Health Care

Second patient says doctor under FBI investigation pushed opioid spray

Overland Park doctor Steven Simon is the focus of two lawsuits brought by former patients who say he aggressively pushed them to use an opioid spray without telling them of its dangers or informing them that the drug’s manufacturer was paying him hundreds of thousands of dollars in speaking fees and expenses.
Overland Park doctor Steven Simon is the focus of two lawsuits brought by former patients who say he aggressively pushed them to use an opioid spray without telling them of its dangers or informing them that the drug’s manufacturer was paying him hundreds of thousands of dollars in speaking fees and expenses.

A second patient has come forward saying that an Overland Park doctor pressured her to use a potent opioid spray without explaining its risks or disclosing his financial ties to the drug maker.

A lawsuit filed Friday alleges that Steven Simon urged Johnson County resident Carey Ballou to take Subsys, an oral fentanyl product with a high potential for addiction, even though less risky, less expensive alternatives existed, and she was reluctant to take the drug.

The complaint was similar to a lawsuit filed the same day on behalf of Olathe resident James Whitham, who told the Star in July that Simon pressured him to take Subsys without informing Whitham that he was being paid by the drug’s Arizona-based manufacturer, Insys Therapeutics.

The suits, filed in Johnson County, allege medical negligence, fraud and conspiracy against Simon and several other parties, including Insys.

They were filed by Kansas City,firm German May PC, and request an unspecified amount of money to compensate Whitham and Ballou for out-of-pocket costs related to Subsys as well as the physical and mental toll of their withdrawal from the drug.

Simon took more than $200,000 in speaking fees and related expenses from Insys, according to federal data compiled by ProPublica. The company’s former executives are under federal indictment for fraud in a case that alleges they used their speaker program to pay kickbacks to doctors in exchange for prescribing more Subsys.

Simon’s clinic was raided by FBI agents in July. The clinic’s owner, physician Srinivas Nalamachu, told the Star that the agents seized the records of all patients for whom Simon prescribed oral fentanyl products, including Subsys.

In addition to Simon and Insys, the lawsuits filed Friday also name as defendants Donna Ruck, a nurse who worked under Simon, and Torgny Andersson, an Insys sales representative who frequented Simon’s clinic.

After being asked for comment, Mark W. Stafford, a lawyer for Simon, told an attorney for The Star that “to the best of my knowledge, Dr. Simon has not been served with the petitions” and that Simon’s legal counsel “will not allow a response.” The Star also left messages with Ruck and Insys Tuesday but didn’t hear back.

Nalamachu said by phone that Simon and Ruck no longer work at The Pain Management Institute in Overland Park, which has moved to a new location and has re-branded as Mid-America Polyclinic. Simon’s medical license remains current but Nalamachu said he did not know if Simon is practicing anywhere else.

The U.S. Food and Drug Administration approved Subsys only for “breakthrough cancer pain,” but federal prosecutors say that Insys pushed doctors to prescribe it “off-label” for other types of pain, then helped mislead insurance companies that were reluctant to cover it for such uses.

An analysis of public data by the Star found that in addition to being the eighth-highest paid Subsys speaker in the nation from 2013 to 2015, Simon and his nurses also prescribed more Subsys to people on Medicare Part D than any other Kansas practitioners.

Whitham’s suit states that he never had cancer and came to Simon seeking relief from gastrointestinal pain caused by ulcerative colitis and recurrent clostridium difficile, or “C. diff.” Simon prescribed Subsys and Ruck later asked him if he’d be willing to say he had cancer or at least pre-cancerous cells, according to the complaint. Ruck denied having that conversation in a statement she sent to the Star in July.

Ballou’s suit says she first started seeing Simon in 2012 for a back injury, “but also had an ongoing diagnosis of leukemia, making her a valuable patient to Dr. Simon and Insys.” It says she complained of adverse effects from the medication, but “Dr. Simon continued to push Subsys on her the entire time she was under his care.” The suit says she was on the drug from 2013 to 2015.

Like Whitham’s, Ballou’s suit says that Simon sometimes had signed Subsys prescriptions waiting for her when she arrived for exams, or had Ruck write refills, because he was out of town on pharmaceutical speaking engagements. It also said Andersson, the drug sales rep, was “often present” for her appointments and worked with Simon and his staff to make sure her insurance would keep covering Subsys.

The suits also say Insys offered a “patient savings plan” with a free “starter sample” that violated a Kansas law that bars free samples for most controlled substances.

The suits call Whitham and Ballou victims of Insys’ “merciless efforts to maximize profits and dramatically expand the market of a highly addictive opioid.”

“The company went to unimaginable lengths to conspire with healthcare providers and entities across the nation to satisfy its profit objectives by spreading an addiction to its dangerous drug in deliberate disregard of the health of their patients,” the suits say.

The suits also say that the plaintiffs first learned about Simon’s financial connections to the pharmaceutical industry when they read a story published online April 30 by the Star.

Insys is one of several opioid manufacturers being investigated by U.S. Sen. Claire McCaskill, a Missouri Democrat. Missouri Attorney General Josh Hawley, a Republican, is also investigating Insys and other opioid makers he says misled doctors and patients about the addictive danger of their products.

Insys’ latest quarterly report shows that in addition to the federal prosecution, the company is also facing at least eight other suits across the country brought by patients like Ballou and Whitham.

Andy Marso: 816-234-4055, @andymarso

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