Supreme Court vaccine ruling: The system for compensating injured children doesn't work.

Health and medicine explained.
Feb. 23 2011 1:32 PM

The Real Problem With Vaccines

Our system for compensating injured children is hurting—and this week's Supreme Court ruling doesn't help.

Baby getting a shot. Click image to expand.
Controversy remains over child-vaccine injuries

The Supreme Court ruled Tuesday in the case of a 6-month-old baby named Hannah Bruesewitz who suffered multiple seizures and long-term developmental damage after receiving a dose of vaccine for whooping cough in 1992. Her parents sued the drug's manufacturer, Wyeth, for providing an outdated and poorly designed product, while the pharmaceutical company said the case should be decided by a special administrative court that compensates injured children from a public fund.

Most commentators saw this week's decision—against the parents, in favor of Wyeth—as a big victory for the pharmaceutical industry, and I suppose it is, though hardly a surprising one. But since I've been following vaccine-injury controversies for the last decade or so I found the ruling slightly painful to watch. The modern-day anti-vaccine movement began with concerns about the whole-cell pertussis shot, the very one that the Bruesewitzes claimed damaged their daughter almost 20 years ago. And the court set up in part to defuse that movement is having trouble doing its job.

Hundreds of lawsuits related to the whole-cell pertussis shot threatened to drive the drug industry out of the vaccine business, until Congress in 1986 passed the National Childhood Vaccination Act, which established the so-called "vaccine court" to hear injury claims and pay out claims from an excise tax, while the vaccine industry—and the public health—were protected from frivolous lawsuits.

Bruesewitz's parents had originally filed their claim in the vaccine court, but now were arguing that they should be entitled to bring their injury case before a civil jury. The Supreme Court ruling centered on a single phrase from the 1986 law stating that vaccine manufacturers were to be protected from civil action over injuries that were "unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." Arguing for the majority, Justice Scalia said this wording—and the word unavoidable in particularexempted vaccines that were of "defective design." Justice Sotomayor, in the minority, disagreed.

Neither voiced an opinion as to whether the whole-cell pertussis vaccine was, in fact, defective. That was probably a good idea because pediatricians, microbiologists, lawyers, parents of brain-damaged children, and others have spent more than three decades debating that question and have yet to reach a satisfactory conclusion. According to Scalia, these subtleties aren't for judges to decide: "[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries."

I'm with him so far. But the Bruesewitz family, whose legal pursuits were effectively ended by the decision, were not well-served by the vaccine court in the first place. Hannah Bruesewitz suffered 125 seizures in the 16 days following her whole-cell pertussis shot in 1992. Eventually she was diagnosed with a residual seizure disorder and pervasive developmental disorder. She's now a 19-year-old woman who can't take care of herself and requires round-the-clock care.

The vaccine in question first went on the market in the United States in the early 1940s. It did its job well, eliminating most cases of whooping cough, a disease that in the 1930s made nearly every child sick and killed about 4,000 of them each year.

Yet within a few years of the vaccine's invention there were reports in leading medical journals of children who suffered seizures after vaccination and became permanently disabled. The debate since then has surrounded the extent to which those disabilities could be blamed on the injections.

No one denies that the whole-cell pertussis vaccine is a "reactive" shot. It's a messy business, made from chemically inactivated pertussis bacteria in their entirety, as opposed to just their purified proteins. As such, it contains a lot of different kinds of molecules, and no one was entirely sure which of them could make you sick, or which might provide immunity to whooping cough infection.

Children who get the shot tend to have high fevers and seizures. That was enough justification for U.S. public health officials to phase out the shot in the early 1990s and replace it with more specific, "acellular" versions.

Less clear was whether children who had received the whole-cell pertussis vaccine were more likely than others to suffer long-term damage.

Facing scientific uncertainty on this point, the vaccine court set up an "injury table" of illnesses occurring after an injection. Without stating specifically that vaccines caused these injuries, it gave parents the benefit of the doubt and provided them with automatic compensation. If the child's illness did not fit on the "injury table," the parents or guardians faced the difficult task of proving that the illness was vaccine-related.

In the early days of the vaccine court, "residual seizure disorder" following a whole-cell pertussis shot—Hannah Bruesewitz's injury—was listed on the table.

But in March 1995—a month before her family filed their claim—a special government advisory committee gave the injury table a radical overhaul. Under the new system, residual seizure disorder no longer qualified a child for compensation. Instead, Hannah's family needed to prove that the vaccine caused her injury, and they were unable to do so.

The arguments that led to the table change are quite interesting to read. The committee members were debating questions about the nature of public health, risk perception, and fairness. Those who wanted to update the table argued that it was too generous to supposed victims and harmed the reputation of vaccines by making them seem more dangerous than they were.

Others, including the late whooping cough expert Gerald Fenichel, argued that it was better to err on the side of the parents, even if they were wrong sometimes. While he agreed that the data suggested the whole-cell pertussis shot wasn't responsible for brain damage, "it is not possible to show an event that may occur one in a million times." Since so many people believed that the damage did occur, he said, it would be better not to take the narrow scientific viewpoint, and instead to compensate "some number of people who perhaps have not been injured by the vaccine, to make the program work."

This same argument, to be sure, could be made for the discredited vaccines-cause-autism theory. But in that case, science has repeatedly failed to find a link and the theories of causation were extremely weak and speculative. The evidence was a bit murkier with the whole-cell pertussis vaccine.

By gutting the table of injuries, the Department of Health and Human Services has made the vaccine court difficult for parents to navigate—an issue that the Supreme Court ruling fails to address. In the view of some experts I've heard from, the current structure of the vaccine court may even encourage its judges—the special masters—to bend over backward with unscientific theories in order to justify an award to a hurting family.

Meanwhile, pertussis remains a disconcertingly difficult disease to manage. It is hard to diagnose, and the mechanisms of immunity remain somewhat mysterious. Put three whooping cough experts in a room together and you'll get three explanations for what type of antibodies protect you against the disease.

Nor does anyone have a convincing argument for why whooping cough has returned with such a vengeance over the past decade. In California last year, it infected more than 8,000 people and killed 10 babies.

The epidemic can be blamed partly on people who don't vaccinate out of fear of autism. But the resurgence has also coincided with the replacement of whole-cell whooping cough vaccines. Some experts believe that the first-generation acellular vaccines may have failed to provide good protection, leaving teenagers and young adults susceptible, and allowing them to pass the disease to unvaccinated children.

Strangely, the legacy of this obscure controversy continues to ricochet around, from the courts to the classroom.

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