Federal prosecutors in Florida reached a settlement with Edward Lubin, a pain management doctor over unnecessary prescription claims of a fentanyl-contained spray last month.

As early as 2013, Dr. Lubin allegedly was involved in an illegal arrangement with Insys Therapeutics, Inc., an American pharmaceutical company based in Chandler, Arizona. With this agreement, Lubin participated in hoax speaking events promoting their main product, Subsys, a fentanyl-based spray applied under the tongue. These talks, in turn, according to federal litigators would "funnel [mass amounts of] money … to doctors who prescribed high quantities of Subsys as a reward for their prescriptions.”. To hide the fact that these payments were bribes used to persuade practitioners to write Subsys prescriptions, the company wrote them under speaker fees or honoraria.

During the time Dr. Lubin was involved with these speeches he “‘was [allegedly] paid between $1,600 and $3,700 per “speech”’ in speaker fees and honoraria, as maintained by the United States of America. This, the U.S. further claims, led to a vast majority of Dr. Lubin's prescriptions of Transmucosal Immediate Release Fentanyl (TIRF ), — the category of drug that fentanyl-based rapid onset opioids like Subsys fall under — to be written for Subsys. Specifically, federal attorneys claim that “99% of Dr. Lubin’s TIRF prescriptions were written for Subsys” and that “he wrote over 500 prescriptions for Subsys and only four prescriptions for an alternative TIRF medication, called Lazanda” between 2013 and 2016. The company further bribed their practitioners, as argued by the U.S. by taking “Speaker Program payments away from practitioners or [reducing] the total volume of Speaker Program payments” if they did not meet minimum prescription requirements. 

Further bolstering their argument against Lubin is their claim that the doctor administered Subsy to patients who did not have cancer: “‘From 2014 through 2016, Dr. Lubin overprescribed the drug  to 61 patients' while ‘only “nine of those patients had cancer.”’ In their complaint, the U.S.  also discovered an account from a patient of Lubin, who recalled, despite never being diagnosed with cancer, receiving doses of Subsy that “steadily increased … from 400 mcg to 600mcg, to 800mcg, and finally to 1200 mcg.” 

With these allegations, the U.S. launched a civil action lawsuit against Lubin in 2021 “to recover damages from false claims for prescriptions tainted by an illegal kickback arrangement that Dr. Lubin caused to be presented to the Medicare and TRICARE programs.” The U.S.’s legal standing in the lawsuit rested upon violation of the federal Anti-Kickback Statute, which prohibits financial payments and incentives in exchange for referrals and prescriptions, and violation of the False Claims Act, an act that penalizes those who knowingly present fraudulent claims to the United States for payment or approval.

In response to this, Lubin in July of 2023, filed for Chapter 11 bankruptcy where he asked the court to halt the case against him. However, the lawyers for the U.S.  Attorney's Office countered this by arguing that his reasoning for bankruptcy did not apply to the government's "police and regulatory power.” In the end, the U.S. Attorney’s Office won with the bankruptcy judge allowing the case to go forward. 

Lubin’s case, which initially was scheduled to begin Monday, October 16, 2023, was resolved when both parties intended to settle out of court. “The parties have reached an amicable resolution of all claims with the parties to bear their own fees and costs” the Notice of Agreement stated and they  “...request that the pre-trial conference …  and the trial set to commence on Monday, October 16, 2023, be taken off the Court’s calendar.”