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Medtronic Reports Another Bad Quarter for Infuse Bone Graft

Aug 22, 2012 | Parker Waichman LLP

Medtronic Inc's spine business is still suffering as a result of all of the controversy surrounding its Infuse Bone Graft product.  According to Medtronic’s earnings report for the first quarter of 2013, sales of Infuse are down 19% from a year ago, from $174 million this time last year to $141 million.  Overall, Medtronic's core spinal business saw sales fall from $645 million in the first quarter,  from $651 million last year.

Medtronic Infuse is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) that is approved for use in a certain type of spinal surgery and some dental surgeries.  Sales of the protein have been sliding since last summer, when a study published in The Spine Journal raised serious concerns about the validity of 13 clinical trials for Infuse.  The Spine Journal authors asserted that the Medtronic-sponsored trials failed to report serious Infuse complications when they were published, including cancer, retrograde ejaculation, sterility in men, infections, bone dissolution and worsened back and leg pain.  The article also criticized Medtronic's financial relationships with some of the researchers who conducted the trials.

The Spine Journal expose sparked, among other things, a Senate investigation of those financial relationships.  For its part, Medtronic has commissioned researchers at Yale University to review Infuse clinical trials in an attempt to salvage its reputation. Results from that review are expected later this year.

In November 2011, another analysis found that the high doses of Infuse that are often needed in off-label procedures could be associated with an increased risk of cancer.   In March, Medtronic agreed to pay $85 million to resolve a federal lawsuit brought by shareholders that alleged the company's officers and executives made false and misleading public statements about Infuse, which then artificially inflated the company’s stock price. About the only good news Medtronic got on the Infuse front was the U.S. Justice Department's decision to close its investigation of into possible off-label marketing of the product without filing any charges against the company.

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