The U.S. Department of Justice (DOJ) has announced that they will intervene in five whistleblower (qui tam) False Claims Act (FCA) cases. The first of the five cases was brought in 2013 by Maria Guzman, a former sales representative for Insys Therapeutics, headquartered in Chandler, Arizona. The five cases were ordered unsealed in the Los Angeles federal district court in mid-May, 2018. Six states, including nearby North Carolina and Virginia, have also joined in the whistleblower court action.
Many Bad Acts
The list of illegal actions that Insys is supposed to have committed is long, with some of them deadly. One patient’s parents have sued Insys over their “reckless” marketing practices, claiming such practices helped cause their daughter’s death.
The allegations in Guzman’s suit include the following:
- Insys marketed their opioid drug Subsys (a fentanyl spray normally prescribed only to cancer patients with severe pain who have already shown a tolerance for opioids) to doctors as a general-purpose pain medication, such as for back pain; notably, Subsys has not been approved by the FDA for uses other than for cancer pain. Such marketing is known as off-label usage, and it is illegal to prescribe drugs to patients on federal government healthcare programs (Medicare/Medicaid/TRICARE) for uses not approved by the FDA. Insys is also alleged to have lied to insurers about the true reason that Subsys was prescribed for patients in order to obtain reimbursement.
- Insys encouraged doctors to prescribe high doses of Subsys that went far beyond the dosage the FDA believes is effective and safe, putting patients at great risk. For example, the FDA’s recommendation for an initial dosage of Subsys is 100 micrograms (mcg), but Insys urged physicians to prescribe doses of Subsys that were eight times the FDA recommendation—800 mcg. One Insys employee even persuaded a doctor to switch a patient from another drug to 1200 mcg of Subsys. And in one week alone during 2013, 12 new patients started using Subsys at an average starting dose of 600 mcg.
- To encourage and persuade doctors, Insys used a variety of kickbacks (which are illegal), including high fees paid to doctors for fake speaking engagements, jobs at Insys for friends and relatives of doctors, and extravagant meals and entertainment, including visits to strip clubs.
- Insys sales representatives were instructed on clever ways to hide the kickbacks given to doctors from authorities.
It should be noted that fentanyl, the main ingredient in Subsys, is an extremely addictive pain medication which plays a significant part in the American opioid addiction problem.
Criminal Cases as Well
On top of the FCA cases, the United States is also pursuing criminal charges against some Insys employees, including its founder, and against doctors who prescribed Subsys. The federal government has charged five physicians in the New York area for taking bribes. Three doctors who prescribed millions of dollars worth of Subsys have already been convicted in criminal cases and sentenced to prison. The Justice Department has asked that FCA litigation not begin until all criminal cases involving Insys are finished.
Acting Assistant Attorney General Chad A. Readler, who works for the Justice Department’s Civil Division, said in a statement, “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.”
According to the CDC, opioids caused a record 42,249 deaths in the United States in 2016. The figure includes both heroin and prescription painkillers like Subsys.
The Whistleblower Lawyer.
If you think you have the facts needed to bring a whistleblower case, the experienced whistleblower attorneys at the Louthian Law Firm can review your case and help you file the appropriate disclosure statement. Under some circumstances, the government will intervene, or join in your lawsuit.
Your chances of succeeding are greater if your whistleblower claim is substantive, clear, and to the point. Because of this, meeting with a qualified whistleblower attorney can increase your chances of winning. The Louthian Law Firm can help you form your claim so that the government will be more inclined to intervene in your case; government intervention can sometimes increase the chances of recovering reward money. Even if the government decides not to intervene, it could still be a good idea to pursue your case without government involvement. Our strong support system can assist you through every step of the process.
For a free, confidential evaluation of your case, call the Louthian Law Firm today or, if you prefer, use our online contact form.