Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA’s Vaccine Shift Raises Legal Red Flags for Doctors, Pharmacists,” by Maaisha Osman. (Read the full version – subscription required.)
Following is an excerpt:
FDA's Wednesday announcement it has narrowed its authorizations for COVID-19 vaccines, rescinding emergency use authorizations (EUAs) and limiting full approvals to certain high-risk populations marks a major shift in the federal government's approach to COVID-19 vaccination and has immediate implications for medical providers, particularly physicians and pharmacists, who must now navigate new eligibility rules and potential liability risks when administering vaccines.
FDA's decision could expose physicians and pharmacists to new legal and disciplinary risks, according to Richard Hughes, a prominent lawyer and vaccine law expert at Epstein Becker Green, as FDA leadership simultaneously sends mixed messages about the availability of the vaccines.
"Physicians may now face malpractice exposure or even disciplinary action if they administer COVID vaccines outside of FDA's revised labeling or Centers for Disease Control and Prevention recommendations -- particularly if a patient suffers harm," Hughes told Inside Health Policy. "Off-label use isn't illegal, but it opens the door to lawsuits and licensing scrutiny if it deviates from the accepted standard of care."
That standard, Hughes emphasized, isn't defined solely by FDA approval or CDC guidance. Courts have long recognized that clinical judgment, professional consensus, and prevailing medical practice all shape what's considered reasonable care. "If a provider makes a well-documented decision based on professional judgment, they may have a strong defense -- but it's not absolute protection," Hughes warned. …
While Congress created special compensation programs to shield providers -- such as the Vaccine Injury Compensation Program (VICP) and Countermeasures Injury Compensation Program (CICP) -- significant gaps remain. "Adult-only COVID vaccines fall outside VICP, and CICP protections under the PREP Act have been repeatedly narrowed by courts," Hughes noted, pointing to rulings that deny federal preemption and allow state malpractice claims to proceed.
"Physicians are not fully insulated," Hughes concluded. "They are still vulnerable to lawsuits, state licensing board investigations, and disciplinary action -- especially in this rapidly evolving legal landscape."
