1. Conclusion
1.1. The United States Supreme Court accepted Bruesewitz' appeal and issued an opinion affirming the lower court's judgement stating that the NCVIA preempted the Bruesewitzes' claim against Wyeth for compensation due to injury caused by DTP vaccine.
2. Impact
2.1. Sebelius v. Cloer, 2013
2.1.1. Cloer received 3Hep-B vaccines and began to experience numbness in her face, arms, and legs and was eventually diagnosed with multiple sclerosis. In 2005, she filed a claim under NCVIA, alleging that Hep-B vaccine caused or exacerbated her MS.
2.1.1.1. Her claim was denied as she brought it more than 36 months after the onset of symptoms.
2.1.1.1.1. Cloer filed a petition for attorney fees and costs incurred in the appeal, which is included in NCVIA
2.2. Germain v. Teva Pharmaceuticals, 2014
2.2.1. In 2010, the FDA determined that the risks of propoxyphene outweighed its benefits and ordered its removal from the market.
2.2.1.1. Plaintiffs in 68 cases alleged that they ingested propoxyphene products prior to its withdrawal and that manufacturers continued marketing propoxyphene after they knew or should have known that risks exceeded benefits.
2.2.1.1.1. The Supreme Court has explained the interplay between state tort law and FDA regulated products
3. Importance
3.1. In Bruesewitz, the family argued that a design defect resulted in harm to their child
3.1.1. As an endocrinologist, this is an issue potentially impacting patient care through the continued availability of medical devices (insulin pumps) that can potentially be life saving
3.1.1.1. Kubicki v. Medtronic, Inc, 2018: Kubicki had Type 1 DM and experienced severe hypoglycemia with resulting traumatic brain injury and persistent vegetative state while using a Medtronic insulin pump. They claim that the pump is unreasonably dangerous to consumers
3.1.2. As a Jeep owner
3.1.2.1. Following the death of a Star Trek actor, a lawsuit was brought against Fiat Chrysler in 2016 claiming that the auto company “fraudulently concealed and failed to remedy a gear shifter design defect affecting 811,000 vehicles and linked to driverless rollaway incidents."
4. Influence
4.1. Defense to Product Liability
4.1.1. Product Liability was developed to protect consumers from unsafe products and creates a means for manufacturers to bear the costs associated with injuries
4.1.1.1. Preemption is raised by defendants noting that the government regulations preempt claims for product liability
4.1.1.1.1. Because market approval is a rigorous process, it preempts common law claims challenging safety or efficacy of a medical device that has been FDA approved
4.1.1.1.2. Does federal law preempt state law in a personal injury action against a drug manufacturer for failing to include an appropriate warning label where the drug in question met FDA labeling requirements?
5. Facts
5.1. Parties
5.1.1. Hannah, Russell, and Robalee Bruesewitz
5.1.2. Wyeth, LLC
5.1.2.1. Subsidiary of Pfizer, Inc.
5.1.2.2. Develops, makes, and markets medical therapies including vaccines
5.2. Events of the Case
5.2.1. 1970's: concern was raised that the pertussis component of the Diphtheria, Tetanus, and Pertussis (DTP) vaccine could cause brain injury
5.2.1.1. There were no studies that showed causation, however at the time there was an increase in vaccine-related lawsuits which caused manufacturers to stop producing the DTP vaccine
5.2.1.1.1. In response to the scarcity of vaccine and the increase in lawsuits against manufacturers, the price of DTP vaccine rose exponentially. Congress passed the National Childhood Vaccine Injury Act in response
5.2.2. 1986: National Childhood Vaccine Injury Act (NCVIA)
5.2.2.1. Reduced the potential financial liability of vaccine makers due to vaccine injury claims.
5.2.2.1.1. Created the National Vaccine Injury Compensation Program (NVICP) to establish a federal no-fault system for compensating vaccine-related injuries or death
5.2.3. 1992: Hannah Bruesewitz receives a dose of DTP Vaccine manufactured by Wyeth as part of routine childhood immunizations
5.2.3.1. Within 24 hours, Hannah begins to experience seizures
5.2.3.1.1. Over the next month, she experiences >100 seizures and is diagnosed with developmental delay and residual seizure disorder
5.2.4. Hannah's parents file a claim for relief under NCVIA
5.2.4.1. One month prior to filing the claim, new regulations eliminated Hannah's seizure disorder from the list of injuries covered under NCVIA.
