HHS Proposes Removing Vaccine-Related Shoulder Injury From Federal Compensation Program

A flu vaccine is administered to a patient at a health clinic in Chicago on September 26, 2002. Tim Boyle/Getty Images

The Department of Health and Human Services (HHS) is proposing to remove shoulder injury related to vaccine administration (SIRVA) from the National Vaccine Injury Compensation Program (VICP), denying compensation for thousands of adults suffering from shoulder pain after receiving a vaccine.

SIRVA is an injury to the shoulder that occurs within 48 hours after a vaccine is given to individuals with no prior history of a shoulder disorder. The injury may cause intense pain, weakness, stiffness, and other shoulder-related injuries like bursitis or ulnar neuropathy.

In a departure from its established legal procedure to modify the vaccine injury table (VIT), the HHS mailed a confidential document to all of the commissioners of the Advisory Commission on Childhood Vaccines (ACCV) before the committee’s regular meeting in March, to solicit individual feedback on its proposal to remove SIRVA from the table by May 21, when the comment period would end.

“This is a critical issue and it affects a number of different levels of the program,” John Howie, a vaccine-injury attorney in Dallas and an ACCV member, said at the commission’s March meeting. “As somebody who’s on the frontline representing people who have suffered shoulder injuries, I read that packet, and quite frankly, I was stunned at some of the comments and suggestions that have been made in support of this idea.”

Howie also addressed his concerns about the HHS’s questionable approach in his letter to the ACCV (pdf), which has the responsibility to “recommend changes in the Vaccine Injury Table.” The VIT (pdf) lists the covered vaccines, its associated adverse reactions, and the time of the onset of reaction after vaccination.

The ACCV was created as an independent committee to “provide oversight and recommendations in how the compensation program could function more efficiently,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times.

The HHS argues that SIRVA should be removed from the compensation program to ensure enough money is in the trust fund (that currently has $4 billion) to compensate children injured from vaccines, and that the shoulder injury is not a result of the vaccines themselves, but to the incorrect administration of the needles.

SIRVA mainly occurs when the vaccine is improperly injected, either too high or too deep into the shoulder. The influenza vaccine is the most common cause of SIRVA in adults as it is administered annually to millions of people, with “73% of petitions filed in the last 2 fiscal years” claiming an injury from the flu shot, according to the Human Resources & Services Administration.

According to the CDC, the flu vaccine is only 46% effective for this year's 2020 flu season.

Several of the ACCV members who supported HHS’s claim for SIRVA to be taken out of the compensation program, was Dr. Cody Meissener, the chairperson of the commission. “Shoulder injury is not from the vaccine,” Meissener said at the March meeting, but rather “due to some deviation from the standard of care that’s recommended for a vaccinated person.”

Howie questioned the legality and scientific argument of the HHS, noting that in the creation of the VICP, nothing was written to exclude injuries caused by improper vaccine administration. “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 said.

Dr. Uma Srikumaran, an orthopedic surgeon at the John Hopkins School of Medicine, in an open letter (pdf), urged the HHS to not remove SIRVA since “evidence supports that both vaccine antigen and injection into or near the bursa or synovium are required to cause SIRVA.”

“SIRVA does not result from the ‘trauma’ of the needle being close to or within the bursa or synovium; rather bursitis and synovitis are directly caused by the vaccine antigen delivered by the needle.”

Compensation Program

In 1986, President Ronald Reagan signed the National Childhood Vaccine Injury Act into law in response to the overwhelming lawsuits vaccine manufacturers were facing in the 70s and 80s by parents whose child was injured by the DTP vaccine or the oral polio vaccine.

The Act was passed to protect the vaccine supply and to provide parents of vaccine-injured children the ability to file a claim for compensation as an alternative to the civil court. It also included regulations regarding informed consent and the creation of a system for healthcare professionals to report vaccine-related injuries, known as the Vaccine Adverse Event Reporting System.

Two years after the Act was passed, the VICP, was established as a no-fault system, to compensate individuals injured by a vaccine (listed on the vaccine table) fairly, quickly, and efficiently.

