I was asked to provide expert witness support for a health-care insurance carrier who was seeking restitution for fraudulent invoices that were paid for the provision of a transmucosal instant release fentanyl (TIRF) products. The plaintiff alleged that the pharmaceutical manufacturer was perpetrating a criminal conspiracy resulting in undue payments.
Many of the considerations in this case relate to the unique properties and regulations surrounding TIRF products. These drugs were developed to treat refractory pain conditions found in cancer pain patients. Fentanyl is a powerful opioid (100x’s the potency of morphine). The profound potency of fentanyl escalates the risks associated with its use. TIRF agents carry a higher risk for both lethal overdose and addiction as compared to more conventional opioids used in medical care. Because of this, the FDA approved this medication’s use in a very narrow subset of patients who are experiencing severe cancer related breakthrough pain. In this unique group of patients, the benefits of the drug (fast-acting relief that can overcome excruciating pain) outweigh the risks, given the perilous, often terminal situations these patients face. Because TIRF medications are so dangerous, they should be treated as a last resort intervention for patients in dire need.
The combination of rapid onset and the high potency of TIRF products results in these agents having a very high-risk profile for problems such as opioid abuse, addiction and lethal overdose. These factors led the FDA to proscribe that the use of these products be exclusively limited to cancer patients with severe breakthrough pain. To help ensure these products would be prescribed in a safe fashion, the FDA placed additional training and certification requirements for any physician who prescribes them. This FDA program is known as the TIRF-Risk Evaluation and Management Strategies (REMS). A central tenant to the TIRF-REMS training and certification program is that trans mucosal fentanyl agents should be strictly limited to a narrow group of patients who have demonstrated opioid tolerance and have severe cancer related breakthrough pain. Using these products in other patient populations is counter to both FDA and TIRF-REMS mandates. Use of trans mucosal fentanyl outside of cancer related break through pain places patients at an unacceptably high risk for significant adverse events including opioid abuse, addiction, and life-threatening respiratory depression.
I reviewed 8 patient files who were prescribed a specific TIRF product named Subsys, which was manufactured by Insys Corporation. I found that all 8 of these patients were inappropriately prescribed Subsys. None of these eight patients carried a diagnosis of cancer or cancer related breakthrough pain. All of these patients had chronic non-malignant pain conditions. For reasons articulated in the paragraph above, the risk of TIRF products is unacceptably high in patients with non-malignant pain and thus Subsys was contra-indicated for each of these patients. Some of these patients also had factors that made them particularly poor candidates to receive TIRF agents. These factors included characteristics that placed some of these patients in a high-risk category for substance abuse such as history of alcoholism, mental health disorders and possessing a history of repeated episodes of non-compliance surrounding medication use.
As part of my work on behalf of the plaintiff in this case, I also conducted research regarding the FDA’s TIRF-REMS program and TIRF medications in general.
I also reviewed internal Insys documents and employee depositions that reflected Insys had been engaged in a conspiracy to illegally market their products. Among the elements of this conspiracy included a division of Insys that fraudulently obtained prior authorizations for Sybsysprescriptions. Insys employees were provided training to communicate with insurance carriers and to deceive them into believing they were talking to a representative of a physician’s practice rather than to a pharmaceutical company employee. These employees were also trained to misrepresent patient diagnosis details when they were in correspondence with the carrier. These Insys employees were directed by their supervisors to submit falsified prior authorization forms describing that patients were experiencing breakthrough cancer related pain, when that was factually not the case. Insys also ran a kick-back program that rewarded physicians who prescribed large quantities of Subsys. These physicians were provided with substantialhonorarium payments for sham speaking engagements. These speaking engagements were purportedly educational seminars, but in reality, were free dinners for the physician and their staff where few, if any, medical providers attended for educational purposes. Internal Insysdocuments indicated that the speaking fees were actually kick-back payments intended to reward high prescribing physicians. These and other findings supported the plaintiff’s claims in this case.
I prepared an expert report that was presented to the court describing my findings related to my review of the patient files, the research conducted, and my review of Insys’s internal documents and related depositions. This report helped the plaintiff substantiate their allegations of fraudagainst Insys corporation. Ultimately, multiple executives at Insys were found guilty of a criminal conspiracy to illegally market Subsys. Multiple Insys executives were subsequently subject to both jail time and restitution payments for damages related to their scheme. InsysCorporation filed for bankruptcy under the weight of this suit, among many others.