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Medtronic MiniMed Insulin Pump Lawsuit & Recall

The FDA has announced a Class I recall for two models of the Medtronic MiniMed Insulin Pump due to faulty manufacturing, leading to incorrect insulin dosing. Incorrect insulin dosages can cause patients to experience hyperglycemia or hypoglycemia, which are both deadly medical conditions. Patients claim that due to the broken ring on the insulin pumps, they have experienced injuries associated with hyperglycemia and hypoglycemia and there has even been a recorded death. It’s for these reasons that the manufacturer faced a number of lawsuits.

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Why Are There Medtronic MiniMed Lawsuits?

It’s alleged that faulty manufacturing of the insulin pumps has led to a piece of the pumps not working correctly. The piece is a ring that connects the pump to the patient’s body. When the ring isn’t on correctly, it can lead to patients accidentally receiving higher or lower doses of insulin. 

Why Did Plaintiffs File Medtronic MiniMed Lawsuits?

When diabetic patients receive the incorrect dosage of insulin, they could experience hyperglycemia or hypoglycemia. Both of these conditions can cause patients to experience a number of adverse side effects, injuries, and, in one recorded instance, even death. 

What Medtronic MiniMed Lawsuits Are There?

There was a wrongful death lawsuit filed in Nevada in April 2022. Roget v. Medtronic claimed that the death of a man with Type 1 diabetes was because of Medtronic MiniMed’s faulty insulin pump. The pump failed to provide the correct and necessary dose of insulin that Roget needed and caused his blood sugar to drop to a dangerous level. The case result is still pending as of September 2023. 

Are There Any Medtronic MiniMed Lawsuit Settlements?

There is no active class action lawsuit in 2023 that required Medtronic MiniMed to provide settlement money. The situation is still being closely investigated as the claims from the plaintiffs still emerge. There are no recorded settlements, but there could be settlements for the company in the future. 

Are There Active Medtronic MiniMed Insulin Lawsuits?

Since the Medtronic MiniMed insulin pumps are still being monitored, there are no active lawsuits occurring right now. The Roget v. Medtronic court case is the only pending lawsuit right now. There may be possible class action lawsuits in the future. 

What Are Medtronic MiniMed Insulin Pumps?

Medtronic MiniMed’s insulin pumps are technologically designed to administer the correct doses of insulin to the patient. The pumps use tracking software to determine the patient’s blood sugar level and deliver the amount of insulin accordingly. The two Medtronic MiniMed insulin pumps that were recalled are Model 630G (MMT-1715) and Model 670G (MMT-1780).

What Are the Components of Insulin Pump Model 630G?

The MiniMed 630G contains a waterproof screen, a small device that continuously delivers insulin to the body, and tubing that needs to be changed every two to three days. This device was only for persons sixteen years and older. 

What Are the Components of Insulin Pump Model 670G?

This pump is also designed to continuously deliver insulin at selectable rates (based on the user’s needs and the doctor’s requirements). The components are the same as Model 630G, but Medtronic claims that this device shouldn’t be used by itself. Instead, it is to be used to provide an indication of when the patient should use a finger stick. This model was only for persons fourteen years and older. 

What Is Diabetes?

Diabetes is a chronic health condition that prevents your body from making 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 Diabetes and Type 2 Diabetes?

Type 1 Diabetes is the less common version of diabetes and is caused by autoimmune reactions that prevent the proper production of insulin. Type 2 diabetes is the most common type of diabetes but also the type that is preventable. Through a healthier diet and an active lifestyle, pre-diabetic patients can delay their diabetes. 

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, doctors recommend taking up a healthier diet and becoming more active through exercise. Additionally, it’s important to take any insulin treatment or medication to ensure that your blood sugar level stays stable. 

What Are the Symptoms of Diabetes?

