Global Healthcare

Supreme Court Hands Vaccine Makers a Big Win

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Vaccine makers won a big victory last week when the Supreme Court ruled by a 6-2 margin that US law effectively protects them from product-liability suits based on claims of poor vaccine design.

The plaintiffs in the case were the parents of Hanna Bruesewitz, who in 1992 received a diphtheria, tetanus and pertussis (DPT) vaccine and subsequently developed a seizure disorder and multiple neurological problems.

The vaccine was made by Wyeth, which was later acquired by Pfizer. Bruesewitz will require expensive medical care for the remainder of her life.

Wyeth had denied that its DPT vaccine caused Bruesewitz’ injuries and warned that an adverse ruling by the Court would presage a flood of similar lawsuits that could threaten the supply chain for childhood vaccines. The Justice Department had supported Wyeth’s position on the matter.

In its ruling, the Supreme Court upheld a decision made by the Court of Federal Claims. In the former case, the Federal Claims court rejected the Bruesewitz’ attempt to receive compensation for medical costs associated with the care of their child. In that ruling, the court argued the parents did not prove that Wyeth’s vaccine caused their child’s injuries.

(The Federal Claims Court, a.k.a. the “vaccine court, was created by the National Childhood Vaccine Injury Act of 1986. Its adjudicates vaccine-injury claims and oversees an associated national compensation program. The vaccine court has awarded nearly $2 billion for vaccine injury claims in 2,500 cases since its inception. Its funds are derived from a tax on vaccines. The Vaccine Injury Act also protects vaccine makers from certain kinds of claims.)

In writing for the majority, Supreme Court Justice Antonin Scalia said the Vaccine Injury Act “pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.”

Pfizer’s general counsel, Amy Schulman was pleased with the decision. The 1986 vaccine law “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,” she said in a press release.

The 2 dissenters were Justice Sonia Sotomayor, Justice Ruth Bader Ginsburg. They argued that the court imposed “its own bare policy preference over the considered judgment of Congress.”

Note that the Supreme Court’s decision still leaves open the possibility that plaintiffs can sue vaccine makers on issues other than vaccine design. These would include improper manufacturing techniques, for example.

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