Artieda - Module 4

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Artieda - Module 4 by Mind Map: Artieda - Module 4

1. Bruesewitz v. Wyeth Inc.

1.1. Facts

1.1.1. Parties

1.1.1.1. Bruesewitz Family

1.1.1.2. Wyeth inc.

1.1.1.2.1. Pharmaceutical Company

1.1.2. What happened

1.1.2.1. Hannah Bruesewitz received her ix-month diphtheria, tetanus and pertussis vaccine in 1992 from the brand manufactured by Wyeth Inc.

1.1.2.1.1. Right after She started developing chronic seizure disorder

1.1.2.2. When Hannah was 3, her parents filed a suit against Wyeth

1.1.2.2.1. The suit was petition one month prior new regulations eliminated Hannah's seizure disorder from the list of compensable injuries

1.1.2.3. The drug was taken out of the market by Wyeth 3 years later after the petition

1.1.3. Procedural History

1.1.3.1. The Bruesewitz Family file suit against Wyeth Inc in state court in Pennsylvania

1.1.3.1.1. The Court dismissed the petition and sided with Wyeth

1.1.3.2. The Supreme Court took the case an Affirmed the lower court decision

1.1.3.2.1. "Plaintiffs are entitled to seek compensation for such injury or death by filing a TIMELY claim in the U.S. Court of Federal Claims"

1.2. Issues before the Court

1.2.1. Federal Preemption

1.2.1.1. Federal law protects against liability design claim - Invalidation of State law by Federal Law

1.2.1.1.1. Thus there is NO need for action to (1) show evidence of a reasonable alternative design NOR (2) prove how that design would have prevented the product from harming users

1.3. Rule of law

1.3.1. The plaintiff needs to prove

1.3.1.1. that the design defect claims expressly DID NOT preempted the Vaccine Act 1986

1.3.1.1.1. the National Childhood Vaccine Injury Act 1986 protected Wyeth from lawsuits over vaccine injury claims.

1.4. Application

1.4.1. the National Childhood Vaccine Injury Act 1986 protected Wyeth from lawsuits over vaccine injury claims.

1.4.1.1. The goal was to ensure a stable market supply, and to provide cost-effective arbitration for vaccine injury claims.

1.4.1.1.1. "(1) 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" as long as "a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufac- turer shows that it complied in all material re- spects with all requirements under the Federal Food, Drug, and Cosmetic Act"

1.4.2. the plaintiff thus

1.4.2.1. CANNOT

1.4.2.1.1. Follow the necessary steps for a design defect claim

1.4.2.2. SHOULD Have

1.4.2.2.1. Proven that the manufacturer did not complied in all material re- spects with all requirements under the Federal Food, Drug, and Cosmetic Act

1.5. Conclusion

1.5.1. The court affirmed

1.5.1.1. "manufacturers are not liable for vaccine-induced injury or death and protected if they are accompanied by proper directions and warnings."

1.5.1.1.1. It was proven Wyeth complied with all the necessary FDA regulations

1.6. Influence

1.6.1. The Supreme Court decision sets a precedent that design claims cannot be look in one-by-one case

1.6.1.1. This would defeat the purpose of preemption of the NCVIA Act 1986 to maintain stable the market

1.6.2. Federal oversight to mediate between the market and victims

1.6.2.1. The Supreme Court on affirming the Lower Court decision "reasoned that Congress had set up a special vaccine court as a way to provide compensation to injured children without driving drug manufacturers from the vaccine market"

1.6.2.1.1. It supposed to act as a NO-FAULT more efficient way to settle claims

1.7. Importance

1.7.1. Preventing state to regulate improvement of vaccines

1.7.1.1. might encourage Pharmaceutical to spend less in budget in safety and technology to test vaccine drugs

1.7.1.1.1. http://www.heinonline.org.proxy1.library.jhu.edu/HOL/Page?handle=hein.journals/dukjppsid6&div=7&start_page=93&collection=journals&set_as_cursor=2&men_tab=srchresults

1.7.2. FDA presents regulations but does not enforce manufacturers to use a safer design for a vaccine already licensed

1.7.2.1. http://www.heinonline.org.proxy1.library.jhu.edu/HOL/Page?handle=hein.journals/dukjppsid6&div=7&start_page=93&collection=journals&set_as_cursor=2&men_tab=srchresults

1.8. Impact

1.8.1. Mutual Pharmaceutical Co., Inc. v. Bartlett 2012

1.8.1.1. The court coined that manufacturers "did not face strict liability for side effects of properly manufactured prescription drugs that were accompanied by adequate warnings." as in Bruesewitz v. Wyeth,

1.8.1.1.1. Similarly The Court found that State-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA

1.8.2. Pliva, Inc., et al. v. Mensing 2011

1.8.2.1. warning labels for a drug call Keglan been strengthened and clarified several times, most recently in 2009, because can cause tardive dyskinesia, a severe neurological disorder,

1.8.2.1.1. Two patients who took it during 2001, claim the labels were not as explicit then than now, Respondents pleaded that the Manufacturers knew, or should have known, both that the long-term use of their products carried a high risk of tardive dyskinesia and that their labels did not adequately warn of that risk.