Insulin pumps, medical devices used to deliver insulin into patients’ bodies in a controlled manner, are designed to offer effective treatment for diabetics. Unfortunately, they have been known to malfunction.
The FDA has received numerous reports about defective Medtronic insulin pumps injuries and deaths, and victims’ and their families are suing the manufacturer. Another recent situation that includes a health-related product liability claim is the power morcellators spreading cancer.
FDA Receives Reports about Insulin Pumps Causing Injury and Death
Defective Medtronic insulin pumps are nothing new. Back in 2009 the FDA issued a Class I product recall (the most serious kind because the products can cause serious adverse health consequences or death) for Medtronic MiniMed Paradigm Quick-Set Infusion Sets because of venting issues that caused the machine to malfunction and lead to injury and death.
Just prior to that recall, the FDA sent a warning letter to Medtronic, citing numerous violations of federal laws including a “Failure to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications.”
Between 2005 and 2009, over 56,000 reports of infusion pump malfunctions, injuries, and deaths were sent to the FDA. In fact, during that time, manufacturers issued 87 recalls for infusion pumps to address the safety issues. Unfortunately, reports of injuries and deaths are still coming in.
A sad case in point: Charles Slack Jr., a diabetic who relied on MiniMed insulin pump and the MiniMed Paradigm Quick-Set Infusion Sets for his condition, died in 2013 because his device failed to operate properly. His estate’s legal complaint states that he suffered a diabetic attack while he slept because he “failed to receive the correct dose of insulin… The pump, set, and reservoir failed to take the necessary, expected, and warranted steps to alert [Slack] of the failure.” He was found unconscious in his bed and taken to the hospital. He slipped into a coma and later died. A lawsuit is pending against Medtronic.
Types of Infusion Pump Problems
The FDA has categorized the problems that have been reported to them about infusion pumps as follows.
- Software problems
- Alarm errors
- Inadequate user interface design (“human factors” issues)
- Broken components
- Battery failures
- Fire, sparks, charring, or shocks
Any of the above can cause the device to malfunction, administer too little or too much insulin to the patient, and cause injury or death.
Free Consult with a Defective Infusion Pump Lawyer in Ohio
Victims of defective infusion pumps (or their loved ones) could file a product liability injury claim or wrongful death claim against the manufacturer if injury or death occurred. Bressman Law can help. Contact us today at (614) 538-1116 for a free consultation.