The executor of the will of a New Jersey man who died of a night-time diabetes attack is suing Medtronic ($MDT) for the alleged failure of its MiniMed insulin pump and infusion set.
Joann Hassan said the company was relying on underqualified high school graduates to test the pump, leading to the device's eventual failure on Charles Slack Jr.
Slack's estate says the April 2013 death occurred because he did not receive the correct dosage of insulin. "The pump, set and reservoir failed to take the necessary, expected and warranted steps to alert [Slack] of the failure," according to Courthouse News Service.
The specific devices used by Slack were the MiniMed Paradigm Real-Time Revel 523 System and MiniMed Paradigm Quick-Set Infusion Sets, the estate said. Medtronic says the Revel provides continuous glucose monitoring and notification of oncoming high and low blood sugar levels, while the infusion sets consist of thin plastic tubes used to deliver insulin from the pump to the patient, the FDA says.
The estate says that the diabetic attack left him "lying in his urine drenched bed, in a state of unconsciousness and unresponsiveness, yet alive." He died after spending the next several weeks hospitalized and in a coma, Courthouse News Service says.
Hassan's suit seeks punitive damages for a variety of claims including breach of warranty, negligence and wrongful death.
Medtronic's MiniMed infusion sets were hit by a Class I recall notice in June 2009. "These infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may cause serious injury or death," the FDA said.
It followed that up with a warning letter, citing concerns about Medtronic's insulin pump manufacturing operations in Puerto Rico and the company's poor response to customer complaints. The letter says that the employee in charge of reporting adverse events to the FDA had only a high school diploma.
Days after the FDA's 2009 action, a patient on the MiniMed infusion set died of a coma resulting from diabetic hypoglycemia, which led to a wrongful death lawsuit from her family in 2012. The following day Medtronic issued a press release publicizing the recall, which said that 60,000 units of the infusion sets, or 2% of them, were defective, reported AboutLawsuits.com.
Hassan is represented by the law firm Pinczewski & Baurkot. Other law firms have also been searching for victims of the recalled device since the defect was uncovered in 2009.
In an emailed statement, Medtronic said, "As a company strongly committed to improving the lives of people with diabetes, we were deeply saddened to learn about the death of one of our customers. Our thoughts are with the family and friends of Charles J. Slack. His passing is a tragic reminder that type 1 diabetes is a serious condition. While we can't provide specific details regarding the complaint filed against Medtronic, we can tell you that we investigate every complaint we receive, and are committed to ensuring the safety and reliability of our products. We test our products rigorously, and they are carefully reviewed by regulatory agencies, such as the Food and Drug Administration. We hold ourselves to highest safety quality standards in the industry."