Supreme Court Upholds Rules on Vaccine Litigation in Bruesewitz v. Wyeth

By Juliana Olsson | February 25, 2011

In Bruesewitz v. Wyeth, the Supreme Court Justices decided that individuals cannot sue drug companies over vaccine defects in State courts, since their claims are preempted by the federal law that requires these cases to be dealt with in the Vaccine Court, a part of the Court of Federal Claims. While claims over faulty manufacturing can be taken to state courts, vaccine-design-related claims must go through the Vaccine Court. Why is there an entire court system for just for vaccines?

The court is part of the National Childhood Vaccine Injury Act passed by Congress in 1986. The Act created a national Injury Compensation Program for vaccine-related-injury claims, which would allow for individuals to seek restitution while simultaneously shielding manufacturers from the costly tort system to ensure that adequate supplies of vaccines would be produced nation-wide.

The argument for shielding vaccine manufacturers like Wyeth (now part of Pfizer) goes like this. The cost of creating a vaccine is extremely high, it’s a long process from research to production and distribution, and vaccines are not very profitable drugs—for these reasons, the threat of a costly lawsuit down the line is enough to nip a vaccine in the bud. Why invest in the costly medicine if you’re only going to get slammed with a lawsuit as soon as it comes on the market? Better to focus on drugs that are proven money-makers. When companies refuse to create vaccines, or are driven out of business by tort claims, national shortages can occur, which is a huge public health liability.

At the same time, while vaccines are overwhelmingly beneficial, side effects can still occur, including conditions like Guillain-Barre Syndrome; individuals should have some form of protection or at least compensation for such circumstances.

Enter the vaccine court. Manufacturers pay into a no-fault government-administered fund, from which compensations are paid. These compensations cover medical and legal expenses, loss of future earning capacity, up to $250,000 for pain and suffering, and even death benefits of up to $250,000. The National Vaccine Injury Compensation Program (VICP) uses a no-fault system for resolving claims surrounding design defects, and there is no jury. The court also has the lowest level of burden-of-proof: a plaintiff only needs to present a preponderance of evidence showing a causal link between the vaccine and the type of injury they suffered. This is different from demonstrating “beyond a reasonable doubt” that a particular dose caused the plaintiff’s particular condition, since if medical records show the plaintiff contracted one of several listed adverse effects soon after vaccination, the court assumes the condition was caused by the vaccine. In some cases, even if a claim is denied, the plaintiff may receive some compensation.

This sounds like a win-win situation, but some wonder if big pharmaceutical companies should be quite so sheltered from the market. In their dissent to the opinion delivered on the 22nd, Justices Sotomayor and Ginsberg pointed to a “regulatory vacuum in which no one [...] ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.” Then again, as the majority opinion states, the legal field (or at least the tort system) may not be the best place to decide the safety of vaccines: in the words of Justice Scalia, “leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”