While much of the federal government is focused on fighting the coronavirus pandemic, a small program is quietly proposing a giant change that could affect thousands of injured people.
A division of the Department of Health and Human Services is proposing to remove the leading cause of vaccine injuries from the federal program that compensates victims.
"We think this is highly unfair in a time where the country and everyone is so concerned about how do we prevent illness," said Leah Durant, an attorney who devotes most of her D.C. law practice to those cases after suffering the injury herself.
It's called SIRVA, short for shoulder injury related to vaccine administration. It's happened to thousands of people across the country who went in for a simple vaccine, just like millions do each year.
But the location of the shot on their arm or the angle at which it was given caused the life-changing injury.
"This is not just an ouchy shoulder ... these are injuries that severely impact people's lives," Durant said. "The pain is debilitating."
Just three years ago, the Department of Health and Human Services added SIRVA to the list of vaccine injuries eligible for quicker and easier payouts through the program.
"The science is still valid. Nothing has changed, just many more people have become aware of the injury," Durant said.
A News4 I-Team investigation in 2018 first exposed that half of all the new cases being filed in the Vaccine Injury Compensation Program were not from catastrophic vaccine reactions, but from SIRVA, which derives from the way the shot is administered.
That number has climbed to more than 60% so far this year.
"The staff at DOJ and HHS are overwhelmed by these cases," said Michael Milmoe, who retired from the Department of Justice after 30 years representing the government in vaccine injury compensation cases.
Milmoe questions the motivation of this new proposal to remove SIRVA from that list.
"The only thing that's changed has been the number of cases filed, and I think that's the real reason behind the proposed regulation," he said.
He also questions the timing and how the proposal has been confidentially circulated among those who work in the program.
"They're trying to do it in the dark of night without anybody knowing about it," said Milmoe, who is married to Durant and now works in her law firm.
Milmoe wrote a letter to HHS Secretary Alex Azar opposing the proposed change, as did prominent orthopedic surgeon Uma Srikumaran, who directs a shoulder fellowship at Johns Hopkins School of Medicine and chairs the Department of Orthopedic Surgery at Howard County General Hospital.
A member of the Advisory Commission on Childhood Vaccines, which normally would approve these kinds of changes, also wrote a letter questioning how it's being done and voiced concern at their March meeting.
"Quite frankly, I was stunned at some of the comments and suggestions that have been made in support of this idea," said commission member John Howie.
He was particularly distressed by HHS's new assertion that SIRVA doesn't belong in the program because the injury is not caused by what's inside the syringe.
Dr. Cody Meissner, who chairs the commission, reiterated that point in the meeting.
"It's not a fault of the vaccine, and I think that's what's driving this change," Meissner said.
Howie told the I-Team that for weeks HHS has rebuffed his requests for answers from experts and a public debate. Durant thinks that's because they don't want to contradict their own research.
"HHS has already evaluated this and found that SIRVA are valid injuries," she said.
Howie said he recently heard from HHS that they may be willing to organize a phone meeting to answer commissioners' questions about the proposal prior to the comment period ending May 21.
The I-Team first questioned a division of HHS in January 2019 regarding rumors of an effort to remove SIRVA cases from the program. At the time, a spokesperson said there were no plans to do that.
Now, when questioned about the reason for the proposed change and how it's being done, the same spokesperson said the agency has no comment.
Milmoe says the real solution is to prevent SIRVA injuries from happening by notifying and retraining shot givers who cause the injuries, not to take away the rights of patients who have suffered, especially now.
"When the coronavirus pandemic issues are being dealt with by all of the higher levels at HHS, I'm afraid that there is a concerted effort to slip this through while nobody's looking. That's certainly the way that they're acting," said Milmoe.
Also distracted are doctors, nurses and pharmacists who give vaccines and vaccine makers — all of whom would be subject to vaccine injury lawsuits without protection from this program. It was created to preserve the vaccine industry and has paid out more than $4 billion to patients, $162 million of that for SIRVA claims.
"Unfortunately, if this proposed rule were to pass, it would cause many people not to have any recourse as a result of these injuries," Durant said.
Reported by Jodie Fleischer, produced by Rick Yarborough, and shot and edited by Jeff Piper.
