Sunday, April 10, 2016

“I, for one, feel duped,” said Dr. Charles Rosen. “I used Infuse on a lot of people.”

The Strib has a terrific investigative story on Medtronic's Infuse scam.

Medtronic asked doctors to scan patients’ files and report any “adverse event” following surgery. Doctors shared more than 1,000 such issues, ranging from minor to serious. Four patients had died.

Federal law requires medical device companies to report possible product-related injuries to the Food and Drug Administration within 30 days of learning about them. Instead, Medtronic employees shut down the study in spring 2008 without telling the government anything.

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