FDA Refuses To Take Action After 500,000 Complaints Related To One Device

The Dexcom G6, a medical device marketed to diabetics, is the center of a wrongful death lawsuit in Georgia. Yet, the FDA has received over 500,000 complaints related to the device and has no plans from removing it from the market.

One woman who has filed a wrongful death lawsuit on behalf of her husband woke up to find him snoring strangely and unresponsive. When she called paramedics, they revealed his blood sugar was abnormally low, even for a diabetic.

The device features an attachment that goes on the abdomen and reports data directly to the user’s phone. According to Dexcom, the device is supposed to send an alarm any time the wearer’s blood sugar gets too high, too low, or the app crashes. The husband’s alarm did not go off until he was well on his way to the hospital. The man died of hypoglycemia ten days later.

Part of the issue appears to be immunity offered to device makers once they are granted approval by the FDA. Even though the failure of the device to work caused the death of a patient, pursuing damages may be difficult for the plaintiffs. A federal judge in Georgia has allowed the lawsuit to move forward even though a claim for punitive damages has been tossed out. It is one of those instances where the regulatory failures of our system are causing patient deaths.

Lawsuits against medical device makers 

Lawsuits against medical device makers take several forms, but something like a diabetes monitor is tricky. Firstly, the device must work 24 hours a day 7 days a week. That means that there must be some upkeep on the device. Device makers can claim that the plaintiff failed to use the device properly or failed to maintain the device and that resulted in the device’s failure. But let’s assume that the device failed for some other reason.

Typically, claims made against device makers are that they are intrinsically dangerous. This device wasn’t dangerous so much as it was unfit for the marketed use. With over 500,000 complaints filed with the FDA, complaints against the device generally involve allegations that it failed to report a dangerous drop in blood sugar until it was too late.

So, the patient is told that the device will help prevent diabetic events and will help them control their blood sugar. They come to rely on the device for that information. Then the device fails. They suffer an extreme medical event as a result of that failure. Should the device maker be held liable for those failures? A jury will need to decide that matter, but similar cases involving devices could result in breach of warranty cases even if the company is protected from personal injury lawsuits under some circumstances.

Talk to Tampa Personal Injury Lawyer Today 

If you’ve suffered due to a dangerous medical device, the Tampa personal injury attorneys at The Matassini Law Firm may be able to recover damages related to your injuries. Call today to schedule a free consultation and discuss your options in more detail.

Resource:

11alive.com/article/news/investigations/the-reveal/diabetes-device-wrongful-death-lawsuit-in-georgia/85-d7e35c61-f091-4bb9-8e1c-da7616b0e027