Vaccine Court’s Tough Standards May Face Supreme Court Test

The U.S. Supreme Court is being asked to decide whether people who suffer harmful vaccine side effects should have an easier time winning compensation from the government.

Congress created what’s known as the vaccine court in 1986, setting up a no-fault system to shield drug makers from crippling jury awards and compensate those who are hurt in the pursuit of a greater public good. The question about how the system works -- and whether more injured parties should get the benefit of the doubt -- is being raised as some contagious diseases including measles resurface and debate rages over whether vaccine skeptics should be allowed to choose not to have their children inoculated.

“The government is in a difficult position,” said Ed Kraus, a professor at the Chicago-Kent College of Law who represents plaintiffs in vaccine cases. He said the U.S. is walking a tightrope in trying to protect all Americans’ health as well as those few who have bad reactions to vaccines.

The court works well for many, he said, but when cases aren’t clear-cut “it’s not meeting the needs of people who have legitimate claims because the science is so complex and the burden of proof is high.”

The case the Supreme Court will this week consider taking was filed by the parents of Ilya Dobrydnev, who had a hepatitis B vaccination in 2001, when he was 10. He had a fever, swollen lymph nodes, inner ear inflammation and eventually debilitating memory loss. Now 23, he’s disabled by chronic fatigue syndrome.

In 2004, his lawyer petitioned the National Vaccine Injury Compensation Program. The vaccine court -- which consists of special masters at the U.S. Court of Federal Claims -- in 2013 granted his parents $1 million and annual payments to cover the cost of his care.

Victim-Friendly Standard

The U.S. Justice Department challenged the decision the next year, saying there wasn’t sufficient evidence of cause to support such an award, and a federal appeals court overturned it. The Dobrydnevs’ Supreme Court petition claims the government set too high a bar and asks the justices to order the vaccine court to adhere to the more victim-friendly standard their lawyer contends was envisioned by Congress.

“I happen to think vaccines are extremely important for public health,” said their lawyer, Mark Friedlander of McLean, Virginia. “But if something goes wrong, people think the government’s going to be there for them. They’re not.”

Nicole Navas, a Justice Department spokeswoman, declined to comment on the case. The Supreme Court is scheduled to consider whether to take it on Friday.

Vaccine Tax

The vaccine court was created after a wave of litigation in the 1980s, including high-profile verdicts against makers of whooping cough and polio immunizations. Huge civil judgments raised prices and reduced the number of companies willing to make vaccines. That threatened public health goals.

At the same time, Congress recognized that immunizations eliminating many diseases put some individuals at risk. So lawmakers set up the no-fault system of recovery for injury or death, with relaxed rules of evidence. Most liability is shifted to the government, with damages capped. Plaintiffs can’t pursue a claim in a regular federal court until they’ve exhausted efforts in the vaccine court. Compensation is paid out of a $3.5 billion fund built from a 75-cent-per-dose tax on vaccines.

While a count of vaccines administered in the U.S. isn’t available, the number of compensation petitions is small compared with the billions of doses produced. The vaccine court has given $2.9 billion to about 3,900 claimants. Another 10,000 or so cases have been dismissed, according to the Department of Health and Human Services.

Autism Cases

Injuries are “certainly rare, but we don’t know exactly how rare,” said Kraus, the professor, who’s a member of the HHS Advisory Commission on Childhood Vaccines.

Some parents are convinced vaccines are harmful to children’s immune systems and shun or delay inoculations. A measles outbreak that began at Disneyland last year was linked by some medical studies to low vaccination rates.

In the court’s early years, more than 90 percent of cases were fast-tracked: If someone suffered a particular side effect within a specified period of time after getting vaccinated, the shot was deemed to have caused the injury and the complaining party received an award within a year or two.

Awards ranged from $25,000 to $50,000 for a sustained but non-disabling allergic reaction, after a shot for diphtheria, whooping cough and tetanus, to millions of dollars for a permanently disabling brain injury.

Science-Driven

In the early 2000s, the vaccine court was flooded by more than 5,000 claims asserting that the mercury-containing preservative thimersol and the measles-mumps-rubella vaccine triggered autism. The court rejected claims in six test cases; most of the the autism cases have since been dismissed.

By 2014, according to the Government Accountability Office, fewer than 2 percent of vaccine cases were submitted as fast-track claims. The others had to meet a stricter threshold of a “preponderance of evidence.” That was a decision of HHS, which implements the law that established the vaccine court. What evidence is needed to meet that standard is at issue in the Dobrydnev case.

The change in the standard was driven by science, according to Anna Kirkland, a political science professor at the University of Michigan who is writing a book about the court.

Safer versions of whooping cough and polio vaccines enabled the department to eliminate certain injuries from the fast-track compensation process, she said. Other fast-track claims for some kinds of seizures and other injuries were weeded out based on studies by the Institute of Medicine, which the department, under the law, had to consider. The department decided in the late 1990s that injuries from newer vaccines like chicken pox, flu and hepatitis B would be eligible for compensation but not with the fast-track standard.

More Weight

The special masters are “doing the best they can with the science they have,” Kirkland said. “They’re getting it from both sides. Mainstream pediatricians think they’re compensating way too much -- some lawyers say not enough.”

In the Dobrydnev case, the family presented opinions from doctors specializing in chronic fatigue syndrome that the vaccine caused the illness. That should have been enough under the generous standard Congress intended, according to Friedlander, the family’s lawyer.

The appeals panel held that more weight could be given to government experts -- and they said Ilya wasn’t in good health before getting the hepatitis B shot, so his case didn’t meet the burden of proof for compensation.

His mother, 51-year-old Yuliya Dobrydneva of Norfolk, Virginia, said the process has been devastating. “We absolutely didn’t get a fair shot. It was vicious.”

The Supreme Court is the family’s last chance for compensation, she said. “We’ve exhausted all appeals, all our options. This is it. This is where it ends.”

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