Medtronic Insulin Pump Lawsuit Filed Over Recalled Infusion Sets

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Irvin Jackson

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A wrongful death lawsuit has been filed against Medtronic by a woman whose daughter allegedly died due to problems with Medtronic Paradigm Quick-Set Infusion sets used with the MiniMed insulin pump. 

The complaint (PDF) was filed by Alice Pierce in the U.S. District Court for the District of Minnesota on July 3.

Pierce’s daughter, Carol Givens, died after using a Medtronic infusion set, which is a small disposable plastic tube used to deliver insulin from the pump.

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The same month as Given’s death, Medtronic recalled approximately three million Quick Set infusion sets for its MiniMed pumps due to manufacturing defects, which the company acknowledged could result in the delivery of incorrect doses of insulin.

Givens used the Medtornic insulin pump without realizing that it was failing to give her the correct dose. As a result, she was hospitalized for diabetic ketoacidosis after failing to control her glucose levels. She was hospitalized several times that year for blood sugar problems, unaware that the insulin pump infusion sets were defective, the lawsuit claims.

In June 2009, Piece indicates that her daughter fell into a coma and never regained consciousness. Givens died July 9, 2009, of cerebral anoxia from a diabetic hypoglycemic coma.

The very next day after Givens’ death, on July 10, Medtronic issued a MiniMed Paradigm Quick-Set Infusion Set recall for all products that had a lot number beginning with “8,” indicating that they may not vent air pressure properly, resulting in incorrect doses of insulin.

Givens’ infusion set was from Lot 8200921.

Medtronic Infusion Set Recall

Paradigm Quick-Set Infusion Sets have vents incorporated into the tubing connector, which is intended to allow air to pass in and out of the pump’s reservoir compartment. The vents equalize pressure in the reservoir compartment of the insulin pump with the surrounding atmosphere and are necessary to ensure insulin is properly delivered to the patient.

According to the complaint, a lubricant applied during the manufacturing process caused the vents in some of the recalled infusion sets to become clogged. This prevented the Medtronic insulin pump from venting air pressure properly, causing the device to deliver too much or too little insulin.

The recall came weeks after the FDA sent a warning letter in June 2009 to Medtronic over problems with quality control and reporting at a Puerto Rico plant. Following an investigation, the FDA indicated that the company had problems with reporting and investigating device malfunctions that may be “symptomatic of serious problems” in Medtronic’s manufacturing and quality assurance procedures.

In a press release issued in July 2009, Medtronic indicated that approximately 2% of the recalled infusion sets were expected to have the problems venting air pressure properly when delivering an insulin dose, which suggested that about 60,000 of the small plastic tubes distributed were defective.

Pierce’s complaint joins a number of similar Medtronic insulin pump lawsuits filed over problems with the infusion sets since the recall.

Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Infusion Pump, Medtronic, Medtronic Paradigm, Medtronic Recall, Minnesota, Wrongful Death
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6 Comments

Amanda
My father passed away 2 days after he recieved the pump. He told his sister and me that something is not right and he is going to make an appt with his doctor on monday. My father wad an Registered Nurse and has had diabetes for over 25 yrs. He died in a motorcycle crash from passing out from high blood sugar on sunday..the day before he was planning to make an appt. Its only been a month and half since his passing..im still dealing with my grief.
Tricia
She had the same problem and unfortunetly my in law had passed away due this pump malfunctioning.
Glendette
Medtronic is a bad company that only cares about making money. My son, Koby was diagnosed with diabetes when he was 3 years old, and he had taken the shots until he was 13. His doctor wanted him to try the insulin pump and we did. He got the pump in Aug. 2009 and in Oct. He was rushed to Children’s Hospital in New Orleans, he was having seizure’s and unresponsive his BS was around 800. When he was on the shots everything was fine but he had to take 3 to 4 shots a day. My baby was in hospital for a week, this kept happening over the next few months he would have seizures and he never had seizures before the pump, he was in NICU four more times and we were in he ER alot and they didn’t know what was going on, when we got to the Hospital and they took the pump off everything would get better and when then put it back on him his BS would start messing up again and his doctor would not take him off the pump. I made a appointment with a new doctor but my son died in his sleep at the age of 14. On Aug. 22, 2009, Medtronic’s insulin pump killed my son. Three days later I received a recall letter in the mail on the lot 8, tubing, my son had and was using that tubing when he died. I found out later that the factory where the tubing was being made was trying to cut corners and the were having problems and was supposed to report those problems to the FDA in 30 days but they waited until the FDA came to do their inspection and the FDA found many problems and they never reported the problems and it was 180 days since they had first discovered the problems, the FDA shut that factory down. If they would have reported the problems just three days sooner my son would still be here. That Medtronic insulin pump bad many other problems with it also, the alarm didn’t sound and it would not prime sometimes and other things. That company started making all their products cheaper and they r cutting way too many corners and it is hurting and killing people, they only care about making money. Anyone who uses a Medtronic products please stop before it too late. If anyone that reads this has any information or a story like mine please text me at (985)335-8113 or I am on FB under Glendette Kennedy. Thank you and God Bless…
Matt
I have had diabetes since 1986, a pump user since 1998. I can assure you there is something wrong with either the quickset mmt-399 lot 5033578 or reservoir mmt-332a lot h8970932! After eating and infusing myself, never thought anything about it. Woke up in the middle of the night with above 600 blood sugar. Throughout the night I injected over 80 units barley getting it down below 500. I started using a needle to inject my insulin which I was able to get it down. This is the second time, with the same lot numbers. The first time sent me to the hospital with dke! I have the pump on everything was switched out 2days ago and never had any issues the weeks before. I have taken picture and videos this time knowing how they blamed everything else last time.
jean
Look at the dates, the reservior was a 2013 recall the infusion set recall was in 2009. I also have type 1 diabetes since 1980 and have used an insulin pump for 16 yrs. Over the years there have been times that managing my bg’ s was simple. More recently have had times when nothing seems to work and I am unable to keep bg’s below 300. Diabetes can be very tricky and I am sorry that you are so quick to assume they should have known better or done something different. I hope you continue to enjoy minimal problems in the control of your disease. Please have some empathy for others who can get into dangerous situations even when doing things by the book and consider that just maybe the company medtronic has cut corners and quality control has suffered over the last few years.
Chris
This is a fabricated case. As a lifetime juvenile diabetic & pump user I can tell you the facts of this case are wrong and it is completely without merit. The recalled part you are speaking of not an infusion set, it is the resoviour set, that is the flow tank for the insulin to be stored in the pump. Infusion Sets are the little adhesive cathetor like things that attach to the body and allow the insulin to enter the body. Neither of these things working or not would have caused a person to have hyperglycemic conditions to drive them to kedoacidoisis unless they were in very poor control of their blood sugars and not taking necessary measures to get blood sugars in check as problems occur. Lots of things can elevate blood sugrs but to hav them go that high and stay high for that long falls on the user. Totally!! rediculous. This is why are health costs are so high. how did this case go to court?

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