RFK Jr. Could Blow Up the Vaccine Industry With One Simple MoveA seemingly obscure change to liability laws could wreck the market for some vaccines.
PERTUSSIS CAUSES RAPID, violent coughing, which is why it’s known as “whooping cough.” It can be deadly for infants and young children. Toxins from the infecting bacteria damage the linings of their small airways, making it difficult for them to clear mucus. They gasp and can turn blue in the face until, in the most extreme cases, they suffocate. The disease killed thousands of children annually in the United States until the 1950s, when wide introduction of a vaccine dramatically lowered the death toll—first to a few hundred every year, then to a few dozen, and finally, by the 1970s, to just a few isolated cases nationwide. But in the early 1980s, medical societies began warning members to delay some of the recommended boosters, because of a severe shortage. The problem was not a lack of know-how or production capacity, although breakdowns at one particular factory had worsened the shortage. The underlying issue, instead, was something public health authorities had warned was coming: Manufacturers were abandoning the vaccine business, citing the high cost of liability. That era’s version of the pertussis vaccine¹ caused some serious but rare side effects, prompting lawsuits against manufacturers. Links to the most severe complications were tenuous, and plenty of cases never went far. But jury awards were frequent and big enough to spook the companies. In December 1984, one of the last two firms selling the pertussis vaccine announced it was getting out of the business, leaving the United States with just one. That news—along with warnings of coming shortages for other vaccines, including polio—got the attention of Congress. It responded by crafting a no-fault system designed to shield manufacturers from crushing liability costs while creating a quicker, smoother mechanism for compensating families whose children had suffered grave side effects from vaccinations. The program is still in place today, alongside a counterpart program for vaccines like the COVID-19 shots that were developed quickly to address medical emergencies. These programs are the backbone of a liability system that is a big reason—probably the biggest one—that the vaccine market has stabilized, preventing shortages from becoming serious or routine. Now the system’s future is in jeopardy, thanks to Robert F. Kennedy Jr. The health and human services secretary is a longtime critic of the liability regime, which he has called “corrupt and inefficient” and “notoriously biased” against families bringing cases. In late July, he announced in a lengthy tweet that the system “is broken, and I intend to fix it.” Kennedy says the reforms he has in mind would merely help realize “the original congressional intent” for the no-fault system, which is something that could be worthwhile and gain support even from strong vaccine advocates. But some of the changes Kennedy and his aides have been contemplating, according to media accounts and one industry insider familiar with HHS discussions, would go well beyond these sorts of fixes. In fact, it’s not really correct to call them “fixes” at all. Three sets of changes in particular could weaken or even wreck the liability regime. That, in turn, could lead to shortages like the ones that first prompted the modern system’s creation four decades ago—only this time, these shortages could be even more severe. That’s because the public officials with power back in the 1980s shared a commitment to guaranteeing that vaccines were widely available. This is 2025, when the most powerful health care officer in the United States is on a barely disguised crusade to roll back vaccination—and when he seems to be getting his way, thanks to a president who either shares those sentiments or simply doesn’t care either way. THE CONTRAST BETWEEN the political environment now and then is stark, although it’s no accident that the liability problems—and ensuing shortages—happened when they did. As journalist Arthur Allen recounts in his book Vaccine, the euphoria that had come with Jonas Salk’s introduction of a successful polio vaccine in the 1950s was finally fading, right around the same time the public was growing more skeptical of experts and major institutions in the post-Vietnam, post-Watergate era.² Among the institutions facing the most skepticism were corporations and the federal government. And in the early 1980s both the vaccine manufacturers—and the government agencies regulating them—started getting more scrutiny for the dangerous side effects of vaccines. That was especially true for the pertussis vaccine, whose side effects physicians had downplayed and whose most serious complications were thought to include brain damage, although later research suggested no such link.³ Parents didn’t just sue. They went to Capitol Hill, demanding tougher regulation. Manufacturers responded by resisting the push for regulations and seeking what would have amounted to complete immunity from lawsuits. Pediatricians and other public officials weighed in with their own plea, that Congress do something that would keep vaccines in plentiful supply. “The manufacturers told us that they were considering leaving because of liability issues. . . . They were saying we can make a lot more money in other lines of business, more than we do on vaccines,” Tim Westmoreland, who at the time was a top adviser to former Congressman Henry Waxman, told me in a phone interview. “Meanwhile, we had a parents group—an ad hoc group of dissatisfied parents—who were saying, whatever you do, don’t take away any or all liability from the manufacturers.” Waxman, a California Democrat whose work on health care was legendary, ended up cosponsoring a bill in the House. Paula Hawkins, a Florida Republican who chaired a key Senate subcommittee, led the effort in the upper chamber. Working with a handful of others—including a Florida Democratic congressman whose twin cousins were featured in a widely seen television documentary on the pertussis vaccine’s effects—they came up with a compromise that created a new apparatus for monitoring vaccine safety while establishing the no-fault system for compensation. Under the National Childhood Vaccine Injury Act, which Ronald Reagan⁴ signed in 1986 and remains in force today, the federal government specifies both the vaccines and the types of injuries for which individuals can seek compensation. Families seeking compensation bring their cases to the U.S. Court of Claims, where one of several “special masters” awards payments when appropriate, based in part on the expected costs of medical care for the injured person. Families can still bring negligence suits, but the law raised the legal threshold for victory, effectively shielding the manufacturers from the kind of liability suits that spooked them in the 1980s. In return, the manufacturers pay an excise tax into a trust fund, which the government uses to pay out the awards.