Confusing Language and a Dubious Victory for Patients
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.
Dubious is right. Without commenting in any way on the facts of the Bruesewitz case, it would seem that an injury sustained after taking a vaccine would be the exact protection the law should be upholding.
Vaccines represent one of the most spectacular public health successes of modern medicine, eliminating or effectively preventing maladies such as polio, diptheria and measles. But vaccines also provide an instructive case of how lawsuits can run amok: the Vaccines Court was created by the US Congress in the wake of large jury awards against makers of the DPT vaccine in the early 18980s, which caused vaccine makers to exit the market, threatening supplies. The scientific basis for those awards, not surprisingly, have since been conclusively discredited.
I’m certainly not swayed that the Vaccines Court failed to uphold the patient’s rights in this case because the plaintiff’s attorney says so, and I don’t agree with those who believe that every time a patient experiences an adverse outcome it is reflexively the fault of the product maker. Lacking any persuasive evidence that the Court is making unfair rulings, we should respect the Court.
The idea of the Vaccines Court is a very good one, and indeed, the Court should serve as a model for US tort reform of medical liability, which even the current administration has finally agreed is an important component of containing national healthcare costs. Innovation, supply, and affordable pricing of vaccines in the US is only possible due to the Vaccines Court, and both vaccines and the Court should be viewed as triumphs of public health policy.
Leaving aside the lawyers’ stuff, I’d like to read a clear statement of the ways risks associated with the treatment of millions of people can be evaluated.
If 100 000 people go to a football match, some will become seriously ill (or worse) during the week that follows. OK, there may be heart attacks because of elation or despair at the victim’s team’s performance, but apart from that the statistics will be the same as for vaccination, cholesterol treatment, etc. It’s easy to understand the statistical argument until your child falls ill.
My own view is that here needs to be a system whereby specific symptoms which have been shown to be statistically significantly associated with a treatment can be declared to be, for legal purposes, due to the treatment. When other symptoms arise, too bad. In this field you have to base law on probabilities, but sometimes you have to take a risk for the benefit of the community.