1. Impact
1.1. PREP Act
1.1.1. This act was established to reduce the tort liability from medical countermeasures in catastrophic situations
1.1.1.1. Works similarly as NCVIA to protect firms from tort liability
1.1.1.1.1. PREP act came before Bruesewitz v. Wyeth, but lawsuit highlighted importance of lawsuit
1.2. Oversight
1.2.1. Provides governments with more information to conduct oversight on drug manufacturers
1.2.1.1. On the flip side, persuades drug manufacturers to behave ethically and not engage in actions that harm the public for profit
1.2.1.2. NCVIA also provides market stability through oversight- identifying possible issues with vaccines and improving them
2. Importance
2.1. Protection with quid pro quo
2.1.1. By paying a tax, the firms have the ability to relieve themselves of strict liability
2.1.2. The government takes care of the negative effects in an expedited court system
2.1.3. Firms can take a moral stance because they know people who experience a negative effect from the drugs will be compensated
2.2. Allows firms to develop new drugs with a protection against tort lawsuits
2.2.1. Can operate with relative confidence the drugs can make money, which will be an incentive to develop new and more effective drugs
2.3. Stability in Industry
2.3.1. Vaccine suppliers are in short demand
2.3.1.1. This allows those few suppliers to stay in business and provide a worthy service to the public
3. Influence
3.1. Sebelius v. Cloer
3.1.1. Facts
3.1.1.1. Plaintiff claimed Hep A vaccine caused MS
3.1.1.1.1. Filed an untimely petition under NCVIA
3.1.2. Issue
3.1.2.1. Whether attorney fees are payable in an untimely petition of NCVIA
3.1.3. Conclusion
3.1.3.1. Attorney fees are payable
3.1.4. Influence of Bruesewitz v. Wyeth
3.1.4.1. The case was cited in this example because Bruesewitz petitioned the Federal Courts immediately after the seizures began
3.1.4.1.1. The court was able to draw the distinction of a timely petition versus an untimely petition
3.2. Mutual Pharmaceutical Co., Inc. v. Bartlett
3.2.1. Facts
3.2.1.1. Patient received significant injuries from her pain reliever
3.2.2. Issue
3.2.2.1. whether federal law preempts state design-defect claim for which damages were collected
3.2.3. Conclusion
3.2.3.1. Design-defect claim was preempted by federal law
3.2.4. Influence of Bruesewitz v. Wyeth
3.2.4.1. This case was cited in this example as an illustration of how the federal government responds to preemption and regulation
3.2.4.1.1. Prior to case, preemption was left largely to states
4. Facts
4.1. Parties
4.1.1. Defendant: Wyeth, LLC
4.1.2. Plaintiff: Bruesewitz
4.2. What Happened
4.2.1. Plaintiffs' daughter Hannah received DTP vaccine when she was 6 months old
4.2.1.1. They immediately began having siezures from the vaccine. Suffered from "residual seizure disorder" and "developmental delay".
4.2.2. Plaintiffs filed a claim in US Court of Federal Claims under National Childhood Vaccine Injury act.
4.2.2.1. Claim denied.
4.2.2.2. NCVIA is a no-fault compensation program
4.2.2.2.1. NVCIA established so party alleging vaccine related injury may file for compensation
4.3. Procedural History
4.3.1. Rejected unfavorable judgement of US Courtt of Federal Claims and brought suit to PA State Court
4.3.2. Plaintiff removed suit to a Federal District Court.
4.3.2.1. Granted defendant summary judgement. Held the claim was preempted by NCVIA
4.3.3. Moved to the US Court of Appeals for the Third Circuit
4.3.3.1. affirmed Federal District Court's ruling
4.3.4. Plaintiffs appealed to the US Supreme Court
4.3.4.1. US Supreme Court affirmed lower court's judgement
5. Rule of Law
5.1. Preemption under the National Childhood Vaccine Injury Act
5.1.1. Manufacturers pay a tax so they are exempt
5.1.1.1. Quid pro quo
6. Application
6.1. Plaintiff's Argument
6.1.1. Argued inter alia
6.1.1.1. Argued strict liability and liability for negligent design under PA Law
6.2. Defendant's Argument
6.2.1. Argued the claim was preempted by the NCVIA
6.2.1.1. Manufacturers of the drug enjoy significant tort-liability protection as quid pro quo for payout through NCVIA
6.2.1.1.1. Act funded through excise tax on each dose of the vaccine
6.2.1.2. Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore preempted.
6.2.1.2.1. From the opinion: "National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine manufacturers brought by plain- tiffs who seek compensation for injury or death caused by vaccine side effects."
6.2.1.3. The statute fails to mention design-defect liability by choice and not by mistake.
6.2.1.4. Argued that alternative options are limited only by one's imagination, so it is not unavoidable risk
7. Conclusion
7.1. Design-defect claims were preempted by the NCVIA
8. Issue
8.1. Whether a vaccine manufacturer is strictly liable for damages from a vaccine-related death if the death resulted from side effects that were unavoidable even if the vaccine was designed correctly and had proper directions and warnings.
8.1.1. In other words, does the preemption provision in the NCVIA bar state-law design defect claims against vaccine manufacturers.