⁵ “If you didn’t have a system like this, you would fail one or the other or both of two really important goals,” Samuel Bagenstos, a University of Michigan law professor who served as HHS general counsel during the Biden administration, told me. “One is to make sure that there are adequate incentives to produce the vaccines people need, because vaccines serve the public health, while the other is to make sure that people who are injured by vaccines can get compensated for them.” THE 1986 LAW IS WIDELY CREDITED with ensuring a stable supply of essential childhood vaccines, although temporary shortages still occur, while paying out more than 13,000 awards worth more than $5.4 billion That doesn’t mean everybody who gets an award was actually hurt by a vaccine. A major goal is to get people the money they need quickly, which means bypassing lengthy—and inherently difficult—interrogations of whether a vaccine did or didn’t lead to a particular hardship. The idea is to compensate as many people as possible adequately, rather than giving massive payouts to a relative few who have the most sympathetic stories and, maybe, the best lawyers. “We always knew that, given the way it was structured, we would be compensating children who were born with disabilities and were not injured by vaccines,” Westmoreland said. “We figured better that than having people have to fight in court all the way through a long, complicated litigation.” That is not to say payments in the current system are big enough, or that they come quickly enough. To the consternation of both families seeking relief and some of the program’s original architects, the Department of Justice—which represents the federal government in these hearings—has over the years started to challenge claims more aggressively. That pushback helps explain why cases can take years to resolve, frequently with awards that families find woefully inadequate. The liability shield has also come under greater strain because the federal government has added more shots—and because the delivery of vaccines has changed, with so many local pharmacies providing immunizations that make it easy to get a shot while picking up supplies or groceries. Meanwhile, Congress has not touched the program. “Administrative changes have been made, and some policy decisions have been made . . . that put a strain on the infrastructure—which, much like the infrastructure in the rest of our country, is very outdated,” Renée Gentry, one of the nation’s best-known litigators and experts on vaccination who is now a distinguished lecturer at George Washington University. “I think Congress did a good thing, they did a great thing, and then patted themselves on the back and walked away from it and never looked again.” Similar problems have beset injury compensation for the COVID-19 vaccines, only at greater scale, because the liability protection in that case comes from a 2005 law crafted as a way to make sure the United States could quickly deploy medical responses to a bioterror attack or newly emerging pandemic. That law didn’t create the same kind of infrastructure for processing claims, leaving officials tasked with the processing even more overwhelmed. It has also left people who think they have suffered injuries struggling even more to get payments. There’s no shortage of plausible-sounding ideas for how to address these problems. Officials could increase financial awards, which remain at the original 1986 levels, or make the compensation system work more quickly by better specifying what injuries qualify for payment. They could appoint more people to review medical cases and adjudicate claims, plus they could move the COVID-19 vaccines over to the regular compensation program. Kennedy could lead this effort, by using his secretarial power at HHS or leveraging his influence to get congressional action. It could even be a chance to foster some consensus—and to strike a blow for candor—by publicly acknowledging the existence and gravity of rare side effects while reaffirming the vital role vaccines play in keeping America healthy. But, of course, that’s not enough for Kennedy. He wants to strike a blow at the vaccine industry itself. KENNEDY HAS NOT BEEN OVERLY SPECIFIC about how he intends to change the vaccine compensation systems. But based on media accounts and conversations I’ve had with several close observers, including one source who has heard directly about HHS deliberations and asked to remain anonymous, three main modifications are under consideration. The first would be to remove individual shots from the list that fall under the regular liability shield, thus exposing manufacturers to precisely the sort of liability they faced before the 1986 law. It’s easy to imagine Kennedy taking such a step for the measles vaccine, given his long history of misleading and false claims about its efficacy and safety record. The second would be to add specific injuries to the list that trigger payments. The likeliest possibility here would be autism, the condition Kennedy continues to insist that the measles vaccine can cause—again, despite overwhelming evidence to the contrary. The worry here is that adding a condition as prevalent as autism, which now affects 1 in 31 children according to the CDC, would overwhelm the liability system with claims and deplete its funds, causing it to collapse. In theory, either change would require going through the formal process for changing federal regulations, which requires proposing a rule and then allowing public comment, and then addressing those comments before finalizing the change. That process can take months, if not longer, though some of Kennedy’s early moves—like launching a commission to study the roots of autism—could be first steps in that direction. (On Tuesday, Kennedy said the commission was preparing to deliver its findings in September, adding that “we’re finding interventions that are clearly, almost certainly causing autism.”) This assumes Kennedy is willing to follow normal processes. He could try to bypass them somehow, as so many Trump