Contact A Lawyer
Have A Potential Case Reviewed By An Attorney
A group of plaintiffs have filed a lawsuit over recalled Medtronic Quick-Set infusion sets for its MiniMed insulin pump, claiming that the defects in the insulin delivery systems for diabetics caused users to suffer severe injuries and hospitalizations.
The Medtronic insulin pump infusion set lawsuit was filed in U.S. District Court in the Southern District of Texas on November 30, on behalf of six plaintiffs; five diabetics who used the Medtronic MiniMed insulin pump and one of the plaintiffs’ husbands. All five diabetic plaintiffs allege that they were hospitalized after receiving incorrect insulin dosages from Paradigm Quick-Set infusion sets, designed to work with the MiniMed pumps.
On June 29, a Medtronic Paradigm Quick-Set recall was issued for about three million disposable infusion sets used with the MiniMed Insulin Pump after it was discovered that some could deliver incorrect doses of insulin. At that time, Medtronic estimated that about 2%, or 60,000 units, of an entire lot of the infusion sets did not vent air pressure properly when delivering an insulin dose.
The Quick-set infusion sets are plastic tubes used to infuse a diabetes patient from the MiniMed pump. They are usually replaced after three days. The recalled sets were distributed throughout the U.S., Germany, Mexico, Brazil, Great Britain, Canada and the Bahamas.
Affected infusion sets were distributed with a lot number starting with “8” marked on the product box and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399.
The product liability lawsuit cites an FDA warning letter sent to Medtronic just weeks before the recall, which highlighted deficiencies in quality control at its Puerto Rico production facility, which manufactures many of the MiniMed products. According to FDA investigators, the plant had a wide range of problems that included lax testing of products for defects, proper record keeping, and employing someone with only a high school education and some special training as a medical expert for determining the danger of defects.
Medtronic faces potential damages under strict liability, negligence, failure to warn, defective design and manufacturing and breach of warranty. The lawsuit also seeks punitive damages, claiming that Medtronic was aware of the risk of their products and production deficiencies, but “proceeded with conscious indifference to the rights, safety and welfare of others.”
The plaintiffs seek an unspecified amount of damages for compensation of medical expenses, physical pain and anguish, physical impairment, mental anguish, loss of earnings, loss of enjoyment of life, loss of consortium and loss of household services.