The US Supreme Court on Tuesday heard argument in a dispute over whether the family of an infant who suffered a severe reaction to a vaccine can sue the drug maker for allegedly failing to replace an older version of the vaccine with a safer version.
At issue is whether Russell and Robalee Bruesewitz can sue drug maker Wyeth for allegedly selling an unsafe product that caused their healthy six-month-old daughter, Hannah, to suffer seizures that left her developmentally impaired.
The high court appears to be split on the case, with Justice Ruth Bader Ginsburg among those favoring the parents' lawsuit and Chief Justice John Roberts among those leaning toward the drug maker’s and the government’s position that the claim is preempted.
Justice Ginsburg questioned why if Congress wanted to bar civil liability for vaccine manufacturers it wrote a law that is open to conflicting interpretations. “If you wanted to make it clear that there is no design defect liability, then say that,” she said. “The language that they used is certainly, to say the least, confusing.”
The vaccination was administered in 1992. Hannah will celebrate her 19th birthday next week. She will require a lifetime of supervision and care, according to Washington lawyer David Frederick, who is representing the family.
The question now is whether the parents have any recourse in the courts to seek compensation.
The National Childhood Vaccine Injury Act of 1986 granted drug companies immunity from certain lawsuits over vaccine-related injuries or deaths. The law mandates that legal action is preempted “if 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.”
The dispute revolves around the use of the word “unavoidable.”
The Vaccine Act was passed to help address a growing product liability threat looming over drug makers. The statute made it harder to successfully sue vaccine producers, but it also set up a compensation scheme to help families of children who suffer severe reactions from inoculations.
The new law was designed to insulate drug companies from huge adverse judgments, while at the same time providing financial assistance to the vaccine victims and their families.
Tens of millions of childhood vaccine doses are safely administered each year in the US. But the government recognizes that a certain percentage of children will experience a severe negative reaction from a vaccine, including fatal reactions. Roughly 100 to 200 claims are submitted each year for compensation.
To date, the compensation fund has paid out $1.8 billion to 2,500 petitioners. The average award is about $750,000.
In addition, the government spends roughly $2 billion a year for research and development of safer vaccines.
In 1995, the Bruesewitzes filed a petition seeking compensation for Hannah’s injuries. One month prior to the petition, new regulations eliminated Hannah’s seizure disorder from the list of compensable injuries. The family’s petition was denied. Three years later, in 1998, Wyeth withdrew the type of vaccine used in Hannah’s inoculation from the market.
With no recourse under the Vaccine Act, the Bruesewitzes filed a lawsuit against Wyeth in state court in Pennsylvania. They claimed the drug company negligently failed to develop a safer vaccine and was thus liable for preventable injuries caused by the vaccine’s defective design.
A federal judge threw the suit out, ruling that federal law protected Wyeth from lawsuits over vaccine injury claims. The Third US Circuit Court of Appeals agreed.
Mr. Frederick told the justices that the drug company that made Hannah’s vaccine had earlier acknowledged that a safer version of the vaccine existed. He said that despite reaching this conclusion, the company continued to market the more dangerous vaccine for economic reasons.
“The whole idea behind having design defect claims is to put manufacturers to the duty of putting out the safest possible products in light of what the science holds,” he told the court.
Wyeth lawyer Kathleen Sullivan of New York countered that the law preempts all design defect claims. “The manufacturers were being driven out of the vaccine business, imperiling the nation’s vaccine supply by design defect claims,” she told the justices.
Benjamin Horwich, assistant to the solicitor general, joined Wyeth in urging the court to preempt the Bruesewetzes lawsuit. “Socially beneficial products that nonetheless have these adverse effects ought to be on the market and we ought not to allow tort law to push them off the market,” he said.
The vaccine at issue in the Bruesewitz case was the DTP vaccine for diphtheria, tetanus, and pertussis. The vaccine’s design was first licensed in the 1940s. Concerns about its safety had been raised in the 1930s. By the 1960s, Eli Lilly developed a safer version of the vaccine, according to Frederick. But by the mid-1970s, Eli Lilly stopped producing the vaccine.
Wyeth purchased the right to use Lilly’s safer design, but decided instead to use a reformulated version of its original vaccine, according to briefs in the case.
Lawyers for Wyeth say there was no safer alternative to its vaccine that would have benefited Hannah. Although a different version of the vaccine was approved in 1991, it was only approved for children over two years old. It was not approved for use in infants until 1996, Sullivan said.
“We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury [from] vaccines that we compel children to take,” Frederick said at the close of his argument.
“The whole idea behind Congress’s scheme was to balance having vaccine supply available with providing a generous form of compensation to those persons who would be injured.”