Vaccine makers are celebrating a ruling last month by the Supreme Court that affirms their protection from state court lawsuits. The case centered on Hannah Bruesewitz, who as an infant in 1993 suffered seizures and permanent brain damage after receiving a diphtheria-tetanus-pertussis (DTP) vaccine, made by Wyeth.
The Supreme Court was tasked with deciding whether the case even qualified for civil court. In 1986 Congress established special tribunals to protect vaccine makers from mounting lawsuits related to serious side effects. The controversial Vaccine Courts offers something of a trade-off. Victims are allowed to file for compensation without proving causation but caps are placed on how much claimants can be awarded. Congress established the system after extensive lobbying from the vaccine industry, which claimed litigation might start impacting vaccine availability. Critics, like the Alliance for Natural Health, argue that it creates a moral hazard by insulating vaccine companies from serious penalties.
The Bruesewitz case was originally heard before a Vaccine Court in 1995. It was ultimately dismissed because residual seizure disorder is not listed among the side effects specific to the DTP vaccine. The family responded by taking the case to Pennsylvania state court on the grounds that Wyeth failed to design a safe product. Time.com reports that several adverse reactions were linked back to that particular batch of DTP vaccine, which Wyeth ultimately withdrew from the U.S. market. Despite that evidence, the Supreme Court ultimately sided with the company and reinforced lawsuit protection for all vaccine makers.
Writing in dissent of the Supreme Court’s 6-2 majority opinion, Justice Sonia Sotomayor pointed to the fact that the 1986 law was never intended to shield vaccine manufacturers from litigation related to design defects. She argued the court’s decision imposes its own policy preference over that of Congress. She went on to write: “(the) 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.”
Click here for the Supreme Court's full opinion in the case, along with the complete text of Justice Sotomayor's dissent.
Click here for a comprehensive recap of the case.
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