Medtronic (NYSE:MDT) faces lawsuits from three people who claim the company’s surgical staplers seriously injured them — and that the company knowingly sold defective devices and hid the risks, according to a report in the Star Tribune of Minneapolis.
Cynthia Nicholson of Harris County, Texas and Robert Snyder of Gilman, Iowa separately sued Medtronic in Hennepin County District Court in Minnesota in December. The same month, Janet and Randy Adams of Collin County, Texas sued the medical device giant in federal court in the Eastern District of Texas.
Medtronic media relations declined to comment on the lawsuits to the newspaper.
Surgical staplers were the focus of a Kaiser Health News report last year that revealed at least 1.1 million adverse event reports that were hidden from public view through an “alternative summary reporting” repository.
For example, stapler makers including Medtronic and Johnson & Johnson’s Ethicon subsidiary filed more than 5,100 reports of malfunctions or injuries related to the devices during the first 28 months of alternative reporting pathway, according to the Kaiser report. The numbers were much higher than the 112 publicly reported stapler-related deaths between 1994 and 2001
By June 2019, an FDA panel recommended reclassification of surgical stapler devices to a more highly regulated status. By that time, FDA had disclosed that it had received 109,997 reports of surgical stapler problems — including 412 reports of deaths — between 2011 and 2018. About half of the problems had not been public knowledge.