Stryker, Medtronic lose preemption bids in OP-1, Calstrux and Infuse lawsuit

September 25, 2013 by Brad Perriello

A California state court shoots down motions by Stryker and Medtronic to dismiss a lawsuit filed over their respective bone-growth proteins OP-1, Calstrux and Infuse.

Stryker, Medtronic lose preemption bids to toss bone protein case

A California state court ruled out a series of motions seeking to dismiss a lawsuit filed over bone proteins made by Stryker and Medtronic, ruling that federal law does not preempt the case from going forward.

April Cabana sued the medical device companies for alleged off-label promotion of the bone growth products, as well as a hospital and surgeon Dr. Ali Mesiwala for failing to inform her that they were using the experimental products. Cabana allegedly received Stryker's OP-1 Putty in combination with its Calstrux bone-filler during surgery to relieve her back pain. Stryker's OP-1 Putty had clearance under a humanitarian-use exemption, which requires hospital board authorization prior to use. The combination of the putty and Calstrux bone-filler had never been examined or approved by the FDA, according to the complaint.

In a 2nd, corrective procedure, surgeons removed the excess bone and fused the remainder using Medtronic's Infuse bone graft, again in an off-label manner, according to legal documents. Infuse had FDA clearance for use during an anterior procedure, but Cabana claims her surgeon opted for a posterior procedure.