The United States intervened in five lawsuits on April 13, 2018 that accuse Insys Therapeutics Inc. (“Insys”) of violating the False Claims Act in connection with the marketing of Subsys, a sublingual spray form of fentanyl (a powerful but highly addictive opioid painkiller), which was approved by the Food and Drug Administration in 2012 for the treatment of persistent breakthrough pain in adult cancer patients who are already receiving, and tolerant to, around-the-clock opioid therapy.
The United States alleges 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. The United States further alleges that Insys paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients, which took the form of speaker program payments for speeches to physicians that were, in fact, shams; jobs for the prescribers’ relatives and friends; and, lavish meals and entertainment.
The Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services stated in reference to the U.S. Department of Justice’s May 15, 2018 annuncement regarding the federal government intervening in the False Claims Act lawsuits, “Insys allegedly bribed doctors who are more concerned with profits than patients. Encouraging the inappropriate use of this too-often deadly opioid is intolerable enough, but the abuse is compounded when taxpayers are forced to pick up the bill.”
The Acting Assistant Attorney of the Justice Department’s Civil Division explained, “Improper financial relationships between physicians and drug companies can distort a physicians’ best judgment for their patients, in addition to undermining patient health and trust. This is especially troubling when the drugs are opioids. Lying to federal health programs about patients’ medical diagnoses is also completely unacceptable. The Justice Department will pursue these illegal actions and continue to hold drug companies and doctors accountable for their roles in contributing to this deadly epidemic.”
The five qui tam lawsuits have been consolidated together in the Central District of California and are captioned United States, et al., ex rel. Guzman v. Insys Therapeutics, Inc., et al., 13-cv-5861; United States ex rel. Andersson v. Insys Therapeutics, Inc., 14-cv-9179; United States ex rel. John Doe and ABC, LLC v. Insys Therapeutics, Inc., et al., 14-cv-3488; United States ex rel. Erickson and Lueken v. Insys Therapeutics, Inc., 16-cv-2956; and United States ex rel. Jane Doe, et al. v. Insys Therapeutics, et al., 16-cv-7937.
In addition to the five qui tam lawsuits, the United States has separately pursued a number of criminal cases against Insys employees and Subsys prescribers, some of which have resulted in criminal convictions or guilty pleas and others are currently pending.
If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs, and the information is not publically known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act attorney (also known as qui tam attorneys) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may also assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
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