Sunday, May 17, 2015

It Seems The End Draws Near, In Legacy Schering-Plough's Integrilin® Promotional Fraud Case: UPDATED California Federal Court Filings

Almost two months ago, I indicated that Merck would likely ultimately escape this qui tam style lawsuit, without having to go to trial on the merits. The latest filing, in the federal Courthouse for the Eastern District of California, confirms my hunch. It was a reply motion to a motion to reconsider, and in it Merck's lawyers forcefully make the point that Millennium is alleged to have done nothing different than legacy Schering-Plough. And Millennium was dismissed -- because these same claims were the subject of a prior public disclosure or three.

To be clear, it does seem the bad behavior alleged in the case actually happened -- and unsurprisingly, it was directed by Schering-Plough -- to gain an unfair advantage in selling the drug (allegedly). It just seems these matters were already disclosed, and likely resolved, in other court proceedings -- thus presenting a bar to any separate recovery here. In any event, here is a bit from the latest filing, but I expect we will hear little more of material import on this matter -- other than that it has been disposed of -- without a trial.

. . . .The first distinction between Schering and Millennium that Relator’s Opposition seeks to draw with respect to these claims is based on the flawed premise that the [complaint] somehow distinguishes what Millennium allegedly did to promote Integrilin off-label from what Schering allegedly did. But this is not in fact what the [complaint] alleges. . . . In an effort to manufacture support for his argument, Relator seeks to create the false impression in his Opposition that only Schering is alleged to have sent letters to doctors and to have used scientific studies to promote Integrilin off-label. . . .

[T]his Court has already reached conclusions indicating that the off-label promotional claims leveled against Millennium and Schering are essentially the same. In dismissing those claims as against Millennium, the Court found that the [complaint] alleges "Millennium caused the submission of false claims by ‘presenting physicians with false information about off-label uses of Integrilin and encouraging physicians to prescribe Integrilin for such uses . . . which were not approved by the FDA or any relevant drug compendium. . . .’" The Court also found, without distinguishing between Schering and Millennium, that the [complaint] alleges "Defendants, including Millennium, made false and fraudulent representations ‘to physicians that Integrilin was safe and effective for use in off-label patient populations. . . .’"

Tellingly, it was by comparing these allegations to the allegations in the 2007 federal complaints that the Court determined that Relator’s “off-label use allegations” against Millennium were “‘based upon’ public disclosures previously made” in those 2007 complaints. . . .

That seems pretty much rock-solid. Just to sure, though, we will -- as ever -- keep an occasional eye on this particular minor league game -- ice cream cone in hand. . . watching it melt away, on a perfect Spring night. So it goes.

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