Court case alleges woman’s death came from prescribed fentanyl spray: Subsys
As Tim Farquhar remembers it, he woke up to find a small, brown-haired man sitting next to him with his feet up on his hospital bed at Shawnee Mission Medical Center.
“Hi, my name’s Steve and we’re going to get you back up and around and going again,” Farquhar remembers the man saying.
That was 2001 and the man was Steven Simon, a pain doctor now being sued by Farquhar and at least five other former patients. They say he prescribed them a highly addictive fentanyl spray because its manufacturer, Insys Therapeutics, was paying him hundreds of thousands of dollars in speaking fees.
Insys’ top executives, including billionaire founder John Kapoor, were convicted last month in federal court in Boston of bribing doctors to juice sales and are awaiting sentencing. Federal prosecutors announced this month that the company’s new leaders had agreed to pay $225 million to settle a spate of whistleblower lawsuits related to the case. Insys filed for bankruptcy a week later.
All of which has Farquhar wondering whether Simon will be brought to justice as well. He’s sickly and wants to know whether Simon and others will also face charges before he dies.
“I don’t know what the feds are doing,” said Farquhar, 51. “I don’t know if they’re still going after the doctors or whether they’re going to be content or just complacent with having (prosecuted) just Insys. But I’m scared they are.”
Farquhar said that his initial meeting with Simon at the hospital led to more than a decade of escalating doses of opioids and their more potent cousin, fentanyl, that didn’t end until after the FBI showed up at his door in Overland Park asking about Simon, some time in late 2014 or early 2015.
Farquhar is now off opioids, he said, but only after an excruciating withdrawal, no different than if he were on heroin.
Farquhar said he’d like to see more people held responsible for that, starting with Simon but also including people who worked in Simon’s office and pharmacies and drug distributors that failed to flag the unusual amounts of the fentanyl spray, Subsys, that Simon was prescribing.
He also wants his story to be a warning for patients and providers.
“People need to have another option for their pain other than being me, being a f---ing junkie,” Farquhar said. “That’s what they turned me into: a f---ing heroin junkie.”
Representatives of the FBI and the U.S. Attorney’s Offices of Kansas and Massachusetts all said they could not comment on the possibility of more prosecutions related to Insys.
Meanwhile, Farquhar’s lawsuit against Simon, Insys and others is now moving forward again in Johnson County District Court after the end of the criminal trial. But he said he is running out of money and time to pursue it.
He has severe emphysema due in part to the cyanide poisoning that landed him in the hospital years ago. He said his lung capacity is down to 24%
“I won’t go on oxygen,” said Farquhar, who now lives in Lenexa. “I’m tired. It’s time for this s--- to end.”
Simon’s attorney, James Wyrsch, said it wouldn’t be ethical to comment publicly on a pending legal matter.
“Our full response to Mr. Farquhar’s comments will be made in Court,” Wyrsch said via email.
In the past, Simon has denied all allegations of wrongdoing and said that the payments from Insys never influenced his prescribing. He said he was acting in his best clinical judgment.
But among the thousands of pages of internal Insys documents entered into evidence in Boston, a few showed Simon was more intimately involved with the business side of Subsys than previously disclosed.
Blank prescriptions, pre-signed
For years, Farquhar said, he got along well with Simon. Famously, in fact.
He was a complex case, with a spinal injury that caused him pain in addition to the residual effect of the cyanide poisoning that he got from heating PVC pipe to make didgeridoos — the long wind instruments developed by Australian aborigines.
While other patients were lucky to get 15 minutes with Simon, Farquhar said, his monthly appointments frequently ran to an hour.
“I thought we were friends and he really wanted to help me,” Farquhar said. “Not that I was being used.”
Farquhar said he had no idea Simon was taking millions of dollars from pharmaceutical companies. But, like other patients who have filed lawsuits, he said it was clear that the doctor was on the road a lot for speaking gigs.
Like other patients, Farquhar also said Simon pre-signed blank prescriptions for his staff to use when he was out of town.
“Just go through and sign the whole prescription pad,” Farquhar said. “They weren’t filled out, they weren’t written, but it was just a blank prescription pad — signed. I saw that on numerous occasions.”
Farquhar said Simon put him on hydrocodone and oxycodone — short-term and long-acting opioid pills — as well as long-acting fentanyl skin patches, plus a series of oral fentanyl products. He started with Fentora (a tablet that dissolves in the cheek), then Actiq (a lozenge), then chewable gummies and then Subsys, Farquhar said.
The oral products are all transmucosal-immediate release fentanyl, or TIRF, medicines — a special class of drugs that the Food and Drug Administration approved to treat “breakthrough cancer pain” in patients who are already taking other opioids around-the-clock.
Because of their high potential for addiction and overdose, TIRF medicines are more tightly controlled than almost any others. Patients prescribed them outside of a hospital or nursing home have to sign contracts with their doctor, and their doctor is supposed to require them to read a “Medication Guide” that outlines the risks. Only pharmacies that have enrolled in a special TIRF program can distribute them.
