The U.S. Department of Justice said it joined five lawsuits filed by whistleblowers against INSYS Therapeutics Inc. over how the company marketed its opioid painkiller, Subsys.
The government alleges that the U.S. drugmaker paid kickbacks to doctors and nurse practitioners to prescribe Subsys and that INSYS employees misrepresented patients' diagnoses to insurers to obtain reimbursement for the medication.
"Our intervention in these cases is just one part of the Justice Department’s multi-pronged efforts to combat the opioid crisis," U.S. Attorney Nicola T. Hanna said in a statement. "Our goal is to bring about an end to the tragic epidemic that is harming untold numbers of people across the United States."
INSYS said it continues to have a discussion with the DOJ regarding the investigation, which has been in progress for more than four years. The probe was conducted in tandem with the whistleblower litigation, which was filed under seal and was unsealed May 14, the Phoenix-based company said in a statement.
The drugmaker is facing multiple federal and state investigations for its alleged role in fueling the U.S. opioid epidemic through its promotion of Subsys. The company said it had accrued $150 million as of Sept. 30, 2017, which is the company's current best estimate of the minimum amount it expects to be paid out over five years in relation to the DOJ's probe.
"As the company has documented in various public releases, today INSYS is a completely transformed organization, with a promising pipeline, a strong commitment to serving patients as well as an organizational culture of high ethical standards," INSYS said. "Throughout this transformation, INSYS has learned from the past and remains committed to significant innovation and investment in R&D, which the company believes will result in improving the lives of many patients."
The DOJ said the U.S. has separately pursued a number of criminal cases against INSYS employees and Subsys prescribers, some of which have resulted in convictions or guilty pleas and some of which are pending.
The company's founder and former CEO, John Kapoor, was arrested in October 2017 on charges of leading a conspiracy to bribe doctors to prescribe the opioid drug and to defraud insurers. Kapoor has said he is confident he has committed no crimes.
