On February 9, 2018, a Mississippi man filed a new Medtronic MiniMed lawsuit as a representative of his deceased wife. He claims that his wife’s Medtronic MiniMed insulin pump caused serious injuries that led to her death. He seeks in excess of $75,000 in damages. The case is pending in the Northern District of Mississippi, Greenville Division.

Woman Changes MiniMed Insulin Pump, Goes to Bed, and Doesn’t Wake Up

According to his complaint, the plaintiff’s wife was a healthy, 56-year-old resident of Mississippi. She worked as a loan officer at a local bank., and the couple had two children. She was also a diabetic who depended on a Medtronic MiniMed insulin pump to deliver the insulin she needed to treat her disease. The wearable pump was designed to store about one week’s worth of insulin and periodically inject a much smaller, controlled dose directly into her body via plastic tubes called an “infusion set.”

On January 6, 2017, the plaintiff’s wife changed her insulin set while at home, as is regularly required, and loaded her insulin pump for the next week. Then she went to bed.

The next morning, her husband was unable to wake her. He called for emergency help, and paramedics arrived at their home. The plaintiff’s wife was rushed to the hospital where doctors discovered that she had suffered a stroke caused by severe hypoglycemia.

Hypoglycemia, a very low level of blood sugar, requires immediate treatment to stabilize blood sugar levels. Without intervention, the condition can lead to serious complications, including abnormal heartbeat, seizures, and loss of consciousness.

The plaintiff states that due to a product defect, his wife’s MiniMed insulin pump had delivered up to an entire week’s worth of insulin at one time, causing hypoglycemia that resulted in her stroke. Plaintiff’s wife survived for two months in the hospital, but never fully recovered. She died from her injuries on March 14, 2017.

MiniMed Infusion Sets Recalled, but Too Late for Plaintiff’s Wife

On November 18, 2017, the FDA announced a Class 2 device recall for over two million Medtronic MiniMed Sure-T Infusion sets. The devices had the potential to over-deliver insulin and induce hypoglycemia. The manufacturer began warning doctors in September 2017 that certain infusion sets lots contained defective “vent membranes” that could become blocked during priming and fill-tubing and lead to insulin over-delivery.

Medtronic stated in a press release that when the infusion sets become blocked, the malfunction can “lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.” Unfortunately, these warnings came too late for the plaintiff’s wife.

The plaintiff notes that Medtronic’s MiniMed insulin pumps have been associated with other problems over the years. In 2009, the FDA warned Medtronic regarding the company’s failure to properly report and address potentially dangerous defects in their MiniMed insulin pump. The FDA also noted that a number of Medtronic manufacturing facilities did not have adequate procedures in place to identify and prevent potentially hazardous product defects.