Rochon Genova and Cardill Law commenced the proposed class action suit against Medtronic, Medtronic MiniMed and Medtronic of Canada over the insulin pumps approved for use in the country in 2016 and 2018. The pumps have become subject to some issues, with the most recent coming in the form of an expansion of an FDA Class I recall that resulted in 463,464 devices being recalled.
For the same issue — missing or broken retainer rings that could result in the over- or under-delivery of insulin — Health Canada issued a Type II Medical Device Recall in 2019, then a Type 1 recall earlier this month, according to a news release.
The proposed class action alleges that Medtronic knew or ought to have known that the devices were suffering from a defective retainer ring but failed to take the steps to address it or offer warnings to users until the devices had been on the market for several years and were in use by thousands of Canadians.
“Canadians have a right to be informed about the risks associated with the medical devices that they use,” Rochon Genova partner Joel Rochon said in the release. “Failure to provide adequate warnings can have serious consequences. In this case, the plaintiffs needlessly suffered severe hyperglycemia requiring hospitalization.”
The claims have not yet been proven in court.
Medtronic did not offer direct comment on the class action suit but referred to its Oct. 5 news release covering the issue with the MiniMed 600 series devices.
That news release said that the review of safety data related to the MiniMed 600 series insulin pumps with clear retainer rings has not confirmed that adverse events were directly related to the damaged clear retainer rings, but that the company is “proactively accelerating our replacement plan so we can strive for the greatest possible reliability and quality in our insulin pumps and help patients optimally manage their diabetes.”
“Insulin pumps are sophisticated medical technologies that work to normalize blood glucose levels as much as possible in individuals with diabetes who don’t have the ability to produce insulin naturally,” Medtronic Diabetes CMO Dr. Robert Vigersky said in the release. “As with all therapies, there are risks that should be considered when a patient and their healthcare provider decide to use a pump for insulin delivery rather than multiple daily injections. The totality of evidence from both controlled, large scale clinical trials and real-world studies strongly support the safety and benefits of insulin pump therapies.”
