In a recent court decision a pharmaceutical sales manager claimed that his employer’s actions violated the False Claims Act because off-label prescriptions were expected and intended.  The Fourth Circuit Court of Appeals disagreed, in U.S. ex rel. Noah Nathan v. Takeda Pharmaceuticals, Dkt. No. 11-2077 (January 11, 2013).
The plaintiff alleged that his employer had marketed drugs for off-label uses, in other words, beyond the drugs’ approved indications. He also alleged that the manufacturer was providing physicians with samples of a certain size dosage that must have resulted in prescriptions being written for off-label uses and, thereafter, claims for payment being presented to the government.
The case was dismissed, however, because the allegations did not relate to the specific presentation of a false claim submitted to the government for payment.  More specifically, even if the plaintiff’s allegations were true – about which the court made no specific finding – those allegations did not include any actual proof that certain prescriptions were written or that any claim for payment was presented to the government.  The allegations actually failed to even allege that the defendant manufacturer had intended there to be a submission for payment.  The mere fact that the actions could have led, but need not necessarily have led, to presentment of a claim for payment was found to warrant a dismissal of the case. 
Among other things, the court rested its holding on the False Claims Act’s requirement that knowledge or intent is a required element of proof. The Court also analyzed the federal “pleadings” standards and felt that the plaintiff had not met those standards – even though he had amended the complaint three times. 
This case provides some insight into off-label pharmaceutical marketing and its treatment by the courts in real-world situations – and how courts will approach alleged non-compliance.  Perhaps more importantly, because the plaintiff in this case was a whistle-blowing employee of the manufacturer, the case can also be seen as limiting the claims available to whistleblowers. 
quoted from here