David Frederick, a partner at Kellogg, Huber, Hansen, Todd, Evans & Figel, has made a habit of arguing successfully against federal pre-emption before the Supreme Court.
It's a high-stakes specialty that casts him in frequent opposition to big business, which tends to like pre-emption because it provides one set of regulations (federal) to deal with, instead of messy rules and tort actions in each of 50 states.
One sign of the importance of these cases is that Frederick's adversaries tend to be former solicitors general like Seth Waxman (in Wyeth v. Levine and Bates v. Dow Agrosciences) and Theodore Olson (in Altria v. Good.)
On Tuesday, Frederick's opponent was no less formidable and may have been the toughest of all: Kathleen Sullivan of Quinn Emanuel Urquhart & Sullivan, the former dean of Stanford Law School.
She, instead of Waxman, was representing Wyeth this time around in the case of Bruesewitz v. Wyeth, which asks whether the federal vaccine law pre-empts all design-defect lawsuits in state courts against vaccine manufacturers.
Using a bare-knuckles argument style, Sullivan accused Frederick of misleading the Court and asserted that exposing manufacturers to liability will "drive manufacturers out of the market" and jeopardize public safety. "Congress wants people to take vaccines," she said. Sullivan noted ominously that 5,000 families have argued that childhood vaccines cause their children to develop autism and suggested that all those cases could end up in state court if the high court rules against pre-emption.
Frederick fought back just as hard, ending his argument by urging the Court to leave open a limited avenue for litigation to redress "the most horrifying and horrible injuries" that result from the vaccines that society "compels children to take."
Frederick represented the family of Hannah Bruesewitz, who was a healthy baby until she was given Wyeth's DTP vaccine in 1992. According to Frederick, Hannah "immediately suffered scores of seizures and has been developmentally impaired ever since."
The 1986 vaccine law, aimed at protecting the vaccine industry from excessive litigation, says manufacturers are not liable for injuries from side effects that were that were "unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
The Bruesewitz family tried first to use the "vaccine court" system created within the U.S. Court of Federal Claims by the law, which gives quick compensation for recognized vaccine-related injuries. But her injuries had been "de-listed" from the vaccine injury table used by the court just before the family filed. They then took the case to Pennsylvania state courts, but after several steps, the 3rd U.S. Circuit Court of Appeals ruled that the litigation was pre-empted by the vaccine law. Wyeth argues that allowing suits like Bruesewitz's would thwart the purpose of the law, as if the law "changed nothing."
Much of the hour-long argument centered on the wording of the statute and whether Congress meant to preclude all state court litigation for design defects. Justice Stephen Breyer, conceding the language was ambiguous, wondered if Congress could have intended to "turn it over to judges and juries" with the result that vaccine makers flee the market and "lots of children will die." When Frederick sought to minimize the impact of a ruling against pre-emption by suggesting that only a small number of lawsuits would ensue, Chief Justice John Roberts Jr. said, dubiously, "It doesn't take too many $60 million verdicts" to discourage the manufacture of vaccines.
But other justices seemed critical of the Wyeth position as well. Justice Sonia Sotomayor appeared the most sympathetic toward allowing state tort suits against the drug companies. If the vaccine court is the only recourse for vaccine victims, she said, "what would motivate" vaccine makers to produce the safest possible vaccines? Sullivan said the U.S. Food and Drug Administration works closely with the manufacturers in an open process that is different from other kinds of drugs. Justices Ruth Bader Ginsburg and Anthony Kennedy also asked why, if Congress meant to pre-empt state court litigation over vaccines, it did not say so explicitly in the law.
When the Court first agreed to hear the case last spring, Roberts recused, apparently because he owned Wyeth stock. But new Justice Elena Kagan indicated in September that she, too, would recuse. As solicitor general, in a related vaccine case, she had urged the Court to grant review in Bruesewitz. After that announcement, Roberts confirmed that he sold his stock and rejoined the case, giving the litigants an eight-member Court. A 4-4 tie would result in a win for Wyeth, leaving the 3rd Circuit ruling in place.