Medtronic Scores a Big Legal Win

Published: Sep 27, 2016

Hundreds of plaintiffs failed to prove that they had a valid claim against Medtronic when it came to alleged off-label use of Infuse bone graft devices, U.S. District Court Judge Timothy S. Black in southern Ohio said in a court order issued last week.

The case involved several hundred patients of Cincinnati orthopedic surgeon Atiq Durrani, who fled the country for Pakistan after his 2013 indictment regarding the procedures.

FDA granted Medtronic a PMA for Infuse in 2002, approving it only for use in a single-level fusion in the L4–S1 region of the lumbar spine via the anterior lumbar interbody fusion procedure and in combination with the LT–Cage.

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