Medtronic to report patient death; also: Whistleblower documents ‘hint at lucrative financial relationships’

A couple of legal developments being reported about Medtronic in the last 12 hours:

The Wall Street Journal reports that the Fridley medical-device maker is moving to report a patient death to the FDA, three months after a woman died following surgery with one of its spine products. Medical-device companies are required to report “adverse events” they learn about in patients with their products. Medtronic said it only recently learned in a lawsuit of the woman’s death.

And the Star Tribune’s Janet Moore reports on a federal whistleblower lawsuit that alleges Medtronic “induced” doctors to use its Infuse bone-graft product in ways not approved by the FDA. Documents filed in the case “hint at the lucrative financial relationship” between Medtronic and several doctors at Twin Cities Spine Center.

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Comments (1)

  1. Submitted by Tom Poe on 12/12/2008 - 10:08 am.

    Hospitals must report adverse effects with devices used in their facilities. The reporting protocol informs the manufacturer and FDA, as I understand things. So, why would the paper let Medtronics get away with their sleazy “shocking” excuse? Another example of shoddy journalism of lying to the public in hopes of current or future advertising revenues from Medtronics.

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