebelius (Health & Human Services) v. Cloer (2013)
1.1.1. Cloer files for compensation for injuries, specifically the development of Multiple Sclerosis, sustained as a result from receiving the Hepatitis B vaccination.
1.1.2. Held that an "untimely NCVIA petition may qualify for an award of attorney’s fees if it is filed in good faith and there is a reasonable basis for its claim".Source: Sebelius v. Cloer, 569 U.S. 369 (2013)
1.2. Milik v Secretary of Health & Human Services (2016) Source: FindLaw's United States Federal Circuit case and opinions.
1.2.1. The Milik family files for compensation for their child's debilitating injuries suffered as a result of receiving the MMR vaccination.
1.2.2. Malik family claims that Bruesewitz v. Wyeth, LLC finding is unconstitiutional.
1.2.2.1. Congress cannot take away an individual's access to Article III courts for resolution of common law claims.
1.2.3. The court affirmed the lower court's finding.
2. Importance in Business
2.1. Establishes jurisprudence for Federal preemption to limit civil torts against manufacturers in strict liability cases.
2.1.1. By establishing that "unavoidably unsafe products" exist, it opens the door for other industries to pursue the same limitation of liability.
3. Influence
3.1. Removed incentives for vaccine manufacturers to make vaccination research and safety testing as robust as possible after FDA approval. Source: Holland, Liability for Vaccine Injury: The United States, the European Union, and the Developing World The 2017 Randolph W. Thrower Symposium Minding the Gap: Law and Practice in Public Health Emergencies.
3.1.1. Protects manufacturers from litigation resulting from unproven links between a product and a harm.
3.1.2. Stabilizes the vaccination industry allowing vaccines to be produced for the public.
3.1.3. Prevents the outbreak of previously irradicated diseases through vaccination.
3.2. Plaintiff liability claims for pharmaceuticals and medical devices are limited to manufacturing, design, and warning. The burden of proof is on the plaintiff. Source: Notes on Bruesewitz | Lexology
4. Rule of Law
4.1. The National Childhood Vaccine Injury Act (NCVIA) of 1986.
4.1.1. The Act establishes the legal guardian of a person injured by a vaccine may file a petition for compensation in the U.S. Court of Federal Claims.
4.1.1.1. The Act establishes no-fault compensation program for persons injured by a vaccine.
4.1.1.2. Meant to expedite claims faster than the civil tort system.
5. Application
5.1. Plaintiff
5.1.1. Claims Wyeth, LLC had strict product liability for the adverse side effects leading to their child's seizures and developmental delays
5.2. Court
5.2.1. Federal District Court
5.2.1.1. Held the claim was preempted by NCVIA
5.2.1.1.1. NCVIA includes provisions protecting manufactures from liability for unavoidable, adverse side effects.
5.2.2. Their Circuit U.S. Court of Appeals
5.2.2.1. Confirms the Federal District Court Findings.
5.2.3. U.S. Supreme Court
5.2.3.1. Establishes preemption
5.2.3.1.1. The federal statue NCVIA takes precedence over a conflicting state regulation on strict liability.
5.2.3.2. Establishes quid pro quo in the case of NCVIA.
5.2.3.2.1. Tort liability for manufacturers designed to stabilize the vaccination industry.
5.2.3.2.2. As long as the manufacturer complied with all regulatory requirements, liability is eliminated for the manufacturer.
5.2.3.2.3. In exchange for immunity from tort litigation, vaccine manufacturers must establish a fund to compensate victims harmed by vaccines.
5.2.3.3. Establishes "unavoidably unsafe" products
5.2.3.3.1. Determines that products exist that are "incapable of being made safe for their intended and ordinary use".
6. Conclusion
6.1. The United States Supreme Court affirmed the lower court's judgement.
6.1.1. NCVIA preempted the Bruesewitzes' claim against Wyeth for compensation for the injury caused by the DTP vaccine's side effects.
6.1.2. NCVIA preempts all design defect claims against vaccine manufacturers.
7. Issue
7.1. Whether the National Childhood Vaccine Injury Act of 1986 preempts the pharmaceutical company's strict liability for vaccine injuries.
8. Facts
8.1. Parties
8.1.1. Plaintiff: Russel and Robalee Bruesewitz
8.1.1.1. Parents of Hanna Bruesewitz
8.1.2. Defendant: Wyeth, LLC
8.1.2.1. A subsidiary company of Pfizer, Inc.
8.1.2.2. Develops, makes, and markets medical therapies, prescription and over-the-counter medications, and other healthcare products.
8.1.2.3. Owns Lederle, a company that makes the diphtheria, tetanus, and pertussis (DTP) vaccination.
8.2. What Happened?
8.2.1. Hannah Bruesewitz, age 6 months, received DTP vaccination from her pediatrician.
8.2.1.1. Vaccination is recommended by Centers for Disease Control on childhood vaccination schedule.
8.2.2. Within 24 hours of vaccination, Hannah has new onset of seizures.
8.2.2.1. Hannah has more than 100 seizures within the next month.
8.2.3. Hannah is diagnosed with "residual seizure disorder" and "developmental delay.
8.3. Procedural History
8.3.1. Mr. & Mrs. Bruesewitz file a claim for compensation in the U.S. Court of Federal Claims under NCVIA.
8.3.1.1. This claim was denied.
8.3.2. The Bruesewitzes filed suit in a state court agains With, LLC, alleging strict product liability.
8.3.3. The suit is moved to Federal District Court.
8.3.3.1. The court held that the claim was preempted by NCVIA.
8.3.3.1.1. NCVIA includes provisions protecting manufacturers from liability from a vaccine's "unavoidable adverse side effects."
8.3.4. The case is appealed to the U.S. Court of Appeals for the Third Circuit.
8.3.4.1. The court affirmed the district courts judgement.
8.3.5. The Bruesewitzes appealed to the United States Supreme Court.