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.
By 2005 Paulos had become concerned that the pain pumps were the underlying factor in a number of cases of acute chondrolysis, defined as destruction of the shoulder joint. He and his partner, Dr. Charles Beck, had begun seeing chondrolysis among some of their own patients and were receiving referrals for others who had been treated with Stryker’s pain pumps, according to court documents.
"Dr. Paulos became increasingly alarmed that these infusion pain pumps, being marketed and sold by Stryker and by other companies to be specifically used in the intra-articular space, was [sic] causing catastrophic and irreversible damage to his patients and the patients of other orthopedic surgeons," according to the documents.
Paulos allegedly reached out to Stryker to raise the alarm about the potential damage caused by the pumps, but the company "never took any steps to research, investigate, test or follow up in any meaningful way on these express warnings of catastrophic damage," even after Paulos warned that several of his colleagues had similarly noticed issues with patients treated with the pumps. Stryker also failed to notify the FDA of the adverse events, the lawsuit claimed.
The lawsuit accused all 4 device makers of engaging in a "disinformation campaign," creating and distributing false marketing materials and refusing to acknowledge or disclose the growing concerns of researchers who warned that the pain pumps may cause irreversible damage in the joints.
"All of defendants’ efforts after being notified of the harmful effects of their pumps were taken to avoid, decrease or reduce their individual obligations to repay Medicare for the results of their improperly cleared, and fraudulently marketed products," according to the complaint. "In engaging in the off-label marketing, the creation of false and fraudulent documents and marketing materials, and in the omission of information related to differences of opinion about the pain pumps, the defendants acted knowingly in that they actually knew or acted in deliberate ignorance of the truth of falsity of their representations."
But the U.S. Court of Appeals for the 8th Circuit upheld a lower court’s determination that Paulos’ allegations are substantially identical to prior published reports of the link between the pain pumps and chondrolysis, according to court documents.
"As the district court discussed in detail, the public documents laid out precisely these points. These independent sources show the following allegations and transactions: (1) various pain pump manufacturers attempted numerous times to obtain FDA approval to market pain pumps for placement in joint spaces, and in every instance the FDA refused approval; (2) Stryker and I-Flow nevertheless encouraged healthcare providers to use pain pumps in joint spaces; (3) neither company disclosed the lack of FDA approval for this use; (4) both companies knew the pumps had never been safety-tested for such use; and (5) both companies continued to market pain pumps for such use even after learning of a possible connection to chondrolysis," according to the documents. "Finding no meaningful distinction between the public disclosures and Dr. Paulos’s claims, we conclude the district court did not err in finding a public disclosure sufficient to meet [the relevant statute]."
