Vaccine Maker Wins in High Court

Staff Writer

The U.S. Supreme Court came down firmly on the side of a vaccine manufacturer today, arguing that parents whose teenager daughter was apparently seriously injured by a vaccine she got as a toddler aren't entitled to sue the company. The case was closely watched on all sides because it challenged the 1986 National Childhood Vaccine Injury Act (NCVIA); that act sought to protect manufacturers from a flood of liability claims—and thereby stabilize the vaccine market—but also preserve a family's right to be compensated for vaccine injuries.

The justices ruled 6-2 in favor of Wyeth, the vaccine maker.

(The 9th justice, Elena Kagan, did not participate because her former office in the Obama Administration had filed a legal brief in the case.) In an opinion joined by five of his colleagues, Antonin Scalia carefully parsed the language of the 1986 act, which didn't mention the specific type of problem the girl's family had raised: a so-called design defect. The parents of Hannah Bruesewitz argued that she had received a "scientifically outmoded" DTP (diphtheria, tetanus, pertussis) vaccine and that Wyeth had decided not to modify it "because it viewed the economic costs as outweighing any potential gain in market share."

The justices on both sides spent pages trying to decide Congress's intentions when it used words such as "avoidable" and clauses such as "even though" in the NCVIA.

"Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution (an approval that it could take years to obtain)? Or does it suffice that a vaccine design has been approved in other countries? Or could there be liability for failure to use a design that exists only in a lab?" Scalia wondered in the brief. Without guidance from Congress to answer these questions, he concluded that "design defects were not mentioned because they are not a basis for liability."

Two justices, Sonia Sotomayor and Ruth Bader Ginsburg, disagreed that this was Congress's plan. In a dissenting opinion, they accused the court of imposing "its own bare policy preferences" to protect vaccine manufacturers and said it was important for companies to be pushed, at times by litigation, to improve on existing vaccines. "Nothing in the text, structure, or legislative history remotely suggests that Congress intended" to prevent this, they wrote.

Posted in Health