August 11, 2014 by Brad Perriello
A federal appeals court upholds the dismissal of a whistleblower lawsuit filed against Stryker, Orthofix and 2 other makers of pain pumps.
A federal appeals court last week upheld the dismissal of a whistleblower lawsuit accusing Stryker (NYSE:SYK),Orthofix (NSDQ:OFIX), I-Flow Corp. and DJO Global of illegal off-label marketing of their respective pain pumps.
Dr. Lonnie Paulos, a Florida orthopedic/sports surgeon who once consulted for Stryker’s orthopedic business, filed the qui tam lawsuit in 2011, claiming that Stryker sales reps pitched him on unapproved pain pump uses and that he knew of colleagues who were similarly approached. The suit accused the device makers of explicitly marketing pain drug pumps for use in articulating joints such as the shoulder and knee, despite the FDA’s rejection of the devices for orthopedic uses.
The FDA has not approved or cleared any pain pumps for use in synovial cavities, the spaces between bones that meet at a synovial joint, the most common type of movable joint in the human body. Stryker acquisition McKinley Medical’s pain pump had FDA clearance for orthopedic indications for a period of about 6 months, but that indication was granted mistakenly and revoked in March 1999, according to court documents.
“Stryker did not advise Dr. Paulos, or as far as he knows advise his colleagues, that the use of pain pumps for infusion into the knee and shoulder joints was in fact not only an off-label use, but that such a use had been specifically rejected on multiple occasions by the FDA,” according to the complaint.
