Dive Brief:
- Dexcom is facing a proposed class action lawsuit over problems with its flagship glucose sensor. The complaint, filed in the U.S. District Court for the Central District of California last week, alleges that Dexcom’s G7 devices were “defective, prone to dangerous alert failures, and subject to recall” by the Food and Drug Administration.
- The complaint was filed last week by Kelly Grisoli, a parent whose child uses the continuous glucose monitor to manage Type 1 diabetes. The lawsuit alleged that Dexcom’s device did not perform as advertised, and that the plaintiff “repeatedly experienced failed alerts and dangerously inaccurate glucose readings” compared to finger sticks.
- The plaintiff is seeking an order certifying the lawsuit as a class action and unspecified damages. Dexcom did not immediately respond to requests for comment.
Dive Insight:
Dexcom has faced a warning letter and two class I recalls this year that involve the G7 device. The lawsuit mentions the recalls, which include the lack of an audible alarm for glucose alerts and problems with a “sensor failed” alert, but it also lists other problems with the devices.
Grisoli wrote that she bought the CGM for her child in early 2024. The devices never lasted their advertised 10-day wear period, according to the complaint, sometimes failing after just two days. Because of this, Grisoli had to buy frequent replacements. At one point, Dexcom allegedly threatened not to replace the sensors, claiming she had requested too many within one month.
Grisoli said she would not have purchased or continued to use the devices if Dexcom had disclosed the defects, inaccuracy or risk of critical alert failures mentioned later in the recall.
The complaint also listed several adverse events from the FDA’s database, from 2023 to early 2025, mentioning problems with the devices failing early.
The plaintiff is seeking counts including violation of the California Consumer Legal Remedy Act, violation of the California Unfair Competition Law and violation of the False Advertising Law.
