NH woman suing drug maker, physician’s assistant

Jan. 26--DOVER -- A Rochester woman who became hooked on the powerful painkiller Subsys is suing its makers, the physician's assistant who prescribed it for her and the pain center where he worked for medical negligence and violating the state's Consumer Protection Act.

Attorney Michael P. Rainboth of Portsmouth filed the lawsuit Wednesday in Strafford County Superior Court in Dover on behalf of McKenzie Colby, 36, of Rochester, who is married and the mother of three children.

She is suing Christopher Clough, a physician's assistant who treated her from October 2012 to August 2015 and whose license was revoked by the state Board of Medicine last year; Dr. O'Connell's PainCare Centers Inc. of Somersworth, and Insys Therapeutics Inc. of Chandler, Ariz., the maker of Subsys.

The New Hampshire Union Leader was unable to reach Clough for comment. Neither the PainCare Center nor Insys Therapeutics returned messages left for comment.

Rainboth said prescriptions for Subsys can cost $20,000 a month, and prescriptions were being written for non-intended use.

"This company was bribing doctors to get people hooked on it," Rainboth alleges. "It's reprehensible."

In 2007, Colby broke her tailbone when she was eight months pregnant. She eventually underwent surgery at Massachusetts General Hospital where her tailbone was removed, leaving her with chronic pain.

Clough prescribed powerful opioid pain medication for Colby on Oct. 1, 2012.

Thirteen months later, Clough told her he had a new medication for her and asked what kind of insurance she had. He immediately took out his phone and texted someone, according to the lawsuit. He then told Colby he would write her a prescription for Subsys, a sublingual spray more potent than morphine and heroin.

Subsys was approved for use in January 2012 by the Federal Drug Administration (FDA) for the relief of pain in cancer patients 18 years of age and older who are already receiving and are tolerant to opioid therapy.

New Hampshire patients received more than 800 Subsys prescriptions and more than 100,000 units of Subsys during 2013 and 2014, according to the lawsuit. Based on available data, N.H. patients represented the second most prescriptions of Subsys per capita in the country.

More than 80 percent of those N.H. prescriptions were written by Clough while he was working at PainCare in Somersworth, according to the lawsuit.

Colby received her first shipment of Subsys in November 2013. The prescription was for 200 micrograms, four times a day, sprayed under the tongue. A year later, Clough had increased the dose to 1200 micrograms, four times a day.

At the same time, Clough had prescribed Colby four other opioid medications and he continued with several injections for lumbar and cervical pain.

By November 1, 2014, Colby was highly addicted to Subsys and her usual shipment of Subsys had not arrived.

Three days later, Colby was suffering from severe symptoms of withdrawal from Subsys when she had an office visit with Clough. She had flulike symptoms which included sweating, abdominal discomfort, chills, hot flashes and vomiting. She felt like she was going to die, according to the lawsuit.

Clough, according to the lawsuit, was unsympathetic to her condition. He told her he was also cutting her other opioid medications in half. Clough, it turned out, was under investigation at the time by the New Hampshire Board of Medicine for improperly prescribing opioids and improper injection practices.

Colby became distraught, was crying hysterically and literally begged him to put her back on Subsys. She told him she needed help to stop the withdrawal symptoms. "I'm being watched," Clough allegedly told her and refused her request.

Over the next eight months, Clough continued to prescribe reduced doses of opioids for her. In August 2015, Clough advised Colby in an office visit that it would be his "last day" at PainCare. He told her he was "going back to school" and that he would no longer be working at PainCare.

Clough's license was suspended by the state Board of Medicine later in 2015 and was revoked in 2016.

In the New Hampshire attorney general's investigation of Clough and Insys, officials determined that 84 percent of all Subsys prescriptions in the state were written by Clough in 2013 and 2014.

Insys, according to the attorney general, paid Clough $44,000 to promote Subsys at speaking engagements which investigators said was a "sham." The events were mostly social gatherings at high-end restaurants attended by Clough's family, friends and coworkers, and not people who could prescribe Subsys, according to the Attorney General's Office.

Clough became one of the highest prescribers of Subsys in the country and the highest prescriber in the state.

The state state sued Insys in Merrimack County Superior Court alleging its speaker program was a scheme to induce medical providers to prescribe Subsys.

The U.S. Attorney in Massachusetts in December indicted six former executives of Insys on racketeering, mail fraud and wire fraud conspiracies. They allegedly headed a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe Subsys in nine states, including New Hampshire.

In that indictment "Practitioner #8," is described as a physician assistant at a pain management clinic in Somersworth, who signed a speaker agreement with Insys. Rainboth says "Practitioner #8" is Clough, who generated enough demand on his support staff that he requested the sales representative handle the administrative work associated with obtaining prior authorization from his patients' insurers and pharmacy benefit managers, according to the indictment.

"To accomplish this, Practitioner #8 routinely assembled the medical charts of each patient for whom he prescribed the fentanyl spray and gave them to the sales representative, or to a company employee assisting the sales repesentative. The sales representative then took the patient charts to her apartment in Boston, Mass., where she or her assistant filled out the required prior authoriation paperwork and faxed to the reimbursement unit in Arizona," according to the Massachusetts indictment.

Earlier this month Insys agreed to pay New Hampshire $2.95 million for its part in the scheme.

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