Federal prosecutors said Insys executives weren’t satisfied just marketing Subsys to cancer patients. They wanted doctors prescribing it for all kinds of chronic pain. But insurance companies often wouldn’t cover it for unapproved, or “off-label” use. So they worked with providers to alter records in ways that made it seem they were prescribing it for cancer pain, even if it was actually going to people who hadn’t had cancer in years or, in some cases never had it.
Farquhar and other former patients who are now suing said that happened in Simon’s office. One plaintiff, Carole Tudhope, said Simon and Insys employees worked directly with the University of Kansas Cancer Center’s pharmacy near her home in Lee’s Summit to make sure she could get her Subsys there, even though she hadn’t had cancer for more than a decade. According to her suit, Simon was treating her for pain due to arthritis and fibromyalgia.
A KU spokeswoman said the cancer center, which is also a defendant in that suit, had no comment.
Tudhope’s first name is sometimes spelled without the “e” in the lawsuit’s complaint.
Not ‘a whale’
Insurance fraud was one pillar of the Subsys scheme, according to the feds. The other was identifying doctors who would prescribe a lot of Subsys in exchange for lucrative speaking gigs.
When Subsys was approved in 2012, Simon was already a well-established pharmaceutical speaker in the pain medicine realm. But he didn’t just speak for Insys. He also trained other physician speakers and served on an Insys advisory board.
Insys emails entered into evidence in the Boston case now show that he also helped company executives evaluate whether other doctors were likely to write a lot of Subsys prescriptions.
In October 2012, Insys drug sales rep Casey Hanoch wrote to superiors — including CEO Michael Babich — that he had taken Simon to Oklahoma to talk to a couple of other pain doctors about prescribing Subsys.
He said one of the other doctors had concerns about the safety of the product and its potential for abuse.
“Dr. Simon addressed those concerns well, but Dr. Simon also recommended after we were finished that I follow up with another speaker in the future,” Hanoch wrote. “We both agreed that the goal of this group practice as with all HCP’s (health care providers) that have yet to write (a Subsys prescription) is for them to try with their first patient as soon as possible.”
After meeting with another Oklahoma doctor, Hanoch wrote that he and his regional sales manager took Simon out to dinner “to discuss the likelihood of Subsys (prescriptions) being written.”
“We both agree as of right now I will not rely on him (the other doctor) to be a whale” — a lucrative target, Hanoch wrote. “However, we did make headway in discovering who the decision maker in the office was. His daughter is the the RN/semi-office manager and holds more weight than previously thought. The dinner was well worth it and due to everything I learned, the next two weeks will decide whether this office is worth being one of my top three offices or further down the list.”
Wyrsch, Simon’s attorney, declined to comment on the emails, saying they may come up in court.
“If and when this matter is brought up in one or more of the pending cases we will make a full response at that time,” Wyrsch said.
Hanoch, who now owns a landscaping company in the Dallas area, said Simon’s role in the physician visits was “just purely educational.”
“I didn’t really know Dr. Simon all that well,” Hanoch said by phone. “That was in the very beginning of the company kind of launching Subsys. There was very little interaction between he and I.”
Hanoch said he didn’t remember much about the trips.
“I really don’t think I’d be able to help you with much of anything,” Hanoch said.
In the years that followed those emails, Simon was the top-paid Subsys speaker in Kansas and among the top 10 nationwide, taking in more than $200,000 from 2013 to 2015.
Those speaking payments are legal, as long as there’s no explicit arrangement to pay doctors more if they prescribe the drug more. But during those years, several Insys employees filed whistleblower lawsuits alleging that’s exactly what was happening, and started working with the feds to gather evidence of it.
One of the whistleblowers was Torgny Andersson, the Subsys sales rep assigned to Simon’s Overland Park office.
Most documents in Andersson’s suit remain sealed, and his attorney, Brian Madden, said he wasn’t yet able to talk publicly because the feds are still finalizing the details of the Insys settlement.
The FBI served a search warrant at Simon’s clinic in 2017, seizing records related to patients he had prescribed oral fentanyl products.
By then Babich and other Insys higher-ups had already been indicted, though they wouldn’t be tried and convicted until more than a year later.
An FBI agent from Kansas City, Kansas, was on the prosecution’s witness list for the trial , but wasn’t called to testify. A spokeswoman for the U.S. Attorney’s Office in Boston said the agency couldn’t divulge what he might have testified to had he been called.
Simon has never been charged with with a crime in connection to the Insys case, though the lawsuits allege that at least one of his Subsys patients — Tonganoxie resident Doris Jordan — died of a fentanyl overdose.
There is evidence of ongoing state and federal investigations in Insys’ financial disclosure filings with the Securities and Exchange Commission. The company continues to note that it received subpoenas and other requests for information from U.S. Attorney’s Offices in a number of states, including Kansas, “regarding specific healthcare professionals with which we have interacted in those states.”
Insys also disclosed that it received investigative requests from a bevy of state Attorney General Offices, including in Kansas and Missouri, “which have ongoing investigations directed at our Company.”
The financial disclosures also say that at least 12 doctors and nurse practitioners in other states have faced criminal charges.
But Farquhar said that’s not enough.
“To me, in my honest opinion, they’re letting the doctors play the stupid card,” Farquhar said. “And these doctors, they knew what was going on.”