1. 2. Issue before the Supreme Court
1.1. Whether the plaintiff in a product liability, design defect case is able to prove that the 1) a safer alternative existed and was available to the manufacturer and, 2) the design change could have prevented the injury.
2. 1. FACTS
2.1. Parties
2.1.1. Plaintiffs, Bruesewitz family representing minor, Hannah Bruesewitz, from Pittsburgh, PA.
2.1.2. Wyeth Laboratories, LLC.- manufacturer of a vaccine received by then-child, Hannah.
2.2. What happened
2.2.1. A minor child, Hannah Bruesewitz, began experiencing seizures 24 hours after receiving a routine childhood vaccine for dipstheria, tetanus and pertussisis administered by her pediatrician. The (now) adult Hannah is mute and in need of 24-hour care.
2.3. Procedural history
2.3.1. Plaintiffs, Russell and Robalee Bruesewitz, brought suit in 1995 in the U.S. Court of Federal Claims which presides over the specially designed "Vaccine Court" to receive claims regarding vaccine injury. There is no jury in Vaccine Court, and it uses a no-fault system. Compensation is awarded from a federal fund established under the National Childhood Vaccine Injury Act of 1986 (NCVIA), and the fund is furnished by an excise tax applied to each vaccine dose. The burden of proof lies entirely on the petitioners.
2.3.1.1. Their petition was dismissed on lack on lack of failure to prove a link between their minor daughter's seizures and developmental delays and the DTP vaccine she received previously.
2.3.1.1.1. The plaintiffs then filed a civil suit in the PA state court (their home state) against the manufacturers of the vaccine in question, [now] Wyeth LLC, claiming product liability and tort.
2.3.1.2. The U.S. Supreme Court presided over the case the Bruesewitzs brought against Wyeth LLC in October 2010.
3. 3. Rule of law
3.1. Elements of a design defect case (Product-Liability Law)
3.1.1. Grounds for liability rests on three findings; defective manufacture, inadequate directions, and defective design.
3.1.1.1. The plaintiff's counsel must show that injury from the design was avoidable if design changes had been considered by the manufacturer.
3.1.1.2. They must also show that the manufacturer bears responsibility and liability because there was a safer alternative that it did not address for public use.
3.2. The NCVIA preempts vaccine manufacturers from liability in civil actions from an administered vaccination.
3.2.1. The FDA and CDC decide which vaccines are safe for public administration and manufacture. Each manufacturer must be certified and compliant to Federal regulations during each step of the manufacturing process.
3.2.1.1. The NCVIA created a no-fault compensation plan to stabilize the vaccine market that was overrun with liability suits and unable to maintain surplus for U.S. demand. The Health and Human Services Secretary receives all claims, and decisions are held to strict deadlines.
4. 4. Application and Analysis
4.1. The defendant, Wyeth LLC, argues that the design of the vaccine itself is not open to question, but whether the vaccine was "labeled and manufactured properly" and subject to question when determining tort action under the NCVIA.
4.1.1. The defense argues that the wording of the Statute states that the wording of "unavoidable" does not hold manufacturers responsible to using a different design in order to avoid side-effects, since "side-effects can always be avoided by using a less-effect design that does not contain the harmful, but key element."
4.1.1.1. The NCVIA preempts all design-defect claims resulting after the installment of the Act in 1986.
4.1.1.1.1. The statute cites only two of the grounds for product liability, manufacture and warnings, thus, design-defect must be left out on purpose, and unavoidability must refer to the former two qualifiers.
4.2. The plaintiff had the burden of proving
4.2.1. The defendant, Wyeth LLC's defective design was negligent and they were subject to strict-liability laws.
4.2.1.1. The plaintiff also focuses heavily on the wording of the statute, claiming that a safer vaccination was available and thus, injury was "avoidable."
4.2.1.1.1. The plaintiffs heavily base their claim on the fact that tort-law leads to improved designs, and provides compensation for injury.
4.3. The court ruled
4.3.1. That under the Committee Reports about the bill, that if a plaintiff could not find fault in either the manufacture, or the labeling of the drug/vaccine, they must find repose in the compensation system provided by the NCVIA, not the tort-system.
4.3.1.1. The court must uphold the most plausible and widespread definition of the word "unavoidable" for statutory interpretation.
4.3.1.1.1. The Supreme Court upheld the decision that the plaintiffs did not provide evidence of design-defect and that the statute must stand as written.
5. 5. Conclusion
5.1. Ruling
5.1.1. The judgement made the Third Court of Appeals stands. After being tried in the highest court of the land, the case is offically closed.
5.2. Impact
5.2.1. This ruling essentially preemptively blocked many other suits of the same kind- liability and tort claims against individual manufacturers of drugs and vaccinations.
5.2.1.1. It reinforced the procedure that was set forth by the NCVIA to avoid costly, and timely civil suits against manufacturers that provide life-saving technology.
5.3. Importance
5.3.1. Pharmaceutical industries have incredible responsibility to society to advance life-saving innovation.
5.3.1.1. If the U.S. allowed tort-claims against these businesses, productivity would slow and fear would stall progress.
5.3.1.1.1. Congress acted preemptively to protect medical progress and compensate for inherent injury claims.
5.4. Influence
5.4.1. In Lorena Mora v. Secretary of Human Health and Services (2015) a mother who brought action and filed a claim under the NCVIA but later dismissed the case. She later moved for judgement on the abuse of discretion standard, claiming her attorney gave grossly negligent advice.
5.4.1.1. The plaintiff claims that a flu vaccine made her otherwise-healthy daughter confined to a wheelchair.
5.4.1.2. The court upheld the NCVIA and further ruled that there must be a balance struck between litigation and justice.
5.4.2. Holmes v. Merck (2011) arose after a one-year old suffered seizures and developed encephalopathy after receiving an MMR vaccination manufactured by the defendant. The child later died.
5.4.2.1. The court upheld the decision that the NCVIA precludes tort-claims against vaccine manufacturers that properly manufacture and label their products under FDA guidelines.