1. Rule of Law
1.1. 3 grounds for Product Liability suits (These are general state statues because there is no congressional statue on Product liability, except MUPLA, which is for voluntary state adoption)
1.1.1. Defective manufacturing
1.1.1.1. The National Childhood Vaccine Injury ACT (NCVIA) of 1986 explicitly mentions defective manufacturing leading to vaccine side-effects as an exception for which manufacturers are not liable. (Statutory Law passed by congress - at issue Section 22(b) 1)
1.1.2. Inadequate directions or warnings
1.1.2.1. NCVIA explicitly mentions inadequate labeling leading to vaccine side-effects as an exception for which manufacturers are not liable (Statutory Law passed by congress - at issue Section 22(b)1)
1.1.3. Defective design
1.1.3.1. Defective design is NOT explicitly mentioned in the NCVIA statue of 1986
2. Influence
2.1. Vaccinations are a public health matter. Manufacturers are protected from unavoidable occurences.
2.1.1. Manufacturers can continue to do business without being threatened by a detrimental damage lawsuit
2.1.1.1. Public health sector is boosted
2.2. Public Safety is given greater importance over individual cases resulting from injuries caused by vaccinations
2.2.1. Parents right to choose in an educational setting
2.2.1.1. Should student vaccinations be mandatory?
2.2.2. Individuals who receive the vaccination vs. individuals who choose not to receive the vaccination
2.2.2.1. Complicates the anti-vaccination movement
3. Importance
3.1. The National Childhood Vaccine Injury Act (NCVIA) was created to exclude possible financial liability from manufactures as a result of vaccine injury claims. As a business professional working for a manufacturing company as such: it would be a concern if we will be sued, cost of liabilities and tarnished reputation.
4. Impact
4.1. Manufacturers are prohibited from liability
4.2. Manufacturers must label vaccines in an appropriate manner
4.3. Ramifications for pending vaccine cases in the U.S. (claims will likely be restricted under Bruesewitz)
4.4. United States Court of Appeals, Federal Circuit. Lorena MORA, G.G.M., a minor, by and through her Guardian Ad Litem, Petitioners-Appellants v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee
4.4.1. Defendant used Bruesewitz holding where the National Childhood Vaccine Injury Act preempts all design/defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects. In Mora, the Plaintiff’s attorney failed to conduct basic legal research pertinent to the Act and the Bruesewitz holding.
4.5. United States Court of Appeals, Federal Circuit. Marek MILIK, Jolanta Milik, Legal Guardians and Parents of A.M., Petitioners–Appellants v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent–Appellee.
4.5.1. Plaintiff argued that the Court of Federal Claims is constitutionally required to conduct a de novo review of the special master's decision (the special master found no evidentiary basis to conclude that the Plaintiff's disability was vaccine-caused) as was found in Bruesewitz v. Wyeth.
4.6. United States Court of Appeals, Ninth Circuit. Erin HOLMES; Shawn Holmes, Plaintiffs–Appellants, v. MERCK & CO., INC., Defendant–Appellee.
4.6.1. The question in this appeal is whether the National Childhood Vaccine Injury Act preempts all or part of the Plaintiffs' claims that included allegations of negligence, strict product liability, negligent design, failure to warn, misrepresentation, express warranty, implied warranty of merchantability, implied warranty of fitness for a particular purpose, and punitive damages.
5. Conclusion
5.1. Case moved to federal district court which granted summary judgement dismissal
5.1.1. The U.S Supreme Court agrees with the district court
5.1.1.1. Interpreted a provision under the National Childhood Vaccine Industry Act
5.2. Manufacturers need protection from unavoidable side effects so as long as the manufacturer puts warning and labels on their products, the manufacturer is protected from unavoidable side effects
5.2.1. Justices reasoned that there is a special vaccine court to compensate injured parties separate from manufacturers to encourage vaccine makers to stay in the market
