In February 2020, Medtronic announced that over 300,000 of the company’s MiniMed Insulin Pump devices have a defect that could cause serious injury or even death to users. Specifically, the Medtronic insulin pumps have a defective retainer ring that can cause the vital insulin cartridge to become disconnected from the pump’s reservoir.
If the pump’s retainer ring is dislodged, it can lead to over-or-under-delivery of insulin. If the insulin pump delivers too much insulin, it can cause hypoglycemia (low blood sugar), which, as any diabetic knows, can be life-threatening. If it delivers too little insulin, the patient is not getting the benefit of the pump, and it can cause hyperglycemia (high blood sugar).
This was a serious recall. The FDA classified the recall as a Class I recall, which is the most serious type of recall and is issued when there is a reasonable possibility that the use of or exposure to the product could cause serious adverse health consequences or death.
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October 2023 Update
In July, two federal judges have recently dismissed separate lawsuits against Medtronic, a medical device company, concerning the failure of their MiniMed insulin pumps. The pumps, designed to deliver insulin to diabetic patients, have faced multiple recalls from 2009 to 2020 due to design issues. These problems allegedly caused underdosing or overdosing on insulin, leading to numerous injuries and a reported death.
Why were the lawsuits dismissed? Both judges claimed the insulin pump lawsuit are prempted. Preemption is a legal doctrine based on the Supremacy Clause of the U.S. Constitution, which establishes that federal law takes precedence over state laws when there is a conflict between the two.
Our lawyers do not believe preemption is appropriate here. But we understand the problem. Preemption comes into play because of the Federal Food, Drug, and Cosmetic Act (FDCA). Amendments to this act, such as the Medical Device Amendments (MDA), require FDA approval for medical devices. A device that goes through this rigorous process and gets approved is sometimes shielded from state law claims due to preemption, because the FDA has already evaluated the device’s safety and effectiveness. Thus, a claim in a state court asserting that the device is unsafe could conflict with the FDA’s determination and might be preempted.
What Are Insulin Pumps?
Insulin is an important hormone that converts sugar from carbohydrates into energy. People who suffer from type 1 diabetes cannot produce enough insulin on their own and often require insulin therapy to control their blood sugar levels. Insulin therapy can come in the form of either insulin injections or an insulin pump.
Insulin pumps are small, computerized devices that mimic how the human pancreas works by continuously delivering small doses of short-acting insulin. The pumps are about the size of a smartphone and are designed to be worn outside your body. The pump contains an insulin cartridge connected to a reservoir system attached to a long tube connected to a thin cannula. The cannula at the end of the tube is placed into the layer of fat around the user’s stomach area.
A small computer chip inside the pump is specifically programmed to release exact amounts of short-acting insulin throughout the day and after meals as required by the individual user. Some pumps connect to continuous blood sugar monitoring devices, which monitor the users’ blood sugar levels all day.
Medtronic MiniMed Insulin Pump a Blessing for Many
Medtronic is the largest medical device company in the world. Its Minimed Insulin Pump was the most popular and widely used of all traditional insulin pump devices on the market for diabetics. When it was first released, the MiniMed Insulin Pump was the first device to track and monitor user blood sugar levels and deliver insulin on an as-needed basis for diabetes. This state-of-the-art capability led Medtronic to describe the MiniMed as an “artificial pancreas.” It featured:
- Improved blood sugar control: By providing a continuous stream of insulin, the pump can help regulate blood sugar levels and reduce fluctuations that can lead to long-term complications.
- Flexibility: Unlike multiple daily injections, the insulin pump allows for more flexible scheduling and the ability to adjust insulin doses more easily in response to changes in activity levels, diet, and other factors.
- Convenience: The pump eliminates the need for multiple daily injections, which can be a logistical nightmare and time-consuming.
- Improved quality of life: By providing more consistent and precise insulin delivery, the pump may help people with diabetes feel better and reduce the risk of complications.
Medtronic MiniMed Insulin Pump Lawsuits
Our Medtronic MiniMed lawyers began following these potential lawsuits three years ago in 2019. The first sign of trouble with the MiniMed Insulin Pumps came in November 2019 when Medtronic sent out alert letters to all registered MiniMed users. The letter warned of a potential problem with the pump.
Then in February 2020, Medtronic issued a class I safety recall covering over 300,000 MiniMed Insulin Pump devices. At this point, you knew there would be a Medtronic MiniMed lawsuit. You have a grave risk of injuries, 300,000 pumps, and a pretty obvious product defect.
So what was the problem? Again, the MiniMed recall was due to a defective retainer ring that can allow the insulin cartridge to become loose or disconnected inside the pump. Once the insulin cartridge becomes disconnected, it can be hazardous for the device user because the pump can give them an acute overdose or underdose of insulin. This can cause the user to suffer acute hyperglycemia or hypoglycemia, resulting in serious damage to the body and vital organs and, in some cases, death.
By the time of the MiniMed recall, Medtronic had already received over 26,000 complaints about the defective pumps, and there have been 2,175 reported injuries and one death caused by the defect.
Example MiniMed Wrongful Death Lawsuit
Several lawsuits have been filed against Medtronic related to its MiniMed insulin pump. Some lawsuits have alleged that the pumps were defective and caused serious injuries or death.
For example, let’s talk about an example MiniMed lawsuit filed in Nevada. The complaint in Roget v. Medtronic (2:22-cv-00646) involves the death of a man with Type 1 diabetes who used a Medtronic MiniMed 630G insulin pump to manage his condition. According to the lawsuit, the insulin pump failed to deliver insulin to Roget when needed, causing his blood sugar to drop dangerously low. The suit claims that the pump’s sensor failed to detect Roget’s dropping blood sugar levels and that the pump’s motor failed to deliver insulin when needed to correct the problem.
The wrongful death lawsuit filed by the man’s surviving family alleges that the insulin pump was defective and caused Roget’s death. Plaintiffs claim the insulin pump and associated equipment were defective and unreasonably dangerous due to manufacturing defects and inadequate testing.
This Medtronic insulin pump lawsuit further alleges that the defendants made false or misleading representations about the safety and effectiveness of the pump and that these misrepresentations induced the decedent to use the device.
So, in sum, the Medtronic lawsuit alleges that the defendants knew or should have known of the defects and risks associated with their products, yet placed them into the stream of commerce and marketed them to the public, including the deceased individual, as safe and effective. The plaintiff asserts several causes of action, including strict liability, negligence, breach of express warranty, breach of implied warranty, and fraud.
The lawsuit was filed in the United States District Court for the District of Nevada. In October 2023, discovery is still ongoing on his case with the judge granting an extension of pretrial discovery on October 10, 2023.
Medtronic MiniMed Class Action Lawsuit
There is not a Medtronic MiniMed class action lawsuit in the MDL as of April 2022. Instead, MiniMed lawyers have brought individual lawsuits throughout the country.
There could be a class action lawsuit in the future, although the recent dismissals in June 2023, do not strengthen the likelihood of a class action.
A class action has pros and cons for victims. It may be that keeping these MiniMed lawsuits as individual claims might ultimately increase the average settlement amounts of these claims and get cases moving toward trial and settlement faster than if a class action lawsuit had been certified. But the preemption issue has cast a shadow on hopes in this regard.
Medtronic MiniMed Lawyer
Our firm handles defective medical device cases all over the country. But we are no longer reviewing new claims.