Insulin pump firm faces lawsuit

Woman dies hours before husband learned of Medtronic recall

Wendy Stellato’s insulin pump was still stuck to her stomach when police found her sprawled on a gravel road, dead from hypoglycemic shock. Hours later, court records show, her husband would open a letter from the pump’s manufacturer and learn the device his wife depended so much on had been recalled.

Medtronic, the world’s largest medical device manufacturer and maker of the pump that the Orlando woman was wearing, now faces a lawsuit alleging the company failed to properly test some of its insulin pumps and sold defective infusion sets. The suit, filed by Michael Stellato in federal court in Orlando last week, also contends that the company failed to remove the recalled devices even after the defects were known.

Wendy Stellato, 54, had just left work Nov. 18, 2017, when the side effects of excessive insulin started to set in, the lawsuit describes. She was driving home, taking her usual route down the BeachLine Expressway, the same commute she’d taken for the past 10 years while working at Golf Channel. But then, instead of getting off at her normal exit at Narcoossee Road, she passed the exit and got off a few miles later before stopping the car at the end of an unfamiliar dirt road.

By now, more insulin had been pumped into her body, unbeknownst to Wendy.

She texted her husband that her car was stuck in the dirt. He called her to find out where she was, but she either didn’t know or by this point was unable to tell him because of the worsening

hypoglycemia. She kept saying “car stuck” and “dirt road.”

She told him she was scared because it was getting dark and started to walk back toward the highway. Eventually, she told her husband she thought she was near Boggy Creek Road.

During the phone calls, Wendy sounded “severely disoriented,” like when her blood sugar levels had dropped before, Michael Stellato says in the lawsuit. Michael called 911 and told his wife to call 911, too, while he searched for her.

Around 7 p.m., almost five hours since Wendy left work, Michael found Wendy’s car at the end of Dowden Road near a construction site in Lake Nona. But Wendy wasn’t there.

Around 2 a.m., law enforcement located Wendy by tracking her cellphone. They found her body about 2 miles from her abandoned car, lying on her back with her purse in her hand. Her insulin pump was on her abdomen. It was later determined that the device had malfunctioned and been injecting Wendy with an “undetected and uncontrolled over-delivery of insulin,” the lawsuit states.

Just hours after Wendy’s death, Michael Stellato says, he received a letter in the mail from Medtronic that the pump his wife wore was being recalled. The letter was dated five days prior.

Now, Stellato is seeking more than $75,000 in damages from

Medtronic.

From 2008 to 2018, Medtronic insulin pumps were the subject of 20 recalls and about 100 lawsuits alleging malfunctions, according to an investigation by the International Consortium of Investigative Journalists, and in that time were potentially responsible for more than 2,600 deaths and 150,000 injuries.

Questioned by reporters from ICIJ, the company denied any wrongdoing. Medtronic declined to comment to the Orlando Sentinel and has yet to file a response in district court.