Justices have agreed to hear an appeal to determine whether drug makers can be sued outside of the protective judicial forum set up by Congress in 1986 over claims that their vaccines caused side-effects in children.
Since 1986, the designated judicial forum or 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 this 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, safer drug.
The appeal was brought by parents in Pennsylvania who filed a case against Pfizer's Wyeth unit claiming that the company's diphtheria, tetanus and whooping cough vaccine caused their child to develop residual seizure disorder.
The parents alleged Wyeth failed to adequately warn them and other parents of the risks associated with the vaccine. The vaccine court rejected the initial claim. The parents then took the case to the federal court, but it also ruled in favour of Wyeth, concluding all design-defect claims were barred under statute.
Pfizer, however, have urged the high court to hear the case to seek resolution on broader legal questions. The Obama administration is also urging a review, but is supporting the company and federal law in question.
The court is expected to make its decision in the upcoming term, which starts in October.
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