Goldberg Segalla partner Frank Ramos wrote an article “The Algorithm Missed the Tumor: Defending AI Medical Device Manufacturers When the Diagnosis Goes Wrong,” for the PLI Chronicle, a periodical published by Practising Law Institute.

A renowned artificial intelligence thought leader and advocate for the ethical adoption of AI by the legal industry, Frank examines the emerging liability landscape surrounding AI‑enabled medical devices, focusing on cases in which diagnostic algorithms fail and patients are harmed.

He opens with a hypothetical – an AI imaging system cleared by the FDA misses a tumor that later becomes fatal – to illustrate the reality that such claims are no longer theoretical.

“That case is coming to a courtroom near you if it has not arrived already,” he says, underscoring the urgency for manufacturers and defense counsel to prepare for this growing wave of litigation.

Ramos explains that AI misdiagnosis cases will almost always involve parallel medical malpractice and product liability claims, creating strategic tension among defendants. Physicians may argue that the software was defective, while manufacturers contend that doctors unreasonably relied on AI output.

“Each defendant points at the other, and the plaintiff sits back and watches the finger-pointing while the jury’s sympathy grows,” he says, while also noting there is an opportunity presented from the parallel claims. “If defense counsel for the manufacturer and defense counsel for the physician coordinate their strategies, they can present a unified narrative.”

A central defense tool, according to Frank, is the learned intermediary doctrine, which places the manufacturer’s duty to warn on the physician rather than the patient. Because AI diagnostic tools provide recommendations, not autonomous decisions, the physician remains responsible for exercising independent clinical judgment. Ramos advises that manufacturers must ensure physicians clearly understand “the tool’s capabilities, limitations, accuracy rates, and known failure modes” through warnings and training.

Frank also addresses the limits of FDA clearance as a defense. While clearance under the 510(k) or De Novo pathways has value, Ramos stresses that it is “a shield, not a fortress.” Many AI tools reach the market without extensive real‑world testing across diverse patient populations, leaving manufacturers vulnerable if the system is used beyond its scope.

Finally, Ramos looks ahead to the evolving standard of care, predicting that AI will soon be expected in medical diagnosis.

“The standard of care in medicine is shifting to include AI,” he says. “As diagnostic AI tools become more prevalent and more accurate, the expectation of what a reasonable physician would do is evolving. The day is coming soon when failing to use an AI diagnostic tool will itself be a breach of the standard of care. When that day arrives, the liability dynamics flip.”

Frank adds this shift creates opportunities but also raises the stakes for AI medical device manufacturers.

“A tool that becomes the standard of care and then fails catastrophically exposes the manufacturer to claims of a magnitude that dwarfs anything the medical device industry has seen before.”

READ THE FULL ARTICLE HERE

MORE ABOUT GOLDBERG SEGALLA’S Frank Ramos:

Frank is nationally recognized legal advisor and litigator, Frank has been defending clients in civil litigation for more than 26 years, focusing his practice on retail, product liability, premises liability, trucking, insurance, and commercial disputes. A seasoned litigator, he has taken numerous trials and arbitrations to verdict or award.

Frank uses his extensive litigation experience to provide counsel, defense, and strategic guidance to retailers, developers, restaurants, fitness chains, hotels, resorts and other hospitality businesses. His representation has included negligent security, slip/trip and falls, catastrophic personal injury, trucking and motor vehicle accidents, employment and construction claims, as well as a variety of commercial disputes ranging from intellectual property and breach of contract to bad faith, franchise agreements, and landlord-tenant issues.