New York Attorney General Eric T. Schneiderman announced that his office has filed a lawsuit against Insys Therapeutics, Inc., a company that sells a highly addictive fentanyl drug called Subsys.
Although Subsys was approved by the Food and Drug Administration to treat excruciating cancer-related breakthrough pain, the complaint alleges that Insys recklessly marketed the drug for much wider use, covering a much broader set of patients.
Additionally, the company allegedly engaged in a pattern of deceptive and illegal conduct by downplaying the drug’s risks of addiction, bribing doctors to prescribe the drug, and lying to healthcare providers to skirt their authorization process.
As a result, the Attorney General’s office is seeking penalties and disgorgement of all revenues accumulated during the period of misconduct—up to $75 million.
“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 Attorney General Schneiderman.
“As we allege, Insys showed a wanton disregard for the law and the lives of New Yorkers and we will hold them accountable. My office will continue to fight the opioid crisis at every level and hold corporations that prioritize profits above New Yorkers’ health and wellbeing to account.”
In late 2012, the FDA approved Subsys for the specific, limited treatment of breakthrough cancer pain in opioid-tolerant patients. Its purpose was to provide relief to cancer patients who were suffering from excruciating pain.
Beginning in 2012, Insys allegedly ignored this limited approval and instead broadly targeted many types of providers and patients, and represented that the drug was appropriate for flares of mild pain. Insys also downplayed Subsys’ risk of addictiveness.
The company further directed its sales representatives to urge providers to prescribe Subsys in high doses, which were more expensive than lower doses. A 30-unit prescription of the lowest strength medicine costs approximately $700, while a prescription for the highest strength costs over $3500.
Additionally, the complaint alleges that Insys sales representatives called on medical offices that employed providers who had been arrested for illegal opioid distribution.
In furtherance of their deceptive and illegal scheme, Insys allegedly formed a business unit devoted solely to securing prior authorization from health plans for as many patients as possible. Insys trained its prior authorization staff to imply that patients had cancer pain, even when they did not.
Additionally, Insys allegedly bribed prescribers to write prescriptions for Subsys. The company paid certain providers between $3000 and $5000 to act as “speakers,” at sham promotional events and implored its sales staff to obtain a “return on investment” on those payments by increasing prescription numbers.
According to Insys’ latest quarterly filing published in November, the company has received subpoenas from at least 15 other states and has already settled lawsuits filed by Oregon, Illinois, New Hampshire and Massachusetts.