Medtronic MiniMed Lawsuit Filed Over Paradigm Insulin Pump Problems

A product liability lawsuit filed by a New York man alleges that a Medtronic MiniMed Paradigm insulin pump caused him to suffer severe hypoglycemia due to a pump malfunction. 

The complaint (PDF) was filed by William F. Mills in the U.S. District Court for the Southern District of New York on June 26, alleging that the Medtronic MiniMed pump was defectively designed, resulting in a failure to deliver the appropriate amounts of insulin to control his diabetes.

Mills indicates that he began using the MiniMed Paradigm insulin pump in 2010, in an effort to manage and control his type 2 diabetes. In June 2012, the complaint indicates that he lost consciousness in his bathroom, falling and injuring his face and hip. He was diagnosed with hypoglycemia, or low blood sugar, which the lawsuit claims was due to the malfunctioning insulin pump.

According to allegations raised in the Medtronic MiniMed pump lawsuit, there have been known issues with the device for years, but the manufacturer failed to take appropriate actions to prevent consumers from suffering serious injuries.

In 2009, the FDA accused the company of dragging its feet on addressing customer complaints in a warning letter that revealed that the company waited 18 months before reporting a MiniMed Paradigm Insulin Pump device malfunction. The company is required to report the incident within 30 days.

Medtronic has had a number of problems with its Minimed Paradigm 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 sets used 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.

Mills accuses Medtronic of failure to warn, designing and manufacturing a defective product, negligence, and breach of warranty, seeking both punitive and compensatory damages.