The Justice Department and six U.S. states have joined a whistleblower's lawsuit against Insys Therapeutics, Inc. In the lawsuit, the drug maker is accused of trying to make more profit on Subsys, a spray form of the opioid fentanyl, by paying kickbacks to induce doctors to prescribe the drug. It is also accused of knowingly having insurers and federal healthcare programs to pay for Subsys when it was not medically necessary.
Subsys is applied under the tongue in cancer patients who are already receiving but are tolerant to round-the-clock opioid therapy. The whistleblower who originally filed the lawsuit is a former Insys sales representative who claims that physicians improperly prescribed Subsys for things like back pain, which is not an approved use of the drug.
Opioids can be highly addictive and overdoses are all too common. According to the Centers for Disease Control and Prevention, opioid prescription drugs and heroin were tied to a record number of deaths in 2016: 42,249 fatalities in the U.S. alone.
Although off-label prescriptions are generally legal, drug companies cannot legally market the drugs for off-label uses. Simultaneous to this lawsuit, criminal charges have been brought against Insys, certain doctors, former Insys executives and sales representatives and even Insys's billionaire founder.
The whistleblower lawsuit claims that Insys encouraged doctors to increase prescriptions of Subsys by paying kickbacks in the form of "sham" speaking fees and lavish meals.
It also claims that Insys's founder and six other former Insys employees intentionally conspired to bribe physicians to prescribe Subsys and to defraud Medicare, federal health programs and private insurers to pay for prescriptions that were not medically necessary, sometimes by misrepresenting patients' diagnoses.
The Justice Department has asked the court to put the civil lawsuit on hold while the criminal cases involving Insys are resolved.
The lawsuit was originally brought in 2013 under the False Claims Act, which allows private-sector whistleblowers to sue on the government's behalf. The government may choose to join these suits, as happened here. In successful False Claims Act lawsuits, whistleblowers can receive a substantial portion of the case proceeds as a reward for doing the right thing.
If you are in a position to report fraud, waste or abuse against a government contract or program, blowing the whistle may be the right thing to do. You should hire a whistleblower lawyer, however, to protect you from potential retaliation and to ensure you are eligible for any available rewards.