Current litigation against medical device company Medtronic primarily involves Series 600 insulin pumps with allegedly defective clear retainer rings.
Plaintiffs claim the defective ring could prevent the insulin reservoir from locking securely into the pump, resulting in the over-delivery or under-delivery of insulin and potentially causing severe hypoglycemia or hyperglycemia.
Some automated MiniMed systems are designed to function somewhat as an artificial pancreas by using glucose data to adjust insulin delivery and reduce reliance on repeated insulin injections.
In February 2020, the FDA classified the Medtronic insulin pump recall as Class I, its most serious recall classification, because use of the affected devices could cause serious injuries or death.
More than 322,000 MiniMed devices were included in the action, and Medtronic had received 26,421 complaints involving the malfunction, with 2,175 reported injuries and at least one death linked to reports associated with the affected pumps.
Lawsuits involving these medical products have since been filed in state and federal court, with MiniMed reporting 28 U.S. lawsuits involving 100 individuals, most of which are coordinated in Los Angeles County Superior Court.
Whether someone may qualify generally depends on the specific pump used, evidence of a malfunction, the resulting injury, and medical or device records connecting the insulin delivery problem to the medical emergency.
Factors that may support a Medtronic MiniMed insulin pump claim include:
- Use of a MiniMed 630G, 670G, or another Series 600 pump with the recalled clear retainer ring
- A broken, loose, missing, or otherwise defective retainer ring or evidence that the insulin reservoir did not remain securely locked
- Evidence that the pump delivered too much insulin, too little insulin, or unexpectedly interrupted insulin delivery
- Severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, seizure, loss of consciousness, coma, or another serious insulin-related injury
- Emergency room treatment, hospitalization, intensive care, or other significant medical treatment following the alleged pump failure
- Medical records, glucose readings, pump data, photographs, replacement records, or Medtronic communications documenting the device and resulting injury
- A claim that remains within the applicable statute of limitations
Using a recalled MiniMed pump alone does not establish that someone has a viable product liability claim.
Medical records, pump downloads, continuous glucose monitoring data, alarm histories, and other evidence can help determine whether an alleged device failure coincided with the patient’s injury.
Claims involving newer MiniMed models or different battery, software, or insulin-delivery problems should be evaluated separately because they are not necessarily part of the clear-retainer-ring litigation currently disclosed by MiniMed.
TorHoerman Law can review the pump model, alleged malfunction, medical treatment, and available evidence to determine whether an injured patient may qualify to file a Medtronic insulin pump lawsuit.
Which Medtronic MiniMed Pumps May Be Involved In These Lawsuits?
The Medtronic MiniMed insulin pump lawsuits primarily involve certain Series 600 pumps equipped with the recalled clear retainer ring.
Medtronic announced the recall after reports that damaged or missing retainer rings could prevent the insulin reservoir from locking securely into the pump.
If the reservoir becomes loose, the device may deliver too much or too little insulin and place patients at risk of severe hypoglycemia, hyperglycemia, diabetic ketoacidosis, or other serious complications.
In February 2020, the FDA issued a Class I recall affecting more than 322,000 Medtronic MiniMed insulin pumps, the agency’s most serious recall classification.
The reported injuries and at least one reported death caused additional concern about the potential consequences of incorrect insulin delivery.
Although later MiniMed models have been subject to separate safety actions, the current retainer-ring litigation is primarily associated with Series 600 devices.
MiniMed models that may be involved include:
- MiniMed 630G
- MiniMed 670G
- Other Series 600 pumps equipped with the recalled clear retainer ring
