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March 25, 2022 COVID News

COVID

National Geographic Asks: Why Is It So Hard to Compensate People for Serious Vaccine Injury?

Vaccine injury compensation in the U.S. is broken, according to Tara Haelle, an independent science and health writer. In an article for National Geographic, Haelle outlined some of the flaws in existing programs, and what might be done to fix them.

Vaccine injury compensation in the U.S. is broken, according to Tara Haelle, an independent science and health writer. In an article for National Geographic, Haelle outlined some of the flaws in existing programs, and what might be done to fix them.

Haelle interviewed healthcare experts who told her the government’s failure to acknowledge vaccine injuries and compensate the injured has undermined public trust in vaccines and created more “vaccine hesitancy.”

“Vaccine hesitancy stems from lack of public trust,” said Maya Goldenberg, who studies vaccine hesitancy at the University of Guelph in Ontario.

As of March 22, about 217 million people are “fully vaccinated” in the U.S., but 16% of Americans still refuse to get the vaccine, according to the Kaiser Family Foundation. A previous survey found one in five people cite side effects as the top reason for not getting vaccinated.

“People need to be confident that vaccines are safe and effective when they make a decision to get vaccinated,” said Goldenberg. “They also need to know that, insofar as there are real dangers involved, people will be cared for and not stranded in that rare situation [of vaccine injury].”

Walter Orenstein, associate director of the Emory Vaccine Center in Atlanta, told Haelle, “Vaccination is not a per-individual benefit, it’s for societal benefit, and when someone is injured by that vaccine, I think society owes that individual compensation.”

Haelle interviewed several people injured by COVID-19 vaccines, including Jessica McFadden, a 44-year-old fundraising officer in Indiana who was hospitalized with thrombosis with thrombocytopenia syndrome, or TTS, one week after getting the Johnson & Johnson (J&J) vaccine.

McFadden said she’s vexed the government pushed so hard for everyone to get vaccinated and did not push to compensate those who, like her, were harmed.

“It’s like [we’re] the cost of doing business in a pandemic,” she said.

McFadden said she has good health insurance. Still, she was stuck with a bill for more than $7,000 for a five-day hospital stay and she missed two weeks of work not covered by sick leave due.

Cody Robinson, a 36-year-old stuntman from Atlanta who has won awards for his performances in two dozen films, was also injured by a COVID vaccine. After having COVID in July 2021, Robinson didn’t see a reason to get vaccinated right away, but the Screen Actors Guild began allowing productions to require vaccines on set.

After losing several jobs worth more than $40,000 in wages, Robinson said he felt “strong-armed” by his industry. “It became clear to me that the message in the industry was, if you don’t get vaccinated, you ain’t working,” Robinson said.

Like McFadden, Robinson developed multiple blood clots after his J&J jab, including one in his jugular vein. He’s now taking blood thinners and can’t do stunts, so he’s losing money — more than the wage cap of $50,000 established under the Countermeasure Injury Compensation Program (CICP), the government-run program for compensating people injured by COVID vaccines or other countermeasures.

‘If the government’s going to force you to do something, they should provide compensation if they’re screwing you over,’ he said.”

Anna Kirkland, a professor of women’s and gender studies at the University of Michigan and author of “Vaccine Court: The Law and Politics of Injury,” told National Geographic, “the country’s already fragmented and inequitable healthcare system makes it even more important that an injury compensation program functions efficiently.”

“Vaccine injury compensation may be a last line of support for families confronting devastating or lifelong medical conditions because we don’t have a medical or social safety net that reliably keeps sick and disabled people out of poverty in this country,” Kirkland said. “Medical bills are a major cause of bankruptcies.”

How  vaccine compensation programs operate

Typically, someone who is injured by a medical product can sue the manufacturer for damages, as was the case in lawsuits involving opioids and baby powder.

But that’s not the case with vaccines. Legislation passed in 1986 set up the National Vaccine Injury Compensation Program (VICP) to adjudicate and compensate vaccine injury claims in lieu of the civil courts.

Under the VICP, it was still possible to sue vaccine companies for injuries resulting from anything except vaccine design — which arguably covered a lot of ground — but all claims had to first go through VICP before they could proceed to a civil court.

The program was described by the legislation as “no fault:” Victims did not have to prove manufacturer negligence and companies would not be held responsible for the effects of their products. Compensation would be paid from a federal fund supported by an excise tax on vaccines — not by the vaccine manufacturers.

The argument at the time was that companies were halting production of certain vaccines because the legal liabilities were greater than potential profits.

According to the Journal of the American Medical Association, by 1985, families were seeking a combined $3.16 billion in damages for just the diphtheria-pertussis-tetanus (DPT) vaccine — 30 times that vaccine’s entire annual market share.

In 2005, President George W. Bush enacted the Public Readiness and Emergency Preparedness (PREP) Act to protect pharmaceutical companies from financial liability for products developed to address public emergencies.

The PREP Act today bars people from suing Pfizer, Moderna, or J&J for COVID vaccine injury.

The PREP Act also introduced the CICP to cover any injuries arising from emergency measures, including non-routine immunizations, medical devices and drugs.

This legislation took certain vaccines out of the jurisdiction of the VICP, including pandemic vaccines, since they are considered “emergency countermeasures.”

