(Reuters) – As the Biden administration puts the final touches on an emergency COVID-19 vaccine mandate for companies with 100 or more employees, a crucial piece seems to be missing for the unlucky few who experience serious side effects: meaningful legal recourse.
More than 1,300 COVID vaccine-related injury claims are now pending before an obscure government tribunal, which to date has decided only two such cases, one involving swelling of the tongue and throat following the jab, the other alleging long-lasting, severe shoulder pain.
In both instances, the government, which requires claimants to prove their injuries are “the direct result” of a COVID-19 vaccine, denied compensation.
It’s a steep burden of proof. Lawyers tell me the vaccine is so new that there’s virtually no definitive research on injury causation to cite.
Indeed, the overwhelming majority of all litigants under what’s known as the Countermeasures Injury Compensation Program have not succeeded. According to program data, 29 claims have been paid for injuries stemming from other vaccines since the tribunal’s inception in 2010. (Ten additional claims won approval but no compensation.) The other 455 claims – 92% – were denied or otherwise deemed ineligible for review.
For those who prevailed, the median award was $5,677, according to my calculations, spanning from a low of $31 to a high of $2.3 million, for a person who contracted Guillain-Barre Syndrome after receiving the H1N1 influenza vaccine.
There is no provision for damages based on pain and suffering.
For people like Jessica McFadden, who said she developed life-threatening blood clots after receiving Johnson & Johnson’s COVID-19 vaccine in April, legal options are unclear. She’s not optimistic about her odds of recovering her losses, and it’s certain she won’t be able to recover any pain and suffering damages under the Countermeasures Injury Compensation Program.
McFadden, 44, said she was previously healthy and needed two emergency surgeries to remove massive clots in her lungs, heart and left leg. She spent nine days in the hospital, racking up $489,153 in medical bills, she said. Her insurance will cover most, but not all of the tab, she said, and she estimates she’ll pay up to $7,000 out of pocket.
She emailed me a photo of extracted clots, which she said were removed during an agonizing procedure performed while she was conscious. They are thick and ropy, like nightcrawlers on a surgical tray.
McFadden, who said she has returned to work but is still taking blood thinners, has not spoken publicly of her ordeal until now. “I’m not an anti-vaxxer. I understand the need for the vaccine,” she said. “I was just trying to do the right thing.”
To be clear, an experience like McFadden described is extremely rare. The Centers for Disease Control and Prevention in May said that out of 8.7 million people who had gotten the J&J jab, only 28 suffered the complication known as thrombosis with thrombocytopenia syndrome. Per the CDC, there is a “plausible causal association” between the vaccine and the blood clots.
Johnson & Johnson in a statement said, “The safety and well-being of the people who use our products is our number one priority.”
To McFadden, the issue is not that COVID-19 vaccines are bad or that no one should get them. Rather, she said, what’s important is how we care for people “when something catastrophic happens” as a result, especially now that vaccine mandates are becoming so widespread.
For decades, vaccine makers have been shielded from product liability lawsuits thanks to the National Childhood Vaccine Injury Act of 1986. The law was passed after pharmaceutical companies were hit with lawsuits over a brain injury known as pertussis vaccine encephalopathy and threatened to quit making the DPT (diphtheria, pertussis and tetanus) vaccine altogether.
Under the 1986 law, people who claim to have been injured by DPT, hepatitis, influenza and other common shots bring their cases in a special, no-fault tribunal, the Vaccine Injury Compensation Program, known colloquially as “vaccine court.” Payouts (including attorneys’ fees) are funded by a 75-cent tax per vaccine.
The forum is far from perfect, but over the years, it has awarded more than $4 billion to injured claimants.
But that’s not where the COVID-19 vaccine injury cases are being decided.
In March 2020, then-Health and Human Services secretary Alex Azar issued a declaration under the Public Readiness and Emergency Preparedness (PREP) Act of 2005 providing liability immunity for medical countermeasures related to the novel coronavirus. Injury claims would be handled by the Countermeasures Injury Compensation Program, which is run by the Health Resources and Services Administration and is geared toward public health emergencies.
Coverage for claimants is limited: Lost wages up to $50,000 a year and out-of-pocket medical expenses. If the person died,
his or her next-of-kin can seek death benefits up to $370,376.
A spokeswoman for HRSA declined my request for an interview but explained in an email how the process works.
First, the person claiming an injury submits a request for a benefits form and relevant medical records. For COVID-19 vaccine injuries, the claims already include a veritable Merck Manual of maladies, everything from dizziness to deafness to death, according to HRSA data.
The form is “reviewed by CICP medical staff,” who decide whether the requester is eligible for program benefits.
If requesters don’t like the decision, they can ask for reconsideration by “a qualified panel, independent of the program.” The panel makes a recommendation to the associate administrator of the Health Systems Bureau of HRSA, whose decision on the payout is final.
You might notice a few things are missing, like an independent judge, a chance to present one’s case in person, damages for pain and suffering and the right to appeal beyond the agency.
Vaccine court has all these features. CICP has none.
But this is where the COVID-19 vaccine cases are relegated, at least for now. Per the steps laid out in the 1986 vaccine law, for the COVID-19 vaccine to move to vaccine court, the CDC must first recommend the shots for routine administration to children. Then Congress must pass a law adding the 75-cent tax on each COVID-19 vaccine given, and the Secretary of Health and Human Services must move the vaccines to the Vaccine Injury Compensation Program.
All of this could take years.
Legislation is pending in Congress that would expedite the process (as well as upping vaccine court damages, extending the statute of limitations from three years to five and adding more special masters), but it has yet to gain traction.
Spokespeople for the bill’s sponsors in the House of Representatives – Texas Democrat Lloyd Doggett, and Republicans Fred Upton of Michigan and Mike Kelly of Pennsylvania – did not respond to requests for comment.
In the meantime, people like McFadden face a strict one-year deadline from the date of vaccination to file a claim with the CICP. But it’s not clear if filing in the CICP would preclude her from later moving her case to vaccine court, should that become an option.
She told me that she’s waiting until early next year to decide how to proceed.
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