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Injury claims for vaccines could face a bureaucratic ‘black hole’

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Christina Grim displays a memorial tattoo to her mother, Verl Grim, at her home in Littlestown
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A truth most don’t know as they roll up their sleeves is lost in the U.S. introduction of the coronavirus vaccine: In occasional cases of severe illness from the vaccines, the injured are blocked from appealing and steered instead to an obscure federal bureaucracy with a record of seldom paying claims.

Housed in a nondescript building in a suburb of Washington, D.C., the Countermeasures Accident Settlement Program has only four workers and few ordinary court signs. Government officials make decisions in secret, applicants can not appeal before a court, and payments are capped at $370,376 in most cases of death.

Peter Meyers, professor of law at George Washington University, has studied the program for years and bluntly calls it a “black hole,” receiving federal records this summer revealing that in its 15-year existence it has paid less than 1 in 10 claimants.

Historically, vaccines offer broad safety with little risk, but as with any other medications, they come with side effects. In the early days of Pfizer’s COVID-19 vaccine delivery in the U.S., few unexpected adverse effects were recorded, although an Alaska health worker experienced a significant allergic reaction that involved shortness of breath.

But experts are worried that even a good rollout with relatively few adverse effects may be enough to swamp the program with the sheer number of individuals expected to get coronavirus vaccines in the U.S., more than 200 million.

“Dr. Vito Caserta, who oversaw the countermeasures program from its creation until his retirement in 2014, said, “It will have to be ramped up for sure. “They may very, very quickly get overwhelmed.”

Asked about that opportunity, David Bowman, a Health Resources and Services Administration spokesperson who manages the program, said it is “planning to process the potential influx of claims from COVID-19.” … As required, additional workers and contractors will be employed.
The Countermeasures Injury Compensation Program was created by a 2005 law primarily to deal with vaccines developed under the emergency authorization, unlike the more established federal vaccine court that decides instances of injury from most childhood vaccines and other common inoculations. The aim was to give pharmaceutical companies and government agencies the freedom to produce and administer vaccines without the risk of overrunning costly liability litigation to meet immediate public health needs. Under the scheme, it is only possible to prosecute drug companies for “willful misconduct.”

At the time, many senators protested, with the late Democrat Edward M. Kennedy of Massachusetts calling it a “Christmas present to the drug industry and a bag of coal to everyday Americans.”

A decade ago, the vast majority of the claims under the initiative originated from the H1N1 swine flu vaccine. And its nature is reflected by the low number of people awarded money, 29 out of 499.

Within a year after having a vaccine, most lawsuits must be filed, regardless of when side effects occur, and the program does not pay attorneys or expert witnesses fees. For those filing claims to join, it gives no incentive. And the prizes do not pay for damages or pain.

“Sarasota, Florida-based vaccine lawyer Anne Carrion Toale, said, “It’s illusory. “In that program, no one is going to actually get compensation.”

By comparison, within three years, the vaccine court accepts lawsuits, pays attorneys and witnesses, grants pain and distress awards, and allows appeals all the way to the Supreme Court.

vaccines

vaccines

The disparity is not only expressed in the number of awards but also their scale. For an average award of around $200,000 a claim, the countermeasure program paid out $6 million. In recent years, the vaccine court has not only paid out in 7 out of 10 cases, but its $570,000 average per lawsuit is more than two and a half times greater, exceeding $4.4 billion in its three-decade existence.

Law professor Meyers, who obtained the details from the compensation court through a request from the Freedom of Information Act, characterized the 29 awards as “shockingly low” and called for the reform of the scheme.

He also expressed concern that, in the midst of a pandemic that has so far affected more than 75 million people and killed almost 1.7 million people worldwide, it could deter people from taking vaccines.

For anti-vaxxers, it’s a perfect claim to suggest, ‘Oh, my Goodness, this is risky, and if anything happens to you, the program is… going to turn its back on you,'” said Meyers, former chair of the vaccine court’s government advisory group.”

Meyers said it would be useful to know exactly why each application in the payout program was accepted or denied, but it does not disclose even the most basic information, such as the types of diseases people claim to have acquired from vaccines.

Vaccine lawyer Toale claims the one-year filing deadline is one of the greatest causes for rejection. She recalled that a decade earlier, she received hundreds of calls from people saying they had been infected with H1N1 vaccines, some complaining of potential symptoms of Guillain-Barre syndrome, a rare disease of the immune system that can lead to paralysis or death.

vaccines

vaccines

“They’ve all been way too late,” she said. “We couldn’t do anything there.”

That was the case for Christina Grim of Littlestown, Pennsylvania, who said she filed a lawsuit about a year after finding from her mother’s doctor that the Guillain-Barre syndrome that killed the 76-year-old daycare worker was possibly induced by an H1N1 vaccine.

The clock was beginning to tick, but she showed no symptoms. I didn’t know what was going on with her,’ said Grim, whose mom, Verl, ran up $25,000 in hospital bills a few days before she died in 2010 after she was found crawling down a hallway at home, legs limping. “I didn’t know the vaccine was capable of doing this to her.”

No one is sure how many of the more than 200 million Americans expected to receive vaccines against coronavirus are likely to experience significant side effects, and not everyone who does is going to file a lawsuit. About one in a million people who were first given measles, mumps, and rubella vaccinations half a century ago had serious reactions, while other vaccines had higher ratios.

For example, using 25 per million people who experienced serious side effects from the H1N1 vaccine will bring the number of such cases of coronavirus vaccinations to over 5,000. In its entire history, that’s more than 10 times what the countermeasures program has got.

Meyers said one option is to pass coronavirus lawsuits to the vaccine court, officially referred to as the National Compensation Scheme for Vaccine Injuries, but the court itself is struggling to work through a backlog of its own litigation, with its eight judges currently taking more than five years to settle claims.

Support is another problem. The countermeasures program depends on Congress for its budget, unlike allegations in the vaccine court, which is funded by a 75-cent excise tax for every vaccine shot. Congress’ allocation of $30 billion to purchase vaccines and finance other measures to combat coronavirus requires some of the money to be diverted to a fund to pay lawsuits, but none has yet been transferred.

HRSA spokesman Bowman said that as the need for funding arises, those requests will be made.

That’s not good enough, said former Justice Department vaccine lawyer Richard Topping, now a chief legal officer for health insurer CareSource.

“We basically don’t have a plan, no coverage,” he said.

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