According to the CDC, more than 70% of Americans over the age of twenty are either overweight or obese. Making up half of that group are Americans categorized as prediabetic, and more than 10% of our citizens, which accounts for more than 34 million Americans, are diabetic. These statistics show that a massive number of people in our country must monitor and control their blood sugar levels on a daily basis or risk severe health consequences, potentially even death.

As technology advances, other forms of blood glucose management have begun to supplant the traditional finger prick and insulin shot. One such device, which is manufactured by Medtronic, is the MinMed® Insulin Pump. The MiniMed insulin pumps are small, wirelessly connected, computerized pumps that monitor and track blood glucose levels. The controller unit delivers insulin to diabetic patients throughout the day via an implanted intravenous catheter to maintain continuous stable levels. However, there has been an extensive number of malfunctions with these devices and subsequently several recalls. Most recently an extension of a 2019 recall of MiniMed 500 and 600 series has resulted in nearly half a million devices being recalled.

FDA Recalls

July 2009 Recall: Medtronic issued a voluntary recall of more than three million Quickset infusion disposable catheters used with their MiniMed Paradigm insulin pumps due to a malfunction wherein the devices did not vent air pressure properly and could deliver too much insulin to a patient.

June 2013 Recall: FDA requested a Class 1 Recall of the MinMed Paradigm Insulin Infusion Set due to an issue where fluids could come in contact with the tubing connector and if the vents were blocked, the pump could malfunction.

September 2014 Recall: Medtronic recalled more than 500,000 units due to a programming error in the software that could cause the device to administer an incorrect dose of insulin.

September 2017 Recall: Voluntary recall of insulin pump infusion sets due to a vent membrane’s susceptibility to being blocked by fluid during the priming process, which could result in over-delivery of insulin.

October 2021 Recall: Voluntary Class 1 Recall of Model 630G distributed between October 2016 and February 2020 and Model 670G distributed between May 2015 and November 2019. A total of more than 463,000 units were recalled due to the potential for missing or defective locking ring, which can cause the pump to over or under deliver the correct amount of insulin. An incorrect dose can place the patient’s life in jeopardy and potentially cause hypo/hyperglycemia, seizures, Diabetic Ketoacidosis (DKA), and/or death.

Current Status Of Litigation

No current MDL. The expanded recall announced in October 2021 has drawn renewed interest to this issue and firms have begun new marketing initiatives and exploration of litigation. In June 2023 two separate federal judges, in differing circuits, dismissed Insulin Pump lawsuits against Medtronic, finding that they were preempted.

Links:

1. https://www.singlecare.com/blog/news/obesity-statistics/
2. https://www.cdc.gov/diabetes/library/features/diabetes-stat-report.html#:~:text=34.2%20million%20Americans%E2%80%94just%20over,Asians%20and%20non%2DHispanic%20whites.
3. https://www.medpagetoday.com/endocrinology/type1diabetes/94880
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/rescollection_2.cfm?id=83186&create_dt=2009-07-16
5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118883
6. https://www.medtronicdiabetes.com/res/img/pdfs/Mp6025982-011_b.pdf
7. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medtronic-announces-voluntary-recall-diabetes-infusion-sets
8. https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-minimed-insulin-pumps-incorrect-insulin-dosing
9. https://www.consumerreports.org/diabetes/when-diabetes-devices-fail-a2408992822/