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. Impact

1.1. Case 822 F.3d 1367 United States Court of Appeals, Marek Milik, Jolanta Milik, Legal Guardians and Parents of A.M., Petitioners--Appellants v. Secretary of health and Human Services, Respondent--Appellee cited Bruesewitz v. Wyeth, LLC. In this case, the parents of the minor, who is disabled and suffered a severe neurological condition, was allegedly caused by measles. The Miliks cited Bruesewitz v. Wyeth LLC case to insist on a de novo review, given that the Bruesewitz were able to have their appeal reviewed by the Supreme Court. The Court concluded by affirming the special master's decision and affirming the judgment of the Court of Federal Claims.

1.2. Case 131 S.Ct. 2567 Supreme Court of the United States, PLIVA, INC., ET AL. v. MENSING, cited Bruesewitz v. Wyeth, LLC. This case was brought forth by a consumer that developed dyskinesia, which was allegedly caused by the medication she was taking. Mensing cited Bruesewitz v. Wyeth, LLC, stating that the manufacturers were to be held responsible for improper warning lables and that a proper warning regarding the risks of taking the drug was warranted and that it should have been clear. The Courth concluded by reversing the decision of the lower courts (Fifth and Eight circuits) and that conflicting state and federal laws made it impossible for the drug manufacturer to be compliant with both and thus it was concluded the the party could not satisfy its responsibilities.

2. Facts

2.1. Parties:

2.1.1. Petitioner: Russel Bruesewitz, et al.

2.1.2. Respondent: Wyeth, Inc., Wyeth Laboratories, et al.

2.2. What Happened:

2.2.1. After a child suffered seizures and developmental problems after receiving a vaccination for diphtheria-tetanus-pertussis (DTP) the parents of the minor claimed the manufacturer was liable and brought the case to the United States Court of Federal Claims. After the United States District Court for the Eastern District of Pennsylvania granted motion, the parents of the minor appealed.

2.3. Procedural History:

2.3.1. For more then half a century, advances in vaccines have been largely successful in eliminating diseases. Up until the late 1970s and early 1980s, the public was more concerned about eradicating disease than it was about the potential side-effects of that vaccines could cause. In the mid 1980s, however, there was a surge in liability claims against vaccine manufacturers, causing at least two firms to exit the market for vaccines, and thus creating shortages. With liability claims growing, some manufacturers estimated their liabilities to be exceed their annual revenues. In addition to the mounting claims against vaccine manufacturers, claimants expressed concerns over the mere cost and difficult process of pursuing tort relief from vaccine manufacturers. In response to maintain an adequate supply of vaccines and protect manufacturers and claimants, Congress passed legislation in 1986 to protect vaccine manufacturers against liability from injuries caused by the vaccines. After this date, compensation to victims who suffer from vaccine-related injuries would be paid through and excise tax and not by the vaccine manufacturers themselves. The NCVIA was signed into law by President Ronald Reagan. The law was designed to ensure the market would be able to adequately supply vaccines as well as provide a more efficient method of arbitration for claimants of vaccine-related injuries.

3. Conclusion

3.1. The Supreme Court affirmed the judgement of the Court of Appeals in that the National Childhood Vaccine Injury Act of 1986 preempts all design-defect claims against vaccine manufacturers by claimants seeking damages for vaccine-related injuries. The rule does apply, as it stands, but the Court acknowledged some of the wording of the statutory text caused misguidance and decided to apply the rule as the Congress would have intended. Justice Stephen Breyer issued a concurring opinion stating that he would look at the history and purpose of the statute, as well as expert opinions, which all arrive to the same conclusion as Justice Scalia. Justice Sonia Sotomayor issued a dissenting opinion, outlining the dangers of allowing the vaccine manufacturers to produce vaccines without respect to their design, suggesting that a potential lack of innovation would be harmful to society and that it was not the purpose of the court to decide whether the NCVIA preempts design-defect laws, but rather the responsibility of Congress. Justice Ruth Bader Ginsburg joined the dissenting opinion.

4. Issue

4.1. As Justice Scalia delivered the opinion of the court, "The issue being considered is whether a preemption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA) bars state-law design-defect claims against vaccine manufacturers." The petitioner claims that under Pennsylvania common law, the manufacturer was subject to liability as well as liability for negligent design. Essentially, federal law offers vaccine manufacturers liability protection against injury and death claims while Pennsylvania state law offers claimants protections from manufacturer defective designs. In this case, the petitioner argues that an alternative design may have eliminated the injury to the minor after being vaccinated.

5. Rule of Law

5.1. The National Childhood Vaccine Injury Act (NCVIA) of 1986, § 311(a), 42 U.S.C.A. § 300aa–22(b)(1), which created a program (through excise taxes on vaccine sales) to compensate claimants of injuries caused by vaccines and to make it easier for them to pursue compensation. The NCVIA removes a vaccine manufacturer's liability for a vaccine's unavoidable, adverse side effects. After a claimant has filed a petition for compensation in the Court of Federal Claims, a claimant can decide whether to accept the court's decision or to pursue tort relief through the manufacturer.