The program is funded by a $0.75 excise tax that is charged to each vaccine. “It’s billed into the cost,” Randy Knutson, a vaccine-injury attorney in Minnesota, told the Epoch Times. “A clinic gives out a vaccine, they collect that $0.75 and send it to the vaccine court fund.”

As for the HHS’s claim that the fund will run out of money, Knutson says: “I don’t think it’s a money question, although that’s what they’re claiming, that they’ll go broke. That’s not happening. I think its the processing problem, which is another government issue.”

Tamara Overby, Acting Director, DICP, said at the ACCV March meeting that the trust fund not only pays the costs for petitioners and their lawyer’s fees, but also needs to “pay the administrative expenses for the Health Resources & Services Administration, for the Department of Justice, and for the court.”

A Flawed System

According to Fisher, who had worked with Congress to add in the safety regulations to the 1986 Act, amendments were added to the Act in the succeeding years, taking away liability for vaccine makers and healthcare workers administering vaccines.

Individuals injured from vaccines covered on the vaccine injury table were no longer able to file a lawsuit against negligent manufacturers or physicians in a civil court without first filing a petition with the U.S. Court of Federal Claims, or vaccine court, and have their claim be denied or they reject the compensation.

The exterior view of the U.S. Court of Federal Claims that houses a special vaccine court in Washington on Oct. 21, 2014. Susan Walsh/AP Photo

After the U.S. Supreme Court declared that vaccines were “unavoidably unsafe” (pdf) in 2011, this further removed all liability from the vaccine makers and “took away all incentives for the pharmaceutical companies to do the kinds of prelicensure studies,” Fisher said. “You’ve taken away all incentives to improve an existing vaccine or to have a very high standard for the licensing of new vaccines.”

For SIRVA cases to be removed from the compensation program, Knutson says there may be fewer people getting the flu vaccine if there are no courses of action for them to take since vaccine manufacturers are protected from lawsuits under the 2011 supreme court decision.

“I don’t really understand the governments’ position on this,” he said. “They want to give out all these flu shots, but take away anyone’s remedy for getting injured by it.”

As for filing lawsuits against doctors or nurses, Knutson says most attorneys will not undertake a medical malpractice case due to the potential cost of “hundreds of thousands of dollars” to bring the case to court. He said a medical malpractice case is “the most expensive kind of case to bring as an attorney, in that, I have to hire a medical expert, I’m going to have to pay $50,000 in costs to bring it.”

Both Knutson and Fisher say that there are not enough attorneys at the justice department to handle all the petitions that are being filed every year.

“The vaccine court is bogged down with SIRVA cases,” Knutson said. According to Human Resources & Services Administration, for the last two years, 54 percent of the cases in vaccine court were SIRVA-related.

Michael Milmoe, a former Department of Justice attorney, said to NBC Washington, “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.”

Knutson says that it takes six months to a year to get a response from the justice department attorneys of whether a petition will go through or not, when it is supposed to take no more than 30 days. He says it takes three to four years for his client to now get through the system.

All of Knutson’s vaccine-injured clients are SIRVA cases, who are in their 60s or 70s. He says that not all of his cases will get compensated (although they are solid and strong) because in the vaccine court, “two-thirds of the petitions are denied.”

Fisher, who works with many parents of vaccine-injured children, says that the compensation program has not fulfilled the promise of what it was created for. “There is a pattern that [has] become very familiar; they try to deny compensation to two out of three petitioners,” Fisher said.

“They have over the last 30 years, gutted the vaccine injury table, so there’s almost nothing on the table that would fulfill the spirit and intent of the law that was supposed to award compensation in the absence of a more biologically plausible explanation for the injury or death.”

The compensation program was also set up where petitioners do not have to pay their attorney fees as the program would pay for it regardless of the result. The reality is, “if we take a case and we lose it, we usually don’t get paid even though they’re supposed to pay the attorney fees win or lose,” Knutson said. “They basically say if you lose, you brought it in bad faith.”

Knutson says that attorneys are not “bringing petitions for no reason.” He says the compensation program has not delivered what it has been set up to do. “It’s supposed to be fast, expeditious, easily compensated, but what it is, is it’s hard to get compensated, slow, and not easy.”