Bruesewitz v. Wyeth, LLC, 562 U.S. 223 (2011)

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Bruesewitz v. Wyeth, LLC, 562 U.S. 223 (2011) by Mind Map: Bruesewitz v. Wyeth, LLC, 562 U.S. 223 (2011)

1. Facts

1.1. Parties

1.1.1. Russell Bruesewitz, et al.

1.1.2. Wyeth, Inc.

1.2. What Happened

1.2.1. Hannah Bruesewitz developed seizures after being administered Wyeth vaccine.

1.2.2. Family filed a claim under the National Childhood Vaccine Injury Act.

1.2.3. Court of Federal Claims - Claim denied.

1.3. Procedural History

1.3.1. Filed Pennsylvania State Court - Removed to US District Court for the Eastern District of Pennsylvania - Wyeth granted summary judgment.

1.3.2. Affirmed - US Third Circuit Court of Appeals.

1.3.3. Affirmed - US Supreme Court.

2. Issue Before the Court

2.1. Whether a pre-emption provision enacted in the National Childhood Vaccine Injury Act of 1986 bars state-law design-defect claims against vaccine manufacturers.

3. Rule of Law

3.1. NCVIA provides safe harbor

3.1.1. If in compliance with all product regulations.

3.1.2. No liability for unavoidable adverse side affects.

3.2. Vaccine design not open to question

4. Application

4.1. Party Positions

4.1.1. Plaintiffs: defective design of DTP vaccine caused disabilities; company was subject to strict liability and liability for negligent design under PA common law.

4.1.2. Defendants: PA law pre-empted by NCVIA.

4.2. Court Reasoning

4.2.1. Act provides for federal agency improvement of vaccine design and for federally prescribed compensation, which are other means for achieving the two beneficial effects of design-defect torts.

4.3. Compelling Facts

4.3.1. Scalia: The Act's failure to mention design-defect liability is "by deliberate choice, not inadvertence."

4.3.2. Congress has never directed the FDA or any other federal agency to review vaccines for optimal vaccine design.

4.4. Policy

4.4.1. No-fault compensation program - scheme funded through an excise tax on vaccines - which relieved manufacturers of the burden of compensating victims of vaccine-related injuries in most cases. A benefit that creates a valuable insurance policy for vaccine-related injuries.

5. Conclusion

5.1. Lower court ruling affirmed

5.1.1. The NCVIA preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine’s side effects.

6. Importance

6.1. Decision restricts claims to vaccine court and forecloses the possibility of a state tort law alternative for claims. [1]

7. Impact: "Bruesewitz"

7.1. Sebelius v. Cloer, 133 S. Ct. 1886 (2013)

7.1.1. Cloer's complaint denied at appeals level, Statute of Limitations.

7.1.2. Citing to Bruesewitz, Cloer awarded attorney fees: “attorney’s fees are provided, not only for successful cases, but even for unsuccessful claims that are not frivolous.” SCOTUS decision 9-0.

7.2. Holmes v. Merck & Co., Inc. 697 F.3d 1080 (2012)

7.2.1. 9th Circuit Court of Appeals deferred submission pending SCOTUS ruling in Bruesewitz.

7.2.2. 9th Circuit affirms grant of summary judgment in favor of Merck, citing SCOTUS ruling in Bruesewitz; NCVIA.

8. [1] Bruesewitz v. Wyeth's Impact on the Vaccine Safety Debate, www.americanbar.org/newsletter/publications/aba_health_esource_home/aba_health_law_esource_1104_brown.html.

9. Influence

9.1. Provides a level of certainty with respect to potential liability - which encourages vigorous defense of claims as opposed to willingness to settle.

9.2. Encourages the continued development of new products beneficial to public health.