In session: The vaccine court—like vaccines themselves—stands by to help
Education Images; UIG via Getty Images
By Jeffrey Kluger
August 19, 2015
IDEAS
Kluger is Editor at Large for TIME.

Scientists have long since learned to roll their eyes at politicians—especially when the topic is vaccines. Chris Christie and Rand Paul have both blundered into trouble with their support of vaccine opt-outs, a position that puts them at odds with virtually every medical authority on the planet. On Aug. 13, Carly Fiorina echoed a similar theme when she questioned “esoteric immunizations” like the HPV vaccine—which is a strange way to describe a shot that can save a woman’s life. All that, however, is just campaign-season noise.

Less noticed but perhaps more damaging was the moment in late July when Florida Republican Bill Posey rose on the floor of the House of Representatives and raised what has long been the anti-vaccine crowd’s biggest argument: the existence of a “Vaccine Injury Court.”

It’s at that point that the conversation often stops. The court—a federal panel that adjudicates payments to what the anti-vaxxers call “vaccine-injured children”—has long been the kryptonite, the dropped mic, the rapped gavel of any rational discussion of vaccine safety.

And no wonder: Since 1988, when the National Vaccine Injury Compensation Program (VICP) began, more than 16,000 claims have been considered and a whopping $3.18 billion have been awarded to families alleging some kind of harm from vaccines. That sounds awfully damning, and in this case, unlike in so many other cases, the anti-vaccine crowd isn’t just making stuff up. The numbers are real and the federal government is the first to admit it.

But the anti-vaxxers are utterly wrong in their interpretation of what the numbers mean. And in fact, the numbers prove that vaccines are as safe as the medical community says they are. Understanding why that’s so means going beyond the tired alarmism and looking at the facts.

The Court, Then and Now

The “vaccine injury court” is more properly known as the Office of Special Masters, which itself is a division of the United States Court of Special Claims. The special masters were created as part of the VICP, an act passed by Congress in 1986 and signed into law by President Ronald Reagan in 1988. It is a fundamental part of the anti-vax canon that the court is a closely held secret, established by Washington but kept as quiet as possible, lest the public catch wise to the fact that hush money is being paid to injured families.

“It is obvious that the government does not want to publicize the existence of the [court],” reads one website that is typical of the conspiracy wing, “because the more Americans learn that there are vaccine injuries and deaths … the more they may start to question the safety of vaccines.”

That, no surprise, is nonsense. The law was well-publicized at the time of its passage and is even better publicized today, thanks to a website set up by the Department of Health and Human Services (HHS), which not only explains the court in depth, but also provides the names and contact information of lawyers in all 50 states and offers detailed assistance in filing a claim.

The purpose of the court is to reckon with the reality that while vaccines are every bit as safe and life-saving as health authorities say they are, no drug or medical procedure is entirely without risks. Since many millions of children get vaccinated every year, even a few bad outcomes could subject the drug-makers to a storm of liability suits. Some claims might be legitimate, but far more could be frivolous or even fraudulent. Either way, the endless litigation could drive up the costs of vaccines.

In order to ensure that vaccines would be as affordable and available as possible, Congress thus created the VICP, establishing a trust fund for awards financed by an excise tax of 75 cents on every vaccine administered. Under the program, cases are adjudicated on a no-fault basis, with attorneys for the government and attorneys for the families arguing before one of eight special masters. The goal is to settle the matter as quickly and fairly as possible, though petitioners (the no-fault system avoids the word “plaintiffs”) who are unhappy with the special master’s ruling are free to take their case to the traditional civil court system.

The standard the petitioners must meet to recover any award is a comparatively low one—the “preponderance of the evidence” rule of civil law, rather than the “beyond a reasonable doubt” requirement of the criminal court system. In practice, that standard has been even more liberally construed in the vaccine court than it is in ordinary civil court, a fact that generally benefits the petitioners. More frequently still, things don’t go that far. In 80% of all cases brought since 2006, the parties settle, meaning that the petitioner recovers an award with no determination being made about whether the vaccine even caused the claimed harm.

“Settlements are not an admission by the United States or the Secretary of Health and Human Services…that the vaccine caused the petitioner’s alleged injuries,” says the HHS website. Claims may be settled for a lot of reasons, including “a desire by both parties to minimize the time and expense associated with litigating a case to conclusion; and a desire by both parties to resolve a case quickly and efficiently.”

