While the U.S. Food and Drug Administration acknowledges Medtronic is actively working on fixing issues within its diabetes business, especially in regard to some of its insulin pumps, it says the steps took too long and are not enough.
Medtech giant Medtronic took more than three years to replace and start recalling insulin pumps with defective retainer rings after first becoming aware of the problem, according to an FDA warning letter sent to the company in December and recently made public.
The company also failed to investigate more than 800 complaints about defective updated retainer rings from diabetes patients who were using the product. It also failed to promptly notify the FDA within 30 days after discovering that issues with the device could lead to serious injury or death.
"In summary, your corrective actions are still in process, and you have not yet conducted effectiveness checks to ensure the updated procedures and required employee training will prevent reoccurrence of the identified deficiencies," the FDA said in the letter.
The company did not dispute any details in the FDA's warning letter but made the case that it is making necessary improvements in its diabetes business.
"We take these issues very seriously and hold ourselves to the highest standards of quality and patient safety," said Pamela Reese, a spokeswoman for Medtronic. "We are addressing the observations noted in the warning letter, while also working to strengthen our broader quality systems and processes."
While FDA warning letters are relatively common, one expert said the recent one to Medtronic raises very serious concerns.
"In looking through this letter, I think this is on the very high level of serious, severe violations by Medtronic," said Dr. Michael Carome, director of the health research group for the Washington D.C.-based Public Citizen, a nonprofit consumer advocacy group.
"The violations, as described, would have put patients at risk for potential serious harm," Carome said. "The violations are very serious and what makes them the most concerning is a pattern that spans years and multiple violations over that period."
The FDA letter detailed that Medtronic started an internal investigation in June 2016 as it was receiving more complaints about clear retainer rings breaking in its MiniMed 600 series insulin pumps. A plan to alert customers to the issue in 2016 was scrapped.
Medtronic did not introduce redesigned pumps with black retainer rings until August 2019 and did not begin notifying customers of retainer ring failures until November 2019, when it announced a recall.
The FDA letter adds that Medtronic did not adequately assess the serious risk to patients of the medical device failures.
According to its letter: "FDA determined that there was a reasonable probability that the use of, or exposure to, the pumps manufactured with the clear retainer ring would cause serious adverse health consequences, including severe hypoglycemia which can result in loss of consciousness, seizure; severe hyperglycemia ... or death."
The FDA also noted that during the company's original recall of its MiniMed 600 series pumps it told customers who didn't notice any damage could keep using the original pumps. The FDA's letter noted "after redesigning the retainer ring to prevent further risk, you failed to adequately remove the pumps containing the older, less robust ring from the market."
In an updated recall in October the company announced that any insulin pump with a clear retainer ring could be returned and replaced with a pump that has the updated black retainer ring at no charge. A total of 463,464 MiniMed devices have been recalled.
In a letter to customers at the time Medtronic said: "Serious injuries and deaths have been reported with the use of the MiniMed 600 series insulin pumps, but have not been directly correlated with damaged clear retainer rings based on information available to Medtronic and review with independent clinical experts."
The FDA issued the letter to Medtronic on Dec. 9, the company disclosed receiving it on Dec. 15, providing a general overview. The detailed letter became public on the FDA's website after Dec. 28.
The FDA inspected Medtronic's facility in Northridge, Calif. — the headquarters of Medtronic's diabetes business — from June 7 through July 7 last summer. The FDA's letter indicates that Medtronic sent five responses to the agency's findings from July 28 through Dec. 3.
The FDA's warning letter also indicates that Medtronic did not investigate more than 800 complaints about defective black retainer rings, largely because it claimed that the issue was being addressed by a previous investigation of clear retainer rings. The company now acknowledges it should not have done so.
Meanwhile, a law firm in Toronto has launched a proposed class action lawsuit for Canadian users of MiniMed600 series of insulin pumps. The claim, filed in October, seeks $225 million Canadian dollars in damages. The action is specifically for Canadian users of the insulin pumps. Under Ontario law, affected family members can also claim damages.
Reese, the company's spokeswoman, said the lawsuit "is at a very early stage and the company will defend against the claims vigorously. Medtronic believes its actions regarding these devices have been appropriate."
The company's diabetes division changed leadership amid the insulin pump issues. Medtronic veteran Sean Salmon was tapped in October 2019 to lead the diabetes business.
"Since joining the Diabetes Operating Unit, Sean Salmon has been actively working to strengthen the business, including the quality systems and overall approach to quality management. This began with the initiation of the Class 1 recall of the retainer ring in 2019," Reese said.
In December 2020 Salmon added a second post, president of the cardiovascular portfolio, while retaining his leadership role in the diabetes business.
In a statement at the time, Medtronic CEO Geoff Martha said, "I am confident in his ability to continue the turnaround of our diabetes business."