Christopher Porrino |

New Jersey on Thursday filed a lawsuit against the pharmaceutical company Insys Therapeutics Inc., alleging the company engaged in a “greed-driven” campaign of consumer fraud and false claims to health insurance carriers to increase its sales for Subsys, a fentanyl-based opioid used to treat cancer-related pain.

The Division of Consumer Affairs, a branch of the state Division of Law and Public Safety, filed the lawsuit against the Chandler, Arizona-based company in Middlesex County Superior Court.

The four-count complaint charges that, despite Subsys only having Food and Drug Administration (FDA) approval for the “narrow” purpose of treating breakthrough cancer pain in opioid-tolerant patients, Insys unlawfully directed its sales force to push Subsys for prescription to a broader patient population—patients suffering any type of chronic pain—and at higher doses, according to a statement released by Attorney General Christopher Porrino.

The complaint alleges that Insys's conduct has put “hundreds” of lives in jeopardy and “led to the death of at least one New Jersey resident”—a 32-year-old Camden County woman, Sarah Fuller of Stratford, who allegedly was prescribed Subsys for fibromyalgia.

In addition, the suit alleges that two New Jersey state employee health benefit plans paid a total of approximately $10.3 million to reimburse Subsys prescriptions between 2012 and the third quarter of 2016, while the state workers' compensation program paid another $300,000.

“The conduct alleged in our lawsuit is nothing short of evil,” Porrino said in the statement. “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.

“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.

A representative for Insys did not immediately respond to a request for comment.

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 urges that Insys be assessed maximum civil penalties for each violation of the Consumer Fraud Act, and seeks trebled 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.

From the 2012 market launch of Subsys until the present, the drug has accounted for approximately 98 percent of net revenues for Insys, the statement said.

Insys, which has raised the price of Subsys every year since its launch, sold $74.2 million worth of the drug in New Jersey between 2012 and the third-quarter of 2016, the lawsuit said.

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, according to the complaint.

The state's lawsuit alleges that Insys regularly misled health insurance plans and pharmaceutical benefits managers to help secure coverage for Subsys prescriptions.

The complaint charges that Insys representatives used or developed false records, including false diagnoses of cancer, breakthrough cancer pain and other afflictions, to help lock in pre-authorization approvals and ensure paid reimbursement claims.

The complaint alleges that Insys representatives went so far as to conceal 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—trying to obtain insurance reimbursement approvals for prescriptions of Subsys.

The suit also alleges that Insys routinely misled consumers by making false representations that doctors and other prescribers were prescribing Subsys on the basis of their unbiased, independent clinical judgment when, in fact, that clinical judgment had been “co-opted based on Insys's unlawful payment of kickbacks to prescribers.”