This week, vaccine manufacturers won increased protection from liability in a closely watched case before the US Supreme Court. In Bruesewitz v. Wyeth, the Court ruled that federal law prohibits patients who claim to have been injured by a vaccine from suing the manufacturer. Pfizer hailed the decision as a victory for public health, but its effect is to diminish patients’ recourse when they suffer harm from taking faulty products.
After their daughter suffered seizures following the administration of a diphtheria–pertussis–tetanus vaccine, Russell and Robalee Bruesewitz went before the “Vaccine Court” that Congress established in 1986 to adjudicate such claims. The tribunal, which has decided against two out of every three plaintiffs, found that the Bruesewitzes had failed to prove that the vaccine had harmed their daughter.
Seeking compensation, the family filed a product-liability lawsuit. Their lawyer argued that Wyeth-Lederle, the vaccine’s manufacturer, had the technology to produce a less reactive, purified pertussis vaccine, but declined to do so. The case was moved to federal court at the company’s request, and a series of judges ruled that federal law prohibited the case from proceeding.
The case hinged on the 1986 law that created the Vaccine Court. It states that vaccine manufacturers cannot be held liable for damages arising from a vaccine-related injury or death “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 Court’s decision sets out an interpretation of this language, which Justice Ginsburg found confusing. “If a manufacturer could be held liable for failure to use a different design, the word ‘unavoidable’ would do no work,” wrote Justice Scalia in the Court’s opinion.
But Justice Sotomayor’s interpretation of the clause was exactly the opposite of Scalia’s, showing that the confusion has not been dispelled. The “text, structure, and legislative history compel the conclusion that Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines,” she wrote in her dissent.
The Court’s decision means that patients can only seek redress from the Vaccine Court, and not through civil lawsuits. Since the Vaccine Court’s compensation fund comes from an excise tax on vaccines, drug companies will not have to pay any damages resulting from claims of harmful vaccines. The Supreme Court’s decision protects manufacturers from having to pay ruinous amounts in damages, but making patients pay compensation when drugmakers’ products cause harm strikes me as distinctly unfair. I think we need legislation that restores patients’ rights to seek damages, re-establishes accountability for drugmakers, and helps ensure an adequate supply of vaccines for the country.