The Supreme Court of Georgia on Monday upheld a state appeals court ruling that could open the door to product liability claims against vaccine manufacturers by the parents of autistic children.
Justice George H. Carley wrote for a unanimous court that a Fulton County suit against manufacturers filed by the parents of an autistic child may to go to trial. The justices rejected what Carley described as a "far-reaching interpretation" of a federal vaccine statute that defendant vaccine manufacturers argued gave them sweeping immunity from liability.
Carley suggested that the U.S. Supreme Court may be asked to consider the question.
The Georgia high court's ruling conflicts with two federal district courts and state courts in New York and Pennsylvania, which have considered similar suits brought by other parents of autistic children who claim vaccines triggered the onset of autism in their offspring.
Those rulings have held that the federal National Childhood Vaccine Injury Compensation Act of 1986 pre-empts liability claims against companies which produce vaccines approved by the U.S. Food and Drug Administration if an injury or death resulting from a vaccine's side effects are considered "unavoidable."
Lawyers for the drug companies have argued that the federal vaccine law deems any vaccine-related side effect to be "unavoidable" if the vaccine was properly prepared and accompanied by the proper FDA-mandated warnings.
The law created a special, no-fault compensation system for victims of vaccine-related injuries in separate "vaccine courts" outside of the existing state and federal court systems. Lawyers for the drug companies that manufacture childhood vaccines have said the federal law was needed to ensure the availability of those vaccines and encourage their production by shielding the manufacturing companies from product liability claims stemming from the vaccines' known side effects.
The case decided Monday concerns Stefan Ferrari, the son of Marcelo and Carolyn Ferrari. Stefan was born in 1998 and, after he was vaccinated, stopped speaking when he was 18 months old.
The Ferraris sued two pharmaceutical firms, Wyeth and GlaxoSmithKline, that manufactured the vaccines. They claim that thimerosal -- a preservative containing mercury that until 2001 was commonly used in the production of childhood vaccines -- caused Stefan to develop neurological problems associated with autism. The Ferraris have also sued several thimerosal manufacturers.
In 1999, the Centers for Disease Control and Prevention and the American Academy of Pediatrics recommended that thimerosal be removed from childhood vaccines, although the CDC maintains that no causal relationship has been established between vaccines containing thimerosal and autism. However, the mercury-containing preservative has not been found in recommended childhood vaccines, other than the flu vaccine, since 2001.
In their suit, the Ferraris claim that the drug's design, specifically the use of thimerosal as a preservative, was flawed and that its alleged side effects could have been avoided had another preservative been used.
Fulton County State Court Judge Susan B. Forsling in November 2005 granted partial summary judgment to the vaccine manufacturers on grounds of pre-emption, dismissing the design defect claims at the crux of the case.
But a panel of the state Court of Appeals disagreed. Joined by Chief Judge Anne Elizabeth Barnes and Judge M. Yvette Miller, Presiding Judge J.D. Smith acknowledged the logic of other courts that have found that the legislative history indicates Congress' clear intent to pre-empt the issue. But he said a 2005 U.S. Supreme Court decision on pre-emption, Bates v. Dow Agro Sciences, 544 U.S. 431, meant the court couldn't look at the legislative history to determine Congress' intent and instead had to accept any plausible reading of the statute that avoided pre-emption.
While the Georgia high court on Monday affirmed the Court of Appeals, unlike that court, Carley specifically focused on Congress' intent.
He wrote that a reading of the federal vaccine act "and the congressional intent behind it show that the Vaccine Act does not pre-empt all design defect claims."
Instead, Carley noted, the federal vaccine law "provides that a vaccine manufacturer cannot be held liable for defective design if it is determined, on a case-by-case basis, that the injurious side effects of the particular vaccine were unavoidable."
But, the judge added, "The conditional nature of this clause contemplates the occurrence of side effects which are avoidable, and for which a vaccine manufacturer may be civilly liable. In order to bar all liability for defective design and to permit liability only for manufacturing and warning defects, Congress could easily have ... made the bar to civil liability conditional on proper preparations and warnings."
"As the statute is actually written, however," Carley continued, "it is best understood as barring liability only for those side effects which were unavoidable by means other than proper manufacturing and packaging. Conversely, if such effects were avoidable by a feasible, alternative design, liability is not completely barred."
Neither can federal law nor, by extension, Congress unilaterally pre-empt state causes of actions, Carley said. Instead, the justice noted that the question of whether a particular vaccine is unavoidably unsafe -- and therefore subject to immunity from liability -- is a question of fact for a jury to decide.
Carley's exploration of Congress' intent was far-reaching. He cited a 1986 Congressional committee report that labeled "unavoidably unsafe products" as "those products which in the present state of human skill and knowledge cannot be made safe" and further stated that vaccines meeting that definition "not be the subject of liability."
In addition, the committee report "does not use language which indicates that use of the compensation system is mandatory," Carley wrote, noting that the report called the vaccine injury compensation system only "an appealing alternative" to the courts.
"Thus, Congress defended the new compensation system by assuming that it would attract even vaccine-injured persons who may be able to prove that the vaccine was not made as safe as reasonably possible," Carley wrote. "Such an assumption about a no-fault compensation system is certainly questionable, to say the least. However, the assumption is not relevant for its accuracy, but rather for its illumination of congressional intent. ... In the committee's opinion, if a vaccine-injured person does not have a claim for a manufacturing or warning defect, he should find the compensation system appealing even though he is authorized to attempt to prove the existence of a safer design in the tort system."
Carley also referred to a subsequent 1987 report by the same Congressional committee, which he described as "strikingly clear and emphatic."
In that report, Carley singled out the following passage, "The Committee stresses that there should be no misunderstanding that the Act undertook to decide as a matter of law whether vaccines were unavoidably safe or not. This question is left to the courts to determine in accordance with applicable law."
Finally, Carley's opinion took aim at prior court rulings on the subject. The federal courts, he wrote, "failed to explain how the National Vaccine Program set up by the Vaccine Act will better promote the discovery of safer alternative designs if manufacturers are given a blanket tort immunity for design defects." Nor did the district court cite any authority "for its conclusion that FDA approval alone renders a vaccine unavoidably safe," Carley wrote. "We hesitate to hold that a manufacturer is excused from making changes it knows will improve its product merely because an older, more dangerous version received FDA approval."
To do so, he wrote, would have "the perverse effect" of granting complete immunity from liability to an entire industry. "In the absence of any clear and manifest congressional purpose to achieve that result, we must reject such a far-reaching interpretation ... at least until the Supreme Court of the United States has spoken on the issue."
On Monday, the Ferraris' attorney, Lanny B. Bridgers of Atlanta, said that the couple "is obviously pleased and look forward to pursuing their claims at the trial court level."
Daniel J. Thomasch, a partner with Orrick Herrington & Sutcliffe in New York, who argued the case in front of the Supreme Court for the drug companies, referred questions to Wyeth, formerly American Home Products Corp.
Wyeth did not make a spokesperson available by press time. A spokeswoman for co-defendant GlaxoSmithKline said the company is disappointed with the ruling and currently evaluating its options.
The case is American Home Products Corp. v. Ferrari, No. S07G1708.