The United States government is intervening in five whistleblower lawsuits accusing Insys Therapeutics of engaging in unlawful activities to boost sales of its powerful opioid painkiller Subsys.
The U.S. Department of Justice’s intervention in the False Claims Act lawsuits is part of the agency’s sweeping efforts to curb the epidemic of opioid abuse and addiction and crack down on the shady tactics drug makers such as Insys and others have implemented to boost opioid sales.
The U.S Food and Drug Administration (FDA) approved Subsys in 2012 for the treatment of persistent, extreme pain in adult cancer patients who have already received but have become tolerant to other around-the-clock opioid therapy.
Subsys is a spray form of fentanyl, a highly addictive opioid painkiller. The drug is sprayed under the patient’s tongue.
In joining the whistleblower lawsuits, filed by individuals under the False Claims Act, the U.S. alleges that Insys paid physicians and nurse practitioners kickbacks to induce them to prescribe Susbys for their patients, even when those patients did not have breakthrough pain associated with cancer.
According to the DOJ, “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 U.S. investigated whistleblower allegations and determined that Insys employees lied to insurers about patients’ diagnoses so they could obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries. These unlawful practices amounted to submissions of false claims to government funded health care programs.
“Our intervention in these cases is just one part of the Justice Department’s multi-pronged efforts to combat the opioid crisis,” said U.S. Attorney Nicola T. Hanna. “The illegal marketing activities alleged in the government’s case helped fuel the crisis by improperly introducing opioids into the market. We are committed to hold accountable corporations and individuals who use kickbacks, off-label promotions and other illegal activities to sell lethal and highly addictive narcotics. Our goal is bring about an end to the tragic epidemic that is harming untold numbers of people across the United States.”
The qui tam or whistleblower provisions of the False Claims Act allow private parties to file lawsuits on behalf of the U.S. government when they suspect the submission of false claims for government funds. Whistleblowers whose lawsuits result in a recovery for the government receive a share of the total amount recovered – up to 25 percent in cases in which the DOJ intervenes.
The five whistleblower lawsuits that the DOJ backs have been consolidated in the Central District of California.
The U.S. government has separately pursued a multitude of criminal cases against Insys employees and Subsys prescribers. Some of those cases have resulted in criminal convictions or guilty pleas, while others are currently pending.