Vaccine Court Aims To Protect Patients And Vaccines

Jun 2, 2015
Originally published on July 11, 2015 1:29 am

It was a beautiful Saturday in the fall of 2005. The leaves in Cincinnati were changing colors, and Lisa Smith had just finished watching her son's soccer game.

She ran some errands, including something she'd been meaning to do for a week — get a flu shot. She stopped by her local pharmacy.

She didn't think about the shot again until a few days later, when she woke up feeling a bit strange. She had an odd tickle in her throat and her leg muscles were sore.

"Almost like I'd been exercising," she says.

Over the next couple of weeks, the soreness got worse. Then, one evening, with her husband and two sons out of town for the weekend, Smith realized she couldn't stand up. She was stuck on her living room couch.

Her neighbor happened to stop by, and Smith asked her to call an ambulance.

The paramedics arrived. As they loaded her onto a stretcher, Smith began screaming.

"The doctors later told me the nerves were all inflamed," she says. The pain "was like having third-degree burns on my legs."

In the ambulance, the paramedics asked Smith if she had recently received a flu shot. At the hospital, the nurses asked the same question.

"I was like, why does everybody keep asking me if I've had a flu shot?" she says. The nurses told her paralysis was a rare, but known side effect.

Smith was diagnosed with Guillain-Barre syndrome, a condition in which the immune system attacks the nerves. According to Dr. Tom Shimabukuro, a vaccine specialist at the Centers for Disease Control and Prevention, roughly 3,000 to 6,000 people in the U.S. develop the syndrome each year.

Shimabukuro says most cases of Guillain-Barre are not linked to the flu vaccine, but it's possible that some are. He says the data fluctuate from year to year and are inconclusive, but the epidemiology and timing of cases suggests that, at most, one or two people might develop Guillain-Barre per million doses of flu vaccine administered. With roughly 130 million flu shots given in the U.S. each year, that translates to, maybe, 130 to 260 cases across the country, annually.

Lest that put you off getting immunized, it is worth noting, Shimabukuro says, that getting sick with the flu appears to increase one's risk of developing Guillain-Barre syndrome more than getting the flu shot does.

A few days after Lisa Smith received her Guillain-Barre diagnosis, her friend Jackie visited her in the hospital.

"[She] said, 'Lisa, they know this happens,' " Smith recalls. " 'There's a form you fill out and there's a court that you file claims in.' "

Smith did some research, found a lawyer, and took her case to the Office of Special Masters of the U.S. Court of Federal Claims — commonly called the vaccine court.

The court administers a no-fault compensation program that serves as an alternative to the traditional U.S. tort system. The program was established in 1986, after a series of high-profile lawsuits against drug companies. A number of children had serious adverse reactions — including seizures and brain damage — that appeared to be linked to the diphtheria, pertussis, tetanus vaccine or DPT vaccine (this version was later replaced by the DTaP vaccine). The parents filed lawsuits against the makers of the DTP vaccine and, in at least two cases, won awards worth millions of dollars.

Several drug companies then threatened to cease vaccine production, claiming the risk of litigation was too high. Anna Kirkland, an associate professor of women's studies and political science at the University of Michigan, says that threat frightened health officials.

"There was a real fear that some of our childhood vaccines would no longer be available," says Kirkland, who has written several articles on the vaccine court, and has a book in the works on the topic.

In response, Congress passed the National Childhood Vaccine Injury Act, a bill that established the no-fault compensation program for vaccine injuries.

"Basically what it did was shield the vaccine makers from liability," Kirkland says, thereby encouraging them to continue producing vaccines and developing new ones.

The program also created a special fund to compensate vaccine recipients who'd been hurt, through a 75-cent surcharge on every dose of vaccine.

To expedite the compensation process, the court created a list of side effects that, according to the best available science, are sometimes caused by vaccines. This list — called the vaccine injury table — is updated regularly, following reviews of scientific literature by the Institute of Medicine.