5.2.4.1.1. Claim was denied
5.2.5. Bruesewitz family files suit against Wyeth in PA state court
5.2.5.1. Alleged strict product liability
5.2.5.1.1. Case moved to federal district court
5.2.5.1.2. They state that the drug company failed to develop a safer vaccine and should be held accountable for preventable injuries caused by the vaccine's defective design (design defect)
5.2.6. Bruesewitz family appeals
5.2.6.1. US Court of Appeals for the Third Circuit affirmed the district court's judgement
5.2.6.1.1. Family appeals to the United States Supreme Court
5.2.7. The United States Supreme Court accepted Bruesewitz' appeal and issued an opinion affirming the lower court's judgement stating that the NCVIA preempted the Bruesewitzes' claim against Wyeth for compensation due to injury caused by DTP vaccine.
5.2.7.1. 6-2 Decision delivered by Justice Scalia
5.2.7.1.1. Declared that "The Court found that the NCVIA's compensation program strikes a balance between paying victims harmed by vaccines and protecting the vaccine industry from collapsing under the costs of tort liability."
5.2.7.1.2. Justices Sonia Sotomayor and Ruth Bader Ginsburg filed dissenting opinions
6. Issue Before the Court
6.1. Does the National Childhood Vaccine Injury Act protect vaccine manufacturers against suits alleging strict product liability?
7. Rule of Law
7.1. Purpose of Strict Product Liability
7.1.1. Provide protection for consumers against unsafe products
7.1.2. Hold manufacturers accountable for faulty products because they are not in privity contract with the consumer
7.1.3. Manufacturers can bear the cost associated with injuries caused by their products
7.2. Purpose of the NCVIA
7.2.1. Passed by Congress to stabilize the vaccine market and facilitate compensation
7.2.1.1. Establishes a no-fault compensation program to allow for compensation in the United States Court of Federal Claims
7.2.1.1.1. People can receive compensation for medical, educational, and vocational expenses, pain and suffering, attorney's fees, and lump sum in the event of death
7.2.1.1.2. Quid pro quo for this program was tort-liability protections for the vaccine manufacturers against design defect claims
7.3. Requirements for Strict Product Liability
7.3.1. Product must be defective when it is sold by the defendent
7.3.2. Defendent must be engaged in the business of selling the product
7.3.3. Product must be unreasonably dangerous to the consumer because of its defective condition
7.3.3.1. Product was dangerous beyond expectation of the ordinary consumer
7.3.3.2. A less dangerous alternative was economically feasible for the manufacturer, but they failed to produce it
7.3.3.2.1. The family argued that Hannah’s injuries could have been avoided had Wyeth used an alternate design called ACEL-IMUNE (“DTaP”).
7.3.4. Plaintiff must incur physical harm by use of the product
7.3.5. The product defect must be the proximate cause of the injury
7.3.6. The goods must not have been substantially changed from when the product was sold and when the injury occurred.
8. Analysis
8.1. In light of NCVIA, can manufacturers be sued for strict product liability?
8.1.1. Bruesewitz family argues that the vaccine could have been made safer
8.1.2. The Court argues that NCVIA includes provisions protecting manufacturers from liability for "unavoidable adverse effects" of vaccination
8.1.2.1. Allows for compensation to families that meet criteria and file an appropriate claim
8.1.2.2. Covers attorney fees for families
8.1.2.3. Awards are paid out of a fund created by a tax on each vaccine dose
8.1.2.4. In exchange for funding these awards, there is a provision of significant tort liability protection for manufacturers
8.2. Does NCVIA preempt all or part of Bruesewitz' claims?
8.2.1. NCVIA is part of the federal government’s larger program of approving, regulating, and promoting vaccines.
8.2.2. An injured party may not be able to sue the manufacturer of defective products that are subject to comprehensive federal regulatory schemes
8.2.2.1. Vaccines are subject to extensive government regulation and undergo rigorous premarket approval process (FDA)
8.2.2.1.1. NCVIA requires a plaintiff to show that the manufacturer had engaged in conduct that would subject it to punitive damages under the Vaccine Act or failed to exercise due care.