Bruesewitz v. Wyeth Inc.  Supreme Court (Roberts Court) Decision: Feb. 22, 2011

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Bruesewitz v. Wyeth Inc.  Supreme Court (Roberts Court) Decision: Feb. 22, 2011 by Mind Map: Bruesewitz v. Wyeth Inc.  Supreme Court (Roberts Court) Decision: Feb. 22, 2011

1. Impact of the Decision

1.1. In the PLIVA Inc v Mensing case, two individuals had taken a generic drug for a number of years and developed a disorder called tardive dyskinesia. The individuals claimed that the drug manufacturer failed to provide adequate warning labels and were liable. The lower courts agreed with the petitioners finding the manufacturers liable, and that State Tort claims were not pre-empted by Federal Statutes and FDA regulations. However, the Supreme Court reversed this judgement citing Bruesewitz as precedence and held that Federal Statutes and FDA regulations did indeed preempt State Tort claims.

2. Issue/Facts

2.1. Parties

2.1.1. Russel Bruesewitz (petitioner)

2.1.1.1. Advocate: David C Frederick

2.1.2. Wyeth Inc fka Wyeth Laboratories (respondent)

2.1.2.1. Advocate: Kathleen M Sulliven; Benjamin J. Horwich (assistant to the solicitor general, DoJ, for the US)

2.2. Dates

2.2.1. Oral Argument - October 12, 2010

2.2.2. Opinion Argument / Decided - February 22, 2011

2.3. Overview

2.3.1. In 1992, Hannah Bruesewitz received a Diptheria, Tetanus, and Pertussis vaccine at Six Months old. Wyeth labs created the vaccine.  After receiving the shot, she developed debilitating seizures and needs constant care to this day.  The Bruesewitz family claims the vaccine caused Hannah's condition.  At 3 years old, her parents filed a petition seeking compensation for her injuries but were eliminated due to new regulations. In 1998, Wyeth Labs withdrew the vaccine used on Hannah and the Bruesewitz family subsequently filed a lawsuit against Wyeth in the Eastern District of Pennsylvania.

2.4. Claim

2.4.1. The Bruesewitz family claims Wyeth labs did not try to develop a safe drug and should be accountable for Hannah's current condition, which could have been prevented if the vaccine was not defective, as the parents claim

2.5. Lower Court Ruling

2.5.1. Judge issued a summary judgement for the Bruesewtiz's lawsuit stating that Wyeth was protected under the National Childhood Vaccine Injury Act (NCVIA) and Pennsylvania law Title 42 Public Health and Welfare  300aa-22(b)(1) preempted Pennslyvania common law for liability from negligent design

2.6. US Court of Appeals

2.6.1. Affirmed

3. Rule of Law

3.1. National Childhood Vaccine Injury Act of 1986 (NCVIA)

3.1.1. "no fault compensation program to stabilize a vaccine market adversely affected by an increase in vaccine-related tort litigation and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too costly and difficult...manufacturers enjoy significant tort-liability protections. Most importantly, the Act eliminates manufacturer liability for a vaccine's unavoidable, adverse side effects." - Supreme Court Case Syllabus

3.2. State of Pennsylvania Law  Title 42 Public Health and Welfare: 300aa-22(b)(1)

3.2.1. "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 the vaccine after Oct. 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. Application

4.1. The Supreme Court held that the NCVIA preempts all design defect claims with regards to vaccines manufacturers and protects them against litigation for injury. The Supreme Court held that:

4.1.1. 1. Pennsylvania Law Title 42 300aa-22(b)(1): the "even though" clause protects manufacturers against litigation because all vaccines defects could be unavoidable if a different vaccine was used. Thus, the "even though" clause states that as long as the manufacturers do their diligence and take every precaution to make a safe product, they are exempt from liability.

4.1.1.1. Products liability law has three grounds: defective manufacture, inadequate directions or warnings, and defective design. NCVIA purposefully only mentions the first two meaning defective design is not subject to liability.

4.1.2. 2. Pennsylvania Law Title 42 300aa-22(b)(1): the term "unavoidable" is not open to the petitioners interpretation and must have some parameters set on it, hence the "even though" clause immediately following, which disproves the petitioners argument.

4.1.3. 3. NCVIA does not mention design defects. It is the interpretation of the court that this was intentional and meant to allow vaccine manufacturers and the government regulators to improve upon designs for better products without the fear of burdensome litigation while still providing compensation to injured parties.

5. Conclusion

5.1. The Supreme Court affirmed the lower court decision and Justice Antonin Scalia gave the majority opinion. The decision was 6-2 with Justices Sotomayor and Ginsburg dissenting and Kagan abstaining from participation.

5.1.1. Minority Opinion of Sotomayor and Ginsburg state the Blackletter products liability law as recognizing all three grounds (labeling, design, and manufacturing) as open to liability litigation. They interpret the "even though" clause to support liability litigation for all three grounds and not refute it, as the majority claims.

6. Why should business professionals care?

6.1. This type of decision is important professionals in the pharmaceutical industry and related healthcare industries because it means that vaccine makers as well as generic drug manufacturers (Pliva, inc. v Mesing - 2011) cannot be held liable for negative side effects that individuals think were caused by their products.  This provides space for businesses to expand and experiment with new products without heavy penalty costs due to liabilities in case someone sues them. Put another way, it deregulates their industry to promote business growth.

7. Two business practices that have been influenced by the decision

7.1. This decision basically puts to rest any autism suits that claim the injuries were induced by vaccinations. While the evidence shows that vaccines do not cause autism and that it is coincidence that the disease shows up in children around the same time they are vaccinated, anti vaccination suits have had broad negative ramifications for the pharmaceutical industry. These suits center their arguments around "design-defect," which was argued away with the Bruesewitz case. Vaccine companies will now experience less litigation which could free up funding to be put towards R&D or marketing. Further, generic drug manufacturers will benefit as the Bruesewitz decision could be applied in the labeling of generic drugs to decrease the liability of litigation. Basically, generic drug manufacturers do not need to worry about litigation from misapplied or misunderstood warning labels.