Law

We have today another False Claims Act case in which the plaintiff—or, we should say, “Relator”—alleges that reimbursement claims made to the government for drugs purchased for off-label uses are false claims.  United States v. Solvay S.A., 2015 U.S. Dist. LEXIS 166639 (S.D. Tex. Dec. 14, 2015).  That’s nothing new.  But “Relator” did something to make it a little more interesting.  He couldn’t argue that Medicaid hadn’t authorized reimbursement for the off-label uses at issue in this litigation.  It had.  Medicaid authorizes reimbursement for off-label uses of a drug if a qualified compendium cites clinical studies supporting that use for that drug.  And a qualified compendium had done so here.  

But “Relator” didn’t accept that.  He attacked the validity of the inclusion of the studies in the compendium.  He alleged that the pharmaceutical company tricked and cajoled the compendium company into listing those articles, pointing to all the types of evidence that we have seen over the years in product liability cases:  Suppressing bad studies.  Manipulating data.  Ghostwriting articles.  Obscuring bad results by hiding the true number of dropouts from studies.  Publishing articles in non-peer-reviewed supplements.  “Relator” claimed that these improper tactics by the pharmaceutical company created misinformation and misleading studies that the compendium was tricked or wooed into citing.  And, on that basis, “Relator” asserted an FCA claim against the pharmaceutical company.  

Fortunately, the Court didn’t relate.  It rejected these argument for a host of reasons and granted the pharmaceutical company’s summary judgment motion.  Evidence supporting the existence of these practices was weak.  Regardless, evidence that they would have had a material effect was weak.  Evidence that the named authors had no meaningful input into allegedly ghostwritten articles was weak.  Evidence that the pharmaceutical company was even in contact with the compendium company, no less wooed it to cite the studies in the compendium, was weak.  And so on.  Frankly, the decision reads as if the judge had what we would say was the appropriate attitude about this attempt to stretch FCA claims even further.  Good.

But that’s not why we wrote about this decision.  We had a different reason.  We wanted to sing a holiday song—in tribute to “Relator.”  Christmas is two days away, and Santa Claus is coming to town.  Perfect.  And since we’re writing this post in the Great State of New Jersey, we’ll be singing the Bruce Springsteen and the E Street Band version.  Now, it’s hard to believe that anyone in this country doesn’t have that song stuck in their head right now.  But just in case, click here.  It’s old school, not last weekend’s SNL performance.  Give it a listen. And get ready . . . .  . . . . . . . . Done?  OK, here we go:

HAPPY HOLIDAYS


--
Posted By John J. Sullivan to Drug and Device Law at 12/23/2015 11:57:00 AM

--
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
---
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.