By Allison Torres Burtka
Last week, the Supreme Court heard oral arguments in a case that will decide whether defective design claims for vaccines are preempted by federal law. (Bruesewitz v. Wyeth, Inc., No. 09-152 (U.S. Oct. 12, 2010).)
Much of the argument revolved around ambiguous wording in the 1986 National Childhood Vaccine Injury Act, which set up the "vaccine court" system. The act says manufacturers are not 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."
The plaintiffs say the clause means courts should determine on a case-by-case basis whether the side effect was unavoidable. Wyeth, Inc., interprets it to bar all design defect claims. The Third Circuit agreed with Wyeth. (561 F.3d 233 (3d Cir. 2009).)
Washington, D.C., lawyer David Frederick argued the case for the plaintiffs, Russell and Robalee Bruesewitz. Their daughter, Hannah, developed a seizure disorder that they say was caused by a diphtheria-tetanus-pertussis vaccine. They argued that the manufacturer should have used a safer "acellular" design.
The vaccine court dismissed the Bruesewitzes' initial claim, finding they had failed to establish causation. Frederick said at oral argument that the process "allowed for no discovery against the drug manufacturer," but the plaintiffs would have been able to prove causation in state court.
Kathleen Sullivan, a New York City lawyer, argued the case for Wyeth. She said that allowing design defect claims would drive vaccine manufacturers from the market.
Frederick disagreed, saying that "99 percent of the people who go through vaccine court accept the judgment of the vaccine court," and state court plaintiffs face an uphill battle, so those lawsuits would be rare.
Chief Justice John Roberts commented on the remaining 1 percent. "It doesn't take too many $60 million verdicts to make you come out on the other side of your calculus," he said.
The problem with Wyeth's position, Frederick said, is that "it allows for an exoneration from liability even for manufacturers who know there's a safer design available."
If manufacturers are immune from design defect claims, Justice Sonia Sotomayor asked Sullivan, what motivates them to stop selling a problematic vaccine (before the FDA steps in) or to pursue a better design? When Sullivan didn't answer directly, Roberts said, "I think your answer to Justice Sotomayor's question is 'nothing.'"
Wyeth is basically saying, "trust us," said Houston lawyer Collyn Peddie after oral arguments. She also represents the Bruesewitzes.
Peddie disputed the notion that allowing design defect claims will cause a flood of lawsuits. "The truth is, there's no evidence of that," she said.
Several organizations filed amicus briefs. AAJ, Public Justice, and Public Citizen argued in one brief that "it is the absence of state tort liability for design defects that would harm public safety by both reducing incentives for vaccine manufacturers to make safer vaccines and by discouraging vaccine use by increasing fears about vaccine safety."
Preemption law scholars Kenneth Starr and Erwin Chemerinsky argued in a brief for the plaintiffs that "according preemptive effect to ambiguous federal statutes would short-circuit the political safeguards of federalism."
The U.S. Solicitor General and American Academy of Pediatrics filed briefs in support of Wyeth.