Attorney General Porrino Announces State Lawsuit Alleging Greed-Driven Scheme to Boost Sales by Fentanyl Drug Maker Insys
Attorney General
Filed today in
Among other things, the complaint alleges that, Insys's greed has put "hundreds" of lives in jeopardy and "led to the death of at least one
"The conduct alleged in our lawsuit is nothing short of evil," said Attorney General Porrino. "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.
The State's lawsuit includes three counts alleging violation of
From the 2012 market launch of Subsys until the present, the drug has accounted for approximately 98 percent of net revenues for Insys, a
Insys, which has raised the price of Subsys every year since its launch, sold
The State's lawsuit alleges 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.
Off-label use denotes use of a drug for purposes other than that for which it was approved by the
"Insys made tens of millions of dollars in sales in
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
Specifically, the complaint charges, 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 - in an effort to obtain insurance reimbursement approvals for prescriptions of Subsys.
The suit also alleges that Insys routinely misled consumers by, among other things, 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."
More than 840 people in
The complaint further points out that, according to the
"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
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