Bruesewitz v. Wyeth, LLC

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Bruesewitz v. Wyeth, LLC by Mind Map: Bruesewitz v. Wyeth, LLC

1. Influence (ABA)

1.1. The result of this case caused severe setbacks for hundreds of pending case for vaccine injuries. Most of those cases were forces to settled in claims court v. the tort system (ABA)

2. Facts (562)

2.1. Parties

2.1.1. Russell and Robalee Bruesewitz

2.1.2. Wyeth, LLC Inc.

2.2. What Happen

2.2.1. Russell and Robalee Bruesewitz gave their daughter, Hannah Bruesewitz, the DTP vaccine from Lederle Laboratories (now owned by Wyeth, LCC) when she was six months old.

2.2.2. Hannah starting have seizures within 24 hours of receiving the vaccine. Over time, Hannah continue to suffer from hundreds of seizures, which resulted in a seizure disorder and developmental delay through out Hannah life.

2.2.3. The Bruesewitzses attempted to file a petition at the Pennsylvania state court to receive compensation with the claim that Hannah "suffered from on-Table residual seizure disorder and encephalopathy injuries".

2.2.3.1. The petition was denied in state court. The Bruesewitzes were award fees to cover later and court costs.

2.2.3.1.1. The Bruesewitzes rejected the judgment as they felt that Wyeth, LLC had strict product liability due to a defect in the product and decided to seek damages in the Tort system.

2.3. Procedural History

2.3.1. The National Childhood Vaccine Injury Act of 1986 (NCVIA) was put in place to to provide protection to vaccine manufcators against product liability lawsuits due to a increase of product liability suits in the 1980's that resulted in major vaccine manufacturers leaving the market.Vaccine manufacturers leaving the market resulted in vaccine shortages.

2.3.1.1. Under the NCVIA, vaccine manufacturers are not liabilable in civil suits concerning injury sustain form the use of vaccines if the effects were unavoidable "even though" the manufacturer had the proper warnings and labels on the products.

2.3.2. Under NCVIA, the party seeking injury compensation would to file a petition to the Court of Federal Claims. The party wold name the "Health and Human Services Secretary as the respondent". The claimant can chose to accept or reject the ruling and seek "tort relief".

2.3.3. The Bruesewitzes rejected the courts ruling in district court. The case was moved to Court of Appeals Third Circuit which "affirmed" the judgement made by the district court.

2.3.4. Case moved to U.S Supreme Court

3. Issue Before the Court (562)

3.1. Does the injuries sustain by Hannah Bruesewitzes, side effects that were unavoidable and under the protections of the NCVA?

4. Rule of Law (562)

4.1. The case before the U.S Supreme Court is whether or not the omission of term "defective design" can be interpret as a side effects that is unavoidable under NCVIA.

5. Application (562)

5.1. The U.S Supreme Court

5.1.1. The U.S Supreme Court evaluated several different points in this case. 1) If comment "K" from the Restatement of the Tort law plays a part in the case. 2) Interpreting the "even though clause" in the NCVIA. 3) Whether or not the omission of term "defective design" can be interpreted as a side effect that is unavoidable under NCVIA.

5.1.1.1. Comment K states that a manufacturer can be held liable if the product contains a defect that is "unreasonably" dangerous to the consumer; however, products that are consider "avoidable unsafe products" are exempt from the Comment K.

5.1.1.1.1. The problem was properly defining what meets the criteria for unavoidable under the Act.

5.1.1.2. The "even though" clause is deem useless in this case because the term "even though" applies that the injury could have been avoided if better labeling or warnings were given. Any possible defects in the vaccines would be had been eliminated if better warnings labels were put on the products.

5.1.1.3. The Court find that there was no mention of "defective design" with NCVIA. This lead to the Court determining that this was intentional because design defect had no basis in a liability claim.

5.1.2. The Court mention that between the NCVIA and the underlining principles of the comment K restatement, claimants were better off working through the compensation system, not the tort system.

5.1.3. The Court acknowledge that they are flaws with the comment K and the interpretation if the definitions with NCVIA; however, the Court is at the mercy of interpreting the Act under the "traditional tools of statutory interpretation".

5.2. Plaintiff

5.2.1. The plaintiff's case was that the defective design of Lederle’s DTP vaccine was the caused Hannah’s disabilities. The plaintiff was seeking to for Lederle to be held strict liability and liability for negligent.

5.2.1.1. The plaintiff had to prove that defective design was avoidable, which would have remove Lederle from the protections of NCVIA.

5.2.1.1.1. NCVIA did not provide clear guidance or definition for "defective design" implications and therefore the key component for the Plaintiff case was throwout.

6. Conclusion (562)

6.1. The United States Supreme Court affirmed the decision of the lower courts.

7. Impact (ABA)

7.1. There is concern that the strong protections for vaccine manufacturers will provide very little incentive for vaccine companies to improve the vaccines for children's safely (ABA)

8. Citation:

8.1. Cross B. Frank, Miller L. Roger. The Legal Environment of Business pg. 138-139

8.2. ABA Health source."Bruesewitz v. Wyeth’s Impact on the Vaccine Safety Debate". Volume 7 Number 8. April 2011.

8.3. 562 U. S. ____ (2011)