Bruesewitz v. Wyeth, LLC, 562 U.S. 223 (2011)

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Bruesewitz v. Wyeth, LLC, 562 U.S. 223 (2011) by Mind Map: Bruesewitz v. Wyeth, LLC, 562 U.S. 223 (2011)

1. Issue

1.1. Facts

1.1.1. Parties

1.1.1.1. Hannah Bruesewitz - 6 month old daughter of Russell and Robalee Bruesewitz (Father Russell is the plaintiff)

1.1.1.2. Wyeth, LLC - vaccine and drug manufacturer

1.1.2. What happened

1.1.2.1. 1992 - Hannah Bruesewitz (6-month-old female) receives standard scheduled vaccines- combined vaccine DTP

1.1.2.2. Within two hours, Bruesewitz suffers from repeated seizures

1.1.2.3. The child is hospitalized for several weeks and diagnosed with "residual seizure disorder" or RSD

1.1.2.4. 1995 - Three years after the incident, Bruesewitz still suffers from RSD and her parents sue for compensation for her injuries

1.1.2.5. The month prior to the lawsuit, new regulations removed RSD from compensable disorders, so their claim was denied

1.1.2.6. 1998 - Vaccine manufacturer Wyeth, LLC, removed the DTP vaccine used on the Bruesewitz's child off the market

1.1.3. Procedural History

1.1.3.1. 1995 - Russell Buerewitz petitions for compensation for daughter, Hannah's injuries

1.1.3.2. Petition denied

1.1.3.3. Buerewitz filed a lawsuit agains Wyeth for not developing a safer vaccine

1.1.3.4. Federal judge dismissed the lawsuit (citing the National Childhood Vaccine Injury Act of 1986)

1.1.3.5. U.S. Court of Appeals for the 3rd Circuit affirmed

1.2. Can a federal law prevent Wyeth and other vaccine maufacturers from being sued for product liability?

2. Rule of Law

2.1. Federal law protects vaccine manufacturers under the National Childhood Vaccine Injury Act of 1986 which compensates children injured from vaccines

2.1.1. This allows for manufacturers to continue to bring vaccines to the market without fear of being sued

3. Analysis/Application

3.1. Federal Law recognizes that there could be possible product liability as it relates to vaccines

3.1.1. The National Childhood Vaccine Injury Act of 1986 makes the concession for that fact and allows for payment of injury claims under the act

3.2. Protection for vaccine manufacturers is meant to allow manufacturers to continue working/innovating for future developments in vaccine technology

3.2.1. This protection is only extended to the manufacturer IF they made considerable precautions to avoid side-effect(s). They only receive protection if the side-effect is considered to be “unavoidable” under the statute

4. Conclusion

4.1. Impact

4.1.1. Federal law protects vaccine manufacturers againts product liability lawsuits

4.2. Importance

4.2.1. National Childhood Vaccine Injury Act of 1986 allows for injured children to be compensated for damages that may occur as a result of vaccine use while at the same time protecting manufacturers and allowing them to continue to develop in furtherance of health innovation

4.3. Influence

4.3.1. VIS (Vaccine Information Statements) are required to be reviewed with patients/guardians before administering any vaccine

4.3.1.1. Informed consent must be given prior to administration of any vaccine by parent or legal guardian

4.3.2. Vaccine Adverse Event Reporting system is part of the National Childhood Vaccine Injury Act of 1986 and

4.3.2.1. There is a committee to review current literature on adverse events whether the incident is a direct result of the administered vaccine(s) or not

4.3.3. National Vaccine Program office is part of the National Childhood Vaccine Injury Act of 1986

4.3.3.1. coordinates vaccine efforts and information sharing among CDC (Centers for Disease Control), NIH (National Institute of Health), FDA (Food and Drug Administration) and HRSA (Health Resources and Services Administration)