With Thanksgiving over, we move from the relatives to Relators. Not that those two topics are always so different. In some ways, they can be similar. Relatives sometimes complain. Relators always complain. Relatives can be loud. Relators blow big loud whistles. Relators hope to get a big chunk of change from their False Claims Act lawsuit. Relatives . . . well . . . come to think of it, relatives are better.
But in United States ex rel. Worsfold v. Pfizer, 2013 U.S. Dist. LEXIS 167338 (D. Mass. Nov. 22, 2013), no matter how loud and long (about a year) the Relator blew his whistle, nobody saw a reason to come running.
The Relator, Worsfold, was a district manager on Pfizer’s sales team, and he claimed that Pfizer marketed two of its anti-fungal medications for off-label uses. Id. at *2-6. That alleged marketing formed the basis of two types of FCA claims.
First, Worsfold claimed that that Pfizer directly submitted claims for payment to the government that were false because they were based on off-label prescriptions prompted by off-label promotion. Second, he claimed that Pfizer indirectly caused the submission of false claims to the government by doctors who prescribed the drugs off-label because of Pfizer’s alleged off-label marketing. Id. at *17. The logic is a bit tortured, but in essence the Relator alleged that the claims were “false” because they were based on off-label marketing, which he claims violates FDA rules, and weren’t reimbursable because Medicaid and Medicare do not pay for such off-label uses.
It had taken Worsfold five complaints and 14 months to get to this point. Id. at *6. But he kept running into a roadblock: the heightened pleading standard for fraud under FRCP 9(b). This standard, which is generally applied to FCA claims, caused Worsfold all sorts of problems.
His direct claim was unceremoniously dismissed in one paragraph. Despite his many attempts at a complaint, Worsfold’s claims remained “exceedingly vague,” presenting few if any “details evidencing how Pfizer itself, rather than intermediary physicians, submitted a false claim to the government.” Id. at *17. With almost no factual allegations, this claim might not have survived TwIqbal, no less FRCP 9(b).
His indirect claims had almost as many defects. The court saw numerous gaps in the statistical analysis that he attempted to use to state his claim. Worsfold also failed to identify any doctors who actually prescribed off-label or were prompted to do so by Pfizer, any pharmacies that filled such off-label prescriptions, or any resulting off-label claims that were presented to the government for payment. Id. at *20-25.
More important for our purposes, the subtext (and at times the text) of the opinion was that off-label uses are not, in the abstract and often in reality, improper or a per se basis for FCA claims. Declaring a marketing piece off-label doesn’t make it false. None of the marketing materials that the Relator presented in the Complaint claimed that the drugs were approved for something that they were not, or that they were safer for that unapproved use than competing drugs. Id. at *23-24.
Moreover, as most of us know, off-label uses are often the standard of treatment in a particular area of medicine. The FDA does not restrict doctors’ freedom to use their own expertise and judgment to prescribe drugs off-label to treat their patients. And so a doctor prescribing a drug for an off-label use isn’t evidence that she did so because of off-label marketing. Accordingly, the court rejected outright the “assumption” that an off-label prescription “was caused by Pfizer’s action and was not simply the result of that physician’s exercise of his or her independent judgment.” Id. at *22.
And so, much like relatives after Thanksgiving desert, the court ushered the Relator out the door. His complaint was dismissed and his motion to amend was denied. Id. at *25-26. He’d stayed long enough and told his story five separate times, with none better than the last. Until next time . . . .