Editor's note: This story has been updated with additional information and statements.
Several healthcare provider organizations and a pregnant physician have sued Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and other federal officials over the removal of COVID-19 vaccine recommendations, which they describe as emblematic of “the Secretary’s assault on science, public health and evidence-based medicine.”
The complaint was filed Monday in the U.S. District Court for the District of Massachusetts. It argues that a “baseless and uninformed policy decision” to pull the vaccine recommendation for pregnant women and healthy children ages six months to 17 years back in May was unlawful under the Administrative Procedure Act and should be enjoined.
"This step is not one we take lightly," American Academy of Pediatrics President Susan Kressly, M.D., said during a press conference on the litigation held by the plaintiffs. "It's not one we ever want to take at all, but we can no longer wait for government officials to sort this out. Pediatricians cannot stay silent as the system we rely on to support life saving vaccines is chiseled away piece by piece. With Secretary Kennedy leading efforts to sow doubt and distrust in the American success story of vaccines, we are on dangerous path."
The plaintiffs contend that the final agency action was "arbitrary and capricious" for a host of reasons. Just days earlier RFK had testified to Congress that his "opinions about vaccines are irrelevant" and that "I don't think people should be taking medical advice from me," which the plaintiffs described as an admission that "he is unqualified" to issue the change.
The secretary also failed to explain recommendations he said led him to the change, or why he bypassed the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and its expert recommendations when changing the policy, they added.
ACIP has increasingly played a role in vaccine statute passed by Congress over the decades, demonstrating lawmakers' intent that "political appointees like the Secretary not meddle in deciding what vaccines are on the CDC's immunization schedules. [RFK's May directive] contravenes this statutory scheme and is not in accordance with the law," the complaint reads.
Dropping the vaccines from CDC immunization schedules introduces concrete and perceived barriers to the shots, which the plaintiffs said have become standard of care. This include restrictions on pharmacists in many states (including Massachusetts) from prescribing and administering vaccines, COVID-19 shots coverage no longer being required under the Affordable Care Act and licensure concerns for some physicians who administer the shots.
The complaint goes on to outline several other controversial actions taken by RFK, such as the shuttering of vaccination messaging campaigns and the immediate recission of billions in public health funds and orders for the CDC to investigate the debunked link between vaccines and autism. Of particular note are last month's sacking of all 17 members of the ACIP, their replacement with often unqualified individuals affiliated with vaccine skepticism and a meeting agenda that included discussions and recommendations on removing the preservative thimerosal from some vaccines.
Such moves threaten millions of lives and break the promises RFK made to Congress and the public during his confirmation, the plaintiffs said.
“The Secretary’s dismantling of the vaccine infrastructure must end, and halting this effort begins with vacating the [COVID-19 vaccine] Directive,” the complaint reads.
Plaintiffs in the case are the American Academy of Pediatrics, American College of Physicians, American Public Health Association, Infectious Diseases Society of America, Massachusetts Public Health Alliance and the Society for Maternal-Fetal Medicine. Several of the association heads speaking during the press conference said the COVID-19 vaccine recommendation change and RFK's other actions have led to confusion among their members' patients as well as fears that vaccines will no longer be available in the near future.
Also listed among the plaintiffs is an unnamed physician who is more than 20 weeks pregnant and at heightened risk of infectious diseases due to working in a hospital. She plans to obtain a COVID vaccine later in her pregnancy and fears she will be unable to because of the Secretary’s decision.
During the press conference, Richard H. Hughes IV, partner at Epstein Becker Green and lead counsel for the plaintiffs, described the groups' litigation against the nation's top health official as "unprecedented ... but necessary." The organizations are primarily focusing on the COVID-19 vaccine recommendations as "this is really just the first action that we could bring legal claims [against] that really stick," Hughes explained, but they expect to amend their complaint in the future as RFK and the "compromised" ACIP finalizes other vaccine removals from the schedule "or undermines vaccines in other ways."
Listed as defendants alongside RFK are Food and Drug Administration Commissioner Marty Makary, M.D., National Institutes of Health Director Jay Bhattacharya, M.D. and Centers for Disease Control and Prevention Acting Director Matthew Buzzelli. HHS did not immediately respond to a request for comment.
RFK, who prior to his appointment had promoted vaccine skepticism and maintained ties with anti-vaccine groups, has largely painted the nation's existing structure for gauging and reporting vaccine safety as flawed. He's also alleged before and after taking on the secretary mantle that pharmaceutical interests have too much influence over scientists at government agencies as well as those who have participated in advisory roles. Healthcare associations like those that filed Monday's lawsuit suppress members' vaccine safety concerns, he has also alleged.
In the May social media announcement cited in the lawsuit, RFK, flanked by Makary and Bhattacharya, said he "couldn't be more pleased" to announce the COVID-19 vaccine's removal from the CDC's recommended immunization schedule.
Alongside their request that the court declare the pulled recommendation unlawful, the plaintiffs asked that RFK be ordered to announce the vaccine's reinstatement to the CDC immunization schedules on X.
One potential sticking point for the plaintiffs could be the Supreme Court's recent 6-3 ruling in Kennedy v. Braidwood Management, in which the top court upheld U.S. Preventive Services Task Force recommendations for coverage requirements due to the HHS secretary's lawful authority to adopt or reject recommendations and to appoint or fire individual members at will.
"The secretary does have a lot of authority," Hughes said. "However, it's a question of how he wields that authority. ... If he's not relying on sound science, if we're seeing pretext and bias and we're running roughshod over really important, long-standing process and procedures—that's arbitrary and capricious, and that is unlawful."