A whistleblower lawsuit accusing Stryker (NYSE:SYK) and other pain pump makers of illegal off-label marketing might be close to resolution, after a Missouri judge unsealed the original complaint this week.
The court will be among the 1st to hand down a False Claims Act ruling on off-label marketing following U.S. v. Caronia, in which an appellate court ruled that a drug salesman’s off-label marketing activities were protected as free speech.
The newly unsealed suit, which names as defendants Stryker, Orthofix (NSDQ:OFIX), I-Flow and DJO Global, accuses 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.
"From that date until the date of this pleading, the FDA has never approved, and has specifically rejected, the use by McKinley, defendant Stryker, and every other manufacturer of external infusion pain pumps for orthopedic use generally and specifically rejected use of such devices in the synovial/intra-articular space," according to the documents.
Several device makers, including those listed in the lawsuit, have launched FDA bids to win orthopedic indications for pain pumps, but all have been summarily rebuffed by the federal watchdog agency.
Tamara Cutler, Stryker’s vice president for public affairs, told MassDevice.com in an email that, "As a matter of company policy, we don’t comment on legal matters."
The "disinformation campaign"
Whistleblower 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.
"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."
Will another judge protect off-label marketing?
The Caronia decision, handed down in the New York Circuit Court of Appeals earlier this month, directly affects the law in New York, Connecticut and Vermont. According to James Keneally, a partner at Kelley Drye,other judges may look to the case for guidance in deciding FCA suits. Although the Stryker case is unique in many ways, the Caronia decision could influence on its outcome, Keneally told MassDevice.com.
The Caronia case involved misdemeanor charges against an individual salesperson, rather than the organization behind him, Keneally noted. That company, Orphan Medical (now Jazz Pharmaceutical), had separately settled the charges against the employee by the time the Caronia case was closed. But corporations may be treated as individuals under law, meaning that Stryker and other pain pump makers "can use Caronia now in their arguments to try to dismiss the case," Keneally said.
Although judges are not "duty-bound" to follow the Caronia ruling as precedent, it’s likely that all parties are aware of its implications, he noted. Because it was handed down by an appellate court, it "carries pretty heavy weight," Keneally told us.
Neither the pain pump lawsuit nor Caronia are likely to be the last word on off-label marketing. The debate will probably make its way to the U.S. Supreme Court, where the justices will have to settle differences between 2 very strong sides, Keneally told us.
On the 1 hand, FDA rules against off-label marketing are "logically anomalous," given that physicians can prescribe federally approved devices and drugs for off-label purposes based on their medical expertise, he explained. And doctors are also free to disseminate information about and tout off-label practices freely. Device and drug makers, however, are explicitly forbidden from promoting their products in any context other than what has been specifically cleared through federal health regulators, even if doctors have generally agreed on a different use.
On the other hand, it’s no less anomalous "to have a regulatory structure that says you have to prove it’s safe and effective, and you have to show us the purpose for which it’s intended so we can determine whether it’s safe and effective, but once you do that the barn door’s completely open and you can claim whatever the heck you want," Keneally said.
"Those are 2 very, very solid sets of arguments that are butting heads against 1 another," he added. "And they certainly apply to entities as much as individuals, because it’s clearly a commercial free speech issue, and as we know from Citizens United, entities are people too.
"This is the type of thing that will ultimately reach the Supreme Court," Keneally said. "I think we’ll have to wait until that day."
The ongoing battle
The qui tam lawsuit isn’t the only battle pain pump makers are facing.
Earlier this month I-Flow lost a bid for summary judgment in a patient injury lawsuit associated with its On-Q Painbuster continuous infusion drug pump. Plaintiff Gilbert Placencia accused I-Flow and former Orthofix subsidiary Breg Inc. of developing pain pumps that delivered "dangerous doses" of anesthetic medication to his shoulder, leading to cartilage loss and pain.
Breg in 2011 managed to land a win in the 1st of a series of pain pump lawsuits after a jury deemed Breg blameless of charges that it manufactured and sold a pump found to be defective and unreasonably dangerous.