Bruesewitz v. Wyeth (2011)

1. Influence

1.1. The outcome of the decision applies to any major vaccine manufacturers, including for instance Merck and Sanofi

2. Importance

2.1. The case of Bruesewitz v. Wyeth had a major impact on the healthcare industry in that it confirmed that vaccine manufacturers are not liable for vaccine-induced injury or even death, provided that the vaccines are accompanied by proper directions and warnings. The decision highlights the need of the vaccine manufacturers to ensure the formulation of appropriate directions and warnings when distributing the product to the clinics and hospitals, in order to escape their liability for any claims.

3. Impact

3.1. This decision was referred to in subsequent judgements mainly to reaffirm the rule of law, For example, in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. the arguments set out in Bruesewitz were used to confirm that generic drug manufactures cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.

3.1.1. Relevant reference also relates to Sebelius v. Cloer 569 US in which the case was referred to when deciding that an attorney may not charge a fee for services in connection with such a petition for compensation under the National Childhood Vaccine Injury Act of 1986, but a court may award attorney’s fees and costs incurred by a claimant in any proceeding on an unsuccessful petition, if that petition was brought in good faith.

4. Conclusion

4.1. The Supreme Court held that the design defect claims of the plaintiffs in relation to the vaccine were expressly preempted (invalidated) by the National Childhood Vaccine Injury Act of 1986

5. Facts

5.1. Parties

5.1.1. Russell Bruesewitz et al.

5.1.2. Wyeth

5.2. What happened

5.3. The daughter of the main petitioners in the case, Hannah Bruesewitz, received Wyeth's Tri-Immunol DTP vaccine as part of her childhood immunizations. The petitioners filed a suit in the "Vaccine Court" claiming that their daughter’s seizures and subsequent developmental problems were a result of the vaccine

5.4. Procedural History

5.4.1. They subsequently sued Wyeth in the Pennsylvania state court, but the case was moved to the local federal court, which held that the claim was invalidated by a section of the National Childhood Vaccine Injury Act of 1986

5.4.2. The Bruesewitz's petition was dismissed for failure to prove a link between the vaccine and their daughter’s health problems.

5.4.3. This decision was later reaffirmed by the Third Circuit Court of Appeals. The case was subsequently heard by the Supreme Court.

6. Rule of Law

6.1. The National Childhood Vaccine Injury Act 1986 preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine’s side effects

7. Issue before the court

7.1. Does the National Childhood Vaccine Injury Act of 1986 invalidate all vaccine design defect claims against vaccine manufacturers?

8. Application/Analysis

8.1. WYETH argued that the National Childhood Vaccine Injury Act 1986 which provides that 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. Thereby, provided that there was proper manufacturing and warning, any remaining side effects, including those resulting from design defects, are unavoidable.

8.2. THE BRUESEWITZS contended that the interpretation of 300aa–22(b)(1) presented by Wyeth would render part of §300aa-22(b)(1) redundant. The Congress would have more clearly preempted design-defect claims by barring liability, for example by using clear words: "if . . . the vaccine was properly prepared and was accompanied by proper directions and warnings”. The fact that this was not done is evidence that Congress did not wish to preempt such claims

8.3. THE SUPREME COURT based their judgement on the arguments that the 300aa–22(b)(1)’s text suggests that a vaccine’s design is not open to question in a tort action. If a manufacturer could be held liable for failure to use a different design, the “even though” clause would do no work. A vaccine side effect could always have been avoidable by use of a different vaccine not containing the harmful element. The language of the provision thus suggests the design is not subject to question in a tort action.