We blogged before about the Hopper and Bennett cases, in which courts rejected the argument that off-label promotion necessarily generates "false claims" for purposes of the False Claims Act. Well, we're pleased to report that the duo has become a trio. There's a new opinion, and lo and behold, it dismisses yet another action by the recidivist rejected relator Elaine Bennett. U.S. ex rel. Bennett v. Boston Scientific Corp., 2011 WL 1231577 (S.D. Tex. March 31, 2011),
Because Bennett's legal theories sound a lot like her other case, and the result was the same, we'll only hit the high points this time around.
Just because a drug or device is used off label, doesn't mean that the use is medically unnecessary. 2011 WL 1231577, at *3. That goes double for a "Category B non-experimental/investigational medical device" (if you don't know what this is, you don't need to) such as that involved in the case. Id. at *4.
Violations of the FDCA, such as off-label promotion, aren't automatically also "false claims." Id. at *12-13. "[E]ven if a drug or device manufacturer's marketing or promotion activities violate FDA regulations, that is insufficient to plead that the manufacturer caused physicians or hospitals to submit false claims for reimbursement." Id. at *29.
T'ain't no such thing as "implied certification." Id. at *13. If there's no actual certification, there's no claim. Id. at *33.
"Medical necessity" is determined on a patient-by-patient basis by prescribing physicians, so plaintiff's claims fail without some pleading of reliance by individual doctors. Id. at *26-27. Thus, merely "[a]lleging that the use of the [device] ystem to treat [the off-label condition] is 'experimental' does not allege a basis for an inference that such use of the system is categorically medically unnecessary." Id. at *27.
Without allegations tying particular off-label promotion, to particular prescribers, a false claim has not been pleaded with sufficient particularity. Id. at *28.
"Upcoding" allegations likewise require specific pleading of doctors, patients, dates, etc. Id. at *30. Upcoding also requires an allegation of actual health-care-provider knowledge that the code being used was erroneous. Id. at *31.
Since we believe, that in most instances, off-label use is a good thing - and that truthful promotion of off-label use is not a bad thing - we're happy every time we see this kind of theory, in effect seeking to criminalize off-label use because it's off-label, thrown out of court.