1. Facts
1.1. Parties
1.1.1. Parents of Hanna Bruesewitz
1.1.2. Wyeth, LLC (owner of Lederle Laboratories)
1.2. What happened
1.2.1. Hannah Bruesewitz received DTP vaccine as an infant
1.2.1.1. She was administered vaccine by her pediatrician according to CDC recommended childhood immunization schedule
1.2.2. Within 24 hours of receiving vaccination, Hannah started having seizures
1.2.2.1. She suffered over 100 seizures over the next month
1.2.3. Doctors diagnosed with residual seizure disorder and developmental delay
1.2.4. As a teenager Hanna is still diagnosed with both conditions
1.2.5. The DTP vaccine Hanna received was manufactured by Lederle Laboratories, purchased by Wyeth in 1994, who stop manufacturing the vaccine in 1998
1.3. Procedural history
1.3.1. Hannah's parents filed a vaccine injury petition in the US Court of Federal Claims for seizure disorder and encephalopathy injuries. A Special Master denied their claims on various grounds
1.3.1.1. Bruesewitz was still awarded $126,800 in attorney's fees and costs
1.3.2. Hannah's parents rejected the judgement and filed suit in Pennsylvania state court
1.3.2.1. Bruesewitz alleged defective design of DTP vaccine subject to strict liability and liability for negligent design under Pennsylvania common law
1.3.3. Wyeth removed the suit to US District Court who issued summary judgement that Federal statutory law preempted Pennsylvania common law
1.3.4. The US Court of Appeals for the 3rd Circuit affirmed
2. Issue before the Court
2.1. Whether a preemption provision enacted in the National Childhood Vaccine Injury Act of 1986 (NCVIA) bars state-law design-defect claims against vaccine manufacturers
3. Rule of Law
3.1. Common law negligence tort for product liability
3.1.1. Manufacturing defects
3.1.1.1. Usually involves poor-quality materials or shoddy workmanship
3.1.2. Design defect
3.1.2.1. Occurs where the product design is inherently dangerous or defective or risks outweigh benefits (reasonably safe)
3.1.3. Failure to warn
3.1.3.1. Occurs when products carry inherent dangers which are not obvious and can be mitigated through adequate warnings
3.2. Federal law: 42 USC 300aa-22(b)(1) National Vaccine Injury Compensation Program (NCVIA)
3.2.1. 22(b)(1) "No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after Oct 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings"
3.3. Restatement (Second) of Torts 402A comment k "unavoidably unsafe products"
3.3.1. Risky product that does more good than harm, is inherently risky, but not using this product would certainly have serious consequences (ex experimental drugs for terminally ill). Must still be properly prepared and marked
4. Application
4.1. The NCVIA doesn't explicitly say "design defect", for determining liability, only "properly prepared" and "proper directions and warnings"
4.1.1. Statute exempts "design defect" from product liability for vaccines by excluding it from the language. You may sue over doubt of "properly preparing" or "proper directions and warnings". If "proper design" was included, then it would allow one to question whether the vaccine had a design defect
4.1.2. This language was intentionally left out because this statute establishes unavoidably with respect a particular design. Implies the design itself is not open to question
4.1.2.1. Vaccine designs are complex, and peoples reactions to them vary, so there is no one single design that is perfect. A side effect of a vaccine could always be avoided by a different design
4.1.3. Seems intentional that the statute would specifically include 2 of the 3 criteria of establishing product liability, and leave one out. Also there is language of "even though" which implies every design has unavoidable side effects when properly prepared and marked.
4.1.4. Who can determine if a highly technical vaccine has a design defect?
4.1.4.1. Court argues a subject matter expert is better equipped to make this call instead of a jury which is why NCVIA judgements are made by a Special Master
4.1.4.2. FDA has stringent regulations which manufacturers have to meet to produce vaccines.
4.1.5. Context of NCVIA supports argument of intentionally leaving out "design defect" language to exempt this criteria for establishing product liability lawsuit. Also, not a single mention of design defect in all of NCVIA or FDA regulations that regulate drug manufacturing
4.1.6. The quid pro quo structure of NCVIA for efficient compensation program to avoid costly tort litigation and disproportionate jury verdict suggests "defective design" was intentionally left out of NCVIA
4.2. Federal statutory law of NCVIA preempts Pennsylvania common tort law
4.3. House Committee Report 99-908 an "authoritative" account of Congress' intent in drafting the preemption clause of NCVIA
4.3.1. States that vaccine injured persons should use the NCVIA's compensation system, not the tort system
4.3.2. Lists "improperly prepared" and "improper directions or inadequate warnings" for reasons in seeking recompense, again no mention of "design defect"
4.3.3. Plaintiff argues Report's reference to "unavoidable" and "principle of comment k" is used in invoke comment k
4.3.3.1. Restatement (Second) of Torts 402A comment k (1965), exempts "unavoidably unsafe products" from strict liability law
4.3.3.2. comment k states "Such a product, properly prepared, and accompanied by proper directions and warnings, is not defective, nor is it unreasonably dangerous."
4.3.3.3. Unavoidable is a common word, and "unavoidable unsafe" was never used in report or NCVIA
4.3.3.4. Bruesewitz argued majority of courts require case-specific showing that a product was incapable of being made safer for its intended use when determining "unavoidably unsafe" products
4.3.3.4.1. At time of Report's reference to comment k, comment k was highly debated and interpretations varied greatly on whether to apply categorically or on case-by-case