WASHINGTON — The Supreme Court announced March 8 that it would decide whether a federal law protects vaccine manufacturers from lawsuits in state court seeking damages for alleged design defects.
The high court agreed to hear a Pennsylvania case involving a lawsuit by the parents of a 6-month-old girl who suffered seizures after her third dose of a diphtheria-tetanus-pertussis vaccine. They sued the vaccine manufacturer, Wyeth, which Pfizer Inc. purchased last year.
The 3rd U.S. Circuit Court of Appeals in Philadelphia ruled against Robalee and Russell Bruesewitz, saying the National Childhood Vaccine Injury Act of 1986 bars their claims.
It says no manufacturer "shall be liable in any civil action" for any injury that "resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
That law also set up a special vaccine court to handle disputes as part of its aim of insuring a stable vaccine supply by shielding companies from most lawsuits.
The justices agreed to decide the issue after conflicting lower court rulings.
Only one state appeals court, the Georgia Supreme Court, has ruled that families can sue in a vaccine case. It also ruled the federal law allows some design defect claims against vaccine manufacturers.
The vaccine industry has fiercely opposed the Georgia ruling in the case of Marcelo and Carolyn Ferrari. They claim their son Stefan suffered neurological damage after receiving vaccine booster shots made by pharmaceutical companies Wyeth and GlaxoSmithKline that contained the preservative thimerosal.
Stefan was born in 1998, three years before the Centers for Disease Control and Prevention says all routine vaccines it recommends for children under the age of 6, other than some flu vaccines, stopped containing all but trace amounts of thimerosal. The CDC maintains that the evidence doesn't show a causal relationship between vaccines containing thimerosal and autism.
The Obama administration filed a legal brief in the Georgia case that sided with the vaccine manufacturers. U.S. Solicitor General Elena Kagan said the Georgia court's ruling was incorrect and could deter the development and production of vaccines.
The family has since withdrawn its lawsuit, possibly in an effort to avoid an unfavorable Supreme Court ruling, although the Georgia court's opinion allowing similar lawsuits remains in force.
The Obama administration said the federal law expressly prevented design defect lawsuits in state court, but said the uncertainty caused by the conflicting rulings warranted the Supreme Court getting involved.
Wyeth also joined in asking the court to hear the case, saying it presents an important and recurring legal issue that should be resolved.
While the issue remains unsettled, manufacturers' uncertainty about potential liability may harm the public health by deterring development and production of vaccines, administration attorneys said.
Pfizer, in a statement, said it was "hopeful that the Supreme Court will affirm" the Philadelphia appeals court ruling in Wyeth's favor.
"Pfizer is pleased that the U.S. Supreme Court has agreed to resolve this legal issue, which is of critical importance to national public health policy," the company said.
Wyeth discontinued the vaccine at issue in the case in 1998.
There are about 5,000 claims pending under the process set out under federal law alleging a link between childhood vaccines and neurological damage such as autism. The legal issue would affect whether those claimants can also seek damages under state law, the attorneys said.
Last year, special masters appointed by the federal vaccine court concluded that vaccines aren't to blame for autism, disappointing thousands of families hoping to win compensation and others who remain convinced of a connection.
But the vaccine court still must rule on additional cases that argue that vaccines with thimerosal are to blame, if the mercury reached and damaged brain cells.
Wyeth, which denied that its vaccine caused Hannah Bruesewitz's injuries, said in a court brief that the 1986 law sought to keep vaccine makers in the market by shielding them from a deluge of lawsuits.
The company said a Supreme Court decision in favor of the plaintiffs would lead to a flood of litigation that could threaten the supply of childhood vaccines.
According to the lawsuit in the Pennsylvania case, Hannah Bruesewitz was a healthy infant until she received the vaccine in April 1992. Within hours of getting the DPT shot, the third in a series of five, the baby suffered a series of debilitating seizures. Now a teenager, Hannah suffers from residual seizure disorder, the suit says.
Her parents in their lawsuit alleged her seizure disorder and serious developmental delay stemmed from toxins inherent in the vaccine design.
After their claims were rejected under the federal compensation process, they filed a lawsuit in state court. But a federal judge and the appeals court based in Philadelphia both ruled that the federal law barred such lawsuits.
The Supreme Court is expected to hear arguments in the case and to issue its decision during its term that begins in October. Chief Justice John Roberts did not take part in considering the case, an action he usually takes when he owns stock in a company in the case before the court.
The case is Bruesewitz v. Wyeth, 09-152.