1. Analysis/Application
1.1. Plaintiff
1.1.1. Plaintiffs claim poor design of the TRI-IMMUNOL vaccine, in addition to other factors, caused the injury to Hannah
1.1.2. Plaintiffs claim Wyeth and other organizations were aware of the adverse affects attributed to the vaccine
1.1.3. Plaintiffs argue that aforementioned injuries could have been avoided had ACEL-IMUNE been administered instead; hence failing to make the injuries unavoidable
1.1.3.1. Section 22(b)(1) NCVIA exempts manufacturers from civil liability for unavoidable vaccine injuries and deaths under the condition that the vaccine was prepared properly and labeled adequately
1.1.4. Plaintiffs argues NCVIA was enacted by Congress to safeguard vaccine safety and grant fair compensation for vaccine-related injuries
1.1.4.1. Argue that verbiage only grants protection when a safer design could not have been used to prevent against potential side-effect
1.2. Defendant
1.2.1. Defendant, Wyeth Inc., argues Congress enacted the NCVIA to keep vaccine manufacturers from leaving the market due to fear of high litigation costs
1.2.2. Defendant argues their interpretation of the Act acknowledges the mathematics behind weighing the cost (rare side-effects) vs. the benefits that vaccinations incur
1.2.3. Defendant argues Section 22(b)(1) extends broad protection to vaccine manufacturers, safeguarding them in absolute terms against all possible design-defect claims
1.2.4. Defendant claims Plaintiff's interpretation of the Act would lead to no change in protection after the passing of the Act
1.2.4.1. Argue, in fact, that the Plaintiff's interpretation could, in theory, expand manufacturer liability
1.3. Court
1.3.1. Court ruled vaccine makers cannot be held liable for negative side effects believed by parents to be caused by vaccines
1.3.2. Court affirmed Congress intended to supersede design-defect claims when they passed Section 22(b)(1)
1.3.3. Court's ultimate ruling depended on their interpretation of the purpose of the NCVIA
1.3.3.1. This was largely dependent on their interpretation of "unavoidable"
1.3.4. Court reasons that vaccine courts that had been set up by Congress serve as the appropriate recourse to receive compensation
1.3.4.1. Vaccine courts serve as a compromise of courts to guard against vaccine manufacturers leaving the vaccine market
1.3.5. Court rules that so long as proper manufacturing and warning exists, any side effects are deemed unavoidable
2. Conclusion
2.1. The US Supreme Court affirmed the lower courts' decision
2.1.1. The NCVIA preempts all design-defect claims against vaccine manufacturers for injury or death caused by a vaccine's unavoidable and adverse side effects
2.1.2. A special vaccine court system was implemented to compensate injured patients and prevent manufacturers from leaving the vaccine market
3. Impact
3.1. Holmes v. Merck & Co, Inc (2006)
3.1.1. The Plaintiffs' infant child died allegedly as a result of an infection caused by a vaccine manufactured by Merck. The Holmes sued for wrongful death. The District Court rules that under Section 22 of the NCVIA, parents of children injured by a vaccine cannot sue for design defect or failure to warn.
3.1.1.1. The Holmes appealed. The Ninth Circuit Court noted that Section 22 does not allow claims against drug companies solely for design defect of vaccines. The Act's purpose was to maintain the national vaccine supply while compensating those who are injured by vaccines.
3.1.1.1.1. The Court of Appeals affirmed grant of summary judgement in favor of Merk, citing Bruesewitz v. Wyeth ruling.
3.2. Sebelius v. Cloer (2013)
3.2.1. A student developed multiple sclerosis soon after being vaccinated for Hepatitis B. Years later, Dr. Cloer sued under the NCVIA after learning about a possible connection between the vaccine and MS. The claim was denied due to Statute of Limitations. The Federal Claims Court affirmed, the Federal Court of Appeals reversed.
3.2.1.1. The Federal Circuit Court held that Dr. Cloer was entitled to attorney fees, citing Bruesewitz, "The NCVIA established a no-fault compensation system to stabilize the vaccine market and expedite compensation to injured parties."
3.2.1.1.1. The Supreme Court held that the NCVIA states that a claimant may recover attorney fees in proceedings under the Act brought in good faith with a reasonable basis, even if the claimant does not win the case.
3.3. Milik v. Secretary of Health and Human Services (2017)
3.3.1. The plaintiffs sought an award for attorneys' fees and other costs incurred in attempting to obtain program compensation.
