Vaccine Injury Claims Are Few and Far Between

At a time when the failure to immunize children is driving the biggest measles outbreak in decades, a little-known database offers one way to gauge the safety of vaccines.

Over roughly the past dozen years in the United States, people have received about 126 million doses of vaccines against measles, a disease that once infected millions of American children and killed 400 to 500 people each year. During that period, 284 people filed claims of harm from those immunizations through a federal program created to compensate people injured by vaccines. Of those claims, about half were dismissed, while 143 were compensated.

The data comes from the National Vaccine Injury Compensation Program, a no-fault system begun in 1988 after federal law established it as the place where claims of harm from vaccines must be filed and evaluated. It currently covers claims related to 15 childhood vaccines and the seasonal flu shot.

Over the past three decades, when billions of doses of vaccines have been given to hundreds of millions of Americans, the program has compensated about 6,600 people for harm they claimed was caused by vaccines. About 70 percent of the awards have been settlements in cases in which program officials did not find sufficient evidence that vaccines were at fault.

“Vaccine injuries are rare,” said Renée Gentry, a lawyer who has been representing people filing claims of vaccine injuries for nearly 18 years. Still, she said, “they are pharmaceuticals and people can react to them — you can have a bad reaction to aspirin. They’re not magic.”

In recent years, many of the program’s payments have been related to flu shots, mostly involving adults.

A total of $4.15 billion in compensation has been paid out since the program’s inception. A small proportion of the claims involve deaths. In 30 years, about 520 death claims have been compensated. Almost half involved an older vaccine for whooping cough that has not been used for two decades.

The Centers for Disease Control and Prevention has estimated that vaccines prevented more than 21 million hospitalizations and 732,000 deaths among children over a 20-year period.

Ms. Gentry, who co-directs the Vaccine Injury Litigation Clinic at George Washington University Law School, said the vast majority of claims are filed by people who are not vaccine skeptics.

“We’ve been called all kinds of crazy things, including anti-vax,” she said. “We’re not. My law partner’s sister spent her life in a wheelchair because she had polio; I wish she had that vaccine.”

Dr. Meissner said public health authorities now emphasize training health providers to administer vaccines without hurting people’s shoulders.

Many shoulder injury claims involve the flu vaccine, which the program began covering in 2005. Flu shots — which federal officials recommend annually for adults and children — accounted for about two-thirds of compensated claims from 2006 through 2017. During that time, flu immunizations represented about 44 percent of the nation’s total vaccine doses.

Because of flu shots, claims to the program now overwhelmingly involve adults instead of children.

The flu shot has also driven a significant number of claims involving Guillain-Barré syndrome, a rare neurological disorder in which the immune system starts attacking the body.

The tetanus vaccine is considered so vital that 576 million doses containing it (often along with diphtheria and pertussis) were administered from 2006 through 2017 — and 719 injury claims related to it were compensated, the data shows.

Getting tetanus can be devastating, as a 2017 case in Oregon showed. According to a C.D.C. report on that case, a 6-year-old boy who had not been vaccinated developed tetanus from a cut on the forehead and required 57 days in the hospital. For much of that time, he was in so much pain from muscle spasms that he had to be kept in a darkened room, wearing ear plugs. His care cost more than $800,000. The cost for a five-dose regimen of the tetanus vaccine, which would have prevented his suffering, is about $150.

In very rare circumstances, vaccines can cause death. A person can go into anaphylactic shock or have a fatal case of Guillain-Barré syndrome. Since 1988, more than half of the 1,300 claims of death were dismissed because the program found insufficient evidence that the vaccine was responsible.

About 90 of the 520 death claims that were compensated involved the flu shot. Nearly half of compensated death claims involved DTP, an early vaccine against diphtheria, tetanus and pertussis (also called whooping cough). The pertussis formulation, known as whole-cell, was replaced in the 1990s with acellular versions contained in the current DTaP and Tdap vaccines.

The vaccine compensation program was created because a flood of lawsuits, especially ones involving DTP, was prompting pharmaceutical companies to abandon the vaccine business. Public health officials and Congress worried there would not be enough manufacturers providing crucial vaccines.

A 1986 law established the compensation fund, financed by a tax paid by vaccine manufacturers of 75 cents per dose. The law acts as a liability shield for drug companies: People claiming injury are required to seek redress first with the vaccine program in the United States Court of Federal Claims and with the Department of Health and Human Services before they can sue a manufacturer.

There is a backlog of about 2,800 cases that need to be resolved, a process that takes an average of two to three years.

If people reject the compensation or their claim is dismissed, they can sue the vaccine manufacturer, although Ms. Gentry said that because the program requires “a lower burden of proof” than civil court does, it would be hard to win a lawsuit based on the same claim.

“Once you’ve gone through this process, if you lose,” she said, “you’re probably not going to go forth and sue.”


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