Medtronic MiniMed Insulin Pump Lawsuit
On November 18, 2017, the FDA announced a Class 2 device recall for over 9.5 million Medtronic MimiMed Infusion sets. A Class II recall is an immediate threat level recall and identifies products that might cause a temporary health problem. The recall covers the MiniMed Sure-T, Mio, Silhouette, and Quick-Set Infusion Sets manufactured prior to April 2017. Medtronic MiniMed infusion sets used with non-Medtronic pumps and those without tubing are not covered by this recall.
The recalled devices have the potential to over-deliver insulin to patients with diabetes, which can lead to hypoglycemia. Symptoms include anxiety, confusion, cold sweats, trembling, fatigue, hunger, and irritability. In extreme cases, hypoglycemia can cause seizures, coma, and even death.
The company began informing patients and doctors about the recall in September 2017, noting that patient reports linked certain lots of the infusion sets to problems that could result in over-delivery of insulin. They advised consumers to check the company’s website for information on lot numbers to see if they were using a recalled one of the products.
Patients who have suffered serious injuries because of this or other issues with Medtronic insulin pumps and infusion sets may be eligible to file lawsuits in an attempt to recover damages. Some lawsuits have already been filed against the company. Chaffin Luhana is actively investigating whether other patients were hurt.
What is a Medtronic MiniMed Insulin Pump?
Patients with type 1 diabetes produce little or none of the hormone “insulin,” which helps the body process glucose from fuel. Without insulin, the body’s cells can’t draw energy from food. The glucose then builds up in the bloodstream, which can cause high blood pressure and lead to other health problems.
Patients with type 2 diabetes also have trouble with insulin. Either the body has developed a resistance to the effects of insulin or it doesn’t produce enough. Either way, these patients need supplemental insulin to live normal, healthy lives.
Though many diabetes patients receive insulin via injections, there are other modes of delivery that can make it easier for patients to keep their insulin levels stable. An insulin pump is a small electronic device about the size of a mobile phone that the patient can carry on his or her belt or in a pocket. It comes with an “infusion set” that allows the insulin to be delivered into the body.
Instead of a needle, these sets include a small flexible tube or “cannula” that sits just underneath the skin—somewhere on the body a patient would normally inject insulin—and another small tube that goes from the cannula to the pump. The insulin travels through this tube and into the cannula, and then into the body.
Medtronic is the leading provider of insulin pumps and infusion sets on the market today. The company advertises its products as superior to injections, helping patients to “achieve better glucose control.” The pumps are adjustable and are supposed to deliver accurate doses of insulin. According to Medtronic, the pumps provide benefits like improved HbA1c control, fewer hypoglycemic events, and reduction in glycemic variability.
What is the Problem with the Medtronic MiniMed Insulin Pumps?
In this latest recall, the FDA stated that Medtronic’s recalled infusion sets (which go with the pumps) had a defective component that is causing the device to over-deliver insulin under certain conditions. The “vent membrane” inside the set can become blocked during priming and fill-tubing, which can result in insulin over-delivery. The blockage may occur if insulin or other fluids like water are spilled on top of the insulin reservoir during the priming process. Medtronic has advised that it redesigned the vent membrane.
The company stated in a press release that if the infusion sets become blocked, it can “lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.”
Medtronic was allegedly unaware of the issue until it started receiving reports from patients describing incidences of hypoglycemia. The company analyzed the device and found that the vent membrane, which has now been discontinued, could cause blockage shortly after an infusion set change. (The sets must be changed every few days.)
Newer infusion sets, available since April 2017, include a design update of this component, which the company says reduces the risk of insulin over-delivery after an infusion set change. Yet the company did not offer to recall and replace older units until September 2017.
Medtronic has assured patients it will replace defective infusion sets with new ones containing the updated component at no cost.
Not the First Medtronic MiniMed Insulin Pump Recall
This isn’t the first time Medtronic has had to recall defective insulin pumps and related components. In June 2013, it implemented a Class I recall (reserved for dangerous or defective products that could cause serious health problems or death) for 11 million MiniMed Paradigm Infusion sets. The issue was very similar to that addressed with the latest MiniMed recall —if fluids came into contact with the inside of the infusion set, it could cause it to malfunction and over- or under-deliver the amount of insulin.
In 2013, the FDA sent a warning letter to the company notifying it that its Northridge, California facility, which manufactured the Paradigm Insulin Infusion Pumps, was not in conformity with current good manufacturing practices. Specifically, the company failed to identify the actions needed to correct and prevent recurrence of the Paradigm Insulin Infusion Pumps device failure.
In 2014, Medtronic recalled over 550,000 MiniMed Paradigm Insulin Infusion Pumps because accidental button pressing errors could occur. The company had received reports that patients had accidentally programmed the pump to deliver the maximum amount of insulin, again, risking hypoglycemia.
In 2015, the FDA filed a consent decree against Medtronic, Inc., and two of the company’s officers, for “repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems….” These violations occurred at the company’s Columbia Heights, Minnesota facility, which manufactures pumps that deliver cancer medications. The FDA required that Medtronic stop most sales of these devices, because they could lose battery power and fail, or deliver too much or too little medication.
Types of Injuries Associated with Medtronic Insulin Pumps
Patients using Medtronic insulin pumps and infusion sets may suffer from the following injuries:
- Loss of consciousness
Symptoms of hypoglycemia include the following:
- Racing heartbeat
- Pale skin
- Extreme hunger
- Excess sweating
- Vision disturbances
Medtronic MiniMed Insulin Pump Lawsuits
Medtronic has already had to defend against lawsuits filed by plaintiffs injured by its Infusion set products. In one case, the pump allegedly failed to provide a proper dose of insulin while the plaintiff was sleeping. He was found unconscious and slipped into a diabetic coma. He later died. His family filed a lawsuit against Medtronic seeking compensation for medical costs and wrongful death.
If you or a loved one used a Medtronic MiniMed insulin pump and/or infusion set and then experienced serious side effects such as those listed above, you may be eligible to file a Medtronic MiniMed insulin pump lawsuit to recover damages. Chaffin Luhana is now investigating these cases and invites you to call today at 1-888-316-2311.