The most common injury from errant vaccine shots might no longer be paid through a federal program due to a rule change ushered in during the final
The most common injury from errant vaccine shots might no longer be paid through a federal program due to a rule change ushered in during the final days of the Trump administration.
More than 2,200 Americans since 2017 have filed shoulder-injury claims to the National Vaccine Injury Compensation Program.
But a rule change signed last month by former U.S. Department of Health and Human Services Secretary Alex Azar would remove shoulder injuries from the program, known as vaccine court.
The move comes as more than one million Americans get vaccinated against COVID-19 every day at nursing homes, clinics and stadium-style mass immunization sites to curb a once-in-a-century virus. Adding barriers for those who have rare but serious side effects sends the wrong message as the nation undertakes an unprecedented immunization campaign, experts say.
And attorneys who represent consumers who file vaccine claims warn Americans might choose to sue nurses, pharmacists or other vaccine administrators in civil court for such injuries if they’re shut out of vaccine court.
“Of all times to give less protections to the vaccine injured, now’s not the time,” said Anne Carrión Toale, a Florida attorney who specializes in vaccine-injury cases “It’s the worst possible time.”
‘These are real injuries’
Federal vaccine court, established under the National Childhood Vaccine Injury Act of 1986, handles rare cases of people who have serious side effects from a recommended vaccine. The court was established to ensure a steady supply of vaccine and keep costs low for immunizations that provide broad public health benefits.
The court has a list of “table injuries” making people eligible for compensation if they show they received the covered vaccine and document side effects within a set period. If an alleged harm is not listed as a table injury, a person must prove a vaccine caused the injury.
HHS said removing claims of SIRVA, or shoulder injury related to vaccine administration, as a table injury will ease a backlog of cases and allow more timely decisions for other claims.
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The rule change, scheduled to take effect later this month, does not immediately affect those who allege injury from coronavirus vaccines.
Early safety data on the first 22 million people vaccinated found no serious safety problems. People who had allergic response have been treated successfully, according to the Centers for Disease Control and Prevention.
COVID-19 claims are routed through the post-9/11 Countermeasures Injury Compensation Program, which has rejected 90% of vaccine-injury claims over the past decade.
In order to be eligible for vaccine court, the CDC must recommend a vaccine for routine use by children or pregnant women. Clinical trials are underway for children aged 12 and up, and the nation’s top infectious disease expert, Dr. Anthony Fauci, said he hopes children can be vaccinated by late spring or summer.
However, the rule change signed by Azar also eliminates a provision that adds to vaccine court any new CDC-recommended vaccine for routine use by children.
White House Chief of Staff Ron Klain has called for a regulatory freeze that would postpone new rules for 60 days to allow incoming Biden administration appointees to first review such changes.
Health Resources Services Administration, which oversees vaccine court, will “work closely with the new administration to advance appropriate regulations and policies that are in line with the agency’s mission,” agency spokesman David Bowman said in an e-mail.
HHS said shoulder injuries mostly occur when a vaccine injection is improperly administered. Some have experienced side effects even when shots are correctly administered, said David Carney, a Philadelphia attorney who specializes in vaccine-injury cases.
People are diagnosed with conditions such as bursitis, rotator cuff impingement and frozen shoulder. Many miss work, lose range of motion in their arm and are unable to sleep on the injured shoulder, Carney said.
“These are real injuries where a person has an almost immediate onset of severe pain – 10 out of 10 pain that lingers for months,” Carney said.
‘Pain kept me up at night’
Sharifah Wilson, a nurse anesthetist, had to get annual flu shots for her job at a Philadelphia hospital. She never gave it much thought, until she felt a sharp pain in her shoulder after getting one during a 2016 shift.
The Blue Bell, Pennsylvania, resident said months of misery followed. She lost strength in her left arm. Her left hand tingled like pins and needles. She was diagnosed with brachial neuritis and completed eight months of physical therapy. She received an award after filing a claim with vaccine court.
She said her pain eventually subsided but the injury was career altering. She works with pediatric patients often but when she must lift adults, her arm tires easily.
She supports vaccines and received both her COVID-19 immunizations with no side effects. But she said eliminating shoulder injuries from vaccine court is “horrible” and might shut out people who have legitimate injuries.
“The pain kept me up at night,” Wilson said. “I still have some deficits from it.”
Shoulder injury claims surge
Shoulder injuries were added to vaccine court following reviews last decade by the Institute of Medicine and the Advisory Commission on Childhood Vaccines. Rules were drafted during the Obama administration. SIRVA became a vaccine court “table injury” in 2017.
“The Obama-Biden administration went through a very thoughtful process of adding SIRVA as a table injury,” Toale said. “In contrast, the decision to take away SIRVA was done super fast and in a very shady way.”
HHS said the advisory committee discussed the proposed changes in meetings last March and May, and that the agency collected extensive public comments over six months.
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In a July filing of the proposed rule change, HHS said the shoulder-injury cases made up 52.6% of all claims over the last three years. The median award of $71,355 was more than three times what people collected for similar cases filed in civil court.
The Department of Justice also uncovered 27 cases in which medical records were altered, including changes to the vaccine site. The lucrative awards and altered records “threaten the integrity” of vaccine court, HHS said in a filing.
However, Carney said taking away a route for people to get compensation in these rare cases doesn’t benefit the public.
“It’s just one of those things that’s contradictory to what we’re trying to do during a pandemic,” said Carney. “I absolutely think it’s going to lead to public mistrust.”
Ken Alltucker is on Twitter at @kalltucker, or can be emailed at [email protected]