Haelle reported a stark difference in the outcomes for claims brought to CICP and those brought to the VICP. Of approximately 400 eligible cases, CICP compensated just 7%, totaling about $6 million. Nearly all the denied claims were related to vaccines.

The VICP, meanwhile, has compensated 41% of resolved cases and paid more than $4.6 billion since 1988.

In the case of COVID vaccines, the CICP has not yet compensated a single claim, though it did approve one. In contrast, Thailand has paid more than $45 million in COVID vaccine claims.

But clearly, the CICP has been even less favorable than the VICP to those suffering injuries from vaccines.

The CICP has a different standard of proof and a different compensation scheme than the VICP. The VICP standard is a “preponderance of the evidence” — the typical “50% plus a feather” standard of civil liability — whereas the CICP standard compensates for injuries only if people provide “compelling, reliable, valid medical, and scientific evidence” that the medical “countermeasure” — such as a COVID vaccine or treatment — led to the injury.

That’s “an ambiguous standard” that David Bowman, a spokesperson for the U.S. Department of Health and Human Services, told National Geographic is higher than the VICP standard.

One might even conclude it is analogous in practice to the “beyond a reasonable doubt” standard of the criminal courts: for CICP, the vaccines are in effect innocent until proven guilty.

In addition, both compensation and due process are more restrictive under CICP, according to Haelle.

For example, unlike the VICP, which covers pain and suffering up to $250,000, CICP compensates only for out-of-pocket medical expenses and lost wages up to $50,000.

The VICP has open proceedings and judicial appeal, but “none of those rights are available under CICP,” Michael Milmoe, a vaccine injury attorney who spent nearly 30 years working in VICP at the U.S. Department of Justice, told National Geographic.

Also, while the VICP covers all attorney costs for families seeking compensation, CICP does not.

CICP doesn’t even have an injury table for COVID vaccines, according to Haelle. As a result, very few paid claims are paid and the public has little trust in the system.

Calls for compensation reform

One possible solution is to place the COVID vaccines under VICP jurisdiction, which would require the CDC to add the vaccines to the childhood vaccination schedule and recommend the vaccines for pregnant women.

For those who see the vaccines as both unnecessary and unsafe for children and pregnant women, this would be a cure worse than the disease.

It would also require Congress to pass an excise tax on the vaccines — a measure pharmaceutical company lobbyists are likely to oppose.

Moreover, the VICP is backlogged and bogged down by its own procedures. Every expert who spoke with National Geographic agreed reform of the vaccine court is long overdue.

“It’s important in the middle of a pandemic that we maintain confidence in vaccines, and one way of doing that is compensating for injuries that meet the criteria,” said Saad Omer, director of the Yale Institute for Global Health. “These [processes] should be streamlined.”

U.S. Rep. Lloyd Doggett (D-Texas) introduced two bills that would address some of these issues.

The Vaccine Injury Compensation Modernization Act of 2021 (HR 3655) would allow vaccines recommended for adults — not just for children or pregnant women — to be added to VICP.

The bill also would increase the statute of limitations from three to five years, shorten the time required to decide cases, increase the number of special masters (administrative judges who decide cases) to expedite cases and raise the maximum compensation for death or “pain and suffering and emotional distress” to $600,000 with annual inflation adjustments.

Meanwhile, the Vaccine Access Improvement Act of 2021 (HR 3656) would expedite the addition of new vaccines — including COVID vaccines — to the VICP by automatically appending an excise tax to vaccines when the CDC recommends them and by speeding up the process of adding them to the VICP. Sen. Bob Casey (D-Pa.) is sponsoring the Senate companion bill (S. 3087).

“Significant delays [of] up to two years have previously stalled the addition of new vaccines to the Vaccine Injury Compensation Program,” Doggett said, and automating the excise tax process resolves that problem for COVID vaccines and future ones.

Politicization, power slow reform efforts

Bioethicists urge compensating generously for COVID vaccine injuries for another reason as well: “Not since the smallpox vaccine have widespread mandates required adult vaccination outside a healthcare or military setting,” wrote Haelle.

“Vaccine mandates raise the government’s moral obligation to generously compensate people harmed by vaccines,” Arthur Caplan, a bioethicist at New York University, told National Geographic.

“At the very least,” said Jason Schwartz, a Yale associate professor of public health, “we should treat COVID-19 vaccines the same way we treat all vaccines that we recommend or mandate.”

The only way that happens — unless Doggett’s and Casey’s bill passes — is if Congress passes the excise tax on COVID vaccines.

But some in Congress are afraid to address any reform of the vaccine compensation system for fear of lending support to “anti-vaccine” forces.

“The existence of the VICP is often used as a sort of ammunition by critics of vaccine safety,” said Schwartz.

David Gorski, a surgical oncologist who blogs about the “anti-vaccine movement,” told Haelle “The anti-vaccine movement, which now has political power that it never had before, would very much want to make it easier to sue pharmaceutical companies” and to eliminate the vaccine court entirely.”

Haelle noted that vaccines have become a partisan issue: “Polls show greater vaccine hesitancy and refusal among Republicans, and more Republican legislators support bills against vaccine mandates,” she wrote.

The issue has become so politicized that even the common-sense reform measures advocated by the bioethicists interviewed by National Geographic may be stalled not by legal or scientific objections, but by the need to hold the line in this latest front of the culture wars.

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