The symptoms of diabetes are more noticeable in individuals with type 1 diabetes, but symptoms can show up in any diabetic patient. Common symptoms or indicators that you’re at risk of developing diabetes are: 

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

Why Were Medtronic MiniMed Insulin Pumps Recalled?

Many Medtronic MiniMed insulin pumps have been recalled because of a missing or broken retainer ring. This ring helps to lock the insulin cartridge into place. If this isn’t locked into place, the insulin could be incorrectly dispersed, leading to hyperglycemia or hypoglycemia. There have been around 26,421 recorded complaints, 2,175 injuries, and 1 death. 

How Many Medtronic MiniMed Insulin Devices Have Been Recalled?

The focus has been on two major devices: Model 630G and Model 670G. All these models were recalled before the fall of 2019. The total number of these devices that were recalled and sent back to the manufacturer was 322,005. 

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. Hyperglycemia flashes occur often in diabetic patients. 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. This can be caused by other drugs or diabetes treatments and can be treated with a food or drink with a high sugar content as well as 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

What Are the Alternatives for Diabetic Patients?

With MiniMed being under fire for the broken rings in their devices, it leaves a lot of patients asking what they should do next. Insulin is required for diabetic patients and it can be deadly if they do not receive it. 

Medtronic has released new, more advanced devices that patients can try out. Additionally, there are other insulin pump manufacturers such as Abbott and Dexcom who have devices that diabetic patients can use. There are also a number of different treatment options such as oral medication and even islet cell transplants. It’s important for patients to discuss their treatment options and pathways with their doctor.

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

Sources

  1. Diabetes symptoms. (2023, September 7). Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/symptoms.html
  2. FDA product recall: Medtronic recalls MiniMed insulin pumps for incorrect insulin dosing | Summit Health. (n.d.-a). https://www.summithealth.com/health-wellness/fda-product-recall-medtronic-recalls-minimed-insulin-pumps-incorrect-insulin-dosing#:~:text=RECALLED%20PRODUCT&text=Distribution%20Dates%3A,June%202017%20to%20August%202019
  3. Hypoglycemia – Symptoms and causes – Mayo Clinic. (2022, May 4). Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/hypoglycemia/symptoms-causes/syc-20373685
  4. Medtronic. (n.d.-a). Diabetes – Indications, safety, and warnings. Medtronic. https://www.medtronic.com/us-en/healthcare-professionals/products/diabetes/indications-safety-warnings.html#:~:text=The%20MiniMed%E2%84%A2%20670G%20System,to%20fall%20below%20predefined%20threshold
  5. Medtronic. (n.d.-b). Diabetes – Insulin Pump Systems | Medtronic. https://www.medtronic.com/us-en/healthcare-professionals/products/diabetes/insulin-pump-systems.html#:~:text=MiniMed%E2%84%A2%20780G%20System,Indications%2C%20Safety%2C%20and%20Warnings
  6. Medtronic. (n.d.-c). Diabetes treatment – insulin pump technology. Medtronic. https://www.medtronic.com/ca-en/diabetes/home/what-is-diabetes/insulin-therapy/insulin-pump.html#:~:text=It%20delivers%20continuous%20and%20customized,insulin%20production%20of%20the%20pancreas
  7. Medtronic Diabetes. (2023, August 18). MiniMed 630G System [Video]. Medtronic Diabetes. https://www.medtronicdiabetes.com/products/minimed-630g-insulin-pump-system
  8. Professional, C. C. M. (n.d.). Hyperglycemia (High blood sugar). Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/9815-hyperglycemia-high-blood-sugar
  9. Roget v. Medtronic, Inc. et al. (n.d.). UniCourt. https://unicourt.com/case/pc-db5-roget-v-medtronic-inc-et-al-1181421
  10. The Insulin Resistance–Diabetes connection. (2022, June 20). Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/insulin-resistance.html#:~:text=Insulin%20helps%20blood%20sugar%20enter,signaling%20insulin%20to%20decrease%20too.
  11. What is Diabetes? (2023, September 5). Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/diabetes.html