Medtronic Insulin Pump

Medtronic has so far faced at least two lawsuits alleging the Medtronic MiniMed Paradigm insulin pumps are defective and have caused the death of patients relying on the pumps to monitor blood glucose levels. There have been at least two Medtronic recalls of the devices, linked to problems with the pumps providing too much or too little insulin. Attorneys are now investigating whether more patients were harmed by Medtronic MiniMed Paradigm insulin pumps that allegedly failed to work as promised.

Medtronic MiniMed Paradigm Insulin Pumps

Medtronic MiniMed Paradigm insulin pumps are used by patients who have diabetes mellitus and need insulin administered to keep their blood glucose at appropriate levels. The pumps offer continuous glucose monitoring and notification if blood sugar levels are about to drop too high or too low. Concerns have been raised, however, that some pumps have failed to supply proper insulin doses, and further failed to warn the patient that there was a failure.
 

Medtronic MiniMed Recall

In September 2013, the US Food and Drug Administration (FDA) issued a warning letter to Medtronic, stating that the company had violated quality control regulations at the plant where the Medtronic Paradigm pumps are manufactured. Among issues outlined in the letter were concerns that the devices were adulterated, and that some of the plant' methods or facilities "are not in conformity with the current good manufacturing practice requirements…"

In June 2013, the Medtronic and FDA announced a Class 1 Recall of Medtronic MiniMed Paradigm Insulin Infusion Sets. That recall was announced after concerns were raised that the pumps had the "potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors."According to the recall notice, fluids that contact the inside of the tubing connector could block vents that allow the pump to prime properly, which can cause too much or too little insulin to be delivered. Too much or too little insulin can cause hypoglycemia or hyperglycemia, which can be fatal.

A similar recall was also announced in July 2009, when Medtronic initiated a recall of certain lots of the MiniMed Paradigm insulin pumps. That recall involved Paradigm Quick-Set infusion sets that may not have allowed the insulin pump to vent air pressure properly, potentially causing the device to deliver too much or too little insulin.
  Lawsuits have been filed against Medtronic, alleging the company's MiniMed insulin pump failed to work properly, resulting in death. One such lawsuit was filed by the estate of Charles Slack Jr. According to reports, the pump failed to supply a proper dose of insulin while Slack was asleep and failed to alert Slack that there was a failure. He was reportedly found unconscious and stayed in a coma for several weeks before he died. The plaintiff, an executrix of Slack's estate, alleges Medtronic relied on individuals who did not follow strict testing procedures when determining whether or not the insulin pump was safe or reliable.

The lawsuit is Hassan v. Medtronic MiniMed Inc. et al, No. 3:15-cv-2788.

In 2012 a similar lawsuit was filed by Alice Pierce against Medtronic, alleging her daughter, Carol Givens, died as the result of a faulty MiniMed device. According to court documents, Carol was hospitalized repeatedly after using the MiniMed insulin pump due to problems with her blood sugar levels, but did not link the issue to a problem with the device. She died on July 9, 2009, of cerebral anoxia with diabetic hypoglycemic coma.

The lawsuit is Pierce v. Medtronic Inc., et al, case number 0:12-cv-01601.
 

Medtronic Insulin Pump Legal Help

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Last updated on Sep-3-20