The legal costs involved with its Infuse® bone growth product have led to a profit fall for Medtronic.
As we’ve explained, Medtronic Infuse®—approved by the U.S. Food & Drug Administration (FDA) in 2002 to stimulate spine growth in patients suffering from lower spinal degenerative disease—is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) approved for use in one type of spinal surgery and some dental procedures. The product is used, for the most part, in off-label procedures and the product’s approval was based on research funded by Medtronic.
Meanwhile, Medtronic has been at the center of a conflict-of-interest scandal after a government report revealed that none of some 13 Medtronic-funded clinical trials reported Infuse® side effects, despite that data provided to the FDA revealed that at least half of all patients treated with Infuse® suffered complications. The U.S. Senate Finance Committee inquiry initiated in June 2011 probed surgeons paid by Medtronic who had not reported these Infuse®-related complications.
Medtronic Inc. just reported a 26 percent drop in its fiscal, second-quarter profit this week in the face of massive legal fees and flat sales of its heart pacer implants, said the Associated Press (AP). According to the AP, Medtronic has faced challenges trying to maintain its earnings growth against slow sales of its heart defibrillators and spinal implants, two of its top products.
In 2008, Medtronic enjoyed a 40 percent share of the spinal division, according to a prior Trefis.com report. As we’ve said, that figure was buoyed by sales of Infuse® and sales skyrocketed on news of its apparent successes.
Since, the market share enjoyed by Medtronic has dropped and has continually declined. That share now recently only stood at just 35 percent and analysts believed it would likely drop below 30 percent or lower, as long as news surrounding Infuse® continued its negative trend.
Medtronic faces increased federal scrutiny and mounting legal pressure from the many recipients of Infuse®. In addition to manipulating safety data and misleading surgeons and would-be recipients of the product, Medtronic also actively promoted the use of Infuse® for off-label purposes.
While Infuse® is only approved for select spinal fusion surgeries, Medtronic was actively marketing its use to surgeons in other surgeries, including those on the neck as it attempted to gain FDA approval. This has resulted in numerous reports of complications that have caused severe and life-threatening injuries. Those adversely affected by Infuse® have suffered excessive bone growth, severe pain and inflammation, some cases of male sterility, and cancer after receiving the bone growth product in their surgery.
Many recipients claim they were never warned of the dangers of Infuse® before it was used in their surgery and, as times goes by, they, along with federal regulators and company shareholders, are learning of the means by which Infuse® reached the market and bolstered the company’s bottom line.