Even without blame being established, the billions the government has handed over in payouts since the VICP was created does seem to suggest that a whole lot of people are being harmed. But that is not the case. From 2006 to 2014, approximately 2.5 billion doses of vaccines were administered in the U.S. In that time, a total of just 2,976 claims were adjudicated by the special masters and only 1,876 of those received compensation. Divide that number by the vaccine dose total and you get less than a one in a million risk of harm. Going all the way back to 1988—before the flu vaccine became part of the recommended schedule of vaccines—a total of 16,038 claims have been adjudicated and 4,150 have been compensated, bringing the total payouts up to the $3.18 billion figure.

To the anti-vaxxers, the low number of claimants spells its own kind of trouble. Divide overall payout by the relatively few injured parties and you get $766,265 per petitioner. The government wouldn’t hand over that kind of cash unless the injuries people do sustain are severe, right? Wrong.

Flooded With Injury Claims

The website of the U.S. Centers for Disease Control and Prevention (CDC) is very clear about any possible injury or side-effect that could possibly be caused by a vaccine (giving the lie to yet another anti-vaxxer claim that those risks are being covered up). The large majority of the possible problems are minor and transient—a fever, a short-term allergic reaction, soreness at the site of the injection. There is the possibility of autoimmune reaction too, in which the body effectively attacks itself, though the science is still vague on what role, if any, vaccines can play in that. Other possible problems include simple injury to shoulder, when the vaccine needle penetrates the bursa—the sac of cushioning fluid that protects the joint. For many of these problems, the claimants are adults, not kids.

In rare cases, severe neurological reactions have been observed too, but that very rarity makes it impossible to determine if they were caused by the vaccine or were a mere coincidence in timing. Still, the no-fault rule of the VICP doesn’t seek proof of causation, which means that claims like this are covered—and those are the ones that drive up the overall average.

“In cases in which there is a lifetime injury, the award will be the equivalent of many millions of dollars,” says New York-based attorney Robert Krakow, who has represented petitioners in hundreds of vaccine injury claims. “It could be $20 million over a lifetime.” Just three such claims a year—out of the many millions of vaccines administered annually—0ver the course of the 27 years the VICP has been in effect can account for half of the total dollars spent on awards.

No surprise, since the rise of the anti-vax fringe, the VICP has been inundated. In 1998, the year U.K. physician Andrew Wakefield published his fraudulent paper linking the MMR vaccine to autism, just 325 injury claims were filed, 181 were dismissed and 144 were compensated. In 2010, Wakefield’s fraud was exposed, his paper was withdrawn and he was stripped of his license to practice medicine in the U.K. But the anti-vax hysteria had been unleashed, driven in part by anti-vaccine drum-bangers like Jenny McCarthy. The following year, 1,637 claims were filed. In 2012, that figure rose further, to 2,702. The number of awards granted increased as well, but still remained in the low triple digits—266 in 2011 and 263 in 2012.

Certainly, vaccine science is not fixed, and different circumstances lead to different law. The case of Hannah Poling, the 9-year-old Georgia girl who, in 2008, received a $1.5 million award when the court agreed that vaccinations contributed to her later-onset autism, rocked the medical community and only worsened the anti-vax panic. But Poling was a special case; she was suffering from an underlying disorder of the mitochondria, or the energy-processing organelle in the cells. This made her vulnerable to any oxidative stress that could, in theory, be caused by vaccines. Mitochondrial disorders are increasingly being cited in vaccine court claims, but the conditions are not common and are poorly understood. “The belief is that the vaccine triggers a decompensation,” says Krakow, “but this is controversial.”

What’s not controversial is the far bigger picture, which is that medicine has never been about eliminating all risks, but about minimizing and balancing and coolly considering them. Childhood diseases are a manifest danger, capable of sickening hundreds of thousands or even millions of kids each year. Vaccines, which offer powerful—if imperfect—protection, all-but eliminate that peril. Yes, they introduce a tiny bit of their own risk, but they still leave children far safer than they otherwise would be. For the literal one in a million who are harmed, the VICP stands by to help. For the rest, it’s the vaccines themselves that do the helping.

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