To win a claim, a petitioner must provide proof of having received a certain vaccine and, within a specified time frame, subsequently developed a condition included in the vaccine injury table. Petitioners don't have to prove that the immunization caused their condition — the court operates under a presumption of causation if the injury develops within a certain period of time.

In cases where someone has a condition not listed in the table, there is a higher burden of proof. In addition to evidence of vaccination and a medical diagnosis, petitioners must also have a statement from a medical expert — usually a physician — with a plausible explanation of how the vaccine could have caused the injury.

The court is in the process of officially adding Guillain-Barre syndrome to the vaccine injury table. So, for Lisa Smith, the court process was pretty straightforward.

A few months after she submitted her case, Smith got a phone call from her lawyer. She was told that the court had determined that her case had merit. Smith accepted an award; the decision requires that she not discuss the terms.

In 2014, the court received 542 claims and compensated 365 people for a total of $202 million. Settlements ranged from tens of thousands to hundreds of thousands of dollars. Many were for the flu shot and Guillain-Barre syndrome.

Today, 10 years after she first developed Guillain-Barre, Lisa Smith is still dealing with complications from the condition. The settlement helped, she says, but for her it wasn't about the money.

"For me it was an acknowledgment that this happens — they know it happens," she says. "And I want an honest discussion."

Many people who might qualify for compensation in the vaccine court don't know it exists. Anna Kirkland says there has been a lot of discussion over the years about advertising the court's services. But doing that creates a problem, she says.

"Critics, once they see a compensation — you see this on blogs and websites all the time — [say] this means vaccines are dangerous and you shouldn't vaccinate," she says.

Health officials have worried about the downside of such publicity for years, Kirkland says. If the court becomes too high-profile and people keep hearing about payouts to the rare patients who may have been harmed by an immunization, the public might think vaccines are more dangerous than significant research and evidence suggests they are. And, as a result, vaccination rates might fall.

A few years ago, Kirkland says, there was an attempt to promote the court more.

"They had [a] public relations firm prepare this advertising campaign," she says, "and then Congress just didn't fund it."

So the court keeps humming away, quietly, in the background, hearing cases from people who are able to find it.

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AUDIE CORNISH, HOST:

Next we're going to look at a special court that handles only cases involving vaccines - claims, that is. It's known as the vaccine court and it's essentially litigating cases of those who believe they've been harmed by a routine immunization. NPR's Anders Kelto has been looking into the court and joins us now.

Welcome to the studio, Anders.

ANDERS KELTO, BYLINE: Thanks, Audie.

CORNISH: All right. So first, many of our listeners might be surprised to hear that this even exists. How did the vaccine court come about?

KELTO: Yeah, so it started back in the 1980s. There were a number of lawsuits brought against drug companies from the parents of children who had had adverse reactions to something called the DPT vaccine. These were very bad reactions - seizures, in some cases, severe brain damage. And in at least two cases, the parents won lawsuits against drug companies for millions and millions of dollars. As a result, the drug companies said, well, this is unsustainable and this is not a lucrative business in the first place - we don't make a lot of money off of vaccines, so we are going to stop making them. And that threat really scared people.

CORNISH: So this was created out of fear, fear that there'd be vaccine shortages.

KELTO: Exactly. Doctors were scared. The government was scared. And they said, look, we need a steady supply of vaccines. This is important to public health, so we have to figure out a solution here. And what they did was they created this no-fault compensation program that essentially shielded drug companies from lawsuits over vaccines. So if you're a parent, your child has an adverse reaction, you cannot sue the drug company directly. You must come through this separate court that was set up.

CORNISH: So how does this work? I understand you actually spoke with someone who went through this process.

KELTO: Yeah, her name is Lisa Smith. She lives in Cincinnati, Ohio, she works for a jewelry company. And her story starts about 10 years ago on a fall day.

LISA SMITH: It was a Saturday. I got up that day and went to my son's soccer game. It was a beautiful day.

KELTO: And after the game, she ran some errands, including something she'd been meaning to do for weeks - getting a flu shot. She didn't really think anything of it until a few days later, when she noticed her legs were a little sore. And that soreness got worse over the next couple weeks.

