1. Impact
1.1. Milik v. Secretary of Health and Human Services
1.1.1. Case where the petitioner was arguing that their son’s severe developmental delay was caused by the measles, mumps and rubella (MMR) vaccine.
1.1.1.1. Plaintiff argued cited the case as a Constitutional requirement to conduct a de novo review of the Special Master’s decision Court found that the case does not bar the petitioner from filing a later claim in an Article III federal court, and the reliance on the case was misplaced
1.1.1.1.1. Important to show that causation is necessary in some cases. Even with testimony from expert witnesses (Doctors in this case), the Special Master found no causation
1.2. Homes v. Merck & Co., Inc.
1.2.1. Parents of a deceased child brought action against Merck for negligence, negligent design, product liability and other issue
1.2.1.1. After oral arguments, the case waited on the findings from the case (Bruesewitz vs. Wyeth) to see the decision the Court made
1.2.1.1.1. After decision, the plaintiffs argued that this ruling was not applicable because the child in question was not deceased
2. Importance
2.1. Especially those business professionals that work in the vaccine industry would care about this ruling
2.1.1. Claimants cannot sue based on side effects that are “unavoidable” based on design as long as
2.1.1.1. No manufacturing defect of the vaccine
2.1.1.2. All directions/warnings are proper
2.1.2. Understanding this would be crucial in knowing how to respond if sued (although the large drug company law firms are probably highly aware of how these laws apply)
2.2. General product liability is subject to a third provision that vaccines are not, due to the concern for public health and safety
2.2.1. Design defect
2.2.2. If your product has a flaw that can cause injury/death, you can be subject to litigation
3. Influence
3.1. Due to the childhood current vaccine safety fears, this strongly protects companies that produce vaccines from receiving lawsuits about the design of the vaccine itself.
3.1.1. See the Millik case for a specific example of where the MMR vaccine was called into question (following the NCVIA rules to file against the HHS Secretary), and the Special Master ruled that there was not enough evidence to show that the child’s issues were caused by the vaccine
3.1.2. If the injury/death is not noted on the Act’s timetable or is outside of the diagnostic window, then causation is required for a favorable judgment
3.1.2.1. How can causation be proven?
3.1.2.1.1. Confounding variables?
3.2. Public safety and overall health concerns are cited as more important than one off issues seen from vaccine administration
3.2.1. It is more beneficial to society to vaccinate against preventable diseases?
3.2.2. How does this interact with parents’ rights to choose not to vaccinate?
3.2.2.1. We have seen issues such as Disney mumps outbreak
3.2.2.2. Unvaccinated vs. vaccinated children in public places
3.2.2.2.1. Those who choose not to vaccinate
3.2.2.2.2. Those who are not yet ready for the vaccine
3.2.2.2.3. Those who cannot vaccinate for other health reasons
3.2.2.3. Can this choice cause further issues in public health? How does this impact the child vs. parents rights argument?
4. Facts
4.1. Parties
4.1.1. Bruesewitz - parents of Hannah
4.1.2. Wyeth Laboratories
4.1.2.1. purchased Lederle Laboratories in 1994
4.2. What happened
4.2.1. Vaccine for DTP (diphtheria, tetanus and pertussis) administered to Hannah in 1992
4.2.1.1. Lederle’s DTP vaccine was approved in 1948 and given supplemental approvals in 1953 and 1970
4.2.1.2. Within 24 hours of administration of 3rd round of DTP vaccine, Hannah began to experience seizures
4.2.1.2.1. Diagnosed with residual seizure disorder, encephalopathy and developmental delay
4.3. History
4.3.1. Between 1978 to 1981 there were only 9 tort liability litigations filed against manufacturers that made DTP vaccines.
4.3.2. There was a rise in tort liability litigations in the mid-1980s of around 200 suits/year
4.3.2.1. Many manufacturers left the market due to liability issues
4.3.2.2. Much of the public thought that the DTP vaccine was the cause of children’s developmental delays/disabilities.
4.3.2.2.1. Could have been a side effect of the vaccine or due the timeframe the developmental delays manifest in children
4.3.3. Due to distrust in the DTP vaccine, many chose to not vaccinate
4.3.3.1. Vaccines only work when the mass public is vaccinated
4.3.3.1.1. Forced Congress to enact National Child Vaccine Injury Act (NCVIA) in 1986
4.3.4. Plaintiff originally awarded Attorney's Fees, as was not a frivolous lawsuit, but rejected judgment and sued manufacturer (now Wyeth)
4.3.4.1. Wyeth removed the suit to Federal Court
4.3.4.1.1. PA state law was preempted by 42 U.S.C. § 300aa–22(b)(1), which states that the manufacturer shouldn’t be liable for injuries/deaths caused by vaccines if properly prepared and accompanied by valid directions and warnings.
5. Issue Before the Court
5.1. After receiving the DTP vaccine, Hannah presented seizures within 24 hours; the design of the vaccine was called into question
5.1.1. Failure to produce safer vaccine
5.1.2. Negligent failure to warn
5.1.3. Strict liability for design defect
5.1.4. Strict liability for manufacturing defect
6. Rule of Law
6.1. National Child Vaccine Injury Act (NCVIA) enacted by Congress in 1986
6.1.1. Must first seek litigation through Health and Human Services secretary
6.1.1.1. May accept decision or reject and go through traditional tort litigation against manufacturer
6.1.2. “no-fault” compensation program
6.1.2.1. Receive monetary compensation for medical, pain and suffering, death
6.1.2.2. Attorney’s fees for non-frivolous suits
6.1.2.3. Paid for via excise tax on vaccines
6.1.3. Aim to provide faster, easier relief than tort liability litigation
6.1.3.1. If injuries occur within the Act’s timetable, no causation linkage required
6.1.3.2. If outside of the timetable, or unlisted, causation is required
6.1.3.3. Not necessary to show the manufacture was defective or the warnings/directions were inadequate
6.1.3.4. Must be used for suits seeking in excess of $1,000 first
7. Application
7.1. A vaccine’s design is not open to tort actions
7.1.1. Side effects can always be mitigated by a use of different element of a vaccine
7.1.1.1. If someone is allergic to ingredient x, then if ingredient x was replaced with y, then the person wouldn’t have had the reaction
7.2. Complete defense must be unavoidable (with proper warnings/directions) with respect to the particular design
7.2.1. Products-liability law requires these for liability
7.2.1.1. Defective manufacture
7.2.1.2. Inadequate directions/warnings
7.2.1.3. Defective design
7.2.1.3.1. NCVIA only provides for defective manufacture and inadequate directions/warnings, deliberately
7.3. Claimants argued that “even though” the product was properly labeled… and then also argued that the “side effects were unavoidable”
7.3.1. Court found these two statements to be contradictory
7.3.2. Even though suit was for failure to warn and manufacture defect, these items were not addressed in the case summary
7.3.2.1. Since claimants admit that it was properly labeled, there is no failure to warn
7.4. Defendants argued that NCIVA protects the manufacturer from claims against design defect
7.4.1. As long as the proper warnings and directions are provided stating ingredient x is being used, then the product is working as designed
7.4.2. The design is not open to question