RFK Jr. Wants to Change a Program That Stopped Vaccine Makers From Leaving the U.S. Market. They Could Flee Again.
by Patricia Callahan ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as theyre published. Five months after taking over the federal agency responsible for the health of all Americans, Robert F. Kennedy Jr. wants to overhaul an obscure but vital program that underpins the nations childhood immunization system.Depending on what he does, the results could be catastrophic.In his crosshairs is the Vaccine Injury Compensation Program, a system designed to provide fair and quick payouts for people who suffer rare but serious side effects from shots without having to prove that drugmakers were negligent. Congress created the program in the 1980s when lawsuits drove vaccine makers from the market. A special tax on immunizations funds the awards, and manufacturers benefit from legal protections that make it harder to win big-money verdicts against them in civil courts.Kennedy, who founded an anti-vaccination group and previously accused the pharmaceutical industry of inflicting unnecessary and risky vaccines on children for profits, has long argued that the program removes any incentive for the industry to make safe products. In a recent interview with Tucker Carlson, Kennedy condemned what he called corruption in the program and said he had assigned a team to overhaul it and expand who could seek compensation. He didnt detail his plans but did repeat the long-debunked claim that vaccines cause autism and suggested, without citing any evidence, that shots could also be responsible for a litany of chronic ailments, from diabetes to narcolepsy.There are a number of ways he could blow up the program and prompt vaccine makers to stop selling shots in the U.S., like they did in the 1980s. The trust fund that pays awards, for instance, could run out of money if the government made it easy for Kennedys laundry list of common health problems to qualify for payments from the fund.Or he could pick away at the program one shot at a time. Right now, immunizations routinely recommended for children or pregnant women are covered by the program. Kennedy has the power to drop vaccines from the list, a move that would open up their manufacturers to the kinds of lawsuits that made them flee years ago.Dr. Eddy Bresnitz, who served as New Jerseys state epidemiologist and then spent a dozen years as a vaccine executive at Merck, is among those worried.If his unstated goal is to basically destroy the vaccine industry, that could do it, said Bresnitz, who retired from Merck and has consulted for vaccine manufacturers. I still believe, having worked in the industry, that they care about protecting American health, but they are also for-profit companies with shareholders, and anything that detracts from the bottom line that can be avoided, they will avoid.A spokesperson for PhRMA, a U.S. trade group for pharmaceutical companies, told ProPublica in a written statement that upending the Vaccine Injury Compensation Program would threaten continued patient access to FDA approved vaccines.The spokesperson, Andrew Powaleny, said the program has compensated thousands of claims while helping ensure the continued availability of a safe and effective vaccine supply. It remains a vital safeguard for public health and importantly doesnt shield manufacturers from liability.Since its inception, the compensation fund has paid about $4.8 billion in awards for harm from serious side effects, such as life-threatening allergic reactions and Guillain-Barr syndrome, an autoimmune condition that can cause paralysis. The federal agency that oversees the program found that for every 1 million doses of vaccine distributed between 2006 and 2023, about one person was compensated for an injury.Since becoming Health and Human Services secretary, Kennedy has turned the staid world of immunizations on its ear. He reneged on the U.S. governments pledge to fund vaccinations for the worlds poorest kids. He fired every member of the federal advisory group that recommends which shots Americans get, and his new slate vowed to scrutinize the U.S. childhood immunization schedule. Measles, a vaccine-preventable disease eliminated here in 2000, roared back and hit a grim record more cases than the U.S. has seen in 33 years, including three deaths. When a U.S. senator asked Kennedy if he recommended measles shots, Kennedy answered, Senator, if I advised you to swim in a lake that I knew there to be alligators in, wouldnt you want me to tell you there were alligators in it?Fed up, the American Academy of Pediatrics and other medical societies sued Kennedy last week, accusing him of dismantling the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans. (The federal government has yet to respond to the suit.)Just about all drugs have side effects. Whats unusual about vaccines is that theyre given to healthy people even newborns on their first day of life. And many shots protect not just the individuals receiving them but also the broader community by making it harder for deadly scourges to spread. The Centers for Disease Control and Prevention estimates that routine childhood immunizations have prevented more than 1.1 million deaths and 32 million hospitalizations among the generation of Americans born between 1994 and 2023.To most people, the nations vaccine system feels like a solid, reliable fact of life, doling out shots to children like clockwork. But in reality it is surprisingly fragile.There are only a handful of companies that make nearly all of the shots children receive. Only one manufacturer makes chickenpox vaccines. And just two or three make the shots that protect against more than a dozen diseases, including polio and measles. If any were to drop out, the country could find itself in the same crisis that led President Ronald Reagan to sign the law creating the Vaccine Injury Compensation Program in 1986.Back then, pharmaceutical companies faced hundreds of lawsuits alleging that the vaccine protecting kids from whooping cough, diphtheria