The lawsuit, led by plaintiff Kelly Grisoli on behalf of all others similarly situated, demands a jury trial for claims that Dexcom’s representations for its latest-generation G7 continuous glucose monitor (CGM) were false, misleading, and deceptive to consumers.
This class action comes just over a month after a judge threw out a separate class action against Dexcom relating to alleged misrepresentation of sales efforts.
G7, which initially received FDA clearance in 2022, is one of the leading CGMs on the market. It features a 60% size reduction from the previous generation, the G6. It offers a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past). Earlier this year, Dexcom — one of the largest diabetes tech companies in the world — extended its wear time to 15 days as well.
Read more about Dexcom and the rest of the diabetes tech industry in our free Diabetes Technology Special Report.
According to court filings, the nationwide consumer class action says that Dexcom marketed G7 as a superior medical device. However, the plaintiffs allege that the company sold and distributed defective CGMs, prone to dangerous alert failures and subject to FDA recall.
The lawsuit says G7 places users at risk of severe hypoglycemia, hyperglycemia, seizure, coma, or death due to its design. It also alleges that software defects caused inaccurate blood glucose readings and suppressed, delayed or failed alerts. Additionally, users claim the CGM failed to last the intended 10-day wear period as advertised at the time.
Grisoli led the suit after purchasing a CGM in early 2024 for personal and medical use for her child, a type 1 diabetic. She alleges that the device failed to perform as advertised or warranted, citing “repeatedly failed alerts and dangerously inaccurate glucose readings” in comparison to fingerstick measurements.
Her suit said the sensors failed to last the intended 10-day wear period, sometimes failing after just two days. Grisoli claims Dexcom “threatened not to replace” the CGMs, claiming she had too many in a single month after purchasing frequent replacements due to experiencing limited wear time.
“She would not have purchased or continued to use the product had Dexcom disclosed its defects, inaccuracy, or the risk of critical alert failures, including those later confirmed by the FDA’s Class I recall,” the lawsuit reads.
Lawsuit centers around FDA recalls for Dexcom
The lawsuit focuses on FDA recalls in June and September of this year. The agency labeled both Class I, the most serious kind. These recalls came just months after the company faced an FDA warning letter as well.
In June, the FDA notified customers of Dexcom’s recall, a result of a potential issue with the receiver component for certain CGMs. The reason centered around an error that may cause the receiver speaker to lose contact with the printed circuit board. FDA classified the cause as a “nonconforming material/component.”
In September, the FDA issued a notice saying Dexcom warned on a range of its CGM apps. Dexcom told customers that it identified a design error in app versions. The company said the error leads to a missed “Sensor Failed” alert when the sensor’s transmitter encounters a hardware/firmware failure.
In the lawsuit, Grisoli and plaintiffs claim that Dexcom knew of the defects but continued to market and sell the G7. They say the company continued “touting its reliability and safety while minimizing and/or concealing the risks.” Meanwhile, they say they paid a “substantial premium” for the sensor based on the alleged misrepresentations and omissions. In return, they claim they received a product that failed to perform as promised.
“Each purchaser of the G7 CGM unwittingly paid for a device with undisclosed and significant safety risks,” the lawsuit reads. “Each of these purchasers was damaged in that they paid more for their devices than they would have paid had they known about the safety, reliability, and accuracy issues with G7 CGMs, or in that they would not have purchased their G7 CGMs at all had they been informed of its safety risks, reliability, and accuracy. 8. Plaintiff seeks damages, restitution, and other remedies on behalf of herself and the class.”
