RFK Jr.’s Vaccine Court Spin – FactCheck.org

Health and Human Services Secretary Robert F. Kennedy Jr. misrepresented the country’s compensation program for those who are harmed by vaccines, alleging that it’s biased and corrupt and falsely claiming that a person can’t sue a vaccine company “no matter how negligent they are.” He also incorrectly said there is “zero incentive” for vaccine companies to produce safe vaccines.

Kennedy, who has long criticized the Vaccine Injury Compensation Program as an anti-vaccine activist with Children’s Health Defense, announced in a long X post on July 28 that he intends to “fix” the program. He claimed it “has devolved into a morass of inefficiency, favoritism, and outright corruption” and “routinely dismisses meritorious cases outright or drags them out for years.”

As we’ll explain, several experts objected to some of these descriptions, even if they acknowledged flaws in the current system.

In subsequent interviews with the conservative commentator Charlie Kirk and Newsmax, Kennedy also incorrectly described the options for petitioners to pursue civil litigation and wrongly described vaccine makers as having no incentive to prioritize safety.

How the Vaccine Court Works

The VICP is a no-fault legal system that was created with the passage of the National Childhood Vaccine Injury Act of 1986. 

At the time, vaccine makers were facing an increasing number of lawsuits, particularly from parents alleging harms to their children from the diphtheria, tetanus and pertussis, or DTP, vaccine. While most claims of injury did not win, a few did — sometimes with eye-popping jury verdicts. 

Some vaccine makers decided it wasn’t worth the trouble to keep producing vaccines. By the mid-1980s, there was only one company making the DTP vaccine, and the vaccine’s cost had risen. (Studies later showed no link between the DTP vaccine and many of the brain injuries that were being alleged.) People with claims of vaccine injury, meanwhile, faced costly and lengthy trials and long odds of getting any compensation. 

To resolve both of these issues — and understanding that vaccines are safe, but can never be 100% safe — Congress came up with a compromise. Petitioners with reasonable claims of harm could be compensated fairly and quickly in an alternate legal system, without having to show fault, and without being on the hook for legal fees. In return, vaccine companies would be insulated from many of the lawsuits that were driving them from the business, so they could continue to produce existing vaccines and invest in and create new ones. (The same legislation also set up a vaccine safety monitoring system, the Vaccine Adverse Event Reporting System, and required providers to give vaccine info sheets to patients, explaining the risks and benefits of a vaccine.)

To bring a claim for a covered vaccine, an individual files a petition with the U.S. Court of Federal Claims against the HHS secretary, who is represented in the vaccine court by Department of Justice lawyers. Petitioners either try to show that they have one of the conditions listed on the so-called Vaccine Injury Table, which includes conditions that have been linked to vaccines, or demonstrate that their injury was more likely than not caused by a vaccine (a “preponderance of the evidence” standard). The vaccine injury table is meant to make it easier for petitioners, since as long as a person meets the specified criteria, the injury is presumed to have been caused by the vaccine. Court-appointed special masters, legal officials who act like judges, determine whether a person is compensated, and if so, by how much.

Compensation is paid out of a fund financed by a 75-cent excise tax on each disease-preventable vaccine dose that is recommended by the Centers for Disease Control and Prevention for children, and does not necessarily mean there was agreement that the vaccine caused the alleged injury.

While Kennedy accurately describes part of the trade-off in the design of the VICP, he neglects to mention several of the breaks given to petitioners.

“Each case goes in and has to be proven like a regular court of law, and it’s devolved into this very, very cruel, heartless system that is designed to deny vaccine injury and to deny compensation to people who badly need it,” he told Kirk.

But Renée Gentry, the director of the George Washington University’s vaccine injury litigation clinic, told us that the burden of proof is lower in the vaccine court.

“It’s not easier in civil litigation,” she said. “It just isn’t.”

Unsupported Allegations of Bias and Corruption

In his X post, Kennedy referred to the VICP special masters as “notoriously biased” and said they “typically display an extreme bias that favors the government side.” He also suggested the special masters and government lawyers were corrupt and avoided compensating people to “prioritize the solvency of the HHS Trust Fund.”

Kennedy did not offer specific evidence to support his claims, other than to point to the dismissal rates of the VICP.

“The VICP routinely dismisses meritorious cases outright or drags them out for years,” he wrote in the X post. “Instead of ‘quickly and fairly’ awarding compensation, Special Masters dismiss over half of the cases. Most of those that proceed typically take 5+ years to resolve, with many languishing for more than 10 years.”

We asked HHS for support for these claims, but did not receive a reply. While Kennedy is entitled to his opinions, it’s worth providing context to these statements. 

Experts told us they were unaware of any evidence of systematic bias or corruption. 

The eight special masters are appointed “by judges of the Court of Federal Claims, and are hence independent from HHS and DOJ,” Dorit Reiss, a professor of law at University of California Law San Francisco who specializes in vaccine law and policy, told us in an email.

“Generally, cases appealed are upheld,” she added, noting that in at least some overturned cases, the special master had decided in favor of the petitioner.