and tetanus caused unrelenting seizures that led to severe disabilities. (Todays version of this shot is different.) One vaccine maker after another left the U.S. market.At one point, pediatricians could only buy whooping cough vaccines from a single company. Shortages were so bad that the CDC recommended doctors stop giving booster shots to preserve supplies for the most vulnerable babies.While Congress debated what to do, public health clinics cost per dose jumped 5,000% in five years.We were really concerned that we would lose all vaccines, and we would get major resurgences of vaccine-preventable diseases, recalled Dr. Walter Orenstein, a vaccine expert who worked in the CDCs immunization division at the time.A Forbes headline captured the anxiety of parents, pediatricians and public health workers: Scared Shotless. So a bipartisan group in Congress hammered out the no-fault system.Today, the program covers vaccines routinely recommended for children or pregnant women once Congress approves the special tax that funds awards. (COVID-19 shots are part of a separate, often-maligned system for handling claims of harm, though Kennedy has said hes looking at ways to add them to the Vaccine Injury Compensation Program.)Under program rules, people who say they are harmed by covered vaccines cant head straight to civil court to sue manufacturers. First, they have to go through the no-fault system. The law established a table of injuries and the time frame for when those conditions must have appeared in order to be considered for quicker payouts. A tax on those vaccines now 75 cents for every disease that a shot protects against flows into a trust fund that pays those approved for awards. Win or lose, the program, for the most part, pays attorney fees and forbids lawyers from taking a cut of the money paid to the injured.The law set up a dedicated vaccine court where government officials known as special masters, who operate like judges, rule on cases without juries. People can ask for compensation for health problems not listed on the injury table, and they dont have to prove that the vaccine maker was negligent or failed to warn them about the medical condition they wound up with. At the same time, they cant claim punitive damages, which drive up payouts in civil courts, and pain and suffering payments are capped at $250,000.Plaintiffs who arent satisfied with the outcome or whose cases drag on too long can exit the program and file their cases in traditional civil courts. There they can pursue punitive damages, contingency-fee agreements with lawyers and the usual evidence gathering that plaintiffs use to hold companies accountable for wrongdoing.But a Supreme Court ruling, interpreting the law that created the Vaccine Injury Compensation Program, limited the kinds of claims that can prevail in civil court. So while the program isnt a full liability shield for vaccine makers, its very existence significantly narrows the cases trial lawyers can file.Kennedy has been involved in such civil litigation. In his federal disclosures, he revealed that he referred plaintiffs to a law firm filing cases against Merck over its HPV shot in exchange for a 10% cut of the fees if they win. After a heated exchange with Sen. Elizabeth Warren during his confirmation proceedings, Kennedy said his share of any money from those cases would instead go to one of his adult sons, who he later said is a lawyer in California. His son Conor works as an attorney at the Los Angeles law firm benefiting from his referrals. When ProPublica asked about this arrangement, Conor Kennedy wrote, I dont work on those cases and Im not receiving any money from them.In March, a North Carolina federal judge overseeing hundreds of cases that alleged Merck failed to warn patients about serious side effects from its HPV vaccine ruled in favor of Merck; an appeal is pending.The Vaccine Injury Compensation Program succeeded in stabilizing the business of childhood vaccines, with many more shots developed and approved in the decades since it was established. But even ardent supporters acknowledge there are problems. The programs staff levels havent kept up with the caseload. The law capped the number of special masters at eight, and congressional bills to increase that have failed. An influx of adult claims swamped the system after adverse reactions to flu shots became eligible for compensation in 2005 and serious shoulder problems were added to the injury table in 2017.The quick and smooth system of payouts originally envisioned has evolved into a more adversarial one with lawyers for the Department of Justice duking it out with plaintiffs attorneys, which Kennedy says runs counter to the programs intent. Many cases drag on for years.In his recent interview with Carlson, he described the lawyers of the Department of Justice, the leaders of it working on the cases as corrupt. They saw their job as protecting the trust fund rather than taking care of people who made this national sacrifice, and were going to change all that, he said. And Ive brought in a team this week that is starting to work on that.The system is supposed to be generous and fast and gives a tie to the runner, he told Carlson. In other words, if theres doubts about, you know, whether somebodys injury came from a vaccine or not, youre going to assume they got it and compensate them.Kennedy didnt identify who is on the team reviewing the program. At one point in the interview, he said, We just brought a guy in this week whos going to be revolutionizing the Vaccine Injury Compensation Program.The HHS employee directory now lists Andrew Downing as a counselor working in Kennedys office. Downing for many years has filed claims with the program and suits in civil courts on behalf of clients alleging harm from shots. Last month, HHS awarded a contract for Vaccine Injury Compensation Program expertise to Downings firm, as NOTUS has reported.Downing did not respond to a voicemail left at his law office. HHS didnt reply to a request to make him and Kennedy available for an interview