BRUESEWITZ v. WYETH

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BRUESEWITZ v. WYETH by Mind Map: BRUESEWITZ  v. WYETH

1. Facts

1.1. The Childhood Vaccination Act of 1986 -

1.1.1. Design Defects are not clearly identified by the FDA..

2. Rule of Law

2.1. National Childhood Vaccine Injury Act of 1986 (NCVIA)1 bars state-law design-defect claims against vaccine manufacturers.

2.2. “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”1

3. Analysis

3.1. Manufacturers are not liable if they have met all FDA regulations and provided the proper warning to physicians or parents.

3.2. The success of vaccines is dependent on a large percentage of the population using them. The court made their ruling in an effort to stabilize the market..

3.3. The ruling around this case is based on the greater good. - vaccines have prevented thousands of death. The side effects are outweighed by the benefits to the public in administering the vaccines.

4. Conclusion

4.1. The court ruled that the vaccine was clearly labeled at administer properly. Therefore the Vaccine Manufacturer (Wyeth) is not liable for defects.1

4.1.1. Scalia, Roberts, Breyer Thompson, Kennedy, Alito filed concurring opinions. the basis of the ruling was that is the vaccines were properly made, properly administered, properly labeled there is an acceptable level of side effects due to the majority of individuals that are positively effected by the vaccines.

4.1.2. Sotomeyer & Ginsberg filed dissenting opinions - the "even tough" clause was their - “two additional prerequisites” for preemption independent of unavoidability.45 The primary textual justification for the dissent’s position depends on that independence.46 But linking independent ideas is the job of a coordinating junction like “and,” not a subordinating junction like “even though.”1 Sotomeyer - discussed the "Even though" clause. once you engineer out the manufacturing defects, labeling defects - the only othe defect is design. That there is inherently a number of people who will suffer the side effects.

5. Implications - Vaccine Manufacturers will not be held liable for side effects. The public is encouraged to use vaccinations and manufacturers are will have some protection for lawsuits.

5.1. Physicians must report all adminstering of Vaccines in the Vaccine Injury Table. This is a tracking system that keeps the perameters of determining whether the vaccine was a contributor to the injury.

6. Hannah Bruesewitz started having seizures within 24 hours of being administered the DTAP Vaccine. She had over 100 seisures.

6.1. Issue

6.1.1. Children should not have life altering side effects from vaccinations.

6.1.1.1. Text book, exercises 34, 35, 36, 37

7. References: 1. https://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/pdf/USCODE-2010-title42-chap6A-subchapXIX-part2-subpartb-sec300aa-23.pdf 2. :https://www.supremecourt.gov/opinions/10pdf/09-152.pdf

8. Importance - There is an inherent risk to using medications and vaccines for all of us. The predictability of a side effect is very difficult to pinpoint. The ruling from the majority of the court indicated there is an accepted level of safety events (even death) The dissenting position felt the design defects should be examined and engineered out. The majority ruled that if vaccines are labeled properly, manufactured properly and designed properly the risk outweighed the benefit. This ruling sets the precendence that some safety defects are acceptable it the majority of the public have a positive result.