Medical groups sue HHS, RFK Jr. over 'unlawful' vaccine changes
Several major medical organizations filed a lawsuit against the Department of Health and Human Services (HHS) and Secretary Robert F. Kennedy Jr. on Monday over what they are calling "unlawful, unilateral vaccine changes."
The six groups -- including the American Academy of Pediatrics (AAP), the American College of Physicians (ACP) and the Society for Maternal-Fetal Medicine (SMFM) -- as well as a pregnant woman filed the lawsuit in the U.S. District Court for the District of Massachusetts.
The organizations, representing pediatricians, infectious disease physicians and public health professionals, accused the HHS and Kennedy of intentionally taking away vaccines, such as the COVID-19 vaccine, and unjustly replacing the Centers for Disease Control and Prevention's (CDC) entire vaccine advisory panel.
The lawsuit seeks preliminary and permanent injunctions to enjoin Kennedy's new COVID vaccine recommendations and a declaratory judgment pronouncing the change as unlawful.
Kennedy "has been on a warpath. It's gotten to the point that we are going to ... ask the court to put a stop to it," Richard H. Hughes IV, a partner at Epstein Becker Green and lead counsel for the plaintiffs, told ABC News. "This decision to unilaterally overturn the COVID recommendation based on a history of bias -- it was an arbitrary, capricious decision. They didn't make any effort to follow any ordinary processes."
Hughes said the HHS violated the Administrative Procedure Act, a U.S. federal law that establishes procedures federal agencies must follow when making rules.
In response to a request for comment, an HHS spokesperson told ABC News, "The Secretary stands by his CDC reforms."
In late May, the U.S. Food and Drug Administration announced it was planning to limit access to future COVID vaccines to those aged 65 and older and others with underlying health conditions.
Additionally, the agency said it would allow vaccine manufacturers to conduct large studies to assess the safety and efficacy of COVID vaccines in children and younger, healthy adults.
At the time, an HHS spokesperson told ABC News, "The COVID-19 public health emergency has officially ended, and we are entering a new phase in our response to the virus. A rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden administration is now over."
About a week later, Kennedy cut COVD-19 vaccine recommendations for "healthy children and pregnant women" without a vote from the committee and posted the announcement on X rather than through official federal channels, in a break with tradition and stunning doctors.
In the video posted X, Kennedy claimed there was no clinical data to support the repeat booster strategy for children.
The anonymous pregnant woman, who is also a plaintiff, has not yet tried to obtain a COVID-19 vaccine during her pregnancy but intends to, according to her attorneys. She fears she will not be able to get one due to Kennedy's change in recommendations, her attorneys added. The woman is a physician in a hospital, which could place her at high risk for exposure to infectious diseases, according to the lawsuit.
"Secretary Kennedy's changes to vaccine recommendations have frustrated our members' ability to effectively counsel patients regarding the COVID-19 vaccine and compromised the standard of care," Dr. Sindhu K. Srinivas, president of the SMFM, said in a statement.
The statement went on, "Every second the Secretary's dangerous and unsupported decisions regarding the COVID-19 vaccines stay in effect, the Directive is putting up barriers for our members' high-risk pregnant patients to access the COVID-19 vaccine, which is increasing the risk of serious infection and illness and eroding patient trust in all recommended vaccinations."
The plaintiffs also expressed alarm over Kennedy's move last month to remove all 17 members from the CDC's Advisory Committee on Immunization Practices (ACIP) and appoint seven new members. Kennedy originally appointed eight members, but one of them dropped off the panel shortly after.
At the time, the HHS put out a press release justifying the removals, with Kennedy saying. "A clean sweep is necessary to reestablish public confidence in vaccine science."
Kennedy previously told ABC News that the replacements for ACIP would not be "anti-vaxxers." However, some of the new members have previously espoused anti-vaccine sentiments, especially around COVID-19 vaccines and mRNA technology.
During the first ACIP meeting featuring the new members, the chair, Martin Kulldorff, said two new work groups would be established, one focusing on the cumulative effects of children and adolescents receiving all recommended vaccines on the schedule and another reviewing vaccines that haven't been examined for more than seven years.
The latter group may discuss whether the hepatitis B vaccine is necessary at birth before a baby leaves the hospital, according to Kulldorff. Infectious disease experts have said vaccinating babies at birth has been key to virtually eliminating the virus among children.
"The American Academy of Pediatrics is alarmed by recent decisions by HHS to alter the routine childhood immunization schedule," Dr. Susan J. Kressly, president of the AAP, said in a statement. "These decisions are founded in fear and not evidence and will make our children and communities more vulnerable to infectious diseases like measles, whooping cough and influenza. Our immunization system has long been a cornerstone of U.S. public health, but actions by the current administration are jeopardizing its success."
Editor's note: A previous version of this story cited a press release that incorrectly stated the anonymous pregnant female plaintiff was blocked from receiving a COVID-19 vaccine due to Secretary Kennedy’s directive. It has been updated to say she has not yet tried to obtain the vaccine.ABC News' Youri Benadjaoud contributed to this report.
