Medtronic insulin pumps are intended to help patients suffering from type 1 diabetes increase their insulin production. The pumps are designed to replace insulin shots and provide patients with an easier and less invasive means to take their insulin treatments. However, the products have shown the ability to pump too much insulin into the patient, resulting in numerous complications and side effects. This led to an FDA recall for the product. Medtronic is now defending against numerous lawsuits alleging defects in these insulin pumps.
What is an Insulin Pump?
An insulin pump is a small computer that a patient wears strapped to their waist. The device is programmed to deliver a continuous and steady dose of insulin. The delivery is done through a catheter that is implanted in the patient. The catheter is taped into place after insertion. A patient has different options for programming the device, including a higher dose timed to coincide with meals. This device is suited for those who have frequent low blood glucose reactions or delays in absorption of food.
What is a MiniMed Insulin Pump and Infusion Set?
Medtronic “designed, manufactured, marketed and distributed the MiniMed 630G (MMT01715) Insulin Pump and Pro Set Infusion Sets, which were marketed to deliver insulin to a person with diabetes in measured amounts. The MiniMed pump was manufactured with a retainer ring designed to lock the patient’s insulin cartridge into place in the pump’s reservoir compartment. Pro Set Infusion Sets consist of a membrane and disposable plastic tubes which transport insulin from the pump to the
patient’s body.” Complaint
“The Medtronic MiniMed 630G Pump and Pro Set Infusion Sets are used in conjunction with one another to help people with diabetes regulate their blood sugar by providing a constant source of insulin. They provide an alternative to daily injections of insulin the pump connects to flexible plastic tubing that delivers insulin to the body. Users set the pump to deliver insulin throughout the day. It can be programmed to release larger doses at meals or at times when blood sugar levels are too high.” Id
Medtronic MiniMed pump and infusion set recalls 2009- 2020
- “On or about June 29, 2009, these issues led to a Class 1 recall of many of the Defendants’ insulin infusion sets labeled Paradigm Quick-Set Infusion Sets. Said recall
included lots manufactured between 2007 and 2009. Approximately three million disposable infusion sets were recalled.” Complaint
- “On or about June 7, 2013, Medtronic MiniMed Paradigm infusions sets were recalled via a Class 1 recall. The recall was issued “because of a potential safety issue
that can occur if insulin or other fluids come in contact with the inside of the tubing connector. If this occurs it can temporarily block the vents that allow the pump to properly prime.” Id.
- “The 2013 recall admitted that “[t]his can result in too much or too little being delivered resulting in hypoglycemia or hyperglycemia which can be severe and lead to
serious illness.” Id.
- “The 2013 recall was virtually identical to the 2017 recall with regard to the infusion set at issue in this case. The same problems – fluid causing a vent blockage –
resulting in the same outcomes – over-delivery of insulin – are at issue in both recalls.” Id.
- “It is clear that Medtronic did not resolve the problem with their product that resulted in the 2013 recall. Medtronic marketed the subject infusion sets without fixing the
problem, resulting in another recall for the same defect in 2017.” Id.
- “The Medtronic MiniMed pump and infusion set at issue are both the subject of recalls. The component of the infusion set… was recalled by Defendant Becton Dickinson and Company on December 23, 2016. Becton Dickinson notified Medtronic, its sole customer, of a Class 2 recall on December 26, 2016.” Complaint
- “December 23, 2016, issued a Class 2 recall for MiniMed Pro Sets, including Lot No. 6207537, citing a design defect. Said Lot specifically included…Pro Set Infusion Set and according to FDA Recall No. Z-1897-2017, Becton Dickinson and Company notified its sole customer, Medtronic, by email on December 26, 2016. Said recall further indicates that Becton Dickinson and Company recommended that Medtronic notify their customers of the situation.” id.
- “The set was subsequently recalled a second time by Medtronic and the FDA on September 10, 2017, due to the defective condition…” Id.
- “On September 7, 2017, Medtronic issued an “Urgent Medical Device Recall” regarding Medtronic MiniMed Infusion Sets.” id.
- “The Recall Notice states that “Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change.” Medtronic further
notes that it has received reports of hypoglycemia requiring medical attention related to this issue, which Medtronic concedes can result in “hypoglycemia and in extreme cases, death.”
- “The Recall Notice states that this problem is caused by fluid blocking the infusion set membrane during the priming/fill tubing process, which prevents the infusion
set from working properly. The result can be fast delivery of multiple days’ worth of insulin.” id.
- “The Recall Notice also announces that Medtronic has an alternate infusion set design, which contains a “new and enhanced membrane material that significantly
reduces the risk.” Id.
- “Medtronic notified customers of possible defects in the MiniMed Model 630G (MMT-1715) insulin pump on November 21, 2019. The FDA subsequently issued a
Class 1 recall for all lot numbers of the Plaintiff’s pump on February 7, 2020.” Id.
Medtronic insulin pump lawsuits
Medtronic insulin pumps date back to the 1980s. The company has continuously been releasing more advanced models since then. According to the company’s financial statements, the Diabetes Division accounts for nearly $600 million in sales per quarter. Medtronic is one of the dominant companies in the insulin pump sector and figures to be the largest company in the field by 2020.
