Insys Faces Federal Investigation, Criminal Charges over Fentanyl Spray Subsys

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Insys, the company behind the fentanyl sublingual spray Subsys, and former employees at the company face investigations and criminal charges regarding the marketing of Subsys to doctors and patients. The Subsys fentanyl spray, which is used to deliver the powerful opioid to patients, has earned billions of dollars for the company.

A former sales manager and sales representative at Insys Therapeutics—the manufacturer of the fentanyl sublingual spray Subsys—have been arrested by investigators on federal anti-kickback charges. The two former Insys employees are accused of making payments to doctors as part of what officials call a “sham” educational program to prescribe millions of dollars’ worth of the fentanyl spray
to patients.

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.

Federal and local investigations have revealed that Insys paid thousands of dollars to 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.

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.

The investigation of Insys for the company’s promotion of the Subsys fentanyl spray is also not the first time that federal officials have taken action against the maker of oral fentanyl products in recent years. In 2008, Cephalon was forced to pay $425 million in criminal penalties for its off-label promotion of Actiq, the fentanyl lollipop. The FDA later denied Cephalon approval for its fentanyl tablets, Fentora, after learning that the product was already being widely prescribed to non-cancer patients.

Lawsuits Filed on Behalf of Fentanyl Overdose Victims

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.

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. The first step in taking legal action is to speak with an attorney about your case with the experience in fentanyl litigation to handle your case successfully from start to finish.

Jim Orr focuses his practice on complex business litigation and life-altering personal injury matters. During his career, he has represented plaintiffs and defendants in a variety of civil litigation matters in over 30 different states. As a true trial attorney, Jim has tried over 75 cases to a jury verdict. He is Board Certified in Civil Trial Advocacy and Personal Injury Trial Law.

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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.

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