The Qui Tam Blog

 By: Joel Androphy, Rachel Grier, and Scott Braden

Whistleblowers should be mindful that disclosures in foreign periodicals can be considered public if the periodicals are regularly read by an international community. In a recent opinion, a U.S. District Court decided that an article in a foreign scientific journal was a public disclosure, given the international nature of the scientific community. The court reasoned that the foreign publication of a scientific article does not make it “any less accessible to the American public than if it were published in a scientific journal located in the United States.  The court also clarified that not all foreign publications are public disclosures, such as an ordinary article in a Greek newspaper. In these instances, there is no public disclosure when an article is published in a different language in a foreign publication not regularly read by an international community. The case is USA ex rel. Radcliffe v. Purdue Pharma L.P., a court in the Western District of Virginia.

Federal False Claims Act and Qui Tam Actions
Law Journal Press Webinar
By: Joel M. Androphy, Sarah Frazier and Rachel Grier

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By: Joel Androphy, Rachel Grier, and Scott Braden

The Texas FCA does not contain an express limitations period on Medicaid fraud claims. However, under Texas law, if a cause of action does not contain an express limitations period, it is subject to a default four-year limitations period unless the cause of action is one that belongs to the state. The whistleblower argued that a qui tam lawsuit is a right of action belonging to the government and is therefore exempt from the four year limitations period. Relying on Fifth Circuit case law, the court held that if the state has not intervened, the right of action belongs to the whistleblower and is subject to the four year default statute of limitations. The case is United States ex rel. Foster v. Bristol-Myers Squibb Co., a court in the Eastern District of Texas, Lufkin.

By: Joel Androphy, Rachel Grier, and Scott Braden

Medicaid can only reimburse drugs that are used for a medically accepted indication, meaning an indication that is either approved by the FDA or supported by one of three drug compendia. In Rost, the whistleblower, a former Pfizer marketing executive, brought a qui tam suit alleging that Pfizer unlawfully promoted the off-label use of Genotropin (human growth hormone) for treatment of short stature in children. Pfizer argued that one of the compendia, DRUGDEX, cited Genotropin as “possibly effective” for short stature in children.  Citing to a recent statement by the Center for Medicaid and State Operations, the court pointed out that to be reimbursable, an off-label use must be supported by the compendia as opposed to merely listed.  It was unclear from the record whether being cited by DRUGDEX as “possibly effective” could be read to “support” an off-label use. 

The court stated that Pfizer’s stronger argument was that the off-label claims were not false because they were approved by Indiana Drug Utilization Review (“DUR”) Board.  For example, if a state knowingly reimburses for the off-label use of a drug “after a prior authorization review,” the government knowledge could “negate the intent requirement under the FCA.”  This argument, however, was trumped by the allegations (and potential proof) that the false qui tam claims were caused by unlawful kickbacks.