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