The current headlines about three Stryker Biotech employees being charged and pleading guilty to medical device misbranding has become a major discussion of late in the medical device industry. With trade shows commonly subject to FDA enforcement efforts, the prosecution of the Stryker sales reps and manager serves as a warning to the industry.
In case you haven’t heard about the Stryker case, I’ll recap. It has been unfolding since last fall. In November 2008, a former Stryker Biotech sales rep pled guilty to misbranding a medical device. This past February and just this month, a second former rep and a third former employee pled guilty to the same charge. The devices they misrepresented are the OP-1 and Calstrux bone-healing products. The charges state that they encouraged medical professionals to combine the bone products in a way not approved by the FDA. To further validate the FDA charge against Stryker, it was discovered that the distributed brochures giving instructions for mixing these bone products.
In addition to illegal promotion of OP-1 and Calstrux, the FDA is also investigating the company for possible false reporting of the number of patients that were treated under one of the company’s Humanitarian Device Exemptions.
To learn more about scientific exchange of information versus promotion and deeper exploration into acceptable trade show practices, I suggest you check out the Promotion at Trade Shows and Medical Meetings: Not If, but How archived audio conference sponsored by BioWorld Today and Medical Device Daily.