‘Existential threat to vaccination’ — Physicians, public health experts sue HHS over RFK Jr’s COVID-19 vaccine directive

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Vaccine skepticism by the nation’s leading health officer is undermining the physician-patient relationship as people are becoming reluctant to get shots to prevent illness, according to a new lawsuit.

Doctor organizations are among the complainants who filed a federal lawsuit against Health and Human Services Secretary Robert F. Kennedy, Jr. They want a court to overturn Kennedy’s May directive removing the COVID-19 vaccine from the nation’s immunization schedule for pregnant women and health children aged 6 months to 17 years.

“This administration is an existential threat to vaccination in America, and those in charge are only just getting started,” said a statement by Richard H. Hughes IV, partner at Epstein Becker Green and lead counsel for the plaintiffs.

“If left unchecked, Secretary Kennedy will accomplish his goal of ridding the United States of vaccines, which would unleash a wave of preventable harm on our nation’s children,” Hughes said in a news release announcing the case. “The professional associations for pediatricians, internal medicine physicians, infectious disease physicians, high-risk pregnancy physicians, and public health professionals will not stand idly by as our system of prevention is dismantled. This ends now.”

HHS statement

In a brief statement sent to Medical Economics, HHS spokesman Andrew Nixon said: “The secretary stands by his CDC reforms.”

Who’s involved

Robert F. Kennedy, Jr.
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The case was filed by the American Academy of Pediatrics, the American College of Physicians, the American Public Health Association, the Infectious Diseases Society of America, the Massachusetts Public Health Association doing business as the Massachusetts Public Health Alliance, the Society for Maternal-Fetal Medicine. Another plaintiff is an unnamed “Jane Doe” plaintiff described as a pregnant physician working at a hospital. That puts her at high risk for COVID-19, but Kennedy’s words and actions have left her and her husband overwhelmed with stress and uncertainty, the lawsuit said.

Along with Kennedy, named defendants are Food and Drug Administration Commissioner Marty Makary, MD, MPH; National Institutes of Health Director Jay Bhattacharya, MD, PhD; and Matthew Buzzelli, acting director of the Centers for Disease Control and Prevention. The case was filed in U.S. District Court in Massachusetts.

‘Baseless and uninformed policy’

The lawsuit takes aim at Kennedy’s May 27 announcement via social media website X, formerly Twitter, that the COVID-19 vaccine for healthy children and healthy pregnant women was removed from CDC’s recommended immunization schedules.

“Unless the secretary’s baseless and uniformed policy decision is vacated, pregnant women, their unborn children, and, in fact, all children remain at grave and immediate risk of contracting a preventable disease,” the complaint said. “This decision immediately exposes these vulnerable populations to a serious illness with potentially irreversible long-term effects and, in some cases, death. This is not a hypothetical concern, but a pressing public health emergency that demands immediate legal action and correction.”

In the Senate, in the clinic

The lawsuit highlighted some of Kennedy’s testimony from his Senate confirmation process, during which he stated he would not make it difficult for people to get vaccines. The COVID-19 vaccine removal, announced May 27 and issued in a secretarial directive dated May 19, broke that promise to senators, the complaint said.

It also described the recent experiences of the physician leaders of the organizations involved, including ACP President Jason Goldman, MD, MACP, an internal medicine specialist in Florida.

Kennedy’s directive creates a conflict situation with internal medicine physicians and their patients, the lawsuit said.

“When a pregnant patient has requested a COVID vaccine, some ACP member physicians have turned patients away because administering the COVID vaccine is contrary to both the directive and the CDC’s Adult Immunization Schedule, which could lead to licensure problems for the physician,” the lawsuit said. “ACP physicians who now administer the COVID vaccine face financial harm because some insurers do not cover vaccines that are not on the CDC immunization schedules. ACO members are placed in the untenable position of either complying with a directive from the government’s top health official or not providing their patients with the standard of care that they believe they should be providing to their patients.”

Vaccine history

The lawsuit included descriptions of the plaintiff organizations, a summary of vaccine history dating from the 15^th century process of variolation that people use to develop immunity against smallpox. In 1796, Edward Jenner discovered the much less-harmful cowpox virus could protect against smallpox. An outbreak of that disease, and inoculation against it, were at the heart of a 1905 U.S. Supreme Court ruling that states could limit some individual freedoms when necessary to protect public health, “setting a precedent for the role of the government in managing communicable diseases.”

Creating the ACIP

By the 1960s, vaccine science was advanced enough that the nation needed a panel of experts to review the science, and the surgeon general created the Advisory Committee on Immunization Practices (ACIP). Historically, “ACIP recommendations are foundational to U.S. vaccine policy,” not just because of the science. Federal and state laws use ACIP recommendations to guide public health programs and insurance coverage mandates, the lawsuit said.

That board has been subject of attention across health care because Kennedy announced he was firing the 17-member board and replacing them with seven other appointees. The lawsuit did not state the names of the new appointees, but it did question their expertise about vaccine science. The complainants did not seek removal of the current ACIP members or reinstatement of the former ones.

The lawsuit also Makary’s and Bhattacharya’s statements from the COVID-19 pandemic, including co-author Bhattacharya’s Great Barrington Declaration that advocated for growth of herd immunity through natural infection.

What about measles?

The lawsuit also argued Kennedy’s comments have contributed to vaccine hesitancy about measles. That in turn has assisted the spread of that illness from an outbreak in Texas to 38 states as of July 2, according to the lawsuit. Kennedy published a commentary that discussed the importance of vaccination and the personal decision to become vaccinated. Kennedy also implied vitamins could provide protection against measles, when there is no evidence for that claim, the lawsuit said. Meanwhile, HHS official website definitively states vaccination is the best protection against measles.