Health Secretary Robert F. Kennedy Jr. is vowing to “fix” the federal program for compensating Americans injured by vaccines, opening the door to sweeping changes for a system long targeted by anti-vaccine activists.

Health experts and lawyers say updates are needed to help clear a backlog of cases in the Vaccine Injury Compensation Program, created by Congress in 1986 as a no-fault payment system for presumed vaccine injuries.

But they also worry Kennedy’s changes will reflect his history as a leader in the anti-vaccine movement, which has alternately called for abolishing the program or expanding it to cover unproven injuries and illnesses that aren’t connected to vaccines.

Kennedy and other critics believe the program is “too miserly in what it considers to be a vaccine injury,” said Jason Schwartz, a public health expert at Yale University. “That’s created great concern that he could expand what’s included.”

Anti-vaccine groups have long suggested a link between vaccines and autism, despite scientific consensus that childhood vaccines don’t cause the condition. Adding autism to the list of injuries covered by the plan “would dramatically increase the number of compensable cases, potentially bankrupting it,” Schwartz said.

Program is credited with saving the U.S. vaccine industry

Signed into law under President Ronald Reagan, the compensation program is designed to provide quick, efficient compensation to Americans who report known injuries associated with vaccines, such as rare allergic reactions. At the time of its creation, a number of vaccine-makers were exiting the business due to risks of class action lawsuits.

In a recent social media post, Kennedy called the program “broken” and accused federal lawyers and adjudicators who run it of “inefficiency, favoritism and outright corruption.”

Kennedy didn’t specify the changes he’s seeking. But some of the people he’s enlisted to help have a history of bringing vaccine injury cases.

In June, the Department of Health and Human Services awarded a $150,000 contract to an Arizona law firm for “expertise” in the program. The firm’s Andrew Downing, an attorney specializing in vaccine injury cases, was listed in the HHS staff directory for a time.

“We just brought a guy in this week who is going to be revolutionizing the Vaccine Injury Compensation Program,” Kennedy told Tucker Carlson shortly after the award.

Revamping the program would be the latest in a string of decisions that have upended U.S. vaccine policy, including this week’s cancellation of research funding for vaccines using mRNA technology.

Downing and Kennedy have had roles in HPV vaccine lawsuits

Downing has had a leading role in lawsuits against Merck alleging injuries from its HPV vaccine, Gardasil, including a rare movement disorder.

In a podcast last year for people with the condition, Downing lamented that the injury compensation program “has taken a hard line” against such cases, leading lawyers to file injury lawsuits in civil court. Approximately 70% of the Gardasil cases against Merck started as claims filed by Downing in the federal injury program, according to court records.

A judge dismissed more than 120 of those cases, citing “a paucity of evidence” that Gardasil caused patients’ problems.

A spokesman for Kennedy declined to comment on Downing’s hiring.

Kennedy himself has been involved in the Gardasil litigation, as both an attorney and consultant.

Before joining the government, Kennedy received payments for referring potential Gardasil clients to Wisner Baum, one of the law firms suing Merck. Following questions about the agreement during his confirmation hearings, Kennedy agreed to give up his stake in the deal and transfer any future fees to “a nondependent, adult son,” according to his financial disclosures.

One of Kennedy’s sons is an attorney at Wisner Baum.

Experts see need for reform

Experts who study vaccine compensation say real changes are needed to modernize the 40-year-old program.

The cap on compensation remains $250,000 for injury or death, the same as in 1986. Similarly, the program still has eight adjudicators, known as special masters, to review all cases before the government. On average, the process takes two to three years.

The fund has paid out $5.4 billion, compensating about 40% of all people who filed claims.

The U.S. has an “ethical obligation” to promptly pay those harmed by government-recommended vaccines, says Dorit Reiss, a professor at the University of California Hastings College of the Law.

“Plus, I think it increases trust in the vaccination program if you have quick, generous compensation,” Reiss said.

One possible change: Adding injuries

As health secretary, Kennedy has broad powers to reshape the program.

One approach could be adding new diseases and illnesses to the government table of payable injuries.

In the early 2000s, the program ruled against more than 5,000 claims from families who said vaccines led to their children’s autism, citing hundreds of scientific studies discrediting the link.

Critics of Kennedy say he could claim that he has new evidence of harm — perhaps from a large autism study he’s commissioned — and add the condition to the program.

In response, the federal government might have to increase taxes on vaccines to replenish the compensation fund, which would make the shots more expensive and less accessible.

“Then you will start to watch the vaccine program infrastructure in this country disintegrate until someone steps in,” Dr. Paul Offit, a vaccine researcher at Children’s Hospital of Philadelphia who has clashed with Kennedy for years.

A recent Senate hearing titled “Voice of the Vaccine Injured” appeared to make the case for expanding the program. Witnesses included two representatives from Children’s Health Defense, the nonprofit group that Kennedy previously chaired and has repeatedly sued the government over vaccines.

The group’s chief science officer, Brian Hooker, told lawmakers he tried unsuccessfully for 16 years trying to get compensation for his son’s autism, which he attributes to the measles-mumps-rubella vaccine.

Another possible change: Removing vaccines

Another approach would involve removing certain vaccines from the program, making it easier to bring lawsuits against vaccine-makers. Under current law, people claiming injuries from vaccines covered by the program must first pursue a compensation claim before they can sue.

In cases where the science doesn’t support a connection to vaccines, lawyers might be more successful before a jury.

“Jury trials take advantage of the fact that most jurors don’t know anything about science or medicine,” Offit said. “They are not going to be as easily moved by the data.”

Still, attorneys who bring cases before the compensation program say the process has become more burdensome and adversarial over the years.

Even small changes could improve things. For instance, the statute of limitations for claims could be extended beyond the current three years, which lawyers say cuts off many potential clients.

“I’m hoping there will be changes put in place that make the program easier for petitioners to navigate” said Leah Durant, a vaccine injury attorney.

(AP)