The state filed a lawsuit Thursday against the maker of an opioid-fentanyl drug, calling the company’s conduct “nothing short of evil.”
The four-count lawsuit filed in Middlesex County Superior Court charges that Insys Therapeutics Inc. engaged in a greed-driven campaign of consumer fraud and submission of false claims to health insurers to increase the market share for its drug Subsys.
Subsys was given narrow FDA approval to treat cancer pain in opioid-toleratn people, but instead the company unlawfully directed its sales force to push it to be subscribed to patients suffering any type of chronic pain and at higher doses, state Attorney General Christopher Porrino said.
Since Subsys’ launch in 2012, it has accounted for 98 percent of Insys’ revenue. Insys — which rasied the price of its drug every year — sold $74.2 million worth of Subsys in New Jersey as of last year’s third quarter.
The Delaware corporation’s greed put hundreds of lives in jeopardy and led to the death of at least one New Jersey resident, identified only as a 32-year-old Camden County woman prescribed the drug for fibromyalgia.
“The conduct alleged in our lawsuit is nothing short of evil,” state attorney general says
Two New Jersey state employee health benefits plans paid a total of about $10.3 million to reimburse Subsys prescriptions between 2012 and the third-quarter of 2016, while the State Worker’s Compensation Program paid another $300,000.
“The conduct alleged in our lawsuit is nothing short of evil,” Porrino said. “Knowing full well it was putting lives in peril by pushing for broad-based consumption of a highly specialized and incredibly powerful prescription drug – a form of fentanyl approved only for treatment of pain-racked and opioid-tolerant cancer patients — Insys allegedly forged ahead and did it anyway.”
The State’s lawsuit includes three counts alleging violation of New Jersey’s Consumer Fraud Act and one count alleging violation of the New Jersey False Claims Act. The suit asks that Insys be assessed maximum civil penalties for each violation of the Consumer Fraud Act, and seeks three times the State’s actual damages for violations of the False Claims Act, per that statute. The suit also seeks to have Insys held responsible for costs and fees incurred by the State in bringing the case.
“We contend that the company used every trick in the book, including sham speaking and consulting fees and other illegal kickbacks, in a callous campaign to boost profits from the sale of its marquee drug Subsys,” Porrino said.
Corporate decision-makers devised a strategy to expand what they recognized as a limited market for Subsys by aggressively pushing “off label” uses of the drug – even to podiatrists and other specialty practitioners who typically would have little call to prescribe powerful Schedule II painkillers, the suit alleges.
Off-label use denotes use of a drug for purposes other than that for which it was approved by the FDA. Based on their independent medical judgment, physicians have discretion to legally prescribe drugs for off-label use. However, drug companies are prohibited from promoting their products for such uses in an untruthful or misleading way, and influencing healthcare provider’s prescription decisions with payments and other benefits.
“Clearly, raking in more money was the engine that drove this subversive and illegal plan to push a potent and, in the wrong patient, potentially lethal form of fentanyl to a broader audience,” Porrino said. “As we explicitly claim in our lawsuit, Insys and its leadership were willing to do whatever was necessary to make Subsys successful.”
Packed in a single-dose spray device intended for oral administration, Subsys is a transmucosal, immediate-release formulation of fentanyl.
In the drug’s first year on the market, a one-month supply of the lowest available strength of Subsys – 100 mcg doses — cost approximately $2,800. By 2015, the price of the same supply had spiraled to more than $4,000. The state’s lawsuit alleges that Insys regularly misled health insurance plans and pharmaceutical benefits managers to help secure coverage for Subsys prescriptions.
Insys representatives even concealed the company’s telephone number from benefits managers and insurers so those entities would not be aware that it was Insys Reimbursement Center employees — calling directly from Insys — in an effort to obtain insurance reimbursement approvals for prescriptions of Subsys, the suit claims.
More than 840 people in New Jersey died from heroin or opioid abuse in 2010. That number jumped to more than 1,000 in the first half of 2016.
At the same time, the complaint asserts, the number of people admitted to state-licensed or certified substance abuse treatment programs in New Jersey due to abuse of heroin or other opiates increased from about 33,000 in 2012 to more than 38,000 in 2016.
The complaint points to National Institute of Drug Abuse statistics that say 80 percent of new heroin users began their addictions by misusing prescription pain medications. Opiate-related deaths in the nation have more than quadrupled since 1999, according to the national Centers for Disease Control.
“As we allege, the fact that Insys was unlawfully flooding the market with a fentanyl product 50 times stronger than heroin and 100 times more potent than morphine seems not to have troubled the company at all,” Porrino said. “Nor, it appears, was it bothered by the notion that such a strategy could contribute to, and exacerbate, the grave opiate crisis being confronted by New Jersey and every other state. Insys launched a business plan that we allege was propelled by titanic greed and corporate irresponsibility, and we’re committed to holding them accountable for it.”