Medtronic Insulin Pump Problems Were Withheld for Years Before MiniMed Recall, Lawsuit Alleges

Medtronic faces a class action lawsuit that alleges the company placed its desire for profits ahead of the safety of consumers, by concealing information about Medtronic MiniMed insulin pump problems that was known before a series of recalls were issued in recent years.

The complaint (PDF) was brought this month by union pension and welfare funds, pursuing securities fraud claims against Medtronic and several of its executives for failing to disclose issues with the insulin pumps to investors and the public.

According to the complaint, a number of false and leading representations were made about the safety and salability of the Medtronic MiniMed pumps to inflate the stock price, while diabetic patients continued to experience problems with the insulin pumps, which caused serious and potentially life-threatening injuries.

Medtronic MiniMed Insulin Pump Recalls and Lawsuits

The Medtronic MiniMed insulin pumps are small, computerized devices that deliver insulin to diabetic patients throughout the day via a catheter implanted under the skin. They are wirelessly connected to both a monitoring system to track glucose levels, as well as a remote controller designed to communicate with the pump and deliver a specific amount of insulin.

Due to a serious of design problems, Medtronic’s MiniMed 600 series models and the MiniMed 780G models have been subject to recalls in 2009, 2013, 2014, 2017, and 2020, following more than 26,000 complaints of involving problems with the insulin pumps with were identified. Most recently, the FDA announced a Medtronic MiniMed 600 series recall expansion in early October 2021, increasing the number of affected devices to half a million.

The Medtronic insulin pump problems involve devices with retainer ring defects, which fail to lock the insulin cartridge in place. These defects have caused problems with under dosing or overdosing of insulin, which may be responsible for 2,175 injuries and one death.

As a result of the manufacturers’ failure to properly design and test these critical drug delivery pumps, Medtronic MiniMed lawsuits are now being pursued on behalf of patients of suffered serious injury or death when they received too much or too little insulin.

In the latest MiniMed lawsuit, stockholders have raised allegations that Medtronic failed to disclose the ongoing problems with its insulin pumps, which has caused delays in the delivery of new models and financial losses for the company.

The lawsuit claims Medtronic intentionally concealed information from stockholders regarding known problems with its MiniMed 600 series models, while repeatedly making materially false and misleading statements that assured investors that its new MiniMed 780G model would win FDA approval and be unmatched by competitors, driving future growth.

Investor’s allege that the concealment of problems with the MiniMed 600 series models ultimately led to a warning letter from the FDA, which delayed the release of the 780G model’s release and revenue for upcoming quarters.

“The Warning Letter further explained that Medtronic had known about the MiniMed quality issues for several years before the Company finally initiated the recall, and that it failed to appropriately respond to complaints and report safety issues,” the complaint said.

The lawsuit against Medtronic seeks class action status to pursue damages on behalf of similarly situated investors who purchased or acquired stock in the company between the times the Company and the Individual Defendants misrepresented or failed to disclose material facts and the time the true facts were disclosed

Defendants named in the complaint include Medtronic PLC, its retired Executive Chairman and Chairman of the Board Omar Ishrak, current Chairman and CEO Geoffrey S. Martha, its CFO Karen L. Parkhill and its Executive Vice President  Sean Salmon.