In recent years, Medtronic has occasionally run afoul of federal regulators over issues with its pumps. Now the pump company must defend itself against a lawsuit for an insulin pump failure.
According to a Courthouse News article, a 57-year-old New Jersey man who was using the MiniMed insulin pump system was found unconscious in his bed after his device failed. He remained in a coma for two weeks before passing away. The article says that Joann Hassan, who is serving as executrix of the man’s estate, has now filed a complaint and is seeking from Medtronic “punitive damages for breach of warranty, negligence, wrongful death, and other claims.” The suit claims the company has been negligent in training its quality control workers. The article did not provide Medtronic’s response to the suit.
Medtronic has had trouble with its pumps as far back as 2009, when the FDA demanded that the company send out what would become the first of many recall notices, according to the Courthouse News article. In 2013, the FDA wrote a warning letter about Medtronic, saying that the manufacturing plant where the pumps were being made was still not up to code. Displeased with Medtronic’s adjustments, the FDA issued a Class 1 recall notice in July, stating that the device’s vents could become clogged, resulting in improper insulin delivery.
The company’s pump troubles have not been limited to just insulin pumps. Recently, the LA Times reported that the FDA has filed a court order against Medtronic, severely limiting the making and distributing of the company’s implanted Synchromed II drug pumps, which are often used to treat cancer, chronic pain, and severe muscle spasms. Medtronic has complied with the FDA’s order, but under the agreement, it can still provide a limited number of pumps to physicians. So far, Medtronic is advising the majority of pump wearers not to get the device removed, and will not be issuing any new recalls or safety alerts.
It should be noted that Medtronic is not the only medical device manufacturer to come under increased scrutiny by the FDA. In 2014, federal regulators issued 60 recalls of medical devices and supplies. Nor is Medtronic the only diabetes company to run afoul of regulators. Diabetic Supply of Suncoast Inc., Abbott, and Tandem all had recalls of their products in 2014. Tandem’s recall was for its insulin pump cartridges, Abbott had recalls issued for infusion sets and meters, and Diabetic Supply of Suncoast Inc., had its test strips recalled.
If you would like to sign up for email alerts of medical device and supplies recalls, you can do so on the FDA’s website at https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_35.
The first paragraph of this story has been edited. Due to an editorial word choice, an earlier version of this story suggested Medtronic has been “sparring” with federal regulators. There is no evidence of this in the articles referenced.
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