1. The threat of litigation should not be the only motivating factor in new product development.
2. Impact
2.1. Heather Caron vs Secretary of Health and Human Services
2.1.1. Case brought in Federal Claims Court office of Special Masters seeking compensation under NCVIA
2.1.1.1. Heather Caron claims her son developed injuries as a result of vaccinations
2.1.2. Special master denies claim and review is requested
2.1.3. Bruesewitz vs Wyeth Cited
2.1.3.1. Injuries not listed on the injury table for the vaccine are entitled to compensation if the claimant can prove that the injury was directly caused by the vaccine
2.1.4. Court affirms the determination of the Special Master and no award is given
2.2. Kubicki vs Medtronic, Inc
2.2.1. Parents of a Diabetic Patient filed product liability suit when their daughter received a traumatic brain injury due to low insulin when using Medtronic's insulin testing equipment
2.2.2. Bruesewitz vs Wyeth Cited
2.2.2.1. Discussion of how the FDA pre-approval of the insulin testing device is relevant to the issue with respect to federal preemption of state law
3. Importance
3.1. A business person in the pharmaceutical industry would be very interested in this case and the associated regulations
3.1.1. Vaccines have had a wide-ranging positive impact on society
3.1.1.1. At what point does the potential to do good outweigh the potential for side-effects?
3.1.1.1.1. This determination is left to experts at the FDA during the drug's approval process
3.1.2. If the federal regulations shield manufacturers from design-defect litigation, what is the motivation to develop new, lower risk vaccines as technology advances?
4. Influence
4.1. 3-Phase FDA approval process for vaccines
4.1.1. Phase 1: Initial studies to investigate side-effects
4.1.2. Phase 2: Studies to investigate appropriate dose ranges
4.1.3. Phase 3: Large-sample human studies to generate efficacy numbers and identify product labeling requirements
4.2. Vaccines need to have appropriate labeling to identify uses, dosages, administration instructions, risks and side-effects
5. Facts
5.1. Parties
5.1.1. Plaintiff: Russell Bruesewitz
5.1.2. Defendant: Wyeth Laboratories
5.2. Complaint
5.2.1. In 1992, Hannah Bruesewitz developed seizures shortly after her 6-month Dyptheria, Tetatnus and Pertussis vaccine.
5.2.1.1. She continues to have residual seizure disorder and requires a high level of ongoing care
5.2.1.2. Wyeth pulled the vaccine from the market and replaced it with an alternative in 1998
5.2.1.2.1. Hannah's parents filed complaint that Wyeth should be liable for injuries caused by the vaccine when it knowingly was developing a safer alternative
5.3. Procedural History
5.3.1. Hanna's parents filed for in the special vaccine injury court and were denied
5.3.2. The Bruesewitz's then sued in Pennsylvania State Court, claiming Wyeth was in violation of Pennsylvania state product liabilities laws
5.3.2.1. Judge dismissed suit, claiming the federal NCVIA protected Wyeth
5.3.3. Appealed in 3rd Circuit US Court of Appeals
5.3.3.1. Federal court affirmed the lower courts determination that the federal law protected Wyeth
5.3.4. Appealed to US Supreme Court
6. Issue
6.1. Whether a Federal Law designed to protect vaccine manufacturers can preempt product liability suits in state courts
7. Rule
7.1. National Childhood Vaccine Injury Act (NCVIA) of 1986
7.1.1. Wave of design-defect tort cases in the 1980s
7.1.1.1. NCVIA Designed to protect drug companies from costly litigation and judgement and encourage them to keep producing and marketing vaccines
7.1.2. Patients can seek compensation for vaccine related injury in federal claims court
7.1.3. Awards are paid from a pre-established fund
7.1.3.1. Fund is created by "taxing" the manufacture/sales of all vaccines
8. Analysis
8.1. NCVIA offers protection to manufacturers if the injury resulted from unavoidable side effects and if the vaccine was properly prepared and administered
8.1.1. Vaccine side-effects can always be avoided by creating a vaccine that does not contain the harmful element
8.1.1.1. This alternate vaccine might not be as effective as the one with the harmful ingredients
8.1.2. Plaintiff claims that whether the side-effects are unavoidable was intended to be on a case-by-case basis
8.2. Since a manufacturer could always produce a safer vaccine, design-defects are not a source of liability in FDA approved drugs
8.2.1. Interpreting the design quality of complex drugs is left to experts in federal regulatory bodies like the FDA rather than to judges and juries.