Rare vaccine injury claims steered to obscure federal office
Although most people who protect themselves with a coronavirus vaccine will never develop serious side effects, such rare cases will be ruled out by federal court and instead directed to an obscure program with a record of rarely paid claims.
The Injury Countermeasures Compensation Program, specifically set up for handling vaccines under emergency clearance, has only four employees and few features of a due court. Decisions are made in secret by government officials, applicants cannot appeal to a judge, and payments are capped at $ 370,376 in most deaths.
This is in contrast to the much more established federal vaccination court, which rules cases of injury from most childhood vaccines and other common vaccinations.
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George Washington University's law professor, Peter Meyers, has been following the countermeasures program for years and bluntly calls it a "black hole". This summer, he received federal documents showing that he has paid less than 1 in 10 claims in his 15-year history.
Vaccines have historically offered broad, low-risk protection but, like all other drugs, have occasional side effects. No signs of serious side effects have been seen in massive coronavirus vaccine trials involving tens of thousands of participants, and few unexpected side effects were reported in the early days of the COVID-19 vaccine distribution in the US.
However, experts are concerned that given the sheer number of people expected to receive coronavirus vaccines in the U.S. - more than 200 million - even a successful launch with relatively few negative effects could be enough to keep the program running to flood. In addition, such cases are complex and it is often difficult to establish a direct link between disease claims and a vaccine.
"It should definitely be powered up," said Dr. Vito Caserta, who oversaw the countermeasures program from its inception until its retirement in 2014. "You could be overwhelmed very, very quickly."
When asked about that possibility, David Bowman, a spokesman for the Health Resources and Services Administration, which oversees the program, said that he “plans to process the potential influx of COVID-19 claims. ... additional staff and contractors are hired as required. "
The countermeasures program was created by a 2005 law that gives pharmaceutical companies and government agencies the freedom to develop and distribute vaccines to meet urgent public health needs without the risk of being inundated by expensive liability lawsuits. Under the program, drug manufacturers can only be sued for “willful misconduct”.
At the time, several senators had objected. The late Massachusetts Democrat Edward M. Kennedy called it a "Christmas present for the drug industry and a bag of coal for everyday Americans."
The vast majority of information under the program comes from the H1N1 swine flu vaccine a decade ago. And the small number of people receiving money - 29 out of 499 - reflects its design.
Most claims must be submitted within one year of receiving a vaccine, regardless of when side effects occur, and the program does not pay attorney or expert fees. There is little opportunity for those who submit claims to participate. And the awards don't pay for suffering or harm.
In contrast, the vaccination tribunal allows claims within three years, pays attorneys and witnesses, awards awards for pain and suffering, and allows appeals to the Supreme Court.
The difference is reflected not only in the number of awards, but also in their size. The countermeasures program paid out $ 6 million for an average premium of about $ 200,000 per incident. Not only has the vaccination court paid out 7 out of 10 cases over the past few years, but its average per claim - $ 570,000 - is more than two and a half times higher, totaling 4.4 billion over its three decades of history U.S. dollar.
Law professor Meyers, who received the data from the compensation court at the request of the Freedom of Information Act, described the 29 awards as "shockingly low" and called for a revision of the program.
He also expressed concern that this could deter people from taking vaccines amid a pandemic that has infected more than 75 million people and killed nearly 1.7 million people worldwide.
"It's a great argument for the antivaxxers to say, 'Oh my god, this is dangerous and if something happens to you the program will ... turn its back on you," said Meyers, former chairman of a government advisory group on the Vaccination court.
Meyers said it would be helpful to know exactly why each claim in the compensation program was approved or denied, but it doesn't even reveal the most basic details, such as the types of diseases people have claimed from vaccines.
Sarasota, Florida-based vaccine attorney Anne Carrion Toale believes that one of the main reasons for rejection is the one-year filing period. She recalled receiving dozens of calls from people saying they got sick from H1N1 vaccines a decade ago. Some have complained of possible symptoms of Guillain-Barre syndrome, a rare immune system disorder that can lead to paralysis or death.
"They were all way too late," she said. "There was nothing we could do."
No one is sure how many of the more than 200 million Americans expected to receive coronavirus vaccines are likely to develop serious side effects, and not everyone who does will be able to make a claim. Only 1 in a million people who were given measles, mumps, and rubella vaccines, first given half a century ago, had severe reactions, but other vaccines had higher ratios.
Using the 25 per million who suffered severe side effects from the H1N1 vaccine, for example, would bring the number of such cases from the coronavirus vaccines to more than 5,000. That is more than ten times what the countermeasures program has received in its entire history.
Meyers said one solution is to move coronavirus claims to the vaccination court, formerly known as the National Vaccine Injury Compensation Program. However, this court itself is trying to clear a backlog of its own cases, with its eight judges currently taking more than five years to resolve claims.
Vaccines covered by the countermeasures program may be switched to a regular vaccination court once they are recommended for "routine" administration by federal regulators, especially for children or pregnant women. But Meyers said it doesn't happen that quickly.
Another problem is funding. In contrast to vaccination court claims, which are funded from a 75 cent excise tax on each vaccine shot, the countermeasures program relies on Congress for its budget. A US $ 30 billion allocation by Congress to purchase vaccines and fund other coronavirus control efforts will allow some of that money to be transferred to a claims settlement fund, but no money has been transferred yet.
HRSA spokesman Bowman said these requests will be made when the need for funding arises.
Former Justice Department vaccination attorney Richard Topping, now chief legal officer at CareSource, said that wasn't good enough.
"We have essentially no plan, no reporting," he said.
___
Condon reported from New York, Sedensky from Philadelphia.
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