administration officials already have, and challenge the courts to stop him. Or he could try to make these changes informally—by, for example, asking the Justice Department not to challenge vaccine claims in court. That could explain a line near the end of Kennedy’s July tweet, where he wrote that he was “grateful to be working with” Attorney General Pam Bondi “and HHS staff to fix” the system. But the third change would be the quickest one of all—and, perhaps, the one Kennedy is most likely to make, at least initially. “Another lever they have is to take away the liability protection for the COVID vaccine,” Sarah Despres, another former Waxman staffer who also served in the Biden administration, told me. Kennedy could remove protection for either all COVID vaccines or for just the mRNA versions that he’s long singled out (again, against a mountain of evidence). Kennedy could do this with the stroke of a pen, experts told me, because COVID vaccines fall under the bioterror/pandemic program shield—which, by design, was meant to allow for quick action in an emergency. To give a vaccine liability protection, the HHS secretary must merely certify that it’s necessary as part of the response to a biological threat, which is precisely what Alex Azar did for the COVID shots while he was secretary during Trump’s first term and Xavier Becerra did during Joe Biden’s presidency. Becerra ultimately extended the protection through 2029. But Kennedy can undo it with a signed declaration of his own, experts told me, meaning he wouldn’t have to wait for the regulatory process to play out. Despres, who now advises nonprofits on vaccine policy, said that such a move “could dramatically impede vaccine access.” EVEN IF KENNEDY WENT down these routes, people could bring a lawsuit challenging such a decision. The lawyers I consulted all stressed that the laws creating both the regular and emergency liability regimes have some gray areas—including, for example, who would have standing to bring certain lawsuits. It’s hard to know what would or wouldn’t pass muster if Kennedy tried it. And just as there’s uncertainty over whether the kinds of changes Kennedy has in mind would hold up in court, there’s also uncertainty over what kind of reaction they’d prompt from the vaccine industry. Producers might decide they can make a strong enough case in court, where the opinion of the most trusted vaccine experts would weigh heavily. They may determine that they could prevail—or at least avoid huge losses—in such cases. Or they might just decide to wait and see what happens under changes Kennedy implements, having put so much of their business efforts into vaccines. But it’s also easy to imagine major manufacturers giving up on vaccines—or, at least, giving that line of business a lot less attention. That’s especially true when Kennedy is simultaneously taking so many other steps to limit vaccine availability and development, whether it’s purging advisory boards of well-respected mainstream scientists to make room for fringe critics of vaccination or canceling Biden-era grants to fund the development of next-generation mRNA vaccines. “My concern is that if they’re trying to . . . essentially dissolve the liability protections for manufacturers, I worry that this would open the floodgates to lawsuits,” Richard Hughes, a Washington-based attorney with a long career of advising vaccine manufacturers and serving on government boards, told me. “At that point,” added Hughes, who during the COVID pandemic worked for the mRNA vaccine manufacturer Moderna, “why would this be an attractive market to stay in, with that kind of liability threat?” One irony is that some of Kennedy’s potential changes could work out poorly for the very people he purportedly wants to help—those who suffer the rare, but real harms from vaccines. They would be losing their best, most reliable way of getting compensation. But they wouldn’t be the only victims of these changes Kennedy is envisioning. Nor would they be the most numerous. If vaccines for conditions like COVID-19 become scarce, many more people are going to get sick and many more are going to die. 1 Then, as now, the pertussis vaccine was delivered in a shot that also protected against diphtheria and tetanus. Pertussis was the “P” in the “DTP.” Newer versions of the vaccine are a bit different, in that they have an acellular (not complete) version of pertussis pathogen, rather than an inactivated version of the whole. This reduces the incidence of side effects, although it may be less effective as well. That change is why it’s now called the “TDaP” shot. The “a” is for acellular. 2 Allen’s book is one of the very best I’ve read on the subject of vaccines—clear, engaging, and fair. Here’s an excellent review of it by David Oshinsky. 3 Here’s how a 2020 article in Nature summarized things: “The whole-cell pertussis vaccine causes rare but significant side effects. In addition to the usual local inflammatory effects and fever associated with many vaccines, whole-cell pertussis vaccines sometimes trigger prolonged crying and febrile convulsions and, very rarely, hypotonic–hyporesponsive episodes. Claims of causal links to various neurological issues were also made. However, those neurological side effects were observed in very small numbers of children and were later demonstrated to be unrelated to the vaccine, but the reputational damage was done.” 4 Initially President Reagan and his advisers were skeptical, because they feared that establishing a fund to pay out awards would create a new drain on financial resources. They and some similarly skeptical GOP lawmakers eventually came around, justifying their support on the grounds that the vaccine manufacturer excise tax would cover the cost. 5 If you’d like to learn more about the program, the Public Health on Call podcast (from Johns Hopkins School of Public Health) ran a clear, helpful explainer episode back in February. You’re a free subscriber to The Bulwark—the largest pro-democracy news and analysis bundle on Substack. For unfettered access to all our newsletters and to access ad-free and member-only shows, become a paying subscriber.We’re going to send you a lot of content—newsletters and alerts for shows so you can read and watch on your schedule. Don’t care for so much email? You can update your personal email preferences as often as you like. To update the list of newsletter or alerts you received from The Bulwark, click here. Having trouble with something related to your account? 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