DR P. MARAZZI/Science Source

On the last day of its existence, the administration of former President Barack Obama made it much easier for people who sustain serious shoulder injuries from improperly administered vaccines to win cash compensation from a $4 billion government fund financed by an excise tax on vaccines.

Now, after a surge of shoulder injury claims, President Donald Trump’s administration is proposing to reverse that Obama-era regulation. In a quietly circulating proposal, the Department of Health and Human Services (HHS) argues the shoulder injury claims are related to the improper placement of needles and not to the vaccines themselves and says the claims threaten the “limited” pot of money available. (The fund has grown from $3.7 billion to $4 billion since January 2018.) It also contends that those opposed to vaccination are using the rise in claims to support unfounded assertions that vaccines pose a serious threat to public health.

Vaccine injury lawyers and the vaccine-injured are pushing back, saying the government is ignoring the findings of its own scientists and the National Academy of Medicine, both of which found a causal link between vaccine injection and shoulder inflammation.

“It really is an outrage that they are trying to take away the rights of so many people to obtain recovery under the program,” says Leah Durant, an attorney in Washington, D.C., who began to represent vaccine-injured clients after she sustained a debilitating shoulder injury after a tetanus vaccination. “These injuries have such a humungous impact on your quality of life.” (Science wrote in detail about Durant’s experience.)

A no-fault system

Congress wrote legislation creating the National Vaccine Injury Compensation Program in 1986, responding to a wave of lawsuits against vaccine companies that threatened to drive them from the business. It established a no-fault system under which any person who believes they have been injured by any one of a list of 16 vaccines can file a petition with the U.S. Court of Federal Claims; HHS medical experts decide whether the government should compensate or defend against each claim. If the government wants to deny compensation, Department of Justice lawyers mount a defense, with a judge making the final decision. Private attorneys for the plaintiffs are paid by the government after the decision is rendered.

Under the change made by the Obama administration, petitioners no longer have to prove that an injection caused their shoulder injury. Instead, they simply need to document a previously healthy shoulder, the administration of a vaccine in that arm, and the onset within 48 hours of shoulder pain that persisted for at least 6 months. If the U.S. government wants to deny compensation, it has to prove that the injury was not caused by the vaccine.

After the change, claims for shoulder injury related to vaccine administration (SIRVA) shot up; in the 2018 and 2019 fiscal years, they accounted for 54% of 2520 vaccine injury petitions.

Now, HHS under Trump is arguing that because shoulder injuries are caused by incorrect administration—a needle injected too high on the arm so that it penetrates the shoulder joint rather than the arm muscle—they should be jettisoned from the government-sanctioned list of injuries for which petitioners don’t have to prove causation. Instead, HHS argues, people with SIRVA claims should sue vaccinemakers and administrators in the civil courts (an outcome the 1986 act was intended to prevent.)

Needle or vaccine?

Supporters of the new proposal say it correctly focuses attention on the real culprit: injuries caused not because the vaccines themselves are faulty, but because they were improperly administered, inflaming the shoulder joint. “What you’re seeing is a complication that’s not related to the vaccine itself,” H. Cody Meissner, chairperson of the Advisory Commission on Childhood Vaccines (ACCV), told a fractious commission meeting on 6 March. “It’s not a fault of the vaccine and I think that’s what’s driving this change,” added Meissner, chief of Tufts Medical Center’s division of pediatric infectious disease..

Gillian Woollett, senior research scientist with the consultancy Avalere Health believes the change could motivate vaccine administrators, including private medical practices and pharmacy chains that provide vaccine shots, to properly train their personnel, because they could now be sued by people whose shoulders are damaged by improperly administered vaccines. “This is a critically important program—and people should be administering vaccines properly. You shouldn’t have to trade off between the benefit of the vaccine and the worry of misadministration.”