Some special masters are more conservative in the evidence they require than others, but that’s true of any court, Gentry, who represents petitioners in the vaccine court, said.

“There are a couple of appeals that went up to the Federal Circuit arguing that a particular special master was biased,” she said. “The Federal Circuit said in no uncertain terms there was no evidence of bias.”

She noted that that particular special master rarely rules in favor of petitioners, and has been appealed more than any other special master, “but bias is a strong word that courts don’t like, so there’s no evidence of bias.”

Gentry also disagreed with Kennedy’s characterization that special masters “routinely” dismiss credible cases. 

“Obviously, every case that we lose, we think they have dismissed a meritorious case, or we wouldn’t have brought it,” she said. But, she added, “I don’t think that’s correct.”

“This statement is Kennedy’s conjecture, opinion, and gloss on the fact that claims he wanted to be compensated were denied compensation (particularly autism),” Anna Kirkland, a professor of women’s and gender studies at the University of Michigan who wrote a 2016 book about the vaccine court, told us. “The special masters often don’t agree with Kennedy and his supporters that the evidence warrants compensation, and some of the experts on his side have been described as not credible by the special masters.”

As for the statistics, Kennedy is correct that the court has dismissed just over half of cases. As of June 1, 52% of the roughly 25,000 adjudicated petitions since the beginning of the program were dismissed, according to the most recent data posted by the Health Resources & Services Administration, the HHS agency in charge of VICP.

Reiss, however, noted that around 5,000 of the dismissed cases were for claims of autism in the omnibus autism proceeding. An extensive body of scientific research has not shown a link between vaccines and autism.

The proportion of cases dismissed has also fluctuated over time, as vaccines and conditions have been added or removed. The 52% dismissed is for the lifetime of the program, but over the last decade, 77% of cases have been compensated, according to HRSA’s accounting. 

One reason for the increase was the addition of the seasonal influenza vaccine to the program and shoulder injuries as a table injury. These injuries are not from vaccines themselves, but rather from improper administration of the vaccine. In recent years, half or more of all injury claims are from adults and for shoulder injuries.

In any case, Kirkland said the sheer number of dismissals can’t be used to determine whether meritorious cases were dismissed.

“Cases are dismissed when there isn’t enough medical evidence for the special masters to connect the person’s injury to the vaccine,” she said. “The vaccine court has done a good job over the years following the weight of medical evidence while trying to be as generous as possible in cases where it’s a close call or where the exact cause of the injury isn’t exactly known, but there’s a plausible mechanism and a reliable expert to testify.”

As for the speed of the process, Kennedy is right that many cases can take a long time, although it’s unclear exactly how long a typical case takes. HRSA’s latest data release says, “On average, it takes 2 to 3 years to adjudicate a petition after it is filed.” 

But Gentry said that is likely only for table cases, with other, more complex cases taking longer. She said she recently received a judgment for a 10-year-old case. We contacted HRSA for more detailed information, but did not hear back before publication.

A 2014 Government Accountability Office report found that between fiscal years 1999 and 2014, about half of cases took more than five years, although in all but one year since fiscal year 2009, “the program has met the target for the average time to adjudicate claims (about 3.5 years).”

Still, it’s important to understand why VICP can be slow. Some cases are just very complex, but Gentry said a major issue was the limited number of special masters.

“We still only have eight special masters when we’ve got 3,500 cases,” she said, noting that sometimes, cases will wait two years just for a trial date, simply because of a lack of space on the docket.

In other cases, delays come from petitioners, who may need time to collect medical records, especially if they are in a rush to file because of the short statute of limitations, or because petitioners’ attorneys hope to find more scientific evidence for their claims, Kirkland said.

Civil Litigation Still Sometimes Possible

Kennedy also mischaracterized the National Childhood Vaccine Injury Act and the circumstances in which petitioners can bring claims outside of the vaccine court.

“No matter how negligent they are, no matter how reckless, no matter how unnecessary their ingredients or their quality control, you can’t sue them,” Kennedy told Kirk, speaking of vaccine companies. 

He went on to say that “under the original act,” those who didn’t like the outcome from the vaccine court “could go to a real court and vindicate their claim,” but that “the act has changed” so that is no longer true. “It is your exclusive remedy,” Kennedy said of the vaccine court.

That isn’t accurate. As we’ve explained before, there are cases in which a petitioner can sue a vaccine manufacturer, although they must go through the vaccine court first. If it has been more than 240 days since filing, or someone is unsatisfied with a decision, a civil case can be filed for claims related to negligence, fraud, manufacturing defects or a failure to warn a patient’s doctor, Reiss confirmed.

Kennedy himself has filed lawsuits against Merck and its Gardasil HPV vaccine for those exact things.

The one category of claims that petitioners are not allowed to bring to another court are vaccine design defect claims. Kirkland explained that this was in the original 1986 statute but also affirmed in a 2011 Supreme Court case, which is likely what Kennedy meant when he referred to a “change.” 

