Medtronic Insulin Pump Lawsuit Filed Over Recalled MiniMed 600 Series Device

Two women claim the retainer rings in their Medtronic insulin pumps were defective, causing diabetic ketoacidosis and other injuries.

A joint lawsuit filed against Medtronic indicates two women suffered injuries and emergency medical treatment after the retainer rings holding drug cartridges in place in their MiniMed insulin pumps failed due to problems that later led to a major recall.

The complaint (PDF) was brought by Linda Dorn, of Wisconsin, and Brooke Vasquez, of New York, in California Superior Court for Los Angeles County on October 19, naming Medtronic MiniMed Inc., Medtronic Inc. and MiniMed Group Inc. as defendants.

Dorn and Vasquez say the pumps’ retainer rings were defectively designed and improperly manufactured, leading to chipping and breaking. These flaws resulted in a failure to receive the insulin they need as diabetics to regulate their glucose levels. The lawsuit notes that federal regulators found Medtronic failed to turn over adverse event reports detailing retainer ring failures in violation of the law.

Medtronic MiniMed Pump Problems

MiniMed insulin pumps provide diabetics with a steady, continuous flow of insulin throughout the day, providing extra doses when necessary. First introduced in 2006 with the MiniMed Paradigm, Medtronic has since marketed numerous variants and versions.

The pumps consist of a small, computerized device that clips to the belt or is taped to the skin. Using wireless transmissions, this monitors the body’s glucose levels, delivering insulin through a catheter tube when necessary.

Plagued with problems over the years, Medtronic issued a MiniMed 600 series recall in February 2020 due to failures with the retainer rings that could lead to over or under-delivery of insulin. The announcement affected more than 300,000 units, and was linked to more than 26,000 MiniMed pump complaints, including at least 2,175 injuries and one death. The recall was later expanded in October 2021 to include half a million devices.

In light of these concerns, patients are filing Medtronic insulin pump lawsuits over MiniMed failures, accusing the manufacturer of knowing about the problem long before the recalls, and deciding to prioritize profits over patient safety.

Medtronic Insulin Pump Malfunction Allegations

According to the lawsuit, Dorn’s MiniMed insulin pump malfunctioned in March 2017 as the result of a defective retainer ring that caused the device to fail to deliver the proper dose of insulin. The incident led to emergency hospitalization and was one of multiple times the pump failed before a recall was announced.

Dorn claims she has required ongoing medical attention and has paid for much of her treatment out-of-pocket, after Medtronic refused to do so. The problems have allegedly caused her to suffer mental stress, anxiety, worry, humiliation, fear and other personal and financial hardships.

Vasquez states that her MiniMed Model 630G also had a defective retaining ring, which caused the pump to malfunction on January 11, 2021, also requiring hospitalization and emergency treatment. She suffered diabetic ketoacidosis, seizures and other injuries.

Medtronic also refused to pay for medical expenses caused when Vasquez’s device failed, leaving her to pay for treatments out-of-pocket as well. She says she did not learn her device had been the subject of a recall until 2022.

The lawsuit notes that the U.S. Food and Drug Administration (FDA) issued a warning letter to Medtronic, claiming the manufacturer failed to establish proper quality control and corrective action procedures. Inspectors also said the company failed to properly report MiniMed incidents to the agency as required by federal regulations.

The women allege Medtronic knew about the problems with the MiniMed since at least 2016 but left the devices on the market.

“After the FDA conducted an inspection of Medtronic on or around June 7 through July 7, 2021, the FDA issued a warning letter to Medtronic on or around December 9, 2021. The FDA concluded that Medtronic failed to comply with medical device quality system requirements, including by failing to adequately report adverse events, assess risk, and initiate corrective and preventative action.”

– Linda Dorn et al. v. Medtronic MiniMed Inc. et al.

Dorn and Vasquez present claims of failure to warn, negligence, fraud and negligent misrepresentation and concealment. They seek both compensatory and punitive damages.

Medtronic Insulin Pump Lawsuits

The 2021 and 2022 Medtronic recalls were only two of several product removals and corrections involving MiniMed pumps since the devices were first put on the market. These problems have included insulin dosing errors, device malfunctions and cybersecurity weaknesses, resulting in Medtronic insulin pump lawsuits being filed for a variety of reasons over the years.

Of the potential problems, one of the most serious is diabetic ketoacidosis, which occurs when the body lacks enough insulin to break down glucose. This creates dangerous ketone levels that can cause nausea, vomiting, abdominal pain, confusion, rapid breathing and fruity-smelling breath. It can result in dehydration, organ failure and death without immediate medical care.

Medtronic MiniMed devices are also troubled by cybersecurity vulnerabilities that the FDA warned in 2022 could possibly allow someone to hijack the device through the wireless system and interfere with dosing. The agency warns that when the devices are networked to other wireless systems, such as glucose monitors, the vulnerability increases.

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