A California woman is suing Stryker Biotech and Medtronic for the alleged fraudulent promotion of their respective bone fortification products for unapproved, off-label use. These products, which were used during back surgery conducted on a herniated disc, caused her serious injuries, she maintains.
In her complaint, plaintiff April Cabana says she underwent back surgery, during which a mixture of two products manufactured by Stryker--Calstrux and OP-l--were used. Even though the mixed use of the products hadn't been OKed by the FDA and Styker knew combining them could cause unwanted bone growth, the defendant "engaged in extensive and illegal off-label promotion of the mixed use of these two products," according to court documents.
Eventually, Cabana had to undergo a second surgery because of excessive bone growth and migration in her lower back resulting in nerve compression and severe pain. Her surgeon removed "bone of unknown origin" and used Medtronic's Infuse to fuse the bone. However, the surgery didn't help her condition, and her pain as worsened, the plaintiff maintains.
As MassDevice points out, Stryker sold its bone growth products unit to Japan's Olympus for $60 million in December to free itself of the legal woes related to allegations it promoted the off-label combination of its bone growth products. Back in 2009, federal authorities indicted the company and four managers for leading a campaign to promote the combined use of separate bone-healing products. However, the combination led to adverse effects ranging from minor irritations to infections requiring follow-up surgeries.
The case also marks the latest problem for Medtronic's Infuse. The Spine Journal recently published a series of articles alleging that side effects of Medtronic's Infuse were downplayed or omitted in scientific articles by researchers with financial ties to the devicemaker. And in June, Senators Chuck Grassley (R-IA) and Max Baucus (D-MT) fired off a letter to newly installed Medtronic CEO Omar Ishrak, seeking more information about the financial relationships between his company and doctors conducting clinical trials on Infuse.