INSYS Therapeutics, Inc. (INSY), a manufacturer of pharmaceutical cannabinoids and spray technology, has once again found itself in legal hot water.
On Feb. 1, 2018, New York Attorney General Eric Schneiderman filed a lawsuit against the company, alleging that INSYS deceptively promoted its fentanyl-based cancer pain medicine, Subsys. Seeking $75 million in penalties, Schneiderman claims that the company marketed Subsys for purposes other than what was approved by the U.S. Food and Drug Administration.
“At a time when the opioid epidemic was ravaging New York, Insys Therapeutics allegedly marketed a drug illegally by blatantly disregarding the grave risks of addiction and death that opioids pose,” said Schneiderman in a statement. “As we allege, Insys showed a wanton disregard for the law and the lives of New Yorkers and we will hold them accountable.
Additionally, Schneiderman alleges that INSYS engaged in a pattern of deceptive and illegal conduct by downplaying the risks of addiction, lying to healthcare providers to bypass the authorization process, and bribing doctors to prescribe the medication.
This is not the first time that INSYS has found itself in the crosshairs of law enforcement officials. In 2016, seven former executives with the company were arrested for conspiring to bribe medical staff in several states to prescribe medication.
A year later, INSYS was sued by Arizona Attorney General Mark Brnovich for misleading doctors and patients about Subsys. Later that same year, INSYS founder John Kapoor was arrested in Arizona and charged with RICO conspiracy, conspiracy to commit wire fraud, and conspiracy to violate the Anti-Kickback Law for their efforts to secure prescriptions of Subsys.
Although INSYS executives have pleaded not guilty, the company is currently in talks with the U.S. Justice Department and estimates that it may have to pay at least $150 million in fines and penalties. Previously, INSYS has agreed to pay $9.45 million to conclude investigations in Oregon.
In response to Schneiderman’s lawsuit, INSYS defends its actions and points to the fact that prescriptions of Subsys made up a very small percentage of opioid prescriptions in New York. When the drug launched in 2012, Subsys accounts for less than 0.02% of opioid prescriptions.
Similarly in 2015, the year of highest use for Subsys, 9,200 patients were prescribed Subsys compared to the approximately 52 million patients in the United States prescribed opioids. As such, INSYS denies its role in creating the opioid crisis in New York, although it does specifically address the claims made by Schneiderman.