Medtronic Insulin Infusion Set Lawsuit

Why Are There Medtronic Insulin Infusion Lawsuits?

Medtronic has allegedly released defective insulin pumps that can put diabetic patients at risk of receiving too much or too little insulin, leading to fatal results. Patients who use these faulty pumps have been reported to suffer from insulin overdose or under-dose. The results of the incorrect amount of insulin in their bodies include brain injuries, seizures, loss of consciousness, and, in worse cases, death. 

What Medtronic Insulin Pump Lawsuits Are There?

Medtronic Minimed’s lawyers throughout the country have been quietly settling lawsuits to prevent the need for a class action lawsuit. There has not been a Medtronic Minimed class action lawsuit and two federal judges have recently dismissed two separate lawsuits against Medtronic.

There was a wrongful death lawsuit filed in Nevada in April 2022. Roget v. Medtronic involves the death of a man with Type 1 diabetes who used a faulty Medtronic Minimed insulin pump. The pump failed to provide Roget with the insulin he needed and caused his blood sugar to drop. The case result is still pending as of September 2023. 

Are There Any Medtronic Insulin Lawsuit Settlements?

As of February 2023, there have been no recorded Medtronic Lawsuit settlements associated with their insulin pumps. However, as can be seen with Medtronic’s past record with their Infuse Bone Graft lawsuits, they may be likely to settle with affected individuals privately. 

Are There Active Medtronic Insulin Lawsuits?

The Medtronic insulin pump issue is one still being actively monitored. The Roget v. Medtronic court case is still pending and there may be possible class action lawsuits in the future. As of September 2023, there are no active class action lawsuits. 

What Is Medtronic Insulin Infusion Pump?

An insulin pump is a device that mimics a working pancreas. In other words, it delivers continuous and customized doses of rapid-acting insulin 24 hours a day to stabilize the body of a diabetic patient. 

What Are the Components of an Insulin Pump?

An insulin pump comes in three different parts, the insulin pump itself, the infusion set, and the reservoir. The insulin pump is an electronic device that is used to program how much insulin to deliver and keep track of your body’s blood sugar level. The infusion set has a thin tube that goes directly from the reservoir into the body, usually in the spot where typical insulin injections would go. The reservoir is a plastic cartridge that holds the insulin. 

What Is Diabetes?

Diabetes is a chronic health condition that affects how your body turns food into energy. With diabetes, your body doesn’t make enough insulin which is typically released by your pancreas. Without enough insulin, the sugar you intake will stay in your bloodstream and can lead to health problems like heart disease, kidney disease, or vision loss. 

What Is the Difference Between Type 1 and Type 2 Diabetes?

Type 1 diabetes is caused by an autoimmune reaction and stops your body from making insulin. This type of diabetes can be diagnosed at any age and the symptoms develop quickly. Patients with this type of diabetes will need to take insulin every day to survive. There is no way to prevent type 1 diabetes. 

Type 2 diabetes is when your body cannot use insulin well and regulate your blood sugar levels on its own. It develops over the years and is usually diagnosed in young adults. The symptoms for this type aren’t as prominent, so you’ll have to get tested if you’re at risk. Type 2 diabetes can be prevented or delayed through healthy food changes, an active lifestyle, and losing weight. 

How Is Diabetes Treated?

Diabetes is a chronic disease with no cure, so there isn’t a way to completely get rid of it. However, there are recommended things that patients can do to alleviate symptoms of diabetes such as eating healthier and being active. Other things that are recommended include: 

• Taking diabetic medications as prescribed
• Get diabetes education and support
• Make and keep healthcare appointments

What Are the Symptoms of Diabetes?

People with Type 2 diabetes often don’t show any symptoms. Overall signs to be aware of if you think you’re at risk of developing diabetes include: 

• Urinating often
• Extreme thirst
• Loss of weight effortlessly
• Extreme hunger
• Blurry vision
• Numbness in hands or feet
• Fatigue
• Dry skin
• Sores healing slowly
• Increase in infections

What Is Insulin?

Insulin is a hormone produced in the pancreas that regulates the amount of sugar in your blood. When the sugar is taken out of the blood, it can be transferred to the cells and used as energy. It can also be stored in the liver to be used for later. 

What Is Hyperglycemia?

Hyperglycemia occurs when there is too much sugar in your blood and not enough insulin or your body cannot use insulin properly. This is typically an indicator of diabetes and those with diagnosed diabetes can experience hyperglycemia episodes frequently. If left untreated for long periods of time, it can cause nerve damage, blood vessel damage, as well as tissue and organ damage. 

What Are the Symptoms of Hyperglycemia?

Early symptoms of hyperglycemia include:

• Increased thirst and/or hunger
• Frequent urination
• Headache 
• Blurred vision

Symptoms of long-term hyperglycemia include: 

• Fatigue
• Weight loss
• Vaginal yeast infections
• Skin infections
• Slow-healing cuts and sores

What Is Hypoglycemia?

Hypoglycemia is the opposite of hyperglycemia in that the blood sugar level is lower than standard. It’s often related to diabetes treatment but other drugs and conditions can cause low blood sugar. Hypoglycemia needs immediate treatment and involves getting your blood sugar levels up with a high-sugar food or drink along with medication. 

What Are the Symptoms of Hypoglycemia?

Early signs of hypoglycemia include: 

• Pale skin
• Shakiness
• Sweating
• Headache
• Hunger or nausea
• Irregular or fast heartbeat
• Fatigue
• Irritability or anxiety
• Difficulty concentrating
• Dizziness and lightheadedness
• Numbness of lips, tongue, or cheeks

As hypoglycemia progresses, symptoms can include:

• Confusion and unusual behavior
• Loss of coordination
• Slurred speech
• Blurry or tunnel vision
• Nightmares
• Unresponsiveness
• Seizures

Why Was the Medtronic Insulin Pump Infusion Set Recalled?

Medtronic recalled their insulin pumps due to a missing or broken retainer ring. The retainer ring helps to lock the insulin cartridge into place in the pump’s reservoir. Without this locking appropriately, there may be an under or over-delivery of insulin into the body. 

There are a total of 26,421 complaints and there have been 2,175 injuries reported and 1 noted death due to the faulty Medtronic pumps.

How Many Devices Have Been Recalled?

The FDA has called for a Class I recall for Medtronic products, which is the most serious type of recall. Class I indicates that these devices may cause serious injuries or death. The types of Medtronic Minimed products recalled and the dates they were recalled are listed below: 

• MiniMed 600 Series Insulin Pumps
  • Model 630G (MMT-1715) – all lots before October 2019
  • Model 670G (MMT-1780) – all lots before August 2019

The number of devices recalled since the initiated date of November 21, 2019, is 322,005.

What Are the FDA’s Warnings About Medtronic Insulin Infusion Pumps?

The FDA issued Medtronic a warning letter on December 9, 2021. The warning letter highlights Medtronic’s failure to adequately establish procedures for preventative actions against the damaged retainer rings. This warning was issued after complaints came from patients about the broken retainer rings on the Model 630G and the Model 670G. The warning letter also contains other areas of concern that include all of Medtronic’s negligence in addressing and fixing the models.

Medtronic’s newer 700 models have received FDA approval and are so far clear of complaints from patients. This indicates that Medtronic’s newer insulin pump models are manufactured correctly and can be used by diabetic patients. 

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.