Frequent prescribers of Subsys fentanyl nasal spray received payments from manufacturer Insys, federal records show

by Jim Orr

Federal and local investigations have revealed that Insys, the manufacturer of Subsys, paid thousands of dollars in several doctors and other medical professionals who were among the leading prescribers of the fentanyl sublingual spray. According to federal Medicare records, eight out of the top 10 most frequent prescribers of Subsys were paid more than $870,000 in “speaking fees” by Insys during 2013 and 2014. Several of these individuals have faced allegations of criminal or professional misconduct in connection with their prescribing practices regarding Subsys.

Subsys is a sublingual spray which delivers a dose of the powerful opioid painkiller fentanyl to patients. Because of the powerful nature of fentanyl and the drug’s potential for overdose or abuse, Subsys is intended to be prescribed only to cancer patients for the treatment of severe breakthrough  pain. According to Food and Drug Administration records, at least 63 patients have died of complications from Subsys since the fentanyl spray was approved by the agency in 2012.

Seven out of the eight medical professionals who received payments from Insys were doctors. The eighth, a registered nurse from Derby, Connecticut named Heather Alfonso, recently pleaded guilty to accepting $83,000 in kickbacks from Insys in exchange for prescribing Subsys to patients, sometimes to non-cancer patients who were ineligible to take the drug. Between 2013 and 2014, Alfonso was the highest prescriber of Subsys in the state of Connecticut despite the fact that she is not a doctor. During that two year period, Alfonso allegedly wrote more than $1 million in Subsys prescriptions, costing Medicare about $239,000.

According to the indictment filed by the U.S. Attorney in Connecticut, Alfonso received payments from Insys for speaking at more than 70 “dinner programs”. Most of those programs were attended only by Alfonso and sales representatives from Insys, or by the nurse’s colleagues and friends, who had no authority to prescribe Subsys. The former nurse is currently facing a maximum prison sentence of five years and a fine of up to $250,000.

Although the seven doctors who were also on Medicare’s list of top Subsys prescribers have not faced similar allegations of kickbacks, federal records have revealed substantial payments to the doctors that have raised questions about their prescribing practices. Each of the seven doctors received payments from Insys during 2013-2014 totaling between $67,000 and $154,000, mostly in speaking fees similar to those received by Alfonso. Several of these doctors have faced professional or criminal charges in connection with their prescribing practices for the Subsys fentanyl spray.

The leading prescriber of Subsys in the Medicare program, Dr. Gavin Awerbuch from Michigan, was arrested in May 2014 on charges of illegal distribution of controlled substances and health care fraud. Between 2009 and 2014, Dr. Awerbuch billed Medicare for $7 million prescriptions, writing six times as many prescriptions for the fentanyl nasal spray than the next higher prescriber. Awerbuch received more than $90,000 in payments from Insys between 2013 and 2014, mostly for speaking engagements.

Dr. Jerrold Rosenberg of Providence, Rhode Island received fees totaling more than $110,000 from Insys over the two year period. During some months, Dr. Rosenberg received payments from the company every week, with his per-event fee rising from $1,600 to $3,700 by the end of 2014. The physician was later reprimanded by the Rhode Island Board of Medical Licensure and Discipline for writing “off-label” Subsys prescriptions to patients for reasons other than cancer pain without properly documenting the reasons for doing so.

Investigations into the link between Insys “speaker fees” and illegal prescribing practices connected with Subsys are not the first to raise concerns about the company’s marketing of the fentanyl nasal spray. In 2012, a former Insys salesman filed a complaint in Texas court charging that the drug company used its speaker program to “induce” or “reward” prescription writing by doctors. During 2013 and 2014, Insys paid about $10 million to more than 3,000 doctors nationwide, mostly in the form of speaking engagements. These doctors were responsible for writing $30 million in Medicare prescriptions for Subsys during that time. Insys is also facing a class action lawsuit filed by investors over the marketing of the fentanyl spray.

Off-Label Fentanyl Prescriptions and the Risk of Deadly Overdoses

Concerns about the off-label prescription of the fentanyl sublingual spray Subsys are heightened because of the extremely potent nature of fentanyl. Because this powerful painkiller is about 80-100 times stronger than morphine, the drug is intended only for patients who have already developed a tolerance for opioids. In addition, doctors must be careful when prescribing fentanyl to make sure that patients are not taking other central nervous system depressant drugs, which could lead to a combined drug overdose that could lead to death from respiratory failure.

When doctors fail to follow established protocols for prescribing these fentanyl or other painkillers, abuse, addiction, tolerance, or deadly overdoses may result. When patients are prescribed too many painkillers by a doctor, or when these patients are kept on these opioid medications for too long, they may be at risk of suffering an overdose.

The lawyers at Heygood, Orr & Pearson are committed to helping patients and their families who have been affected by doctors or other healthcare providers who irresponsibly prescribe painkillers or other dangerous drugs to patients. Our law firm has represented numerous patients who have suffered complications from opioid painkillers. In fact, the lawyers at Heygood, Orr & Pearson have handled more cases involving the fentanyl pain patch than all other firms in the U.S. combined.

The attorneys at Heygood, Orr & Pearson are trial attorneys in the truest sense and have tried hundreds of cases to verdict. Our three named partners are all board certified* and have been voted by their peers as Super Lawyers in the state of Texas for several years in a row.** Heygood, Orr & Pearson is AV-rated, the highest legal and ethical rating available from the leading law firm rating service.

If you or a loved one have suffered an overdose caused by fentanyl products or other opioid painkillers, you may be eligible to file a lawsuit and receive compensation. For more information about prescription overdose lawsuits and to find out if you qualify to file a case, contact the lawyers at Heygood, Orr & Pearson by calling us toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few simple questions about your case.

by Jim Orr

Jim Orr is a licensed attorney and a partner at HO&P focusing on business and personal injury litigation. Jim was selected multiple times to the Super Lawyers List and has tried 70+ cases to verdict.