Infuse lawsuit: Judge orders Medtronic to produce safety data on bone growth protein
A federal judge in Minnesota orders Medtronic to produce documents detailing the safety profile of its controversial Infuse bone growth protein in a shareholders' lawsuit against the world's largest pure-play device maker.
A federal judge ordered Medtronic Inc. (NYSE:MDT) to produce documents detailing the safety record of its controversial Infuse bone growth protein.
The shareholders' lawsuit accuses the firm of artificially inflating its stock price with an off-label promotion scheme for a bone morphogenetic protein used in the Infuse device. Medtronic is weathering a spate of lawsuits over the product after a Spine Journalissue this summer revealed serious concerns about its safety.
In June, the journal took the unprecedented step of devoting an entire issue to re-examining company-sponsored studies of Infuse. Its investigation found problems with 13 studies by MDT-sponsored physicians, all of which downplayed or omitted the rates of adverse events associated with the protein, known as recombinant human bone morphogenetic protein-2.
Although the furor ignited by the study eventually...
