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 Her parents sued the drug's manufacturer, Wyeth, for providing an outdated and poorly designed product, while the pharmaceutical company said the case should be decided by a special administrative court that compensates injured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."

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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.

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