From time to time, pharmaceutical companies have challenged the reach of the FCA, especially as it is applies to off-label pharmaceutical marketing schemes. Last week, the US Department of Justice weighed in on this debate, when it filed a Statement of Interest in an ongoing FCA case that alleges that Pfizer violated the FCA by off-label marketing its drug Lipitor.

While not intervening in this qui tam action, the Justice Department submitted its Statement to clarify the legal basis for an FCA claim predicted on allegations of off-label marketing by pharmaceutical manufactures. First, it stressed that claims for payment of items or services that are not eligible for reimbursement by federal health programs are “false claims.” Second, the Justice Department argued that a drug manufacturer may cause a provider to submit a false claim for reimbursement if that false claim was a reasonably foreseeable consequence of the drug manufacturer’s conduct. Third, the Government maintained that the identification of specific false claims is not an absolute prerequisite to satisfying the heightened pleading requirements of the FCA. According to the Statement, “So long as the complaint as a whole is sufficiently particular to strengthen the inference of fraud beyond possibility, a court may conclude that [the pleading standard] is satisfied.”

Notably, in this case, Pfizer had argued that a subsequent FDA-approved use absolved the company of any False Claims Act liability. The Government responded: “If a claim was false when it was submitted in 2004, a label change five years later does not transform that false claim into a reimbursable one. To hold otherwise would be to render federal health care program restrictions on coverage meaningless.”

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.