A new report published this week by the International Consortium of Investigative Journalists and media organizations around the world took aim at medical device companies and the regulations that govern the $400 billion industry. And in a related report about Medtronic (NYSE:MDT), the authors zero in on the company’s diabetes unit and its insulin pumps.
Over the last decade, Medtronic’s insulin pumps and its parts were linked to 20 recalls and 100 lawsuits, according to the report. The ICIJ analysis found that the company’s insulin pumps have accounted for 150,000 injuries and 2,600 deaths.
Malfunctioning pumps represent a big problem for users who rely on the technology to effectively deliver insulin. In one case, the report said, a pump problem may have resulted in the delivery of too much insulin, sending the person into a diabetic coma.
Medtronic told the ICIJ that its insulin pump has helped hundreds of thousands of people manage their diabetes and that when a recall is necessary, the company contacts doctors and patients. Medtronic also noted that it’s often impossible to conclusively say if a medical device is at fault in an adverse event report or if its the result of user error.
For years, Medtronic dominated the diabetes market with its technology. But, according to the ICIJ report, the company’s diabetes division began to feel the pressure as competition from other companies grew.
The report cited a whistleblower lawsuit filed by a former sales territory manager in Oregon who alleged that the company offered speaking gigs and trips to doctors in exchange for promotion of Medtronic’s insulin pumps.
A memo from the company also detailed a practice of pulling confidential patient information and highlighting potential pump users.
The whistleblower who filed the lawsuit said he was let go from Medtronic because he complained to the FDA about the company’s practices, but Medtronic denied that claim.
“Allegations are not facts and should not be interpreted to suggest that Medtronic violated our legal, ethical or regulatory obligations in any way,” Medtronic spokesperson Rob Clark said in a statement to the ICIJ. “Our reputation is the result of our commitment to patient safety, transparency, compliance, and ethical business practices.”
In its report about the medtech industry at large, the ICIJ and its partners collected and reviewed more than 8 million device-related records, including recall notices, corporate filings and adverse event reports.
The group also established a searchable portal, called the International Medical Devices Database, that can tell users if a device has been flagged in a collection of more than 70,000 recall notices and safety alerts from 11 countries.
