Module 4 - IRAC Analysis

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Module 4 - IRAC Analysis by Mind Map: Module 4 - IRAC Analysis

1. Russell Bruesewitz v. Wyeth, Inc., fka Wyeth Laboratories

1.1. Facts

1.1.1. Parties Plaintiff - Russel Bruesewitz Father of Hannah Bruesewitz Defendant  - Wyeth Laboratories

1.1.2. What Happened At the age of 6 months, Hannah Bruesewitz received vaccines in 1992 diphtheria, tetanus, and pertussis Hannah was hospitalized due to seizures Required constant care as a result Vaccine, which allegedly caused Hannah's medical issues, was removed from the market by Wyeth Laboratories in 1998

1.1.3. Procedural History 1995 - Bruesewitz filed petition for compensation Denied due to National Childhood Vaccine Injury Act which passed one month prior 1998 - Following Wyeth's removal of the vaccine from the market, Bruesewitz filed a lawsuit in Pennsylvania court Federal judge dismissed due to National Childhood Vaccine Injury Act US Court of Appeals 3rd Circuit affirmed federal judge, Case was brought before the US Supreme Court in 2010

1.2. Issue Before the Court

1.2.1. Whether a federal law protecting vaccine manufacturers from lawsuits can overshadow a victim's ability to seek damages in state court.

1.3. Rule of Law

1.3.1. State verses Federal Law

1.3.2. Necessary elements of National Childhood Vaccine Injury Act Act only protects manufacturers civil liability "unavoidable" vaccine related injuries or death Requires manufacturer to have proper labels and warnings

1.4. Application

1.4.1. Bruesewitz arguement "unavoidable" was not met since they believed the side effects could have been prevented Did not believe there was protection against all design defect claims Did not believe that Congress intended to give blanket protection

1.4.2. Wyeth arguenment Federal Act preempts any design defect claims Negative impact for Bruesewitz was "unavoidable" be definition

1.4.3. US Supreme Court sided with Wyeth and the protection of vaccine manufacturers over litigation rights of design defect in stat courts

1.5. Conclusion

1.5.1. Impact The finding reinforced protection of pharmaceutical companies in design and market launch of new vaccines The reduction in litigation was linked to control of vaccine prices, per American Academy of Pediatrics

1.5.2. Why we care This case was a strong hindrance in consumer ability to obtain compensation for poor product design It allows blanket coverage of pharmaceutical companies on vaccine related litigation

1.5.3. Practices influenced by case Current pharmaceutical development and launch are influenced by protection from the National Childhood Vaccine Injury Act and the ruling of Bruesewitz v. Wyeth Less conservative design principles are used in vaccine development and launch

2. Todd LeClair