Vaccine manufacturers won a monumental victory Tuesday with the Supreme Court ruling that federal law shields them from lawsuits, an especially pertinent decision because of the thousands of claims, so far unproven scientifically, linking vaccines to autism.
In a 6-2 ruling, the high court said the manufacturers are protected by a 1986 federal law that says they can't be sued "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."
As was the case during oral arguments in October, much of the ruling hinged on the term "unavoidable" in the context of the law.
Lawyers seeking the right to sue vaccine manufacturers had argued that dangerous side effects are not "unavoidable" if the vaccine manufacturers could provide a different, safer vaccine.
Justice Antonin Scalia, who wrote the majority opinion, disagreed sharply, saying the 1986 law pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.
"If a manufacturer could be held liable for failure to use a different design, the word 'unavoidable' would do no work," Justice Scalia wrote. "A side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element."
In a dissenting opinion, Justice Sonia Sotomayor, who was joined by Justice Ruth Bader Ginsburg, took the opposite view. She wrote that vaccine manufacturers shouldn't be shielded from lawsuits if "the side effects stemming from the vaccine's design could not have been prevented by a feasible alternative design that would have eliminated the adverse side effects without compromising the vaccine's cost and utility."
Justice Sotomayor further lamented that the court's "decision leaves a regulatory vacuum, in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products."
She argued that the decision to bar all design-defect claims against vaccine manufacturers is one that Congress, not the high court, must make.
"Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins," she said. "Nothing in the text, structure or legislative history remotely suggests that Congress intended that result."
Justice Elena Kagan took no part in the case because of her involvement with the issue during her previous job as solicitor general. The government had filed a brief in the case siding with vaccine manufacturers.
The case centered on the parents of a woman suffering from severe developmental disabilities who wanted to sue Pfizer Inc.'s Wyeth because, they said, a safer vaccine was available when their daughter was immunized as a baby in 1991. Attorneys for the parents of Hannah Bruesewitz said the 1986 law should not shield the company from a lawsuit because the adverse effects she suffered could have been avoided.
Attorneys for Wyeth disputed that a safer alternative existed.
Congress enacted the 1986 law, known as the National Childhood Vaccine Injury Act (NCVIA), in response to a rising tide of lawsuits against vaccine manufacturers that lawmakers feared would cause the manufacturers to stop making crucial vaccines.
The act created a so-called "vaccine court" in which the federal government pays people who suffer side effects after taking vaccines. According to court documents, the court has paid out $18 billion since it opened and generally pays about 50 to 100 claimants each year, roughly half the number of people who file claims.
The "vaccine courts" have two methods to determine whether to award compensation: People must either prove the vaccine caused the side effects or show they suffer from specific illnesses that the government has listed among those for which compensation is automatic.
Ms. Bruesewitz's parents went to the "vaccine court" in 1995 claiming she suffered residual seizure disorder, but the federal government had removed that affliction a month earlier from the list of illnesses for which it would pay compensation. Attorneys for Wyeth said that was because there is no evidence the vaccine causes residual seizure disorder.
The "vaccine court" ultimately determined that the Bruesewitzes did not prove the diphtheria-tetanus-pertussis vaccine she received as a 6-month-old caused her afflictions. Ms. Bruesewitz was healthy before receiving the vaccine, and her symptoms, including major seizures, began hours after her immunization.
The Bruesewitzes then attempted to sue in state court, but a trial court and an appellate court ruled that they couldn't because doing so would conflict with the 1986 vaccine act. The Supreme Court heard an appeal of those rulings.
The case was closely watched as nearly 6,000 claims linking autism and vaccines have been filed in "vaccine court." If the court had ruled in favor of the Bruesewitzes, many of those cases could have gone to court.
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