and declined to answer detailed questions about its plans for the Vaccine Injury Compensation Program. In the past, an HHS spokesperson has said that Kennedy is not anti-vaccine he is pro-safety.While its not clear what changes Downing and Kennedy have in mind, Kennedys interview with Carlson offered some insights. Kennedy said he was working to expand the programs three-year statute of limitations so that more people can be compensated. Downing has complained that patients who have certain autoimmune disorders dont realize their ailments were caused by a vaccine until its too late to file. Congress would have to change the law to allow this, experts said.A key issue is whether Kennedy will try to add new ailments to the list of injuries that qualify for quicker awards.In the Carlson interview, Kennedy dismissed the many studies and scientific consensus that shots dont cause autism as nothing more than statistical trickery. Were going to do real science, Kennedy said.The vaccine court spent years in the 2000s trying cases that alleged autism was caused by the vaccine ingredient thimerosal and the shot that protects people from measles, mumps and rubella. Facing more than 5,000 claims, the court asked a committee of attorneys representing children with autism to pick test cases that represented themes common in the broader group. In the cases that went to trial, the special masters considered more than 900 medical articles and heard testimony from dozens of experts. In each of those cases, the special masters found that the shots didnt cause autism.In at least two subsequent cases, children with autism were granted compensation because they met the criteria listed in the programs injury table, according to a vaccine court decision. That table, for instance, lists certain forms of encephalopathy a type of brain dysfunction as a rare side effect of shots that protect people from whooping cough, measles, mumps and rubella. In a 2016 vaccine court ruling, Special Master George L. Hastings Jr. explained, The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism.Hastings noted that when Congress set up the injury table, the lawmakers acknowledged that people would get compensated for some injuries that were not, in fact, truly vaccine-caused.Many disabling neurological disorders in children become apparent around the time kids get their shots. Figuring out whether the timing was coincidental or an indication that the vaccines caused the problem has been a huge challenge.Devastating seizures in young children were the impetus for the compensation program. But in the mid-1990s, after a yearslong review of the evidence, HHS removed seizure disorder from the injury table and narrowed the type of encephalopathy that would automatically qualify for compensation. Scientists subsequently have discovered genetic mutations that cause some of the most severe forms of epilepsy.Whats different now, though, is that Kennedy, as HHS secretary, has the power to add autism or other disorders to that injury table. Experts say hed have to go through the federal governments cumbersome rulemaking process to do so. He could also lean on federal employees to green-light more claims.In addition, Kennedy has made it clear hes thinking about illnesses beyond autism. We have now this epidemic of immune dysregulation in our country, and theres no way to rule out vaccines as one of the key culprits, he told Carlson. Kennedy mentioned diabetes, rheumatoid arthritis, seizure disorders, ADHD, speech delay, language delay, tics, Tourette syndrome, narcolepsy, peanut allergies and eczema.President Donald Trumps budget estimated that the value of the investments in the Vaccine Injury Compensation Program trust fund could reach $4.8 billion this year. While thats a lot of money, a life-care plan for a child with severe autism can cost tens of millions of dollars, and the CDC reported in April that 1 in 31 children is diagnosed with autism by their 8th birthday. The other illnesses Kennedy mentioned also affect a wide swath of the U.S. population.Dr. Paul Offit, a co-inventor of a rotavirus vaccine and director of the Vaccine Education Center at Childrens Hospital of Philadelphia, for years has sparred with Kennedy over vaccines. Offit fears that Kennedy will use flawed studies to justify adding autism and other common medical problems to the injury table, no matter how much they conflict with robust scientific research.You can do that, and you will bankrupt the program, he said. These are ways to end vaccine manufacturing in this country.If the trust fund were to run out of money, Congress would have to act, said Dorit Reiss, a law professor at University of California Law San Francisco who has studied the Vaccine Injury Compensation Program. Congress could increase the excise tax on vaccines, she said, or pass a law limiting whats on the injury table. Or Congress could abolish the program, and the vaccine makers would find themselves back in the situation they faced in the 1980s.Thats not unrealistic, Reiss said.Rep. Paul Gosar, an Arizona Republican, last year proposed the End the Vaccine Carveout Act, which would have allowed people to bypass the no-fault system and head straight to civil court. His press release for the bill written in September, before Kennedys ascension to HHS secretary quoted Kennedy saying, If we want safe and effective vaccines, we need to end the liability shield.The legislation never came up for a vote. A spokesperson for the congressman said he expects to introduce it again in the very near future.Rene Gentry, director of the George Washington University Law Schools Vaccine Injury Litigation Clinic, thinks its unlikely Congress will blow up the no-fault program. But Gentry, who represents people filing claims for injuries, said its hard to predict what Congress, faced with a doomsday scenario, would do.Normally Democrats are friends of plaintiffs lawyers, she said. But talking about vaccines on the Hill is like walking on a razor blade thats on fire.
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