Bruesewitz v. Wyeth, Inc.

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

1. Facts

1.1. Parties

1.1.1. The Bruesewitz Family, "the Bruesewitzes"

1.1.2. Wyeth, Inc.

1.2. What Happened

1.2.1. On April 1, 1992, the Bruesewitzes took their six-month old daughter, Hannah, to the doctor to receive an injection of the vaccine "DTP"

1.2.2. Not long after the injection, Hannah experienced seizures which left her "lethargic, developmentally stunted, and displaying autistic-like symptoms"

1.2.2.1. In 2003, doctors diagnosed Hannah with residual seizure disorder and encephalopathy. These conditions will likely subject Hannah to lifelong care

1.2.3. DTP did reduce whooping cough infections

1.3. Procedural History

1.3.1. The Bruesewitzes sued Wyeth, Inc. in the U.S. Court of Appeals for the Third Circuit

1.3.1.1. The Bruesewitzes argued that Wyeth's DTP vaccine was "outmoded and inadequately designed"

1.3.1.2. Wyeth argued that Section 22(b)(1) of the National Childhood Vaccine Injury Act "NCVIA" exempted vaccine manufacturers like itself from "all design-defect claims, including the one asserted by the Bruesewitzes"

1.3.1.3. Trail was decided on March 8, 2010 in Wyeth's favor. Issue was then appealed to the U.S. Supreme Court and argued on October 12, 2010

2. Issue

2.1. Whether Section 22(b)(1) of the NCVIA provides immunity to vaccine manufacturers against lawsuits filed by victims seeking compensation for injuries which allegedly arose from their vaccines

3. Rule of Law

3.1. Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986

3.1.1. Section states 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."

4. Analysis/Application

4.1. The Bruesewitzes claim that the side effects Hannah suffered were avoidable as Lederle Laboratories (which was later bought by Wyeth) used a "defective design" which led to Hannah's disabilities. The Bruesewitzes believe the fact that the design was "defective" subjects Wyeth to liability for negligence.

4.1.1. Justice Scalia, in delivering the opinion of the Court, notes that "the language of the (Act) suggests that the design of the vaccine is a given, not subject to question in the tort action." To that end, he states that the Section only applies "with respect to the particular design" and that "the design itself is not open to question."

4.1.1.1. This effectively eliminates the "what-if" claim by the Bruesewitzes, that Hannah could've been fine if a different design was used

4.1.2. Justice Scalia also notes that the Act seems to "(fail) to mention design-defect liability 'by deliberate choice, not inadvertence.'"

4.1.2.1. Per the Court's opinion, the Act "mentions only manufacture and warnings"--not design-defect liability

4.1.2.2. It is also noted that design defects are not mentioned in Food and Drug Administration (FDA) regulations, which "pervasively regulate the drug manufacturing process"

4.1.2.2.1. The lack of mention of design defects in FDA regulations are cited as a strong suggestion that design defects are not a basis for liability

4.1.3. The opinion hones in on the "even though" clause after the word "avoidable" in the Act. Justice Scalia states that this clause "is meant to signal the unexpected," to include unavoidable side effects despite best manufacturing and labeling practices.

4.2. Wyeth's defense is its own interpretation of Section 22(b)(1)--that it cannot be held responsible for injuries arising from vaccine administration as stated in the Act.

4.2.1. The Court may have taken a narrow view of the Act in order to protect pharmaceutical interests as "taxing their product to fund the compensation program, while leaving their liability for design defect...would hardly coax them back into market."

4.2.1.1. Overall, the Court seems to favor a narrow interpretation of the Act for the public good--that minimizing pharmaceutical companies' susceptibility to tort actions would increase motivation for them to develop new drugs for public benefit

4.2.1.2. It is worth noting that the dissenting justices, Sotomayor and Ginsburg, advocated a broader interpretation of the Act, stating that "nothing in the text, structure, or legislative history of the Vaccine Act remotely suggests that Congress intended such a result"

5. Conclusion

5.1. The Supreme Court upheld the U.S. Court of Appeals Third Circuit Court's decision of denying compensation to the Bruesewitzes. Overall, the Court found that the Bruesewitzes' claim of a defective design was inadmissible as "a vaccine's design is not open to question in a tort action."

6. Impact

6.1. Holmes v. Merck (United States Court of Appeals, Ninth Circuit, 2012)

6.1.1. The Holmes filed an action against Merck, a pharmaceutical company for damages resulting from the death of their child as a result of using one of Merck's drugs.

6.1.1.1. The Court ruled in favor of Merck, citing NCVIA's limitation of filing torts against pharmaceutical companies for damages. Bruesewitz v. Wyeth was also a case cited in the decision as precedence.

6.2. Mutual Pharmaceutical Co., Inc. v. Bartlett (2013)

6.2.1. Karen Bartlett, a patient who used one of Mutual Pharmaceutical's drugs, suffered "significant injuries as a result of her use of inflammatory pain reliever."

6.2.1.1. In the U.S. District Court for the District of New Hampshire, a jury awarded Bartlett $21.06 million in compensatory damages based on Bartlett's design defect claim.

6.2.1.1.1. The United States Court of Appeals for the First Circuit affirmed, but Mutual Pharmaceutical appealed to the Supreme Court in 2013. The ruling was reversed, based on the wording of the NCVIA. Bruesewitz v. Wyeth was cited as precedence for limiting tort claims against pharmaceutical companies.

7. Importance

7.1. A business professional would care about this decision as if they were to start or invest in a pharmaceutical company, they can be reassured that a company can continue to develop and release drugs (assuming they have been properly vetted by the FDA, etc. and properly administered) without fear of litigation, which would hinder research and development efforts.

8. Influence

8.1. As a result of the ruling in Bruesewitz v. Wyeth, pharmaceutical companies have continued research and development of drugs

8.2. Drugs and medication are still released to the market, albeit with extreme vetting and field trials performed by the FDA and other regulatory agencies to minimize dangers to the public