The California Health Department is investigating a hospital that may have tested an experimental bone-growth product from Stryker ($SYK) and Medtronic ($MDT) on patients without their consent.
A lawsuit claims the Pomona Valley Hospital Medical Center tested Stryker's OP-1 putty on at least 17 patients without their knowledge, and one plaintiff is suing the hospital and devicemakers as a result, MassDevice reports. According to the suit, the plaintiff "went to the hospital expecting routine surgical treatment and was instead converted into an unwitting guinea pig in a secret 'research project.'"
The suit alleges that Stryker and Medtronic were complicit in the clandestine testing, and documents disclosed by Stryker suggest that the hospital's research board was aware of the project, according to MassDevice.
This isn't Stryker's first blemish with OP-1, a bone morphogenetic protein product designed to spur growth and treat weakened or deteriorated bones. In 2010, the company paid a $1.4 million settlement to Massachusetts to resolve charges that it marketed the product for non-FDA-approved uses and mislead providers.
- read the MassDevice story