In the Bruesewitz v. Wyeth Inc. case, the court determined in a 6-2 ruling that the original law specifically meant to preempt design defect claims. Otherwise, any alleged side effect could be taken to court, undermining one of the law’s major aims of protecting the vaccine supply. 

“Taxing vaccine manufacturers’ product to fund the compensation program, while leaving their liability for design defect virtually unaltered, would hardly coax manufacturers back into the market,” Justice Antonin Scalia’s majority opinion read.

So, Kennedy is correct that for design defect claims, the vaccine court is a person’s “exclusive remedy.” Since this type of claim is the one that most petitioners would like to make, and the other claims are hard to prove for an approved vaccine, experts said, this does limit a person’s legal options.

But that’s not true of several of the examples Kennedy mentioned, including negligence or manufacturing defects (if that is what he meant by “quality control”). And again, Kennedy is well aware of this, having participated in such lawsuits.

False Claim of No Incentive for Vaccine Safety

In two interviews Kennedy gave following his announcement to “fix” VICP, he incorrectly claimed that there is no incentive for vaccine makers to produce safe products.

“There is zero incentive for these companies to make them [vaccines] safe,” Kennedy said in his interview with Kirk. “They don’t get punished for it in the market. They don’t get punished for it in the court.”

“The companies have no incentive to make vaccines safer,” he similarly said in a July 28 interview on Newsmax. “One, because they can’t be sued. Two, because there’s no market-based incentives,” he continued, going on to refer to vaccine requirements for children to attend school.

Companies do face consequences for unsafe products: Their vaccines can be pulled from the market if a serious safety issue crops up — or, in less severe circumstances, be given different recommendations or additional warnings that limit their use. And of course, to get to market in the first place, companies must rigorously test their products and show that at the time, the benefits outweigh the risks.

Reiss noted that in 1999, RotaShield, a rotavirus vaccine, was taken off the market due to a rare but serious bowel obstruction in babies. The vaccine was in use in the U.S. for less than a year.

In the Kirk interview, shortly after making his incentive claim, Kennedy also repeated one of his favorite lines to claim that vaccine injuries are common.

“There’s chronic undercounting in VAERS,” he said, referring to the Vaccine Adverse Event Reporting System, one of the nation’s vaccine safety monitoring systems. “In 2010, CDC did a study of VAERS, and what they found in their own study is that fewer than 1% of vaccine injuries are reported.”

As we’ve explained before, a Harvard Pilgrim Health Care report did state that “fewer than 1% of vaccine adverse events are reported,” but it wasn’t a formally published study and not from the CDC. An author previously told us it “takes into account that many adverse effects of vaccines are mild and expected so not worth reporting (sore arm, fatigue, local redness, etc.).”

Successful, But Room for Improvement

Contrary to Kennedy’s depiction of VICP as “broken,” the experts we spoke with told us that they consider the VICP generally successful, even if it could be improved. 

“The program has two goals: protect the vaccine supply by limiting liability, and give claimants a more generous and quicker way to be compensated than civil courts, one that does not depend on fault,” Reiss said. “It does both and does them well. It’s quicker and easier than the courts (even if not super quick), and it does limit lawsuits, since claimants have to go through it.”

Gentry, who said that in the last five to 10 years that the compensation program has become more litigious and difficult for petitioners, also said that overall, the VICP has been “very successful” in its nearly 40-year history.

There is broad agreement, however, that the VICP could benefit by having more special masters, a longer statute of limitations, inflation-adjusted compensation amounts and more vaccines in the program, Kirkland said.

Many of these proposals were in a 2023 bipartisan bill to modernize the VICP, which Gentry supported. But the legislation stalled, she said, because of a lack of Republican support, particularly over cost concerns and opposition to the tax on vaccines.

HHS did not respond to an inquiry asking for more details of how Kennedy plans to overhaul the VICP. But the compensation amounts, statute of limitations and number of special masters are all written in statute, so it will take an act of Congress to change them, Reiss said.

One thing Kennedy could do on his own is modify the list of table injuries, which has some experts concerned that he may add injuries that are not evidence-based, potentially bankrupting the trust fund. Reiss said Kennedy would have to publish the notice in the Federal Register, give opportunity for comment and address the comments, as is done with federal rulemaking.

Or, if certain vaccines are no longer recommended by the CDC, that would mean people injured by those vaccines could only seek compensation in civil litigation.

That “kicks those people out into the wild,” Gentry said, calling it her biggest fear. 

And if enough litigation were successful, vaccine manufacturers might once again begin pulling out of the market.

“Policy changes should absolutely follow the best available scientific evidence and not cause harm,” Dr. Tina Tan, the president of the Infectious Diseases Society of America, said in an Aug. 12 statement, noting that her group “agrees” there are ways to improve VICP. “Specifically, it is important that the VICP be funded appropriately to compensate injured individuals without putting an infeasible burden on vaccine manufacturers that could jeopardize severely the availability of safe and effective vaccines for the public.”

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