Secret Clinical Trials with Stryker Bone Products
August 3rd, 2012 tmccoy
The California Health Department is currently investigating a local hospital accused of using experimental Stryker and Medtronic bone growth proteins on patients who did not give their consent. Supposedly, at least seventeen patients were involved in a secret research project at Pomona Valley Hospital Medical Center in Pomona California. They were randomized and were given an experimental treatment with Stryker’s OP Putty, without their knowledge or consent that they were part of this research project or that they would receive an experimental procedure.
One woman, Ms. Cabana, had Stryker’s OP-1 Putty put in her back together with Calstrux bone filler during surgery. Stryker’s OP-1 Putty had clearance by the Food and Drug Administration under a humanitarian use exception. A doctor could only use the medical device with hospital board authorization. The mixture of Stryker’s OP-1 Putty and Calstrux bone filler was never examined by the FDA.
Cabana believes that the mixture of those two products caused excess bone growth in her lower back, which caused nerve compression and terrible pain. Cabana had to have a second surgery to remove the excess bone. The surgeons at the second surgery fused her back with Medtronic’s Infuse bone graft in an off-label manner.
Earlier this year, Stryker pled to a misdemeanor charge and paid $15 because the company had marketed their product off label. They even falsified hospital records so as to authorize the use of the OP products because they were cleared only for humanitarian use.
A few months later, the Department of Justice cleared Medtronic of all charges because it closed its investigation against them. There are still several lawsuits pending against Medtronic, including a whistleblower case. That case claims that Medtronic installed a crony at a spine journal to promote infuse.
Massdevice.com
