Medtronic Must Face Failure-to Warn Claim Over Surgical Stapler

March 1, 2021, 8:17 PM UTC

Medtronic Inc. and its unit Covidien LLC must face claims that they failed to warn a man’s physicians about an allegedly flawed surgical stapler, after a California federal court said allegations that the companies abused a former nonpublic reporting system state a plausible claim.

Donald Nichols alleges he was hospitalized for a month because of infection and other complications caused by a flawed Endo GIA stapler used during rectal cancer surgery in 2018.

Nichols didn’t detail the warnings his surgeon received or why they allegedly were inadequate. But his allegations that Medtronic and Covidien abused the Food and Drug Administration’s ...

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