Insulin is normally produced in the pancreas and is needed to transport glucose from the bloodstream across cellular membranes where it can be used as energy. A malfunction of the insulin-glucose system results in the medical condition, diabetes. Diabetics who are not able to manufacture their own insulin must rely on insulin administration which has traditionally been given in one or more daily injections.
Medtronic MiniMed insulin pumps were designed to replace daily administration of injections with an electronic device which delivers insulin through a small needle inserted under the skin of the abdomen. In ideal situations, an infusion pump can provide more predictable and precise delivery of insulin and may be more convenient than injections. Malfunction of the insulin pump or its components can be catastrophic and may result in serious injury or death.
Since the introduction of the MiniMed infusion pump, Medtronic has been forced to issue several recalls of the device or its infusion sets. Medtronic has also faced a number of MiniMed insulin pumps lawsuits due to injuries caused by malfunction of the machine or related infusion sets. Patients have experienced dangerous over dosages, under dosage, or unpredictable dosages which have resulted in coma, serious injury, and death.
Filing a Medtronic Insulin Pump lawsuit
Multiple Medtronic Insulin Pump lawsuits have been filed after the MiniMed pump or its infusion set malfunctioned resulting in:
- Underdosage of insulin leading to high blood sugar levels
- Overdosage of insulin leading to dangerously low blood glucose levels
- Death due to improper insulin dosage
Even though the devices have been subject to a number of recalls and failures, Medtronic has marketed its MiniMed insulin pumps by claiming that it helps patients “achieve better glucose control”. People who have filed lawsuits have claimed that injuries or death were caused by:
- Design or manufacturing defects
- Programming flaws
- Failure to identify and correct manufacturing issues
- Failure to issue a prompt recall
- Failure to adequately warn the medical community and public
- Continued marketing and sales despite risks
Patients using Medtronic insulin pumps and infusion sets have experienced complications due to malfunction and at least one death has been attributed to the device. Medtronic may be facing a number of MiniMed infusion pump lawsuits, including at least one lawsuit for wrongful death.
Medtronic Insulin Pump Complications
In order for the body to utilize glucose, the correct amount of insulin must be available. Too little insulin can result in high blood sugar which may lead to organ damage or failure. Overdosage or too much insulin can result in dangerously low blood sugar or hypoglycemia, coma and in severe cases, may cause death.
Symptoms of hypoglycemia include:
- Anxiety or irritability
- Profuse sweating
- Rapid or Irregular heart rhythm
- Shakiness or tremors
- Excessive hunger
- Pins and needles sensation
- A headache or blurred vision
- Nausea or vomiting
- Weakness or fatigue
- Confusion or changes in consciousness
An overdose of insulin can be fatal. Symptoms of hypoglycemia should be treated immediately Seek medical attention for any suspected problems with a Medtronic pump.
Medtronic Insulin Pump Recalls
In addition to MiniMed Insulin Pumps, Medtronic manufactures a number of medical devices which have faced recalls and been subject to a lawsuit. Medtronic Insulin pumps have been particularly troublesome over the last decade.
In 2009, Medtronic issued a Class 1 recall for its Quick-set Infusion sets that were used for MiniMed Paradigm insulin pumps. The recall affected about 3 million infusion sets and was issued after a manufacturing defect involving the infusion set vent was identified which could possibly result in incorrect insulin dosage delivery.
In 2013, the company issued a Class 1 recall again involving MiniMed Paradigm infusion sets due to a safety issue. If fluid was allowed to enter the infusion set vent, the set could be prevented from priming properly. Failure to prime could result in an improper or unpredictable dosage of insulin.
Also in 2013, a Class 2 recall was issued for the Medtronic Paradigm Insulin Pump itself. The problem involved the pump’s drive system. A support cap could detach and protrude which might allow water to enter and damage internal electronics, prevent buttons from working properly or to affect pump alarm system.
Another 2013 Class 2 recall was issued for the MiniMed Paradigm infusion pump reservoir which holds the insulin drug supply. The reservoir was prone to leakage which could affect the insulin supply and impact performance of the infusion set.
The FDA also sent a warning letter to Medtronic’s Northridge, California manufacturing facility regarding Paradigm Insulin Infusion Pumps. The letter stated that the company was not conforming to good manufacturing practices (GMP) and had failed to identify corrective action needed to prevent recurrence of device failures.
In 2014, a Class 2 recall was issued when it was discovered that the MiniMed Infusion pumps may stop working prior to the expected 7-year lifespan of the device and another Class 2 recall was MiniMed Paradigm Pumps which concerned a programming issue with the pump itself. The company and the FDA had received a number of reports stating that users had accidentally programmed the pumps to deliver maximum insulin boluses inappropriately.
In 2015, the FDA cited Medtronic, Inc. and two company officers for “repeatedly failing to correct violations”. This was not related to manufacturing of insulin pumps, rather to Synchromed II Implantable Pump Systems which delivered cancer medication, however, it may have indicated an ongoing pattern.
Medtronic Voluntary Recall
Once again, in August of 2017, Medtronic was forced to recall MiniMed Insulin infusion pump sets. The voluntary recall was announced by the company and posted on the FDA’s website. The company had received numerous reports prompting an investigation which revealed an issue with the pump sets. The vent membrane of the infusion set could become blocked during priming after infusion set change. Improper priming may lead to over-delivery of insulin shortly after installation of a new infusion tubing set.
Medtronic had redesigned the sets after being made aware of the potential risks and began manufacturing new sets in April of 2017. They did not notify the public, medical community or the FDA or offer to replace older units until September 2017.
Though the sets have been redesigned, addressing the most recent concerns, the company cannot guarantee that overdose of insulin will not occur or that other problems may develop. An overdose of insulin can cause life-threatening hypoglycemia and may have caused several deaths.
Qualifying for a Medtronic Insulin Pump Lawsuit
A number of medical injuries and wrongful death lawsuits have been filed against Medtronic for hypoglycemia events caused by MiniMed Insulin Infusion Pump or infusion set failures. Patients or loved ones of those who have experienced severe hypoglycemia while using a Medtronic MiniMed Insulin Infusion Pump may be eligible for compensation through a Medtronic lawsuit. Medical injury lawsuits can provide financial compensation for:
- medical costs
- lost wages
- future medical costs
- pain and suffering
- wrongful death
If it can be proven that the company knew of the risks of their product, in some cases, punitive damages may also be awarded to punish the company.
Each Medtronic injury lawsuit must be evaluated separately and there are no guarantees. Medtronic insulin pump patients who experienced pump failure or family members of those who were harmed should have their case examined by legal experts.
- Class 1 Device Recall PARADIGM QUICKSET INFUSION SET, U.S. Food and Drug Administration 6/2009
- Class 2 Device Recall Medtronic MiniMed Paradigm Insulin Infusion Pumps, U.S. Food and Drug Administration 3/2013
- Class 1 Device Recall Medtronic MiniMed Paradigm Insulin Infusion Sets, U.S. Food and Drug Administration 6/2013
- Class 2 Device Recall Medtronic MiniMed Paradigm Reservoirs, U.S. Food and Drug Administration 7/2013
- Class 2 Device Recall Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and MiniMed 530G System, U.S. Food and Drug Administration 3/2014
- Class 2 Device Recall MiniMed 620G Insulin Pump, U.S. Food and Drug Administration 9/2015
- Class 2 Device Recall Medtronic MiniMed, U.S. Food and Drug Administration 6/2015
- Medtronic Announces Voluntary Recall of Diabetes Infusion Sets, U.S. Food and Drug Administration 9/2017