Thimerosal Goes to Court: American Home Products Corp. v. Ferrari

Until now, most civil courts have shut their doors to claims that thimerosal contributed to autism. Both federal and state courts have rejected these claims, deciding that only “vaccine court,” the no-fault compensation program under the Federal Court of Claims, may hear them. Four courts have decided previously that the National Vaccine Injury Compensation Act of 1986 preempts, or displaces, all state law product liability claims against vaccine manufacturers. These prior decisions concluded that Congress intended that regular civil courts could not hear vaccine-related cases that plaintiffs brought on tort law theories of strict liability and negligence.

The October 6, 2008 unanimous decision of the Georgia Supreme Court American Home Products Corp. v. Ferrari changed all that. The court resolutely decided that the Vaccine Act permits state courts to hear cases about vaccine design defects. This decision now provides a strong new precedent for vaccine cases to come to civil court.

What the Decision Says:
Marcelo and Carolyn Ferrari sued nine vaccine manufacturers on behalf of their minor son, Stefan Ferrari, in Georgia. They allege that Stefan suffered permanent neurological damage, including autism, because he received thimerosal in his vaccinations in 1998.

The Georgia Supreme Court, reviewing a lower appellate court decision, asks whether the Vaccine Act preempts lawsuits against vaccine manufacturers for design defects. The Court must figure out what the Vaccine Act’s language means. It says:

“No vaccine manufacturer shall be liable…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.”

Does it mean that all vaccine injuries are, by definition, “unavoidable” and subject to preemption? Or, alternatively, does it mean that design defects are preempted only if the side effects are found by a jury, on a case by case basis, to be “unavoidable”? In other words, if the design defects are avoidable, do the manufacturers still escape liability?

In a forceful opinion, the Court decided that the Vaccine Act does not preempt all design defect claims. Instead, it provides that a vaccine manufacturer may be liable for a defective design if the injurious side effects were avoidable. The Court reaches this conclusion by analyzing the language of the statute; carefully reviewing the Congressional intent for the Vaccine Act; reviewing applicable Supreme Court decisions on preemption; and distinguishing its reasoning from the court decisions that have gone the other way. The Court argues that the Vaccine Act’s text itself suggests that some design defects may be avoidable, despite proper directions and warnings, and that Congress intended for civil courts to be able to hear these cases.

The Court clarifies that the Vaccine Act merely protects manufacturers from liability for unavoidable side effects – not avoidable ones. The Court further points out that if the opposing interpretation were correct, manufacturers would get “blanket tort immunity for design defects,” which would remove any incentive for developing safer designs. So the Court rejects preemption “at least until the Supreme Court of the United States has spoken on the issue.”
What does the decision mean?

This strongly worded, unanimous decision from the highest court of Georgia, in the Center for Disease Control’s own backyard, must be sending shock waves through the pharmaceutical industry. Vaccine manufacturers will now be forced to litigate, at least in Georgia, whether the mercury-containing preservative thimerosal was an “unavoidably unsafe” aspect of their vaccine design. Other courts may follow Georgia’s lead to allow such cases, and the Supreme Court, which is particularly focused on the question of preemption, may even decide to accept a case on this vaccine issue.

The Ferrari case won’t alter the playing field for most families coping with autism; the statute of limitations for injuries from thimerosal is past in most cases. But in at least one Georgia civil court, the issue of whether thimerosal was “unavoidably unsafe” may get a full hearing.
Let’s be clear: litigating a case like this will be hugely complicated and expensive, requiring the Ferraris and their lawyers to jump through many, many more hoops to come. They’ll need to request and review enormous numbers of defendant documents; they’ll need to defeat all kinds of motions; they’ll need to present credible scientific evidence to the judge as a threshold matter before ever getting scientific evidence before a jury. It may or may not be easy to prove that including thimerosal as a preservative was avoidably, rather than unavoidably, unsafe.
But this decision is a landmark case in access to justice for vaccine injuries. Until now, the only court to look seriously at the thimerosal question has been vaccine court – with almost no document discovery, arcane procedural rules, and no jury. Now, the Ferraris, and those concerned about this issue, have a new forum for finding out the truth.

Mary Holland teaches at NYU Law School.