(CN) - Wyeth cannot be sued by a Pittsburgh couple whose daughter developed a seizure disorder after being vaccinated for diphtheria, tetanus and pertussis, the U.S. Supreme Court ruled Tuesday, 6-2.
Justice Antonin Scalia authored the court's 19-page majority opinion, which found that the lawsuit was barred by the National Childhood Vaccine Injury Act (NCVIA) of 1986.
Robalee and Russell Bruesewitz's daughter Hannah was vaccinated against the three diseases in 1992 when she was 6 months old. Within 24 hours of the vaccination, she began to experience seizures and had over 100 episodes during the next month. Hannah was diagnosed with having residual seizure disorder and developmental delay, and she still has both conditions.
The Court of Federal Claims, which has handled petitions for compensation for vaccine-related injuries since the passage of the NCVIA, dismissed the Bruesewitz's claims, so the family filed a traditional tort suit for a more favorable judgment - another provision of the act. The Eastern District of Pennsylvania granted Wyeth summary judgment, and the 3rd Circuit affirmed. After agreeing to take up the case, the Supreme Court heard oral arguments in October.
Scalia wrote that the act plainly protects drugmakers from lawsuits "expressly eliminates liability for a vaccine's unavoidable, adverse side effects."
"Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable," the ruling continues. "State-law design-defect claims are therefore preempted."
The text of the act specifically precludes liability for side effects that occurred "even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
Scalia wrote that the act does not specifically mention "defective design," but that it is protected as well.
"Products-liability law establishes a classic and well known triumvirate of grounds for liability: defective manufacture, inadequate directions or warnings, and defective design," Scalia wrote. "If all three were intended to be preserved, it would be strange to mention specifically only two, and leave the third to implication. It would have been much easier (and much more natural) to provide that manufacturers would be liable for 'defective manufacture, defective directions or warning, and defective design.' It seems that the statute fails to mention design-defect liability 'by deliberate choice, not inadvertence.'"
Noting that "design-defect allegations are the most speculative and difficult type of products liability claim to litigate," the justice wrote that his interpretation of the act is reinforced by Food and Drug Administration regulations and licensing requirements.
"A vaccine's license spells out the manufacturing method that must be followed and the directions and warnings that must accompany the product," Scalia wrote, noting that there are more than 90 FDA regulations concerning the manufacturing process.
"Design defects, in contrast, do not merit a single mention in the NCVIA or the FDA's regulations," Scalia continued. "Indeed, the FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use."
Justice Stephen Breyer, who signed off on the majority opinion also authored a separate concurring opinion. He notes that a textual analysis of the act, though ultimately favoring Wyeth, is a close call, but that the majority properly drew from legislative history, statutory purpose and the FDA to support that view.
Vaccinating children against deadly diseases is an important and fragile initiative, Breyer wrote.
"Even a brief period when vaccination programs are disrupted can lead to children's deaths," his seven-page concurrence states.
Breyer continues: "Given these broad general purposes, to read the preemption clause as preserving design-defect suits seems anomalous.
Justice Sonia Sotomayor, joined by Justice Ruth Bader Ginsburg, dissented from their colleagues on the court.
The justices wrote that the majority's interpretation "imposes its own bare policy preference over the considered judgment of Congress."
"Its decision leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products," Sotomayor continued.
"Nothing in the text, structure, or legislative history of the Vaccine Act remotely suggests that Congress intended such a result," according to the 27-page dissent.
Justice Elena Kagan took no part in the consideration or decision of the case.
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