SMITH: Almost like I'd been exercising or doing a whole lot of things where you just feel weak. But throughout the day they got progressively weaker until that evening I couldn't get off the couch at all.

KELTO: She had her neighbor call an ambulance, and when the paramedics got there and put her on a stretcher, she was in serious pain.

SMITH: I would just scream. The doctors later told me the nerves were all enflamed and it was like having third-degree burns on my legs.

KELTO: The paramedics asked if she had a flu shot. At the hospital, the nurses asked the same thing.

SMITH: I finally was like, yeah - why does everybody keep asking me if I've had a flu shot? And they said, oh, this is - paralysis is a known side effect.

KELTO: Lisa was diagnosed with something called Guillain-Barre syndrome, or GBS. It's a condition where the immune system attacks the nerves. A few thousand people in the U.S. develop it each year. Most cases are not linked to the flu vaccine. A few days after Lisa Smith was diagnosed with GBS, she got a visitor.

SMITH: I was still in the hospital, and my friend Jackie came to the hospital and said, Lisa, they know this happens. There's a form you fill out and there's a court that you file claims in.

KELTO: So she found a lawyer and took her case to the vaccine court. To win a claim in the court, you just have to show that you got a certain vaccine and developed a known side effect. GBS is now recognized as a known side effect, so for Lisa Smith, the entire process was pretty straightforward. A few months after she submitted her case, she got a call from her lawyer.

SMITH: The phone rang and it was - I knew their number. And she's like, are you sitting down? I was like, no. She's like, well, you might want to sit down because they just conceded your case. We don't have to go to trial, and you'll get a settlement.

KELTO: She accepted the settlement offer but is not allowed to discuss it. Last year, the court received 542 claims and it compensated 365 people, many of them for the flu shot and GBS. Settlements range from tens of thousands to hundreds of thousands of dollars. Ten years after she first developed GBS, Lisa Smith is still dealing with some complications from the condition. She says the settlement helped, but for her, it really wasn't about the money.

SMITH: For me it was an acknowledgment that, yes, this happens. They know it happens. And that's - I want an honest discussion. Does this happen to everyone? No. But does it happen? Yes, it does.

KELTO: Like Lisa Smith, many people have no idea that the vaccine court exists. Anna Kirkland is a professor of women's studies and political science at the University of Michigan. She's written a book about the court.

ANNA KIRKLAND: Everyone talks about how we really should advertise it more and more people should know about it.

KELTO: But doing that creates a problem.

KIRKLAND: Critics, once they see a compensation - you know, you see this on websites and blogs and all kinds of sources - look, the vaccines were compensated for this, so this means that vaccines are dangerous and you shouldn't vaccinate.

KELTO: She says health officials have worried about this for years. If the court becomes too high profile and people keep hearing about payouts to vaccine victims, the public might think vaccines are more dangerous than they are and vaccination rates might fall. Kirkland says a few years ago there was an attempt to promote the court more.

KIRKLAND: So they had this whole public relations firm prepare this advertising campaign and then Congress just didn't fund it.

KELTO: So the vaccine court keeps humming away quietly in the background, hearing cases from people who are able to find it.

CORNISH: That's NPR's Anders Kelto. And Anders, I have one more question about Congressional funding. Why hasn't Congress funded this?

KELTO: Well, it's difficult to say. I've spoken with a number of people about this and they all seem to mention what you heard at the end of the story, this concern that if too many people know about this court then they're going to be scared that vaccines are more dangerous than they actually are. Vaccination rates might fall. But that's not to say that this is an elaborate conspiracy theory or anything like that. No one believes that they're trying to keep this court a secret. The court is mentioned on the CDC website. There's information about what to do if you have an adverse reaction and how to locate this court. And every single vaccine dose comes with information about possible side effects and information about what to do if you're harmed.

CORNISH: NPR's Anders Kelto. Anders, thanks so much.

KELTO: Thank you, Audie. Transcript provided by NPR, Copyright NPR.