In November 2019, the FDA issued a class 1 recall of Medtronic’s MiniMed insulin pumps manufactured before August 2019. Class 1 is the most serious recall, meaning those using the pumps must stop using them until they are replaced or fixed. The FDA indicated it had received 26,421 direct consumer complaints about malfunctioning devices, of which over 20,000 led to injury and at least one death.
In late 2022, the FDA issued another recall of Medtronic insulin pumps. The recall was the latest cybersecurity vulnerability identified in “smart” medical devices. As privacy ramifications of the latest recall play out, lawsuits about the pump’s past failures continue to plague the company.
Meanwhile, journalists revealed Medtronic ignored a 2021 FDA warning about the quality of the internal communication used in the devices. At the time, Medtronic told users of the devices they had nothing to worry about and could safely continue using the pumps. This latest cybersecurity vulnerability shines another light on Medtronic, one of the biggest medical device companies in the world.
Who is Medtronic?
Medtronic started in 1949 as a medical repair shop. Owner and co-founder Earl Bakken developed a pacemaker with its own battery power. The portable pacemaker revolutionized cardiac care.
Through acquisition and success, Medtronic became a medical device research and development leader. It expanded into other medical care specialties, particularly diabetes, which, until Medtronic came along, required substantial care and regular injections. Although Medtronic MiniMed developed the first “smart” insulin pump in 2003, the insulin pump design is still being refined as technology improves.
What’s An Insulin Pump?
An insulin pump and closed system of monitors manage insulin delivery like a healthy pancreas. It is configured to deliver insulin in microdoses when the body needs it instead of relying on external injections. Diabetes care is evolving away from treating a specific type (1 or 2) and toward looking at insulin delivery issues on a spectrum from mild to life-threatening.
Type 2 diabetes cases are beginning to use technology earlier in the care plan. The result is an increase in the use of insulin pumps.
A Long History of Warnings and Recalls
The technology inside insulin pumps has undergone significant changes over the past 20 years, and unfortunately, the smart medical device industry is susceptible to the same technology jitters as any other tech company. The model for FDA approval of insulin pumps creates a litigious lifespan. Consequently, Medtronic MiniMed had to weather several recalls and warnings, which could have resulted in equipment error lawsuits.
The first recall because of dosing errors came in 2009. Then in 2013, the devices were recalled twice because of mistakes in the priming pump. The FDA recalled insulin pumps in 2014 and 2015 because of insulin reservoir issues and programming errors, and 2017 saw another recall because of insulin delivery issues.
Medtronic MiniMed Insulin Pump Recall: Models 630G and 670G
One group of lawsuits addresses potential injury caused by missing, broken, or damaged seals that hold the insulin in place and ready for delivery. The faulty seals meant patients received incorrect doses.
The recalled insulin pumps are:
- MiniMed 630G (MMT-1715)
- MiniMed 670G (MMT-1780)
The FDA recalled about 322,000 600-series pumps. The 630G recall is for models made before October 2019. The 670G involves models manufactured before August 2019. With the pandemic mostly over, those injured by the insulin pump’s insulin reservoir sealing issue can still seek damages.
Are The Medtronic Issues Over?
With such a colorful history, we would love to declare Medtronic clear from future lawsuits. Unfortunately, that’s not the case. The 600 Series Pump System reportedly has a dangerous cybersecurity vulnerability. Insulin pumps are part of a group of components that monitor diabetes numbers and automatically deliver insulin in needed doses. Theoretically, a cybercriminal could hack into and pair with the insulin pump, then tell it to deliver too much or too little insulin. The result is injury and could be fatal.
Medical devices use internal communication technology to deliver instructions to other devices. For example, an insulin meter monitors glucose levels. A low blood sugar warning uses the internet of things (IoT) and other connections (like Bluetooth) to deliver wireless instructions.
The likely result would be a data privacy breach where those who use this technology are exposed to hackers and cybercriminals looking for vital information for identity theft. Thousands of diabetes patients could be affected.
The 700 Series Controversy
A handful of recent verdicts in regard to other medical devices have shaken Medtronic investors, leading to an ongoing class action lawsuit. The combined judgments mean Medtronic must pay millions of dollars in awarded damages to plaintiffs. The class action case is in the early stages, with courts recently appointing attorneys for both sides. Investors claim Medtronic withheld negative information about its 700 series pumps so it could attract investors in bad faith.
Who Should Pay Attention To Medtronic’s Lawsuits?
Anyone using an insulin pump should pay close attention to all recalls and warnings, mainly because the pumps can be fixed with software updates or equipment modifications. Insulin pumps are FDA-approved medical devices because, despite their issues, they save lives.
Anyone using medical devices that need internet connectivity should always pay close attention because the medical community uses devices even if there are dangers. The alternative is usually worse.
An acceptable reality of medical device adoption and use is the potential for litigation, which is why Medtronic pays damages as a defendant in lawsuits.
As a global provider of medical devices across several critical health specialties, Medtronic is a leader in the Industry. Medtronic has proven its devices save lives, from its first artificial pacemaker to today’s closed-system insulin pumps. As technology and physical health connect in care plans, technology will become increasingly necessary to ensure they work, even with acceptable risk.
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