The HHS move is backed by some physicians and other experts who argue the number of shoulder injury claims are bogging down what is supposed to be a speedy system. (According to the program’s data, payouts for all kinds of claims declined since a high in 2017, but as of 1 March were on track to break records in 2020.) According to a vaccine court opinion last year, shoulder injury payouts have typically ranged from $75,000 to $123,000 when the government chooses not to fight a claim, and from $50,000 to $95,000 in cases that the government has settled without conceding that a vaccine caused a shoulder injury. The government’s proposal states that SIRVA claims resulted in payouts of about $119 million from 2016 through 2019.

“While the number of claims is still very small comparing it to all vaccines administered, SIRVA petitions have driven a significant increase. And that is extending timelines between claim filing and compensation for all cases,” says Kelly Cappio, a vaccine policy expert at Avalere.

Others argue the SIRVA payouts are providing fodder to antivaccine activists. “The antivaccine folks say: ‘Oh, look how dangerous vaccines are because this fund pays out hundreds of millions of dollars every year to people who claim a vaccine reaction.’ Well, in point of fact [SIRVA] is not a vaccine injury, it’s an injury related to … improper insertion of the needle,” says Meissner, who emphasized in an interview with ScienceInsider that he was speaking for himself and not for ACCV.

The American Academy of Orthopedic Surgeons went further last summer, disputing SIRVA’s existence in a position statement it billed as “opinion” and an “educational tool” not based on a scientific review of the literature.

Flawed analysis

Durant and other critics of the new proposal, however, say the HHS arguments are flawed, both legally and scientifically. Nothing in the law that established the program excludes injuries that result from incorrect administration of a vaccine, notes John Howie, a Dallas lawyer who represents vaccine-injured clients and is a member of ACCV. “I have yet to see anything from anybody that says that this program was not designed to compensate people that were injured as a result of a mechanistic-type injury as opposed to a component of the vaccine,” he told Meissner at the commission’s March meeting.

The HHS proposal also “represents the scientific literature in a misleading way,” says Uma Srikumaran, a shoulder surgeon at the Johns Hopkins School of Medicine. In a recent open letter to HHS Secretary Alex Azar that reviews the science, Srikumaran writes that a needle is necessary but not sufficient by itself to cause shoulder injury: The vaccine material itself is needed to trip inflammation. (Physicians regularly inject shoulder joints, for instance, with the anesthetic lidocaine, without causing an inflammatory reaction, he noted to Azar.)

Srikumaran also warned that if SIRVA cases are moved to civil courts, health care providers would have to seek out expensive malpractice insurance to protect against lawsuits. “[T]his could unnecessarily drive up the costs of delivering vaccines and reduce the number of people willing to administer them,” he writes.

The critics also question the timing of the proposal, which has landed in the midst of an unprecedented coronavirus pandemic, and whether it has been handled with adequate transparency. They note that AACV, which advises the HHS secretary on changes to the vaccine injury table, was given a copy of the proposed plan just a few weeks before its last public meeting, on 6 March. The proposal was marked “confidential.” ACCV members were told not to discuss the proposal publicly and it was not mentioned on the public agenda of their March meeting. Meissner obtained late permission from HHS to discuss it at the meeting, he later wrote to ACCV members and brought it up for discussion. (The audio of the polarized discussion that ensued begins 24 minutes into the third segment here.)

In the past, AAVC has spent months reviewing proposed table changes in public sessions. This time, it has been given 90 days, until 21 May, to provide feedback on the plan to the secretary. (The commission’s next public meeting comes after that deadline, in early June. And four of its nine seats are now vacant; three of the five sitting members are medical professionals.) To finalize the change, the administration will ultimately have to publish the proposal in the Federal Register for public comment.

In the meantime, Karen Kain, an ACCV member whose daughter died as the result of a vaccine injury, says she is “very concerned” about the proposed change, especially during a pandemic that experts say ultimately will be defeated only by administering a new vaccine. “We want folks to be vaccinated,” Kain says. “Now that the country is dealing with this public health crisis, the last thing we should be thinking about is taking away” people’s chance at compensation if they are injured, she says. “If people feel they have no recourse if something happens, then I believe they would be fearful to be vaccinated.”

The United States wants to stop compensating for most shoulder injuries, by far the most common claims at the vaccine court.

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