Abbott Faces Lawsuit Over Alleged Fatal Flaw in Glucose Monitor
- 7 deaths and 800 serious injuries linked to defects in Abbott's FreeStyle Libre 3 glucose monitors
- 3 million sensors affected by the FDA's most serious recall (Class I)
- 56% market share held by Abbott in the $15 billion CGM market (2025)
Medical experts emphasize the critical need for patients to verify CGM readings with finger-stick tests, especially when symptoms don't align with device data, to prevent life-threatening errors.
Abbott Faces Lawsuit Over Alleged Fatal Flaw in Glucose Monitor
ONTARIO, Calif. – February 10, 2026 – A wrongful death lawsuit filed against medical device giant Abbott Laboratories alleges that a fatal flaw in its widely used FreeStyle Libre 3 continuous glucose monitor (CGM) led to the death of a California man, prompting a nationwide investigation and intensifying scrutiny over the safety of modern diabetes technology.
The lawsuit, filed on February 2 in Alameda County Superior Court by McCune Law Group, claims that defects in the FreeStyle Libre 3 and Libre 3 Plus systems are responsible for at least seven deaths globally and nearly 800 serious injuries. The legal action follows a massive medical device correction, now classified by the FDA as its most serious recall, affecting approximately 3 million sensors across the United States.
A Lifeline Turned Lethal
At the heart of the complaint is the tragic death of 68-year-old Michael Leroy Ford on November 17, 2025. According to the lawsuit, Ford, who relied on the FreeStyle Libre 3 Plus to manage his diabetes, suffered a fatal cardiac arrest after the device delivered a dangerously inaccurate reading.
The complaint alleges that while his actual blood glucose was a critically high 551 mg/dL, the sensor displayed a reading of just 68 mg/dL—a level indicating hypoglycemia, or low blood sugar. Trusting the device, Mr. Ford reportedly consumed sugar to correct the falsely reported low, an action that the lawsuit claims further elevated his already dangerously high glucose level and ultimately precipitated his death.
Abbott has marketed its FreeStyle Libre line as providing "unsurpassed accuracy" with the "world's smallest and most accurate 14-day glucose sensor," encouraging users to ditch traditional, painful finger-stick tests. The device's ability to push minute-by-minute readings directly to a smartphone has made it a popular and seemingly convenient tool for millions.
"For individuals managing diabetes, a glucose monitor is not just a convenience: it is a lifeline," said Kristy M. Arevalo, a partner at McCune Law Group and lead attorney on the case. "When a medical device manufacturer knows its product is delivering dangerously inaccurate readings and fails to act, the consequences can be fatal."
A Pattern of Problems and Alleged Concealment
Just seven days after Ford’s death, on November 24, 2025, Abbott announced a "medical device correction" for sensors that could report falsely low glucose readings. The U.S. Food and Drug Administration (FDA) quickly issued a safety alert and later escalated the action to a Class I recall—a designation reserved for situations where there is a reasonable probability that using the device will cause serious adverse health consequences or death.
Disturbingly, this was not an isolated incident for Abbott's CGM products. The lawsuit points to a troubling pattern, noting this was the second Class I recall for the FreeStyle Libre line in less than 18 months. In July 2024, the company recalled several lots of sensors for the opposite problem: providing inaccurately high glucose readings. In April 2023, about 4.2 million FreeStyle Libre monitors were recalled due to risks of battery overheating and fire.
The complaint alleges a "systemic failure in Abbott's quality controls," suggesting the same production line may be responsible for both the 2024 and 2025 accuracy-related recalls. Furthermore, the lawsuit accuses Abbott of knowing about the manufacturing defect that led to the falsely low readings through its own internal testing but failing to warn the public until after Mr. Ford had already died. By the time of the public announcement, an estimated 1.5 million of the defective sensors had already been used or had expired.
A Crisis of Trust in a Booming Market
The allegations against Abbott strike at the heart of the rapidly growing CGM market, a sector projected to be worth over $15 billion by 2026. Abbott has been a dominant force, commanding over 56% of the market share in 2025, largely due to the accessibility and lower price point of its FreeStyle Libre systems compared to competitors like Dexcom and Medtronic.
This dominance, however, is now threatened by a growing crisis of trust. Online patient forums are rife with testimonials from frustrated users detailing persistent issues with the FreeStyle Libre 3. "I'm not convinced that any Libre usually reflects my correct blood glucose because historically they simply never have," one long-time user wrote. Another described sensors that were "wildly wrong" when checked against a traditional finger-prick test, and many report frequent signal loss and premature sensor failures.
Medical experts have long cautioned that while CGMs are transformative, they are not infallible. They stress the critical importance of verifying a CGM reading with a finger-stick test whenever a patient’s symptoms do not align with the device's data or before making a significant treatment decision. The risks highlighted by the FDA in its recall notice are severe: an incorrect reading can lead a patient to skip a needed insulin dose or consume unnecessary sugar, potentially resulting in seizures, coma, or death.
As McCune Law Group launches a nationwide investigation to identify other individuals harmed by the devices, the case against Abbott raises profound questions about corporate responsibility and regulatory oversight in the digital health era. The FDA has directed consumers to visit www.FreeStyleCheck.com to see if their sensors are affected and to receive replacements. For millions who depend on these devices, the outcome of this legal battle will be a crucial test of whether the technology they trust with their lives is truly safe.