3.3.1.1. The Miliks cited Bruesewitz v. Wyeth LLC to support their argument that the Vaccine Act is unconstitutional, and that it is required to conduct a de novo review of the chief special master's decision in the Federal Claims Court.
3.3.1.1.1. The Court held that the Vaccine Act “pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.”
4. Facts
4.1. Parties
4.1.1. Bruesewitz et al.
4.1.2. Wyeth, Inc et. al (formally Lederle Laboratories)
4.2. What Happened
4.2.1. Hannah Bruesewitz's parents, argued that Hannah started to experience seizures and became disabled within 24 hours of receiving a diphtheria, tetanus, and pertussis (DTP) vaccine, manufactured by Lederle Laboratories (now Wyeth, Inc.)
4.2.2. Hannah was eventually diagnosed with “residual seizure disorder” and “developmental delay"
4.2.3. The courts held that Wyeth was protected from liability under the National Childhood Vaccine Injury Act of 1986 (NCVIA), which created a no-fault compensation program to stabilize the vaccine market adversely affected by substantial increases in vaccine-related tort litigation
4.3. Prodecural History
4.3.1. 1) Court of Federal Claims denies Hannah's parent’s petition against Wyeth
4.3.2. 2) The Bruesewitzs rejected the unfavorable judgement and filed suit in Pennsylvania State Court
4.3.3. 3) Wyeth removed the suit to Federal District Court, which granted Wyeth summary judgement holding that Pennsylvania state law was preempted by 42 U. S. C. §300aa–22(b)(1)
5. Issue
5.1. Whether the NCVIA preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects
6. Rule of Law
6.1. NCVIA Reinforces 42 U. S. C. §300aa–22(b)(1)
6.1.1. Wyeth followed proper manufacturing method and provided the directions and warnings that must accompany the product
6.1.2. State-law design-defect claims are preempted and not mentioned because they are not a basis for liability
6.1.3. Design-defects do not merit a single mention in the NCVIA or the FDA’s regulations
7. Importance
7.1. Preemption as defense to product liability
7.1.1. Along with Riegel v. Medronic, Inc, the judgment establishes that state common law claims for product liabiliity based on design-defect are preempted for certain devices that are subject to extensive regulatory review (such as the exhaustive premarket approval (PMA) of the 1976 Medical Device Amendments of Food, Drug, and Cosmetics Act), as well as those vaccines that are explicitly exempted from design-defect claims in the NCVIA
7.1.1.1. Manufacturers can continue development of devices and therapies reliant on the fact that the PMA process, the NCVIA, or certain other preempting regulatory frameworks will limit liability for design defect claims for novel products
7.2. NCVIA of 1986
7.2.1. With confirmation of preemption for design-defect claims, the judgment contributed to the goal of the NCVIA to stabilize the vaccine manufacturer marketplace, safeguard the supply of vaccines, and limit skyrocketing litigation costs
7.2.1.1. The NCVIA arrested the flight of vaccine manufacturers from the marketplace and allowed continuing vaccine development
8. Influence
8.1. Preemption liability limitation
8.1.1. While society would not tolerate a high risk therapy for either minimal benefit or that to be applied in a fundamentally healthy patient, many of the PMA's are for those with grave or imminently life-threatening disease for whom current devices and therapies are inadequate. Like the vaccine calculus, progress often includes devices or therapies that have significant risk by design. (i.e. the proton beam therapy for brain tumors has a dose-related toxicity to surrounding tissues and organs)
8.1.1.1. With FDA PMA costs range from $10´s to 100´s million/approval and an approval process that explicitly defines the risks and benefits, manufacturers are reliant on liability limitation for design defect.
8.2. NCVIA liability limitation
8.2.1. While vaccine industry was in a virtually untenable condition until NCVIA, there have been numerous advancements in vaccine development since the Act
8.2.1.1. New vaccine development: Varicella (1996), rotavirus (1998), hepatitis A (2000), pneumococcus (2001), meningococcal conjugate (2005), HPV (2006), shingles (2008)
8.2.1.2. Optimization, reformulation, and recombination of vaccines: DTaP (1997), intranasal influenza (2004)
8.2.1.3. New vaccine regimens: 1) Adolescent vaccinations to include meningococcal conjugate, HP, and meningococcal serogroup B. 2) Adult vaccinations to include formal schedule (2002)