Bruesewitz v. Wyeth Inc.

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Bruesewitz v. Wyeth Inc. by Mind Map: Bruesewitz v. Wyeth Inc.

1. Why a business professional would care about the decision and how it has changed the way business operates

1.1. Business professionals will care about this decision because the court's interpretation of Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 (“NCVIA”)

1.2. The court states NCVIA’s compensation program strikes a balance between paying victims harmed by vaccines and protecting the vaccine industry from collapsing under the costs of tort liability

2. Facts

2.1. • When Hannah Bruesewitz was six months old, her pediatrician administered a dose of the DTP vaccine according to the Centers for Disease Control’s recommended childhood immunization schedule.

2.2. • Within twenty-four hours, Hannah began to experience seizures. She suffered more than one hundred seizures during the next month.

2.2.1. • Her doctors diagnosed her with “residual seizure disorder” and “developmental delay.”

2.3. • Hannah’s parents, Russell and Robalee Bruesewitz, filed a claim for relief in the U.S. Court of Federal Claims under the National Childhood Vaccine Injury Act (NCVIA) of 1986, which set up a no-fault compensation program for persons injured by vaccines.

2.3.1. • The claim was denied.

2.4. • The Bruesewitzes then filed a suit in a state court against Wyeth, LLC, the maker of the vaccine, alleging strict product liability.

2.4.1. • The suit was moved to a federal district court, which held that the claim was preempted by the NCVIA, which includes provisions protecting manufacturers from liability for “a vaccine’s unavoidable, adverse side effects.”

2.5. • The U.S. Court of Appeals for the Third Circuit affirmed the district court’s judgment.

2.5.1. • The Bruesewitzes appealed to the United States Supreme Court.

3. Rule of Law

3.1. • To stabilize the vaccine market and facilitate compensation, Congress enacted the NCVIA in 1986.

3.1.1. • The Act establishes a no-fault compensation program designed to work faster and with greater ease than the civil tort system.

3.1.2. • A person injured by a vaccine, or his legal guardian, may file a petition for compensation in the United States Court of Federal Claims

4. Application or Analysis

4.1. Court Overview

4.1.1. Defendant argued Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 (“NCVIA”) exempts vaccine manufacturers from civil liability for “unavoidable” vaccine-related injuries or death as long as the vaccine was properly prepared and adequately labeled

4.1.1.1. Section 22(b)(1) extends far broader protection, guarding vaccine manufacturers in absolute terms against all possible design-defect claims

4.1.1.1.1. Plentiff argues the word “unavoidable,” in Section 22(b)(1) protects manufacturers only when a vaccine’s harmful side effects are “incapable of being prevented

4.1.1.1.2. Plentiff argues Section 22(b)(1) rules out the possibility that the NCVIA bestows a blanket immunity on vaccine manufacturers

4.1.2. Plaintiff argued that Section 22(b)(1) does not protect vaccine manufacturers against all design-defect claims

4.1.2.1. 22(b)(1) shields manufacturers against design-defect claims only when a vaccine’s harmful side effects could not have been prevented through a safer design

4.1.2.1.1. Defendant contends that the Plaintiff interpretation leads, ironically, to an expansion of manufacturer liability, exposing manufactures to design-defect claims in states whose own law forbids such claims

4.1.2.1.2. Defendant further argues that had Congress truly intended to preserve design-defect claims, it could have stopped Section 22(b)(1) after the word “unavoidable.

5. Issue before the Court

5.1. • Should the National Childhood Vaccine Injury Act (NCVIA) law protect vaccine manufactures from product liability lawsuits in state courts that seek damages for serious health problems suffered by children had been vaccinated.

6. Conclusion

6.1. • The United States Supreme Court affirmed the lower court’s judgment.

6.2. • The NCVIA preempted the Plaintiff's claim against Wyeth for compensation for the injury to their daughter caused by the DTP vaccine’s side effects

6.3. • The Court found that the NCVIA’s compensation program strikes a balance between paying victims harmed by vaccines and protecting the vaccine industry from collapsing under the costs of tort liability

7. The impact of the decision

7.1. The United States Supreme Court’s decision in this case now makes is almost impossible for vaccine victims to seek recovery for design defects by vaccine manufacturers.

8. At least two current business practices that have been influenced by the holding

8.1. The holding will affect Pharmaceutical Companies and medical equipment manufactures who produce vaccines since it exempts them from civil liability