1. IRAC Analysis
1.1. Facts
1.1.1. Parties
1.1.1.1. Russell and Robalee Bruesewitz
1.1.1.2. Wyeth, LLC
1.1.2. What Happened
1.1.2.1. Hannah, the daughter of Russell and Robalee Bruesewitz, was taken in for her 6 month diphtheria, tetanus, and pertussis vaccine (DTP)
1.1.2.2. Hannah immediately started having seizures and was hospitalized for weeks
1.1.2.3. Hannah was diagnosed with residual seizure disorder and developmental delay requiring her to have "lifelong medical care"
1.1.3. Procedural History
1.1.3.1. The Bruesewitz's filed a petition in the Courts of Federal Claims under the National Childhood Vaccine Injury Act of 1986 for Compensation (NCVIA)
1.1.3.1.1. Claim was Denied
1.1.3.1.2. Residual seizure disorder was not listed under DTP know complications from vaccine list provided by the NCVIA Act of 1986
1.1.3.2. The Bruesewitz's filed suit in Pennsylvania State Court claiming Strict Liability and liability for negligence in design under Pennsylvania tort law
1.1.3.2.1. Wyeth, LLC removed suit to Federal District Court
1.1.3.3. Suit proceeded in US Federal District Court of Eastern Pennsylvania
1.1.3.3.1. Summary Judgment was made in favor of Wyeth, LLC
1.1.3.3.2. Judge ruled that Pennsylvania tort law was preempted by 42 U. S. C. §300aa-22(b)(1) which protects vaccine manufacture from civil action for damages...from unavoidable side-effects...
1.1.3.4. Appealed to Third Circuit Court of Appeals
1.1.3.4.1. Decision Affirmed
1.1.3.5. Appealed to the Supreme Court
1.2. Issue Before the Court
1.2.1. Whether vaccine manufacturers are exempt under the NCVIA of 1986 and bars them from state tort law design and defect claims
1.3. Rule of Law
1.3.1. National Childhood Vaccine Injury Act of 1986 for Compensation (NCVIA)
1.3.1.1. Protects vaccine manufacturers from liability stemming in civil actions for damages from a vaccine-related injury or death associated with a vaccine given after October 1, 1988...
1.3.1.1.1. as long as the the injury or death was from side-effects that were "unavoidable"
1.3.1.1.2. and the vaccine was prepared and accompanied by proper directions and warnings
1.3.2. Strict Liability
1.3.2.1. Due care in design of the product
1.3.2.2. Due care in production process
1.3.2.3. Adequate warnings and dangers associated with the product
1.3.2.4. In terms of NCVIA of 1986, it must not be an "unavoidable" side-effect
1.3.2.5. Causes unreasonable Danger
1.4. Application
1.4.1. The appellant argues that Wyeth's DTP drug is in violation of the NCVIA of 1986 and Wyeth should be liable
1.4.1.1. Appellant shows that the DTP vaccine has not been updated since the 1940's
1.4.1.2. There was a safer vaccination available, called "DTaP"
1.4.1.2.1. Defendant argues that DTaP was only FDA approved for injections 4 and 5 in 1991 after the first 3 injections of DTP were administered
1.4.1.2.2. FDA approval of DTaP for all injections was not approved until 1996
1.4.1.2.3. Defendant also acknowledges that they stopped distribution of DTP in 1998 following approval of DTaP
1.4.1.3. Appellant argues that the batch used for Hannah's inoculation had design defects causing over 65 FDA complaints resulting in 39 emergency visits, 6 hospitalizations, and 2 deaths
1.4.1.3.1. Courts argue that there is no design defect that caused injury or death that was an "unavoidable side-effect" of the drug
1.4.1.3.2. Supreme Court also rules that vaccine was properly designed, prepared, and accompanied with warnings and labels.
1.4.2. The appellant argues that NCVIA should not preempt states tort law
1.4.2.1. Court states that a procedure for complications is already in place for cases involving compensation - Court of Federal Claims
1.4.2.1.1. Wyeth funds this program though special taxes on the vaccine at time of sale
1.4.2.2. Supreme Court states that without this protection from unavoidable harm suppliers of vaccinations would leave the market completely
1.4.2.2.1. Unavoidable harm from vaccinations does not outweigh the need for vaccinations
1.5. Conclusion
1.5.1. Supreme Court affirmed the lower courts decision
2. 3 I's
2.1. Impact
2.1.1. Mutual Pharmaceutical Co. v. Bartlett No 12-142
2.1.1.1. Case involved Karen Bartlett who was given the generic drug Clinoril by her doctor for shoulder pain. She developed toxic epidermal necrolysis that destroyed the skin over half of her body. She was in a medically induced comma for months and countless surgeries
2.1.1.2. District Court and Appellant Court ruled in Bartlett's favor
2.1.1.2.1. Appealed to supreme court to decide whether New Hampshire State Law Preempts Federal Law in that Federal law prohibits generic drug manufacturers to change the label from the brand name version under Drug Price Competition and Patent Term Restoration Act of 1984
2.1.2. Mojabi et al v. Secretary of Health and Human Services
2.1.2.1. Ryan was given an MMR shot and developed an encephalopathy. His case was transferred to Caccine Court’s Autism Omnibus Proceedings.
2.1.2.1.1. Although judgment was awarded in his favor this case proves that Bruesewitz v Wyeth, LLC decision that Corporations that develop these vaccines are in fact not liable
2.2. Importance
2.2.1. This case laid the blueprint for other vaccination litigation cases to follow. Explaining the differences between avoidable and unavoidable side effects as well as explaining the text in detail from the NCIVA of 1986 and giving it an interpretation for the future to follow.
2.2.1.1. Primarily it gives manufacturers a sense of relief that they will not be liable for unavoidable side effects resulting from their vaccinations given it was prepared correctly and accompanied with the correct warning labels and material
2.2.1.2. A Business professional cares about this decision when evaluating whether to enter the vaccination industry and in creating or ceasing operations for new and existing vaccinations
2.3. Influence
2.3.1. This case has made the pharmaceutical and vaccination industry create more informed material and help states in policy making by attending briefs and giving scientific data to task forces and committees.
2.3.1.1. Although Lobbying has been linked to this, it is still a step in the right direction as long as the policy makers are the ones making the decisions
2.3.2. With new technology we can see the push for better and more cost effective vaccines. Wyeth, LLC themselves had discontinued their Flu vaccine because the margin of profit was to low.
2.3.2.1. With new equipment and technology vaccines can get the appropriate updates needed