Recently, the Department of Justice (DOJ) has intervened in five anti-kickback lawsuits against Insys Therapeutics, Inc. (Insys), the manufacturer of Fentanyl. In 2012, Insys received approval from the Food and Drug Administration (FDA) for Fentanyl to treat persistent breakthrough pain in adult cancer patients who developed tolerance toward around-the-clock opioid therapy. It is a spray form of an opioid painkiller called Subsys. The limited approval was intended to avoid abuses seen in other opioids.
Insys Sued for Kickbacks
The consolidated case is being tried in California and alleges numerous kickbacks were used by Insys to induce physicians and nurse practitioners to prescribe Subsys for their patients. The kickbacks included paying prescribers as speakers at sham events, giving jobs to relatives and friends of prescribers, and providing lavish meals and entertainment.
The case also alleges that Insys encouraged physicians to prescribe Subsys to patients who did not have cancer. Also, that Insys employees lied to insurers about patient diagnoses to get reimbursed for Subsys prescriptions written for Medicare and TRICARE beneficiaries. A Special Agent in Charge for the Inspector General of the U.S. Department of Health and Human Services stated that the abuse is intensified when taxpayers pick up the bill.
False Claims Act
The original five cases arose from qui tam sections of the False Claims Act that allow a whistleblower to file a case on behalf of the federal government if they believe a party has submitted false claims for government funds. The whistleblower may be awarded a share of the recovery if a lawsuit based on their case is successful.
The federal government found the cases important and chose to have the DOJ take them over. The DOJ appears to be taking an aggressive stand against opioid manufacturers and prescribers to address widespread opioid addiction. A member from the DOJ stated that improper financial relationships between physicians and drug companies can distort a physician’s best judgement for their patients and alter patient health and trust.
The federal government is also pursuing separate criminal cases against Insys employees and Subsys prescribers. In 2017, the founder and several executives of Insys were charged with Racketeer Influenced and Corrupt Organizations Act (RICO) crimes, including conspiracy to commit fraud.
Philadelphia Physician Lawyers at Sidney L. Gold & Associates, P.C. Advocate for Physicians’ Rights
Whistleblowers face an uncertain future if they choose to inform authorities or pursue a case under the False Claims Act. If you are aware of an act to defraud the government, talk to an experienced Philadelphia physician lawyer at Sidney L. Gold & Associates, P.C., who can offer insight and strategies to protect your interests. We represent clients throughout Philadelphia, Pennsylvania, including Bucks County, Chester County, Delaware County, and Montgomery County, and throughout the state of New Jersey. Call us at 215-569-1999 or submit an online contact form for a free consultation today.