Pain Pump Marketing Pains Stryker (and others)
A False Claims Act complaint against Stryker Corp., and others, alleges the firms’ marketed pain pumps for off label use that the U.S. Food and Drug Administration had specifically denied. The False Claims Act dates back to the Civil War and imposes liability on companies (or persons) that defraud government programs. Stryker and the others are accused of submitting payment claims to federal programs, including Medicare, for unapproved uses of their pain pumps.
The orthopedic surgeon that brought the case, as the “relator” or “whistleblower”, worked as a consultant to Stryker at one time. He claims that he raised concerns about improper product testing before marketing pumps for in-joint use. He had seen marketing presentations by the various defendants at industry trade shows in which they were marketed for off label use. The surgeon claims that the pumps were specifically denied approval for in-joint use. The U.S. was allegedly fraudulently charged more than 12 million dollars as a result of the off label marketing and use of the pain pumps.
Any person or company that submits claims to the federal government (or state governments) must be certain that the billing is in accordance with applicable rules and regulations. Additionally, marketing materials and presentations must be vetted to ensure compliance with approved uses of products.