Lawsuit Filed Over Medtronic MiniMed Insulin Pump Quick-Set Problems
Published: December 14th, 2009 • Comments: 7
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.
Comment by Karen on 18 January 2010:
My mother has been in the hospital numerous times because of this pump. Her sugar level has gone over 1000 and has lead her to have heart atracks and kifdney failure. Doctors kept thinking that the pump was working, but it was not until recent that she was taken off the pump because they figured that was the problem. She now has ongoing kidney problems and is having to do shots again.
Comment by beverly on 21 January 2010:
i had a medtronic pain pump and i had it removed this past july 2009. the dr. left the mesh pocket in me and the catheter? i am having severe problems with this and the dr does not seem to care? i itch all over and i am having like hot flashes? is there a suit against medtronic for this? who and how can i get something done about this? i have to have artery replacement next month and because of this i can’t have an epidural!! my dr said i might go paralzed if they do it? he first told me that he took the catheter and everything out and now after ct scans and mri i have had instead of just a piece breaking off like he told me? about and inch or so the whole thing is in there! i also have severe stomach pain where the pouch is and pulling pain where the catheter runs around to my spine from my abdomen? this is not normal and he is not doing anything to help me but keeps lying to me?
if i had it to do over i would have never let him implant the pain pump in me! he never explained all this to me and i told him specifically i wanted all of it taken out but he just took the pump pout and left all the other in me!!
Comment by Nancy on 29 January 2010:
My daughter was using the minimed insulin infusion pump (paradigm model) She started on it in late July and we had made sure that it was not Lot 8 since we were aware of the recall. Nevetheless, the insulin pump malfunctioned after she had been using it for 2 weeks and administered a large bolus dose shortly before she went to bed. She went into a coma and suffered severe brain injury. She came out of her coma after several days but continues to suffer from cognitive deficits. I am curious to know if there are others out there who have also had this occur.
Comment by Connie on 6 February 2010:
My Granddaughter has been on this insulin pump for almost 4 years. The last year and a half we have had a very hard time keeping her blood sugar where it should be. We have had problems with air bubbles, and high blood sugars even though we are giving her the amount of insulin that she should be getting. She is only 10 years old, and we are thinking of taking her off of the pump. We just don’t trust if anymore.
Comment by Pat on 21 February 2010:
I too am recently having problems with air bubbles causing high blood sugars. I am using MMT-325 Quik-set and 326-A reseviors. I have been a pump user for 12 years. Any comments?
Comment by Angela on 25 February 2010:
I was on the medtronic insulin pump for 7 months. And in the 7 months I had 4 occasions where my sugars were between 600-700, I was hospitalized twice, in ICU. I am now off the pump because I didn’t trust it.
Comment by dbmeyer2 on 14 March 2010:
Pat, my wife had used the Disetronic insulin pump for 10 years and never I repeat never had air bubble issues. We move, she got a new Endo and was forced to change to the Medtronic. As soon as she went to the Medtronic the air bubble problem started. Her constant high blood sugar numbers have left her weak and most of all paranoid of the entire system itself. We can not change to different doctor and then a new system because insurance will not cover the cost. Calling Medtronic only gets us the canned response ” you are not handling your insulin correctly” or ” air is inherent to the insulin process”. My wife has been an RN for close to 30 years, she knows how to draw meds, she knows how to handle them. The air bubble problem is inherent to the Medtronic design.
I think all Medtronic users MUST band together to get this thing resolved!!! Everyone please respond to my email address.