insulin pump lawsuits and complications
Medtronic insulin pumps are intended to help patients suffering from type 1 diabetes increase their insulin production. The pumps are designed to replace insulin shots and provide patients with an easier and less invasive means to take their insulin treatments. However, the products have shown the ability to pump too much insulin into the patient, resulting in numerous complications and side effects. This led to an FDA recall for the product. Medtronic is now defending against numerous lawsuits alleging defects in these insulin pumps.
What is an Insulin Pump?
An insulin pump is a small computer that a patient wears strapped to their waist. The device is programmed to deliver a continuous and steady dose of insulin. The delivery is done through a catheter that is implanted in the patient. The catheter is taped into place after insertion. A patient has different options for programming the device, including a higher dose timed to coincide with meals. This device is suited for those who have frequent low blood glucose reactions or delays in absorption of food.
Medtronic insulin pumps date back to the 1980s. The company has continuously been releasing more advanced models since then. According to the company’s financial statements, the Diabetes Division accounts for nearly $600 million in sales per quarter. Medtronic is one of the dominant companies in the insulin pump sector and figures to be the largest company in the field by 2020.
Complications with Medtronic Insulin Pumps
Medtronic has had several recalls of this product this decade. In 2013, Medtronic received a warning letter from the FDA regarding the manufacturing conditions in its plant. The following year, its product were recalled for a malfunctioning button that resulted in an overdelivery of insulin.
In 2017, Medtronic initiated a large-scale recall of its insulin pumps. Like prior recalls, the issue behind this recall was the over-delivery of insulin. This specific problem involved over-delivery after an infusion set change. If fluid comes into contact with the insulin reservoir, it can cause a blocked membrane. This disrupts the continuous delivery of the insulin and can cause an excess of insulin to be delivered at times. The recall was intended to change the membrane to keep fluid from coming into contact with it during an infusion set change.
The over-delivery of insulin can cause hypoglycemia, which is low blood sugar. In a worst-case scenario, this can cause death. In one instance, a man in Mississippi has claimed that his wife died after her Medtronic insulin pump administered too much insulin while she was asleep. In another instance, a New Jersey estate claimed that a man died while using a Medtronic insulin pump since the pump did not give him enough insulin.
Lawsuits Against Medtronic
There are various product liability lawsuits that have been filed against Medtronic, given that many of its different pump models have been plagued with issues. The issue for Medtronic is all the more pronounced due to the multiple recalls that have been issued regarding its products. For Medtronic, there is a large potential liability given the high sales volume of these products.
Given the dire side effects of hypoglycemia, many of the claims against Medtronic have involved wrongful death claims. The lawsuits are rooted in the theory of product liability. Some of the complaints have called attention to issues that Medtronic has experienced in its manufacturing process. The FDA had cited Medtronic in the past for failure to report to the FDA that it came into possession of information that its product caused injury. The complaints have made light of the fact that Medtronic is alleged to have insufficient personnel on hand at its manufacturing facility in Puerto Rico to conduct product testing. Federal law requires that people responsible for testing be doctors, nurses or others with advanced degrees. Instead, Medtronic allegedly had lax testing procedures that included relying on an individual with only a high school diploma.
The Medtronic insulin lawsuits have alleged defects in the manufacture of Medtronic’s insulin pumps such that when the membrane got wet or was blocked, it resulted in the overdelivery of insulin that could cause hypoglycemia. Specifically, Medtronic had an obligation to properly design and test the product, but did not do so. Additionally, the plaintiffs allege that Medtronic had a duty to anticipate the conditions under which its product would be used and properly warn patients of the potential risks of using the product. Medtronic should have continuously tested its product after it was placed onto the market, the allegedly did not do so.
If you have used a Medtronic insulin pump and experienced side effects, including Hypoglycemia, you should immediately contact a Medtronic insulin lawsuit lawyer and provide them with the facts of your case. The Medtronic insulin lawsuit lawyer can inform you of the process that you would have to follow in order to have a chance at obtaining a legal recovery from Medtronic.