Wrongful Death Lawsuit Filed Over Medtronic MiniMed Pump Malfunction

Concerns over problems with Medtronic MiniMed pumps malfunctioning led to a recall in February 2020.

According to allegations raised in a recently filed wrongful death lawsuit, a Medtronic MiniMed pump malfunction led to fatally low blood sugar levels that killed an Alabama man.

The complaint (PDF) was brought earlier this month by Carla Wiggins, pursuing damages for the estate of her father, Carlton D. Gautney, Jr., who died of severe low blood sugar in May 2020 which occurred after his insulin pump malfunctioned, resulting in an overdose of insulin. The Medtronic Minimed pump used was later the subject of a recall for just that problem.

Medtronic Minimed pumps are small, computerized devices intended to deliver specific amounts of insulin to diabetic patients throughout the day, via a catheter implanted under the skin. They are wirelessly connected to both the patient’s blood glucose meter and a monitoring system to track glucose levels, as well as a remote controller designed to communicate with the pump and deliver a specific amount of insulin.

According to the lawsuit, which names Medtronic Minimed, Inc. as the defendant, Gautney was a Type 1 diabetic who used a Medtronic MiniMed 670G system to use insulin to regulate his blood sugar. However, on May 17, 2020, he was found dead on a motel bed after suffering an insulin overdose.

The same insulin pump was subject to a recall on February 7, 2020, and on December 9, 2021, the FDA issued a warning letter indicating that the manufacture of the devices was not done using good manufacturing practice requirements.

When the Minimed infusion pumps were recalled, Medtronic indicated there was a defect in the locking retainer rings, which prevent the insulin reservoir from being properly set inside the pump when it is loaded, potentially preventing the delivery of life-saving insulin.

“Carlton Gautney’s MiniMed 670G insulin pump was manufactured with defects in the pump’s clear retainer ring, which caused the Subject MiniMed 670G insulin pump to fail to allow the reservoir to properly seat within the pump, causing an over-delivery of insulin,” the lawsuit indicates. “The manufacturing defects were the direct result of Medtronic’s failure to comply with the relevant FDA regulations in manufacturing the MiniMed 670G insulin pump.”

When functioning properly, these devices and their components mimic the ways a healthy pancreas works by delivering continuous and controlled doses of rapid-acting insulin, 24 hours a day, to match the user’s body needs. However, following more than 26,000 reports involving Medtronic Minimed pump malfunctions, the manufacturer acknowledged that certain products may be prone to over or under deliver the programmed amount of insulin.

The case raises allegations similar to those presented in a growing number of similar Medtronic Minimed pump lawsuits filed since the recall, each claiming the manufacturer knew, or should have known, defects with the 600 series insulin pumps posed a serious risk for consumers.

Over the coming months and years, as product liability lawyers continue to investigate claims for individuals who experienced problems after a Medtronic Minimed pump failure, the size and scope of the litigation is expected to continue to increase, likely involving hundreds of lawsuits that may be filed in courts nationwide.