Parents who claim a range of preventive vaccines given their young children can cause serious health dangers will have their appeal heard by the Supreme Court.
The justices on Monday agreed to decide whether drug makers can be sued outside a special judicial forum set up by Congress in 1986 to address specific claims over safety. The so-called "Vaccine Court" has handled such disputes and was designed to ensure a reliable, steady supply of the drugs by reducing the threat of lawsuits against pharmaceutical firms.
The question in the latest case is whether such liability claims can proceed, if the vaccine-related injuries could have been avoided by better
product design, and if federal officials had approved another, allegedly safer drug. Oral arguments in the dispute will be held in the fall.
The lawsuit was brought by the parents of Hannah Bruesewitz, a girl from the Philadelphia, Pennsylvania, area. They claimed she was in fine health as an infant in 1992 when given a series of DPT shots - a combination of vaccines to prevent diphtheria, pertussis (whooping cough), and tetanus. After the third series, according to court briefs, the child began having seizures and became disabled. Now a teenager, Hannah continues to suffer what is described as "residual seizure disorder."
The Bruesewitzes alleged Wyeth Laboratories failed to adequately warn them and other parents of the risks associated with the vaccine. The vaccine court rejected the initial claim, so the family tried to revive the lawsuit in the federal courts. Their lawyers claimed the 24-year-old law does not ban all lawsuits, especially those filed when the harmful side effects were avoidable.
A federal appeals court eventually ruled for Wyeth, now owned by Pfizer, Inc., concluding all design-defect claims were barred under statute. Despite that victory, the company urged the high court to hear the case, saying it seeks final resolution on the broader legal questions. The Obama administration also urged review and is supporting the company and the federal law in question.
Wyeth and other drug manufacturers say their products are generally safe, but side effects can occur in very rare cases. They also say the vaccine industry is generally not profitable, but that the health benefits for society in general have kept them in the business. For that, they say, legal protection provided by Congress is essential to ensure such drugs are widely available and affordable.