Plaintiffs in AAP v. Kennedy File Amended Complaint Seeking Reconstitution of ACIP, Addressing Harms of Shared Clinical Decision Making

Plaintiffs in American Academy of Pediatrics et al. v. Robert F. Kennedy, Jr. et al. today announced the filing of an amended complaint in the U.S. District Court for the District of Massachusetts, expanding its plea to request that the Advisory Committee on Immunization Practices (ACIP) be disbanded and reconstituted under court supervision.  

The amended complaint asserts that the current ACIP has been arbitrarily and capriciously -- and therefore unlawfully -- appointed, necessitating that all decisions made by the committee be declared null and void. This action underscores the plaintiffs’ commitment to restoring lawful, science-based vaccine policy and safeguarding public health. 

The amended complaint also brings to light the significant harms caused by the Secretary’s directive and subsequent decision-making by ACIP to change the CDC’s immunization schedule for Covid-19 vaccines to shared clinical decision making (SCDM). The SCDM designation, without being accompanied by additional guidance from CDC for families and clinicians as it typically is for other vaccines, has placed additional burdens on clinicians and families. In practice, this has caused confusion among doctors, pharmacists, and patients, leading to denial of vaccines, increased stress, and uncertainty about eligibility and insurance coverage. 

"This case is about safeguarding public health and ensuring that vaccine policy reflects science and transparency. Our goal is to restore confidence in the systems that guide our nation’s immunization policies,” said Richard Hughes IV, partner at Epstein Becker Green and lead counsel for the plaintiffs. “With this litigation, we are reinforcing the principle that public health decisions must be lawful, transparent, and rooted in science.”  

“The US government must not be allowed to restrict the ability of Americans to protect themselves and their families.  We are bringing this lawsuit to ensure continued access to life-saving vaccines. The Secretary’s actions have made it significantly harder for people to get vaccinated, sown unfounded doubt in vaccines, and contributed to mistrust of medical science knowledge for infectious diseases including Covid-19, measles, and hepatitis B.  This is leaving individuals, health care systems, and communities increasingly vulnerable to severe disease and destabilizing outbreaks. Our nation’s infectious diseases physicians will not allow this dangerous injustice to stand,” said IDSA President Ronald Nahass, MD, MHCM, FIDSA.  

The original complaint challenged actions undermining evidence-based immunization policy. The amended filing strengthens plaintiffs’ arguments by adding new prayers for relief and detailed evidence of harm caused by Secretary Kennedy’s broad assault on the United States’ vaccine infrastructure.  

The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists, and pediatric surgical specialists dedicated to the health, safety, and well-being of infants, children, adolescents, and young adults. 

The American Public Health Association champions optimal, equitable health and well-being for all. With our broad-based member community and 150-year perspective, we influence federal policy to improve the public’s health. Learn more at www.apha.org. 

The American College of Physicians is the largest medical specialty organization in the United States, with members in more than 172 countries worldwide. ACP membership includes 161,000 internal medicine physicians, related subspecialists, and medical students. Internal medicine physicians are specialists who apply scientific knowledge and clinical expertise to the diagnosis, treatment, and compassionate care of adults across the spectrum from health to complex illness. 

The Infectious Diseases Society of America is a global community of 13,000 clinicians, scientists, and public health experts working together to solve humanity’s smallest and greatest challenges, from tiny microbes to global outbreaks. Rooted in science, committed to health equity and driven by curiosity, our compassionate and knowledgeable members safeguard the health of individuals, our communities, and the world by advancing the treatment and prevention of infectious diseases.  

The Massachusetts Public Health Alliance is a nonprofit organization that promotes and improves the health of all residents of the Commonwealth and fosters conditions for people to achieve their full health potential.  

The Society for Maternal-Fetal Medicine, founded in 1977, is the medical professional society for obstetricians who have additional training in high-risk, complicated pregnancies. SMFM represents more than 6,500 members who care for high-risk pregnant people and provides education, promotes research, and engages in advocacy to reduce disparities and optimize the health of high-risk pregnant people and their families. SMFM and its members are dedicated to optimizing maternal and fetal outcomes and assuring medically appropriate treatment options are available to all patients.