I don’t usually feel a personal connection to a Supreme Court decision, but as the parent of three children, I was elated (and relieved) to see the Court come to the right conclusion today in Bruesewitz v. Wyeth. The Court’s holding that state tort suits against vaccine manufacturers are preempted by federal law is absolutely crucial to maintaining the continued availability of the many vaccines that protect the lives and health of tens of millions of Americans, particular school-age children like mine.
The parents of Hannah Bruesewitz sued the manufacturer of the diphtheria, tetanus, and pertussis (DTP) vaccine in state court, claiming it caused her medical problems, including “development delay.” The Supreme Court held that their defective design claims were preempted by the National Childhood Vaccine Injury Act of 1986. That Act was passed by Congress because an explosion of state tort lawsuits against vaccine manufacturers was driving them out of business, imperiling the supply of childhood and other vaccines in the United States. In fact, as the Court pointed out, this destabilization of the vaccine market drove two of the three domestic manufacturers of DTP out of the market, and the remaining manufacturer (the target of this lawsuit), estimated that its potential tort liability exceeded its annual sales by a factor of 200.
To maintain our vaccine supply, Congress set up a no-fault program that provides compensation for the adverse side effects of vaccines through a trust fund administered by the Department of Justice and paid for through an excise tax on every vaccine dose. Congress recognized a known scientific fact: no matter how safely a vaccine is designed and manufactured, a small percentage of the population will inevitably have an adverse reaction. But the injuries to that very small population cannot be allowed to endanger the protection such vaccines provide to millions of other individuals.
Injured individuals can file a claim through a special vaccine court. More than 1,500 people have been paid more than $1.18 billion since 1988 for their injuries and awards are often in excess of $1 million. It is a no-fault system and includes a “Vaccine Injury Table” that lists the known side effects of vaccines for which compensation will be provided. The trust fund even provides attorneys’ fees for unsuccessful claims as long as they are not frivolous.
However, there was no scientific proof that the DTP vaccine caused the “development delay” suffered by Hannah Brueswitz, so her claim under the vaccine fund was denied. The state tort lawsuit her family filed was a way of getting around this requirement by convincing a state jury that she deserved compensation from a deep-pockets drug company despite the fact that the company was not at fault. As the court said, the “quid pro quo for this [compensation system], designed to stabilize the vaccine market, was the provision of significant tort liability protections for vaccine manufactures.”
Numerous unsupported claims have been made that various vaccines cause autism and development delays, all of which have turned out to be scientifically untrue. The medical journal Lancet recently admitted that a 1998 paper it published linking the MMR (measles-mumps-rubella) vaccine to autism, which led parents worldwide to avoid getting their children immunized, was “an elaborate fraud.” These types of false claims have led to epidemics of measles, mumps, bacterial meningitis and whooping cough that have hospitalized and killed children, children who would have been safe had they been vaccinated. Whooping cough is the popular name for the disease the DTP vaccine guards against – six children died in California in 2010 alone from whooping cough, and the epidemic patterns match counties where there is a higher percentage of kids not immunized because of their parents’ mistakenly-held beliefs about vaccines.
The design of the DTP vaccine at issue in this case was approved by the federal government, as was the manufacturing method, as were the labels and warnings that went to doctors with the vaccine. The federal law does not preempt lawsuits against manufacturers for defective manufacturing or not complying with the warning requirements approved by the federal government. But as the Court said, preempting defective design claims “reflect a sensible choice [by Congress] to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”
Even liberal Justice Stephen Breyer agreed, although he did so in a separately-written concurrence based on the legislative history and the views of the relevant expert government agency. Unfortunately, the dissent written by Justice Sonia Sotomayor (and joined by Justice Ginsburg) provides prima facie evidence of her activist judicial mindset that should have disqualified her from ever being confirmed to the court. Justice Sotomayor thinks that preempting state product liability claims is not good public policy. As Justice Scalia says, “the dissent’s belief that the FDA and the National Vaccine Program cannot alone spur adequate vaccine innovation is probably questionable, but surely beside the point.” It is beside the point because such a public policy decision was up to Congress to make, not a lone justice on the Supreme Court. Unless, of course, she is an activist who believes that she had the right to substitute her policy judgment on vaccine design for that of members of the legislative branch.
After oral arguments in this case last October, I wrote that it was no exaggeration to say that if the Supreme Court decided this the wrong way, it was virtually certain that the development and manufacture of life-saving vaccines would be largely shut down in the United States. Thankfully, six justices of the Supreme Court understood that and decided this case based on the plain text of the federal statute, carrying out the clear intent of Congress to preempt state tort defective design lawsuits and protect the vaccine supply of the country. And so my children (and yours) will continue to receive the vaccines that are vital to preventing the epidemics that in times past took the lives of so many.