Designed to monitor blood glucose levels, the Medtronic MiniMed Paradigm insulin pump has gone through multiple recalls over faulty operation and parts. The device has been linked with at least two deaths, and in response, patients or family members have started filing lawsuits against the manufacturer.
Background
This Medtronic insulin pump is specifically for patients with diabetes mellitus. These individuals need insulin provided at appropriate levels, and this pump is supposed to deliver a consistent supply in accordance with the patient’s levels and to indicate whether they are too high or low.
However, multiple recalls reveal that the pumps provide too little or too much insulin and don’t notify the patient when this occurs.
The FDA first recalled the device in 2009, over the Paradigm Quick-Set infusion component. Reports at the time reveal this part didn’t allow the pump to correctly regulate its air pressure.
By June 2013, Medtronic announced its own Class I recall, this time over an over- or under-delivery of insulin when fluids come in contact with the Medtronic Paradigm Tubing Connectors. When this happens, the vents causing the pump to function properly get blocked. As a result, some patients end up experiencing hypoglycemia or hyperglycemia, which may be fatal if untreated.
Following this instance, the FDA sent a warning letter to Medtronic that same year, stating the company violated quality control regulations at its manufacturing plant. The communication revealed that, because the plant wasn’t operating in accordance with good manufacturing practices (GMP), the pumps may have been altered.
After this point, a Class II recall followed in 2014 over the same issue. This report alleged Medtronic programmed their pumps to deliver the maximum amount of insulin possible, regardless of the patient’s needs. Further, settings on the main menu could accidentally result in delivering a consistently high dose.
In total, about half a million devices are affected globally. Individuals not getting the proper amount of insulin may start to display:
- Trembling
- Excessive sweating
- Weakness
- Hunger
- Confusion
- Headaches
- Loss of consciousness
- Seizure
- Death
Lawsuits
Multiple lawsuits, including product liability and wrongful death claims, have already been filed against Medtronic. In these instances, the plaintiff alleges the pump’s failure to work correctly resulted in death or put the patient in a coma. Further, the lawsuits claim Medronic was negligent in failing to train its workers on proper quality control procedures.
Have your or a loved one gone through this experience after being given a Medtronic insulin pump? If so, have Trantolo & Trantolo hold the manufacturer accountable. To present your claim, contact any of our locations to speak with a product liability attorney today.