6. TEAM 8
7. Case Facts
7.1. Parties
7.1.1. Plaintiff: Russell Bruesewitz; Robalee Bruesewitz; Hannah Bruesewitz (a minor)
7.1.2. Defendant: Wyeth, Inc., fka Wyeth Laboratories, et al.
7.2. Synopsis: The parents of Hannah Bruesewitz filed an injury petition in the Court of Federal Claims declaring that their daughter became disabled after receiving a DTP vaccine manufactured by the Lederle Laboratories which is now owned and operated by Wyeth. Upon appeal, the Bruesewitz's further claimed that it was the defective design of the vaccine that caused the injuries to Hannah, and that the company (Lederle) should be held to a strict liability for negligent design under Pennsylvania law.
7.3. United States Court of Appeals for the Third Circuit (3/27/09); Supreme Court of the United States (Granted 3/8/2010); Supreme Court of the United States (Dec. 2/22/11)
8. Application
8.1. Plaintiff
8.1.1. Interprets the words "even though" as laying grounds for conditions under which the manufacturer is not liable for vaccine side-effects
8.1.1.1. Because only manufacture defects and inadequate labeling are mentioned then the defendant is liable for vaccine design defects that result in side-effects
8.1.2. The use of the word "unavoidable" in the NCVIA statue needs to be interpreted according to Restatement (second) of Torts 402A (1963-1964) comment K, which stipulates "unavoidably unsafe products" as exempt from strict liability
8.1.2.1. However this vaccine was AVOIDABLY unsafe because it was capable of being made safer.
8.1.2.1.1. The avoidable side-effects are as a result of a design defect thus the defendant must be liable
8.1.2.2. "Unavoidable" in this statue is used as a legal word of art
8.1.3. The word "if" in the statue is meant to imply some side-effects from the vaccine are avoidable while others are not avoidable. Hence the statue is phrased in conditional tense.
8.1.3.1. Avoidable side-effects are thus not covered by the NCVIA statue.
8.1.3.1.1. A vaccine design defect that leads to side-effects is an avoidable event
8.1.4. When state interpretation is in question, an interpretation that preserves state-law should hold
8.2. Defendant
8.2.1. Section 22(b)1 as interpreted by plaintiff (vaccine manufacturers are still liable for design defects) does not achieve the intended purpose behind passage of the act
8.2.2. As interpreted by plaintiff, the statue will be punitive in states where vaccine design defects are not grounds for tort.
8.2.2.1. The preemption of the Act will instead increase liability claims for vaccine manufacturers in such states
8.2.3. If defective design were an exception, congress would have stopped after the word "unavoidable"
8.2.4. Regardless of interpretation challenges, the statue still preempts state-law
8.3. Court
8.3.1. Interpretation of "even though"
8.3.1.1. "Even though" is not meant to delineate prerequisites for preemption independent of 'unavoidability'.
8.3.1.1.1. "Even though" can be substituted with the word "and". In this case, it is meant as a coordination junction for further substantiation of the statue
8.3.1.1.2. "Even though" is meant to clarify the preventative measures a vaccine manufacturer must have taken for side-effects to be considered avoidable
8.3.2. Defective design is omitted in the statue because it is under federal regulation whereas manufacturing defect and inadequate labeling are directly under the manufacturer's control
8.3.3. Regarding comment k of Restatement (second) of Torts (1963-1964)
8.3.3.1. The NVCIA statue was enacted by congress in 1986 and there is no evidence that it was worded to clarify or in awareness of comment k
8.3.3.1.1. The court does not isolate a single word ("unavoidable") in a statue but rather seeks to interpret a statue as a whole.
8.3.4. Regarding the word "if" and "avoidable"
8.3.4.1. The word "unavoidable" is meant to cover all the grounds for product liability for which the vaccine manufacturer could be held liable, including defective design
8.3.4.2. Side-effects of vaccine could always be avoidable by use of a different vaccine design not containing the harmful element
8.3.4.2.1. The language of the statue assumes proper design is a given and thus not actionable as tort