Parents can't sue drug firms when vaccines cause harm, Supreme Court says

The family of an infant who allegedly suffered a severe reaction to a vaccine may not sue the drugmaker for failing to update the vaccine with a newer, safer version, the US Supreme Court ruled on Tuesday.

In a 6-to-2 decision, the high court said Russell and Robalee Bruesewitz’s lawsuit was preempted under the National Childhood Vaccine Injury Act of 1986. The law grants drug companies immunity from certain lawsuits from injuries or deaths tied to vaccinations.

“We hold that the National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects,” wrote Justice Antonin Scalia in the majority decision.

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In a dissent, Justices Sonia Sotomayor and Ruth Bader Ginsburg said that, by preempting all design defect lawsuits by vaccine victims, the high court was imposing “its own bare policy preference over the considered judgment of Congress.”

The decision “leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing and distributing their products,” Justice Sotomayor wrote.

Millions of infant vaccines are safely administered each year throughout the United States. But government officials acknowledge that a small percentage of infants experience a severe negative reaction from a vaccine. In some cases the reaction can be fatal.

Faced with open-ended damages from lawsuits filed on behalf of those who suffer severe reactions from vaccines, drug manufacturers considered avoiding the vaccine market altogether.

In passing the National Childhood Vaccine Injury Act, Congress sought to strike a balance that would protect vaccine manufacturers from open-ended liability from private lawsuits while also creating a special fund to compensate those who suffer side effects from vaccines.

Roughly 100 to 200 claims for compensation are submitted each year to a special vaccine court. To date, the compensation fund has paid out $1.8 billion to 2,500 petitioners. The average award is about $750,000.

But compensation is only part of the Vaccine Injury Act’s purpose. Congress also sought to preempt lawsuits seeking open-ended money damages against vaccine manufacturers.

The problem with the law is that Congress did not specifically spell out which lawsuits may move forward in the courts against vaccinemakers and which must be dismissed.

The law says in part that no vaccine manufacturer shall be held liable for a vaccine-related injury or death “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

Products liability law establishes three grounds for potential liability – if there is a defect in the manufacture, if there were inadequate warnings, or if there is a defective design.

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