April Cabana, 34, of Rancho Cucamonga, Calif., said she underwent back surgery for a herniated disc as a result of a car accident. She was treated using devices from both Stryker’s and Medtronic’s spinal fusion product lines, according to a complaint filed in the Superior Court for the state of California. According to Cabana, she was first implanted with Stryker bone putty and void filler, then underwent a second surgery using Medtronic’s Infuse bone graft and was ultimately left with debilitating pain.
Cabana claims Stryker engaged in "extensive and illegal off-label promotion" of its Calstrux and OP-1 spinal fusion products, which resulted in excessive bone growth and migration that caused nerve compression and severe pain in her lower back.
“The mixed use of these two products (Calstrux and OP- l) had-not been approved by the FDA and defendant Stryker knew, or should have known, that mixed use of these two products was ineffective and could lead to unwanted bone growth,” Cabana alleges in the complaint.
The plaintiff underwent a second surgery to remove the unwanted bone growth and surgeons used Medtronic’s Infuse bone graft to fuse her spine, which failed to remedy her condition and made the pain worse according to the attorneys’ press release.
"The INFUSE Bone Graft had only been approved for a limited surgical procedure, yet Medtronic illegally promoted it for a number of off-label procedures," the complaint reads. "The surgeon in this case used the INFUSE Bone Graft in an off-label manner."
Kalamazoo, Mich.-based Stryker sold off its bone growth products unit to Japan-based Olympus Corp. (OTC:OCPNY) for $60 million in December in an attempt to free itself of the legal woes related to allegations it promoted the off-label combination of its bone growth products.
Federal investigators in Oct. 2009 indicted the company and four managers charging that they led a two-year campaign to promote the combined use of separate bone-healing products, each granted a narrow, provisional "humanitarian device exemption" by the FDA. Combining the treatments and devices — the OP-1 Implant, OP-1 Putty and the bone void filler Calstrux — caused adverse effects in patients ranging from minor irritations to infections requiring follow-up surgeries. The indictment also charged that Stryker and former Stryker Biotech president Mark Philip lied to the FDA about the number of patients treated each year with OP-1 Putty.
Medtronic is still knee-deep in problems with its Infuse product line, which has led to a senate probe and a slew of published research regarding the company’s failure to fully disclose risks associated with the product as well as conflicts of interest arising from research conducted by physicians on the company payroll.