Medtronic weathers the Infuse storm, but problems linger

July 1, 2011 by Brad Perriello

Shares of Medtronic stock climbed back after falling on news of problems with its Infuse bone growth product, but the long-term implications — for patients, physicians and the company's finances — are less clear.

Shares of Medtronic Inc. (NYSE:MDT) stock recovered following a week of high-profile publicity around the company's Infuse bone morphogenetic protein and a Spine Journal issue dedicated to problems with 13 studies by MDT-sponsored physicians.

MDT shares were trading at $38.95 in mid-day activity today, about even with their June 27 open of $38.20 (but down 10.8 percent from a year-to-date high of $43.20).

But even as the furor dies down on Wall Street (where analysts warned of a possible 3-cent-per-share dip in overall profits), Medtronic and Infuse are under intense scrutiny elsewhere. The U.S. Justice Dept. and the U.S. Senate are each conducting probes into the bone morphogenetic compound and its Fridley, Minn.-based maker's marketing practices.

More significant, however, is the pall cast over the product's safety. Infuse uses the orthobiologic, known as recombinant human bone morphogenetic protein-2, and an implant to promote bone growth after spinal fusion surgeries. The Spine Journal devoted its entire June issue to an examination of previously published Infuse reports, finding serious and troubling discrepancies between those reports and data from the studies as reported to the FDA, follow-up reports and administrative and organizational databases.