A Missouri pharmacist faces treble damages under the False Claims Act as a result of a civil lawsuit brought against her by the U.S. Attorney’s Office for the Eastern District of Missouri.
“This kind of an effort by the Justice Department started a few years ago when they decided to use civil tools in addition to criminal tools to go after pharmacies that were filling prescriptions that are, in their opinion, unlawful,” said Patrick A. McInerney, a former state prosecutor, and Western District of Missouri assistant U.S. Attorney. “It's another angle that Department of Justice is taking.”
Elizabeth Dembo is accused of unlawfully filling prescriptions for an oral fentanyl spray while disregarding red flags described under federal regulations, which indicated the prescriptions were potentially fraudulent, according to a Department of Justice statement online.
“These red flags are designed to give doctors and pharmacists a roadmap for determining whether there is a risk of fraud or a risk that opioids are being distributed inappropriately, which can include prescriptions for unusually high doses or that are combined with drugs that a pharmacist or a physician should know are dangerous when combined,” said McInerney, who is currently a partner with Spencer Fane.
Only the federal government can sue an individual under the Controlled Substances Act and the False Claims Act but Dembo faces the same civil burdens, civil discovery, and civil procedures that would have occurred if a civil lawsuit were brought against her by a private individual.
“The monetary sanctions that come along with these lawsuits include treble damages for violations of the False Claim Act and those are huge,” McInerney told the St. Louis Record. “I've been involved in a couple of these investigations and it comes down to whether there was a legitimate medical purpose for the prescription and they tend to be expert opinion-heavy cases.”
The Riverbender reported that Dembo prescribed high doses of Subsys even though she was aware the patients did not qualify for the drug and that most of the drug Dembo dispensed was prescribed by Warrenton neurologist Dr. Philip Dean who did not dispute the allegations that he distributed prescription drugs illegally, including to women with whom he had lived and with whom he had had personal relationships.
“If a pharmacist or a physician who, as a routine matter of practice, is writing 20, 40, or 60 prescriptions a week, each one of those prescriptions is a separate violation and carries with it a separate penalty and separate treble damages,” McInerney said.
The Controlled Substance Act outlines a specific standard for a legally valid prescription for a reason, according to McInerney.
“There are specific definitions so that pharmacists and doctors can consult the regulations and know what's right, what's wrong, and how to conduct themselves,” he said.