1. Facts
1.1. Parties
1.1.1. Hanna Bruesewitz's parents
1.1.2. Wyeth LLC
1.2. What Happened
1.2.1. In1992 when Hanna Bruesewitz was six months old,her pediatrician administered routine doses of diphtheria- tetanus- pertussiss (DTP) vaccine.
1.2.1.1. The DTP vaccine was manufactured by Lederle Laboratories which was later purchased by Wyeth LLC.
1.2.2. Hanna immediately started to experience seizures and continued to suffer seizures after being vaccinated.
1.2.3. In 2003, doctors diagnosed Hannah with a residual seizure disorder and encephalopathy.
1.2.4. Hannah will likely require lifelong medical care.
1.3. Procedural History
1.3.1. In 1986 Congress mandated preemption of design defect claims when it adopted the National Childhood Vaccine Injury Act of 1986 (the Vaccine Act), which established a national, comprehensive, no-fault compensation program for vaccine-related injuries.
1.3.1.1. The American Academy of Pediatrics ( (“AAP”) described the threat vaccine manufacturers faced when Congress enacted the NCVIA.
1.3.1.2. Llitigation had substantially impacted manufacturers’ malpractice coverage. Consequently, vaccine prices ballooned to cover these costs, sometimes by as much as 900 percent.
1.3.1.3. Vaccines play a critical role in public health, and are credited for saving lives.
1.3.1.4. Congress was justifiably worried about shortages as some manufacturers chose to exit the market due to heavy litigation. In fact, by 1986, only two companies still produced DTP.
1.3.2. The Bruesewitzes submitted their case before the Vaccine Court, an Office of Special Masters created by Congress to adjudicate vaccine related claims on design defect claims.
1.3.2.1. The Vaccine Court found that Hannah’s residual seizure disorder and encephalopathy were not listed on the Vaccine Injury Table for DTP, and that causation was not proven.
1.3.3. The Bruesewitzes rejected the judgment of the Vaccine Court and filed a products liability suit against Wyeth, the vaccine’s manufacturer.
1.3.3.1. The district court granted judgment for Wyeth, holding that the Vaccine Act expressly preempts all design defect claims arising from a vaccine-related injury.
1.3.4. The Bruesewitzes appealed the district courts ruling to the Third Circuit Court.
1.3.4.1. The Third Circuit’s ruling affirmed that Congress intended to preempt all design defect claims in passing the Vacine Act.
1.3.5. The Bruesewitzes subsequently appealed to the U.S. Supreme Court.
2. Issue before the U.S. Supreme Court
2.1. Whether the National Childhood Vaccine Injury Act provides a blanket immunity to vaccine manufacturers from tort actions filed in state or federal court by injured victims seeking compensation for injuries allegedly arising from defectively designed vaccines.
3. Rule of Law
3.1. The National Childhood Vaccine Injury Act of 1986 (the Vaccine Act), established a national, comprehensive, no-fault compensation program for vaccine-related injuries.
3.1.1. The burden is on the plantiffs. They need to prove that the National Childhood Vaccine Injury Act does not provide blanket immunity to vaccine manufacturers for injuries allegedly arising from defectively designed vaccines.
4. Applications
4.1. Plaintiff contend that Wyeth and other medical professionals and organizations were aware of several adverse effects associated with the vaccine.
4.1.1. Hannah’s injection was drawn from a vaccine lot that had over sixty five complaints of adverse reactions filed with the Food and Drug Administration.
4.1.1.1. Of these, thirty nine resulted in emergency room visits, six in hospitalizations, and two in death.
4.1.1.2. The Bruesewitzes contend that Hannah’s injuries could have been avoided had Wyeth used an alternate design called ACELIMUNE (“DTaP”) .
4.1.2. The Bruesewitzes focus on the word “unavoidable,” commonly defined as “not avoidable” or “incapable of being prevented,” to support their view that the Vaccine Act protects manufacturers only when a vaccine’s harmful side effects can’t be prevented.
4.1.2.1. The Bruesewitzes note that “unavoidable,” a legal term of art, entails a specialized legal meaning relating directly to the existence of a safer alternative design.
4.1.3. Plaintiffs contend that the phrasing of Section 22(b)(1) of the Vaccine Act rules out the possibility that the Act bestows a blanket immunity on vaccine manufacturers. The Vaccine Act contains no language explicitly stating that all vaccines give rise to unavoidable side effects.
4.1.3.1. Furthermore, Section 22(b)(1) of the Vaccine Act is phrased in a conditional tense, suggesting that Congress did not intend to impose a sweeping categorical exemption of all design defect claims against vaccine manufacturers.
4.2. Wyeth contend that the Vaccine Ace exempts vaccine manufacturers from civil liability for “unavoidable” vaccine related injuries or death as long as the vaccine was properly prepared and adequately labeled.
4.2.1. Wyeth argues that the Bruesewitzes’ textual interpretation of “unavoidable” results in an absurd outcome that would allow alleged vaccine victims to remain as free after the passage of the Vaccine Act as before to advance design defect claims in the civil court system.
4.2.1.1. Wyeth contends that the Bruesewitzes’ interpretation would lead to an expansion of manufacturer liability, exposing manufactures to design defect claims in states whose own law forbids such claims.
4.2.1.2. Furthermore, Wyeth argues that had Congress truly intended to preserve design defect claims, it could have stopped Section 22(b)(1) in the Vaccine Act, it would have stopped the paragraph after the word “unavoidable.”
4.2.2. According to Wyeth, the Vaccine Act aims to hold manufacturers liable for the defective manufacturing or labeling of a vaccine, acts which are solely within the manufacturers’ control, but not for the negligent design of a vaccine, an act which is outside the manufacturers’ control and heavily dependent on federal regulation.