The Supreme Court today ruled that vaccine companies cannot be sued for design defects, handing the pharmaceutical industry a victory and making it more difficult to bring cases against vaccine manufacturers for allegedly causing autism.
A 1986 law established a federal system for compensating patients injured by "unavoidable" side effects after being given a vaccine. The law aimed to make collecting damages for children injured by vaccines easier and faster by giving the Health and Human Services Department the authority to hear the cases and hand out compensation, funded by an excise tax on pharmaceutical companies making vaccines. President Obama’s fiscal 2012 budget estimated the vaccine fund would have $3 billion. The fund has paid out over $2.5 billion since its inception.
A ruling that allowed suits against the vaccine producers for a "design defect" might have opened up the pharmaceutical industry to thousands of cases alleging that vaccines caused autism in children.
The case heard by the Supreme Court, brought by Russell and Robalee Bruesewitz, alleged that their daughter Hannah was disabled by a diphtheria, tetanus, and pertussis (DTP) vaccine she received as an infant in 1992 manufactured by Lederle Laboratories, now owned by Pfizer Inc.’s Wyeth unit. After the family was denied compensation in the federal vaccine court in 1995, they filed the suit that ultimately reached the Supreme Court, charging that the defective design of the vaccine caused their daughter’s disabilities and that the company could be held liable for negligent design under Pennsylvania law.
The court ruled 6-2 to uphold the ruling of the 3rd Circuit appellate court, finding that the federal law preempts all “design-defect claims” made against vaccine manufacturers. Justice Antonin Scalia, writing for the majority, said the statute only holds manufacturers liable for proper manufacturing and labeling, not for the actual design of the drug.
“Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore preempted,” wrote Scalia.
Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, saying the decision creates a "regulatory vacuum" where vaccine manufacturers are not required to “adequately take account of scientific and technological advancements when designing or distributing their products." Justice Elena Kagan recused herself because she had worked on the case for the Justice Department.
Pfizer Executive Vice President and General Counsel Amy Schulman welcomed the decision.
“The Vaccine Act that Congress enacted nearly 25 years ago appropriately places the responsibility for determining the optimal design of life-saving childhood vaccines in the hands of expert federal agencies, not a patchwork of state tort systems,” said Schulman. “We are pleased that the U.S. Supreme Court affirmed the ruling of the 3rd Circuit.”
But Valerie Nannery, a litigation counsel at the Center for Constitutional Litigation, said the decision holds vaccine makers to a lesser standard for accountability.
“We are disappointed because the tort system is there to hold pharmaceutical companies accountable for vaccine design,” said Nannery. “Now these companies don’t have to defend themselves in court for drug design.”
This article appears in the February 22, 2011 edition of National Journal Daily PM Update.