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U.S. accusing Insys Therapeutics of promoting powerful opioid

Staff Writer | May 16, 2018
On April 13, 2018, the United States intervened in five lawsuits accusing Insys Therapeutics of violating the False Claims Act in connection with the marketing of Subsys, an opioid painkiller manufactured and sold by Insys, the Department of Justice announced.
Insys Therapeutics
Health   False Claims Act
Subsys is a sublingual spray form of fentanyl, a powerful, but highly addictive, opioid painkiller. In 2012, Subsys was approved by the Food and Drug Administration 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, headquartered in Arizona, paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients.

Many of these kickbacks 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 United States also 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 qui tam provisions of the False Claims Act allow whistleblowers to file lawsuits on behalf of the United States when they believe that a party has submitted false claims for government funds, and to receive a share of any recovery.

The United States has the right to intervene and take over responsibility for litigating these cases. Here, the United States has intervened in five separate lawsuits that have been consolidated together in the Central District of California.

The United States has separately pursued a number of criminal cases against Insys employees and Subsys prescribers. Some of these cases have resulted in criminal convictions or guilty pleas, while others are currently pending.