Dexcom Lawsuit

Dexcom G6 is a continuous glucose monitor (CGMs) designed to help diabetic patients keep track of their blood sugar. CGMs can be used by any diabetic patient, no matter if they have type 1, type 2 or gestational diabetes. 

CGMs are wearable devices. They differ from other glucose monitoring systems because they provide an on-demand readout of blood sugar and do not require patients to prick their fingers for data.

The Dexcom G6 has three main components:

• The receiver is a small device with a touchscreen. It is paired to the patient’s sensors and receives and stores the blood glucose readouts.
• The sensor and applicator. The sensors are small oblong plastic devices with adhesive and a needle on one side. The applicator is a larger device that looks similar to a computer mouse with a single button. Sensors are loaded into the applicators. Patients remove the adhesive cover from the bottom of their sensor, place the applicator against their skin and press the button to deploy the sensor. Each sensor is worn for 10 days.
• After the sensor is placed, patients attach the transmitter. It slots on top of the sensor, providing a smooth cover over the device. Transmitters send a patient’s blood sugar data to the paired receiver. Each transmitter is reused for three months.

Patients set up their blood glucose alerts on the receiver device. Alerts tell patients when their blood sugar is outside their set low or high levels. The Dexcom G6 also had an associated smartphone app for patients to use in place of their receiver.

Medical manufacturer Dexcom markets its CGMs as discreet and advanced systems capable of sending real-time readings to smart devices. Dexcom positioned the G6 to fully replace inconvenient fingersticks. It was the first FDA-approved integrated continuous glucose monitoring system.

While the device is often praised for its convenience, some question its safety. They allege the device took faulty readings and the phone app failed to alert patients of impending low blood sugar. If a patient misses these alerts, they could face dangerously low blood glucose, leading to coma, seizure or even death.

Who is eligible for a Dexcom lawsuit?

Dexcom G6 cases can be complicated. For many people, the G6 device works well and makes their lives easier. Motley Rice’s goal is not to take a beloved product off the market. Rather, our lawyers wish to help people who have been seriously harmed by the product through no fault of their own. 

If the following criteria describes you or a loved one, you may be able to file a Dexom G6 lawsuit.

• You (or a loved one) experienced a serious hypoglycemic event leading to drastic injury. This might include seizures, coma or death.
• Your diabetes is typically well-controlled. This often looks like a documented history of an A1C under 7%.
• The injury must have occurred before 2024. In 2024, Dexcom launched a phone app update that solved a few of the software problems that may have led to injuries.

Keep in mind that patients who experienced hyperglycemia or who have a history of poorly controlled diabetes likely aren’t eligible to file a Dexcom G6 lawsuit. Read on to learn more about the defects with the Dexom G6 and its associated app, how many people have been harmed and how attorneys can help.

In 2022 alone, medical researchers found that several top CGM brands had a total of 281,963 “adverse events.” This included 268,310 malfunctions. About 62% of the issues reported were faulty glucose readings. This was the Dexcom G6’s top adverse event. 

The FDA’s reporting system for device malfunctions, Manufacturer and User Facility Device Experience (MAUDE), registers hundreds of thousands of reports concerning the Dexcom G6 CGM. This includes nearly 50 reported deaths.

“As a type 1 diabetic myself, I know firsthand how hard it can be to manage blood sugar. Significant strides in technology have been made over the years to help make our lives a little easier. But these advancements lose value if we can’t trust the tech to work as intended. When our technology fails, it puts our lives at risk,” said Motley Rice medical device attorney Jonathan Orent. “We believe Dexcom has led users to believe that their devices are foolproof, which makes patients completely reliant on the product. While the product is important, we believe the foolproof marketing concept is dangerously negligent and gives patients a false sense of security.”

Focusing on the Dexcom G6 defects

The FDA received nearly 809,000 complaints about the G6 by 2022. Still more reports have been filed since then. 

The issue with the Dexcom G6 largely centers around the IOS app installed on users’ phones. Lawsuits allege the app failed to warn users of low blood sugar, leading to serious hypoglycemic health impacts. 

Here are a few examples of complaints from medical professionals and product users and their families, edited for usage and clarity:

• “… changes during sleep are potentially extremely dangerous and [are] precisely the type of situation that the CGM is intended to monitor.”
• “We have discussed this with our endocrinology practice and they are seeing this as a widespread issue.”
• “We had to be particularly mindful of sending many extra sensors for a three-week camp session to allow for failure, which did happen …”

You may have suffered severe health complications or lost a loved one. If so, a medical device attorney can help determine your options for seeking compensation. Civil litigation may also effectively compel medical manufacturers to improve their products.

People with diabetes rely on precise insulin measurements to adjust their blood sugar levels. If those measurements are wrong or users are not alerted to low blood sugar episodes, the results can be severe.

Short-term signs of low blood sugar include:

• Dizziness
• Fatigue
• Hunger
• Mood changes, such as confusion, irritation or anxiety
• Pale or sweaty skin
• Shaking

These symptoms could be a sign that a G6 device isn’t working properly. 

Longer-term dangers of low blood sugar can include:

• Brain injury
• Coma
• Seizures
• Death

Is there a Dexcom G6 recall?

Dexcom maintains that its G6 is safe for use. No recall for the device has been issued, despite mounting reports of alleged malfunctions. However, the G6 iOS app was recalled in 2020. According to FDA documents, “the user’s low alarm feature on the iOS application [was] not properly alerting users when the user has enabled the Alert Schedule feature.” This means users who set up scheduled alerts for low blood sugar were not receiving them.

The IOS app was recalled under a Class 2 Device Recall. In this case, the “Class 2” refers to the category of the product, not the severity of the recall. The FDA has three device classes, determined “based on the level of control necessary to assure the safety and effectiveness of the device.”

Class 2, or Class II, devices do not require premarket approval and notification requirements. The FDA is far less involved in medical device approval than one might think.

Motley Rice Dexcom attorneys have extensive experience litigating claims related to faulty medical devices. They have the resources to act on your behalf, including:

• Determining whether the manufacturer took adequate measures to ensure the safety of those using the G6
• Investigating whether the G6 harmed your health
• Reviewing applicable laws and government regulations
• Gathering evidence to strengthen your case

Learn more about our medical device litigation experience. 

Our attorneys have experience litigating for victims of defective medical drugs and devices, including diabetes products. We represent patients who allege their Medtronic insulin pumps delivered inaccurate doses. We have also litigated cases for clients involving:

• Diabetes medicines Actos® and Duetact®, which are alleged to cause an increased risk of developing bladder cancer 
• Incretin mimetics Januvia®, Victoza®, Janumet® and Byetta®, which are related to pancreatic cancer
• SGLT2 inhibitors Invokana®, Invokamet®, Farixga®, Xigduo XR®, Jardiance®, Glyxambi® and Synjardy®, which allegedly increased the risk of kidney failure
• GLP-1 diabetes medicines like Ozempic, Wegovy and Mounjaro, which have a host of serious unlisted side effects

Read more about our experience with diabetes litigation.