A federal magistrate judge has recommended that a federal court dismiss a whistleblower lawsuit brought by two former Solvay reps, who contended the drugmaker concocted an illegal scheme to promote a drug for off-label use and, consequently, caused the federal government's Medicaid program to overpay by millions of dollars.
The drug in question was Marinol, which was originally approved to treat nausea and vomiting for chemo patients who failed to respond to standard meds and, later, anorexia for AIDS patients who suffer considerable weight loss. But Jim Hopper and Colin Hutto alleged Solvay improperly promoted Marinol off-label as an appetite stimulant, because the FDA-approved market was too small.
However, in a 27-page report, Magistrate Judge Thomas Wilson of the US District Court in Tampa, Florida, recommended their 2004 suit be dismissed because they failed to clear a legal hurdle known as rule 9b, a controversial provision of the False Claims Act, which requires a whistleblower to provide specific info about false claims submitted to the government for payment. The level of detail might include amounts charged, drugs prescribed, patient diagnosis and individuals involved in billing.
In explaining his decision, Wilson wrote the former reps "concede that they have no evidence of a false claim...they have provided detailed allegations of various schemes to promote Marinol's off-label use, but their allegations that the defendant's alleged illegal marketing campaign caused the submission of false claims for government reimbursement totaling millions of dollars are not supported by any facts concerning false claims actually submitted to the government for reimbursement."
The upshot - if one files a whistleblower lawsuit, be prepared to have specifics.
Hat tip to the FDA Law blog
pic thx to katerha on flickr
7 Comments
Any documentation, preferably in writing, may be an asset to a whistleblower. Something showing the rep being directed into off-label promotion, for example. Detail peices are another example.
If an organization CAUSES the submission of a false claim, with deliberate intent and reckless disregard, then it is valid. Franklin v. Pfizer (Parke Davis) proved this.
It's no wonder pharma companies do what they do! This hurdle being put in place is too high. If a company is practicing blatant off-label promotion, then they should be held accountable for such actions and face civil and criminal penalties.
Dan - Can you explain your second comment, re: "CAUSES the submission of a false claim." I'm not sure I follow it. Thank you.
It's just something I read about that case. It was unique, as I recall, because it proved one is possibly guilty if they encourage false claims to be submitted. I'm suprised that judge in Fla. used this argument, as it has been defeated in the past.
On the other hand, I'm no lawyer......
JIM - it is the second act listed that one can be liable for:
(2) knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government; (link from the TAF website)
Very useful, harpy, thanks. This does, indeed, seem to obviate the need for itemized receipts unless a particular magistrate chooses to demand them.
Is this, I wonder, a reflection of a general policy change of the sort we've seen in several contexts - closing accountability doors more and more tightly?