Supreme Court Hears Arguments Over Vaccine Preemption

Supreme Court Hears Arguments Over Vaccine Preemption

WASHINGTON, D.C. - (Mealey's) The extent to which tort claims for alleged vaccine injury are permitted by legislation that created a federal compensation system was brought before the U.S. Supreme Court Oct. 12 (Russell Bruesewitz, et al. v. Wyeth, Inc., et al., No. 09-152 U.S. Sup.).

David C. Frederick argued for Russell and Robalee Bruesewitz that interpreting the Vaccine Act as conferring blanket immunity for design defect claims went against the language of the statute and the public policy goal of ensuring safe vaccines.  He said Section 22(b)(1) of the Vaccine Act, preempting liability "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," was written to encourage manufacturers to create the safest possible vaccines.

"They take the concept of unavoidability completely out of the statute," Frederick said. He said 99 percent of Vaccine Court petitioners "accept the judgment" of that court's special masters, suggesting there would be no flood of litigation in the event the court ruled for the Bruesewitzes.  Chief Justice John Roberts replied that "It doesn't take too many $60 million verdicts."

Justice Ruth Bader Ginsburg said that if Congress had wanted to grant blanket immunity from design defect claims, it could have used simpler language than what appears in the act.  Justices Ginsburg and Sonia Sotomayor asked Kathleen M. Sullivan, representing Wyeth, what incentive exists for manufacturers to improve vaccines or remove unsafe ones from the market if the court accepted Wyeth's position that the act confers absolute immunity from design defect claims. Sullivan said that to interpret the act any other way would potentially unleash 5,000 new autism claims into state courts and nullify the act's goal of protecting manufacturers from tort claims.

With only minutes left, Justice Ginsburg asked Benjamin J. Horwich, assistant to the solicitor general as amicus curiae in support of Wyeth, about testimony that the diphtheria-tetanus-pertussis (DTP) Hannah Bruesewitz received came from an especially virulent batch, sometimes called a "hot lot."  A summary prepared for the court by Steven D. Schwinn of the John Marshall Law School in Chicago said Hannah's third vaccination came from a lot that generated 65 reports of adverse reactions, 39 emergency room visits, six hospitalizations and two deaths.  Horwich responded that the question of a hot lot had been dismissed on the merits by the trial court.

Horwich also supplied a key piece of historical context to hypothetical questions by several justices regarding how the U.S. Centers for Disease Control and Prevention determines which vaccines to recommend.  For years, Horwich said, the CDC recommended the Sabin polio vaccine because, although riskier than the Salk vaccine, it was also more effective.  As polio became largely eradicated, Horwich said, the CDC "transitioned" to the safer Salk vaccine.

The Bruesewitzes argue that Wyeth should have adopted a safer, acellular version of the pertussis antigen before Hannah received the DTP.  They say Tri-Immunol was initially licensed in the 1940s.  Eli Lilly & Co. obtained approval in the 1960s for Tri-Solgen, a safer non-cellular pertussis vaccine, they say, which came to dominate the market.  Internal Lederle studies showed that Tri-Immunol was more "reactogenic" than Tri-Solgen, they say.  Wyeth briefly investigated producing a non-cell product in the late 1960s, they say, but concluded according to internal documents that "[t]he effort is not worth it for the total market."

Despite acquiring the rights to Lilly's Tri-Solgen after Lilly stopped producing it in the mid-1970s, the plaintiffs say, Wyeth kept Tri-Immunol on the market for the next two decades.

Justice Elena Kagan, whose former office is amicus in the case, has recused herself.

The case stems from the denial in 2002 of a Vaccine Court petition claiming that Hannah developed seizures two hours after being administered her third diphtheria and tetanus toxoids and pertussis vaccination in April 1992, when she was 6 months old.  The plaintiffs sued in the Philadelphia County Court of Common Pleas, and Wyeth removed the suit to U.S. District Court for the Eastern District of Pennsylvania, where the claims were dismissed as preempted by the Vaccine Act.  The Third Circuit U.S. Court of Appeals affirmed, and the parents appealed to the Supreme Court. 

[Editor's Note:  Full coverage will be in the October issue of Mealey's Litigation Report: Thimerosal & Vaccines.  For all of your legal news needs, please visit]

For more information, call editor Michael Lefkowitz at 610-205-1161, or e-mail him at