Medtronic MiniMed Wrongful Death Lawsuit Filed Over Insulin Overdose from Recalled Infusion Sets

  • Written by: Irvin Jackson
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A wrongful death lawsuit has been filed over problems with a Medtronic MiniMed insulin pump, after the device allegedly malfunctioned, pumping an entire week’s worth of insulin into a Mississippi woman in one night. 

The complaint (PDF) was filed last month in the U.S. District Court for the Northern District of Mississippi, by Michael Davis, on behalf of himself and his late wife, Debbie Myers Davis.

Prior to her death, Debbie Davis used a Medtronic MiniMed pump to receive appropriate amounts of insulin to control her diabetes, according to the product liability lawsuit.

In January 2017, Davis used a Medtronic MiniMed Quick-Set Infusion set to change and load her insulin pump before going to bed. The next morning, she was found unresponsive, after suffering a stroke due to severe hypoglycemia.

According to allegations raised in the complaint, defects with the infusion sets and Medtronic MiniMed pump caused the injuries, because an entire week’s worth of insulin was pumped into Davis’ body while she slept.

She never recovered from the stroke, and died on March 14, 2017.

Only a few months after Davis’s death, a Medtronic MiniMed infusion pump recall was announced, following reports of consumers suffering hypoglycemia after the pumps delivered too much insulin. Davis’s pump was one of those affected by the recall.

Medtronic indicated that a discontinued component, called a vent membrane, was responsible for the problem, and changed the design in April 2017, months before it alerted the medical community and consumers to the problem.

“Defendants were aware or should have been aware of the defects and risks associated with their products, but proceeded with conscious indifference to the rights, safety and welfare of others,” the lawsuit states. “Over-delivery of insulin is a serious matter that poses catastrophhic, lethal risks.”

Medtronic MiniMed Problems

Medtronic has had a number of problems with its Minimed infusion products over the years.

In September 2014, Medtronic issued a MiniMed Paradigm insulin pump recall for more than half a million units following reports that programming errors led to patients receiving the wrong dose of insulin. At least one report of hypoglycemia was linked to the problem, which caused some users to accidentally give themselves the maximum insulin dose.

In June 2013, the company issued a MiniMed Paradigm infusion set recall because fluid could get into vents, preventing the pump from priming properly, which could cause severe or even fatal health problems for diabetics. It was one of four recalls or urgent device notifications involving Medtronic’s insulin pumps that year alone.

In 2009, Medtronic Inc. issued a similar recall for approximately three million Quick-set infusion setsused with its MiniMed Paradigm insulin pumps, due to a manufacturing defect that could result in the delivery of incorrect doses of insulin and cause injury or death for diabetics using the Medtronic insulin pumps.

Following that recall, a number of Medtronic infusion set lawsuits were filed on behalf of patients of suffered serious injury or death when they received too much or too little insulin.

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Image via Ken Wolter /

1 comment

  1. Barry Reply

    My sister was killed by Medtronic infusion sets blockage. Initially Medtronics said it was blocked, and could result in over or under delivery. So high or low blood sugar can result. Insulin shock, strokes, brain damage, and loss of sensorium prior to the loss of consciousness are obvious problems of getting too much insulin. Rapidly increasing ketoacidocis, violent sickness, loss of sensorium, confusion, and coma, heart and brain malfunction and death is the obvious problem of a patient not getting their insulin. The obvious question is why does Medtronics wait months to tell FDA they’ve had problems, then fix the problem and begin selling the repaired improved version months thereafter, WITH NO ANNOUNCEMENT OR DISCLOSURE TO MARKET, MEDICAL COMMUNITY OR CUSTOMERS. Then, 5 months later , 4 weeks after my sister died of blocked infusion set, the notice arrives on the front porch, “urgent recall” on a small package of replacement infusion sets. How many “in hand” infusion sets were out in the hands of users and clinics, and retailers and distributors being used up, at risk of a fatal outcome, while they had the solution for sale, no notice to anyone. Each one used worldwide for that 5 or 8 month period was one they didn’t have to replace and dispose of. 10s of millions? How many injuries, hospitalizations, strokes or deaths occurred after they got their indication of a problem back in ’16?

    How much market share would they lose if they told users to start using syringes again until they get it fixed, or switch over to B &D or J &J infusion sets. That’s a lot of motivation to keep it a secret.

    An anxious and increasingly confused and sickened user would have knowledge to try a new infusion set, instead of the obvious, wondering why the pump wasn’t delivering. It’s well known that diminished brain function comes with deficient diabetic controls. They should know to give simple instructions as warnings, for most of a year the world was kept in the dark.

    Indeed, even on the responses to FDA problem reports, deaths, mostly, the company’s responses were virtually 100% ” send in your pump.. followed by ” the pump is testing fine” with no mention of the retention and sending in the KNOWN defective infusion sets, or reporting the set’s serial and manufacturing codes. That’s deceit, not negligence. Comprehensive investigations and honest assessments are not kept under wraps, and a continuum of minimal responses for months and months is highly questionable, and probably should be punished.

    Shame on them; shareholders okay with this? Surely not on a moral scale, profits excluded. Shame.

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