6. Analysis/Application

6.1. Plaintiff:

6.1.1. The plaintiffs claimed that the design of the vaccine administered to the minor was defective and caused Hannah's disabilities, and that under the Pennsylvania common law, Lederle was liable as well as liable for negligent design. Even though the National Childhood Vaccine Injury Act of 1986 provides protections to vaccine manufacturers against claims for unavoidable injuries, the plaintiffs interpreted the Pennsylvania common state law as protecting them from a defective design of the vaccine that caused Hannah her injuries. They presented evidence of Hanna's seizure disorder, encephalopathy injuries and delayed development to demonstrate the alleged injuries caused by the vaccine. The plaintiffs argued that the design of the vaccine itself is what caused the injuries to Hannah and that these side-effects were avoidable, and thus, subject to tort relief from the vaccine manufacturer. The plaintiffs also argue that the exclusion of design-defect in the NCVIA was to promote more effective designs through innovation.

6.2. Defendant:

6.2.1. Wyeth motioned for summary judgment on the liability and negligence design-defect claims and was granted the motion, arguing that the Pennsylvania common law was preempted by the National Childhood Vaccine Injury Act of 1986. Wyeth interpreted the NCVIA law as protecting vaccine manufacturers from liability against vaccine-related injuries regardless of the design. Wyeth presented the statutory text, "No vaccine manufacturer shall be liable in a civil action for damages arising form 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." as freeing themselves from tort liability. Wyeth argued that side-effects experienced by Hannah were unavoidable and that the NCVIA protected them against liability regardless of the vaccine's design and that design of the vaccine was not in question, given the proper manufacture, warning labels and directions accompanied with the administration of its vaccines.

6.3. Court:

6.3.1. The United States Court of Appeals for the Third Circuit affirmed and the United States Supreme Court granted certiorari. The Supreme Court stated that the "design" of the vaccine is "given" and not subject to tort liability and that the exclusion of any mentioning of design was purposefully left out of the statutory text "by deliberate choice, not inadvertence." and cited Barn-hart v. Peabody Coal Co., 537 U. S. 149, 168 (2003). The main statutory text in question pertains to the "unavoidable" side effects of a vaccine, which would imply that some vaccines could be designed in such a way that there would be avoidable side effects. The Court does not think this is the case, but rather a statement that if a claimant sustained an unavoidable vaccine-related injury, the manufacturers would not be held liable, essentially implying that all side-effects from vaccines are unavoidable. The Supreme Court also rendered the part of the clause stating "even though" as a "useless appendage" but that it did not invalidate what it states, nonetheless. The Court also recognizes that there is no established procedure that a manufacturer must follow to maintain regulatory compliance and that even if there were, it wouldn't be an easy task for an agency such as the FDA to develop. As design-defects are not mentioned in the legislation, the Court recognizes the difficult balance of creating a safe but also effective vaccine and suggests this as the reason it is not mentioned in the legislation. The Court believes that design-defect was not mentioned in the Act because it was not meant to be used to hold manufacturers liable, and that it is perhaps best to leave the suitability of vaccines to agencies such as the FDA. In all, the Supreme Court affirmed the judgement of the Court of Appeals by reinterpreting the law to preempt all design-defect claims against vaccine manufacturers by claimants seeking damages for vaccine-related injuries.

7. Importance

7.1. A business professional would certainly care about the Supreme Court's decision to affirm the NCVIA. Investors and other managers of wealth may recognize the relatively low risk for a vaccine manufacturer to be held liable for injuries related to its products. Vaccine manufacturers themselves may be less concerned with developing newer and safer vaccines and instead more focused on producing and selling larger quantities to focus exclusively on profit. If the Court had ruled in favor the of plaintiff, business professionals may be concerned with the future viability of vaccine manufacturers and thus may be inclined to sell or short-sell the stocks or securities of a publicly traded firm upon hearing about the decision.

8. Influence

8.1. One business practice by vaccine manufactures that may have resulted as a result of the Supreme Court's decision is the performance of Pharmaceutical companies' stock. Profits margins from vaccine manufacturers are substantial. Aside from stock performance, other business decisions would include the rapid expansion of pharmaceutical companies that has taken place; it is notable on a global scale, and the industry is estimated to be worth tens of billions of dollars. Given the sizable profit margins, firms have an incentive to produce more vaccines designed to safeguard against an ever-increasing amount of ailments, worldwide.

9. Sources


9.2. 131 S.Ct. 1068 Supreme Court of the United States

9.3. 822 F.3d 1367 United States Court of Appeals, Federal Circuit.

9.4. 131 S.Ct. 2567 Supreme Court of the United States