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On May 15, 2018, the U.S. Department of Justice (DOJ) announced that it was joining the plaintiffs in five whistleblower lawsuits that accuse Insys Therapeutics of paying illegal kickbacks and defrauding federal health programs in connection with the marketing of fentanyl sublingual spray (SUBSYS),[1] a rapid-acting, highly addictive, dangerous opioid that is sprayed under the tongue. The Food and Drug Administration limited its 2012 approval of the drug to treating breakthrough pain in...
On May 15, 2018, the U.S. Department of Justice (DOJ) announced that it was joining the plaintiffs in five whistleblower lawsuits that accuse Insys Therapeutics of paying illegal kickbacks and defrauding federal health programs in connection with the marketing of fentanyl sublingual spray (SUBSYS),[1] a rapid-acting, highly addictive, dangerous opioid that is sprayed under the tongue. The Food and Drug Administration limited its 2012 approval of the drug to treating breakthrough pain in adult cancer patients who are not responding adequately to other opioids.[2]
Newly unsealed complaints filed in federal court under the False Claims Act between 2013 and 2016 by four former Insys sales representatives and two pharmacy benefits managers that processed Subsys insurance claims reveal outrageous and dangerous measures allegedly taken by Insys employees to encourage doctors to misprescribe Subsys.[3],[4]
One former sales representative alleged that when she told her sales manager that she wanted to increase her Subsys sales but feared that this might cause patients to become addicted, her sales manager dismissed her concerns and instead encouraged her “to behave more sexually toward pain-management physicians, to stroke their hands while literally begging for prescriptions” and “to ask physicians to prescribe Subsys as a ‘favor.’”[5]
A second former Insys sales representative contended that Insys “instituted programs throughout the country to induce doctors to prescribe SUBYS over those of competitors by means of monetary payments, trips to strip clubs and shooting ranges, stock options, hiring physician’s significant others, and expensive meals in violation of federal anti-kickback laws.”[6] She cited one doctor who was promised a $100,000 payment via a speaker program in exchange for his “support on [S]ubsys.” She also said that in 2012, Insys hired a dental hygienist who had no pharmaceutical sales experience to be a sales representative, allegedly “to have sexual relations with doctors in exchange for SUBSYS prescriptions.”
When the DOJ announced that it was intervening in the whistleblower lawsuits against Insys, the government alleged that “Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and that Insys employees lied to insurers about patients’ diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries.”[7]
The DOJ’s actions follow the 2017 arrest of John Kapoor, the billionaire founder of Insys.[8] Kapoor has been charged with “leading a nationwide conspiracy” to profit by bribing doctors to inappropriately prescribe the company’s fentanyl spray product and by defrauding health insurers.
If these allegations are proven, Insys should be slammed with crippling financial penalties and company executives should be sentenced to lengthy prison terms for recklessly endangering thousands of patients across the U.S.
References
[1]U.S. Department of Justice. United States Attorney’s Office, Central District of California. U.S. intervenes in ‘whistleblower’ lawsuits alleging Insys Therapeutics paid illegal kickbacks to promote Subsys. May 15, 2018. https://www.justice.gov/usao-cdca/pr/us-intervenes-whistleblower-lawsuits-alleging-insys-therapeutics-paid-illegal-kickbacks. Accessed June 14, 2018.
[2]Insys Therapeutics. Drug label: fentanyl sublingual spray (SUBSYS). December 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf. Accessed, June 14, 2018.
[3]U.S. Department of Justice. United States Attorney’s Office, Central District of California. U.S. intervenes in ‘whistleblower’ lawsuits alleging Insys Therapeutics paid illegal kickbacks to promote Subsys. May 15, 2018. https://www.justice.gov/usao-cdca/pr/us-intervenes-whistleblower-lawsuits-alleging-insys-therapeutics-paid-illegal-kickbacks. Accessed June 14, 2018.
[4]Lurie J. “Behave more sexually:” How Big Pharma used strippers, guns, and cash to push opioids. https://www.motherjones.com/politics/2018/05/insys-subsys-whistleblower-lawsuits/. Accessed June 14, 2018.
[5]Case no. 2:16-cv-07937-JLS-AJW, document 1. Filed October 25, 2016. https://assets.documentcloud.org/documents/4489345/M-S-v-Insys.pdf. Accessed June 14, 2018.
[6]Case 2:13-cv-05861-JLS-AJW, Document 33. Filed June 13, 2016. https://assets.documentcloud.org/documents/4489339/Guzman-v-Insys.pdf. Accessed June 14, 2018.
[7]U.S. Department of Justice. United States Attorney’s Office, Central District of California. U.S. intervenes in ‘whistleblower’ lawsuits alleging Insys Therapeutics paid illegal kickbacks to promote Subsys. May 15, 2018. https://www.justice.gov/usao-cdca/pr/us-intervenes-whistleblower-lawsuits-alleging-insys-therapeutics-paid-illegal-kickbacks. Accessed June 14, 2018.
[8]U.S. Department of Justice, United States Attorney’s Office, District of Massachusetts. Founder and owner of pharmaceutical company Insys arrested and charged with racketeering. October 26, 2017. https://www.justice.gov/usao-ma/pr/founder-and-owner-pharmaceutical-company-insys-arrested-and-charged-racketeering. Accessed June 14, 2018.