Complications with Medtronic Insulin Pumps
Medtronic has had several recalls of this product this decade. In 2013, Medtronic received a warning letter from the FDA regarding the manufacturing conditions in its plant. The following year, its product were recalled for a malfunctioning button that resulted in an overdelivery of insulin.
Medtronic initiated a large-scale recall of its insulin pumps
In 2017, Medtronic initiated a large-scale recall of its insulin pumps. Like prior recalls, the issue behind this recall was the over-delivery of insulin. This specific problem involved over-delivery after an infusion set change. If fluid comes into contact with the insulin reservoir, it can cause a blocked membrane. This disrupts the continuous delivery of the insulin and can cause an excess of insulin to be delivered at times. The recall was intended to change the membrane to keep fluid from coming into contact with it during an infusion set change.
The over-delivery of insulin can cause hypoglycemia, which is low blood sugar. In a worst-case scenario, this can cause death. In one instance, a man in Mississippi has claimed that his wife died after her Medtronic insulin pump administered too much insulin while she was asleep. In another instance, a New Jersey estate claimed that a man died while using a Medtronic insulin pump since the pump did not give him enough insulin.
There are various product liability lawsuits that have been filed against Medtronic, given that many of its different pump models have been plagued with issues. The issue for Medtronic is all the more pronounced due to the multiple recalls that have been issued regarding its products. For Medtronic, there is a large potential liability given the high sales volume of these products.
Dire side effects of hypoglycemia
Given the dire side effects of hypoglycemia, many of the claims against Medtronic have involved wrongful death claims. The lawsuits are rooted in the theory of product liability. Some of the complaints have called attention to issues that Medtronic has experienced in its manufacturing process. The FDA had cited Medtronic in the past for failure to report to the FDA that it came into possession of information that its product caused injury. The complaints have made light of the fact that Medtronic is alleged to have insufficient personnel on hand at its manufacturing facility in Puerto Rico to conduct product testing. Federal law requires that people responsible for testing be doctors, nurses or others with advanced degrees. Instead, Medtronic allegedly had lax testing procedures that included relying on an individual with only a high school diploma.
Medtronic had an obligation to properly design and test the product
The Medtronic insulin lawsuits have alleged defects in the manufacture of Medtronic’s insulin pumps such that when the membrane got wet or was blocked, it resulted in the overdelivery of insulin that could cause hypoglycemia. Specifically, Medtronic had an obligation to properly design and test the product, but did not do so. Additionally, the plaintiffs allege that Medtronic had a duty to anticipate the conditions under which its product would be used and properly warn patients of the potential risks of using the product. Medtronic should have continuously tested its product after it was placed onto the market, the allegedly did not do so.
Mara Schwartz Medtronic lawsuit allegations:
- “Mara Schwartz used Medtronic MiniMed Pro Set Infusion Sets to deliver insulin from the pump to her body.” Mara Schwartz complaint PDF
- ” On or about the night of February 24, 2017, at her home in Greenwood County, South Carolina, Mara Schwartz’s pump was low on insulin. She followed the
steps Medtronic indicated were necessary to properly fill a reservoir with more insulin, attach a new Pro Set infusion set, and restart her MiniMed insulin pump.” Id.
- “After Ms. Schwartz refilled her insulin pump on the night of February 24, 2017, her pump and/or infusion set malfunctioned and delivered her pump’s entire reservoir
of insulin to her body at one time, causing her to become hypoglycemic. Ms. Schwartz has a service dog who has been trained to detect when her blood sugar is low. When Ms. Schwartz’s service dog alerted her, she checked her blood sugar and found it to be 36, at which point she drank some juice and ate some honey. She then lost consciousness and was in a diabetic coma for the remainder of the night.” Id.
- “When she regained consciousness at 5:30 the next morning, she was disoriented and confused.”
- “Her movement was uncoordinated and her vision was impaired, causing her to determine she needed glucose treatment. She was also bruised and in pain. She had bitten her tongue and had multiple lacerations, indicating that she had experienced hypoglycemic seizures while she was unconscious. This made taking in hypoglycemia treatment difficult. When her blood sugar started to rise and her vision returned, she discovered additional injuries to her arm. Medical examination indicated that she had sustained orthopaedic, neurological, and muscle injuries, as well as psychological trauma and emotional distress.” Id.
- “Upon information and belief, the Medtronic MiniMed pump and infusion set which over-dosed Ms. Schwartz malfunctioned as a result of defects that: (1) failed to
allow the reservoir to properly seat within the pump and (2) allowed fluid to block the infusion set membrane during the priming, fill tubing process, which prevented the infusion set from working properly and causing an over-delivery of insulin.” Id.
Medtronic insulin lawsuit lawyer
If you have used a Medtronic insulin pump and experienced side effects, including Hypoglycemia, you should immediately contact a Medtronic insulin lawsuit lawyer and provide them with the facts of your case. The Medtronic insulin lawsuit lawyer can inform you of the process that you would have to follow in order to have a chance at obtaining a legal recovery from Medtronic.