Fentanyl Manufacturer Sued Over Sham Speaker Fees

August 31, 2017

Article

The Arizona Attorney’s General Office alleges that Insys made millions off illegal schemes.

In the latest in a string of lawsuits against opioid manufacturers, the Arizona attorney general announced today that it is suing Chandler, AZ, based Insys over what it is calling “sham” speaker fees.

According to Attorney General Mark Brnovich’s

, Insys is guilty of engaging in a “nationwide scheme in which it deceived insurers, patients, and doctors” over its drug Subsys. According to the label, Subsys is a sublingual fentanyl spray, designed to treat breakthrough pain in cancer patients tolerant of other opioids, but the Attorney General alleged that Insys used illegal tactics to push the drug-tactics such as deceiving insurers, hiding facts from doctors and patients, and paying doctors fake speaker fees, “all in order to increase the sales of Subsys, without regard for the health and safety of patients.”

This is not the first time Insys has been sued over its marketing of Subsys. Earlier this month, Insys settled a 2016 lawsuit with the state of Illinois for $4.5 million over claims of deceptive marketing. In 2015, Insys settled with the state of Oregon for $1.1 million over similar claims. In May of this year, an Insys sales manager was put on trial on trial for illegally pushing the drug onto patients, only to become addicted himself.

Those state settlements, along with Arizona’s current lawsuit, alleged that Insys promoted the drug for additional off-label uses to health-care professionals. Around June 2012, the Arizona complaint alleges, Insys made changes to its presentation slides. The slides had a definition of breakthrough cancer pain as “a flare of mild-to-severe pain in patients with otherwise stable persistent pain.” Claiming that breakthrough cancer pain included mild pain was, according to the complaint, “unsupported and misleading.”

According to the complaint, top officers at Insys developed a scheme under which certain health-care providers collected “speaker fees,” under the condition that those providers prescribe high levels of the Subsys. Three physicians-Steve Fanto, Nikesh Seth, and Sheldon Gingerich-were allegedly part of that scheme in Arizona. Between March 2012 and April 2017, Subsys gross sales reached $51.87 million. The defendants were each paid around $200,000 annually for speaker fees. The three physicians were responsible for 64% of sales in that time, each writing nearly 1,000 prescriptions. During that same period, the 145 physicians in Arizona who prescribed Subsys and were not paid speaker fees wrote on average fewer than 14 prescriptions each. Before they defendants began receiving payments, they collectively wrote around nine prescriptions each month, but after receiving payments that number climbed nearly sevenfold to 62 per month.

Insys is also accused of misleading health insurers and PBMs into paying for Subsys. The company allegedly used “deceptive and unfair practices” to raise the prior authorization rates from previously low rates of 33% in November 2012 to rates of 100% in November 2013. The complaint alleges that Insys engaged in practices such as informing insurers and PBMs that non-cancer patients did have cancer or that calls to those groups came from health-care providers’ offices and not from Insys.

“We need to put a stop to the unethical and greedy behavior in the pharmaceutical industry that is fueling the opioid crisis in our state,” said Brnovich in statement.

Brnovich is seeking an injunction to stop Insys from continuing to perform the alleged practices, along with restitution to customers and to remove all profits gained as a result of any illegal practices.

In a response to its Illinois settlement, Insys said that the payment there “reflects our firm commitment to take responsibility for actions by our former employees and we affirm our continued intent to put patients first as reflected by our actions and ethical behavior,” but that “we do not believe it is factually accurate to state that Insys has materially contributed to the opioid crisis in the State of Illinois or the nation.”