Here's another "guest" post (at this point, only in the sense that we have to load it) from our semi-regular contributor, Melissa Wojtylak of Reed Smith. She gets all the credit for her work. ************* The FourthCircuit is the latest court to reject a claim that prescribing a drug for offlabel use gives rise to False Claims Act liability. As regular readers of the blog know, the FalseClaims Act imposes liability for knowingly presenting a false or fraudulentclaim for payment to the government. See 31 U.S.C. § 3729 (a)(1)(A). And as regular readers also know, in recentyears, enterprising relators (who can often also be described as “disgruntledformer employees of the defendant”) have attempted to cash in under the FCA bybringing qui tam actions against pharmaceutical companies, claiming that thecompany purposely marketed its drugs for off-label uses. While various explanations and theories areadvanced by these relators, the underlying premise of these actions is essentiallythe flawed proposition that the mere existence of off label use of a drug is,in and of itself, a bad thing. Which, orcourse, it isn’t. As we’ve discussed on the blog in the past, several courts have seen the flaw in this logic and sentrelators packing.
The court began its analysis by noting that the relator’scomplaint was governed by Rule 9(b), which sets out the minimum standard forpleading an actionable (i.e., false) representation under the FCA. This relator, faced with a pesky absence ofspecifics about things such as the dates on which reimbursement claims weresubmitted to the government and who submitted them, argued that Rule 9(b)’sstandard could be met if the complaint pled acts sufficient to show a scheme bythe defendant to promote the drug for off label use. Id.at *11-14. Once that was done, relatorargued, the court could plausibly find that false claims must have beenpresented as a result of this scheme. Id. Well, no, the court responded. Justbecause the existence of such a scheme could have led to presentation offalse claims, it need not necessarily have done so, and therefore the relatorwas still required to plead some facts that showed that false claims actually werepresented. Id.at *14. The court rejected cases citedby the relator in which other courts had relaxed the standard, while at thesame time acknowledging that without such relaxation, some relators would facea tough road. In essence, the courtheld that the rules are the rules, for better or for worse, and the relator’scomplaint would have to be judged by them.
Things quickly fell apart for the relator at that point. The Fourth Circuit examined four types ofallegations from the third amended complaint that supposedly satisfiedrelator’s pleading burden, rejecting every single one. First, the relator alleged that the company’ssales reps had marketed to doctors who didn’t even treat the condition that thedrug at issue was labeled to treat. Id. at *16. Somewhat disappointingly, the court didn’tcall this statement out for the nonsense that it is, and instead just notedthat the third amended complaint didn’t allege that any of these doctors had actuallywritten prescriptions for the drug. Id. at *17. (Yeah, we know that’s the appropriate legal analysis, but still, alittle smackdown on the flawed logic would have been nice). Given the failure to allege thatprescriptions were even written, the relator could hardly have plausiblyalleged that reimbursement claims for the costs of these prescriptions werepresented to the government for payment, and on this point, the allegationsfell short of the standard. Id.
Moving on, the court next rejected a variation on the theme. Relator alleged that 98 prescriptionswritten by 16 primary care physicians had resulted in false claims because 1)those physicians had gotten samples of the drug in a 60 mg dosage, which wasonly approved for treatment of one condition, and 2) primary care physicianstypically do not treat this condition. Id. at *18-19. Ergo, these primary care physicians must havebeen writing the prescriptions for off-label uses. There’s that underlying theme that wementioned earlier – that if it’s an off-label use, it must bebad/wrong/fraudulent.
But here it gets even more incredible: while the relator pled that 98 prescriptionsfor the drug were filled after being written by PCP’s who got the 60 mgsamples, he didn’t even plead the dosages of the prescriptions that thesephysicians wrote. Instead, relatorargued that physicians tend to prescribe drugs in the same dosage as thesamples that they give to patients, so these 98 prescriptions must have beenfor the 60 mg dosage. The relator tried to buttress this sheerspeculation by quoting a statistic that 93% of all prescriptions written forthis particular drug were for the 60 mg dosage.
Here the court delivered a gentle form of the smackdown wewere hoping to see earlier. It pointedout that 1) if it was true that PCP’s don’t normally treat the condition forwhich the 60 mg dose was approved, then it would be more logical to assume thatthese doctors were not prescribing this dosage; 2) the third amended complaintdidn’t directly allege that the prescriptions were written for off-label use(to which we say, “so what if it had?”), and 3) the mere fact that PCP’s don’tnormally treat the condition for which the 60 mg dose was approved doesn’tnecessarily mean that they weren’t treating the condition inthe patients for whom the 98 prescriptions were written. Id.at 20-21.
The relator next tried to argue that because 9,000prescriptions had been submitted to government agencies for reimbursement injust two of the defendant’s sales districts during certain time periods, thismust support the averment that false claims were presented. The court made short work of this one, notingthe stark lack of detail with regard to who wrote these prescriptions, theillnesses that they were intended to treat, and – importantly – whether thesephysicians had been on the receiving end of the defendant’s (alleged) sampledistribution practices. Id. at 21-22.
Finally, the court rejected the affidavits of threedifferent doctors submitted with the latest version of the complaint, in whichthe doctors said they had prescribed the 60 mg dose of the drug to Medicarepatients because they didn’t know the drug was available in a lower dose,thanks to the company’s bang-up marketing efforts for the 60 mg dose. (Note to these physicians: you should check out this fabulous newinvention called the “internet” – or even an older one called the “PDR.” You’d be amazed what you could learn aboutthe drugs you prescribe.) The courtsimilarly shot down this claim, noting that the physicians and the relator hadfailed to provide critical details such as dates of prescriptions, or to allegethat the Medicare patients actually filled these prescriptions, thus resultingin claims to Medicare for reimbursement. Id. at 22.
After looking at these four groups of allegations identifiedby relator, the court boiled down the relators’ alleged factual bases for hisclaims as follows:
Relator essentially has alleged that some claims must havebeen presented to the government for payment because prescriptions of this kindare frequently and routinely obtained by persons who participate in health careprograms sponsored by the federal government, or because federally insuredpatients receive off-label prescriptions.
Id. at *24. The court noted, however, that allegations ofthis type don’t survive a motion to dismiss because they are “inherentlyspeculative in nature.” Id. The court also reminded the relator that thepurported scheme, as alleged, was not “an integrated scheme in whichpresentment of a claim for payment was a necessary result.” Id.
Good stuff, but what happens next is our favorite part. The Fourth Circuit affirmed the districtcourt’s denial of the relator’s motion for leave to amend his complaint yetagain, finding no abuse of discretion where the relator had been given twoyears and four chances to get a properly-pled complaint on file. (Because of this, we were tempted to titlethis post “Four Strikes and You’re (Finally) Out”). The Fourth Circuit noted that allowing yetanother amendment – the fifth complaint, as it pointed out - “would underminethe substantial interest of finality in litigation and unduly subject[defendant] to the continued time and expense occasioned by Relator’s pleadingfailures. “ Id. at *25-26. We couldn’t have said it betterourselves.
Hiç yorum yok:
Yorum Gönder