Tags: Medical Malpractice
A former Gessler Clinic doctor, Edward Lubin, has been sued in Orange County, Florida for alleged fraudulent prescriptions of Subsys fentanyl. The lawsuit was brought by Wayne Automatic Fire Sprinklers and alleges that an employee's spouse (who was covered by the company's health insurance plan) became addicted to oioids as a result of Subsys fentanyl prescriptions written by Dr. Lubin.
The lawsuit claims that the manufacturer of Subsys (Insys Therapeutics) engaged in a "massive fraud scheme and criminal enterprise to obtain money from Wayne for illegally prescribed painkillers through Wayne's employee health insurance plan." This type of lawsuit appears to be a novel legal theory in Florida. The lawsuit seeks a new legal precedent forbidding off-label prescribing in cases where financial motivation is apparent.
Insys is a publicly traded company and reported $330.8 millions in revenue with $91.1 million from the Subsys product. The Wayne case claims that Insys used Gessler Clinic and Dr. Lubin to illegally prescribe and dispense the painkiller "with the sole motivation of financial gain including kickbacks." In particular, the spouse involved in the Wayne case did not have cancer at all and, therefore, could not have had late-stage breakthrough cancer pain. Specifically, the lawsuit alleges that an individual named "David" told the administrator for the health plan that the patient had been diagnosed with malignant cancer pain by Dr. Lubin in order to get reimbursement for Subsys. However, it was later determined that Dr. Lubin had never actually diagnosed the patient with breakthrough cancer pain. Insys commented to CNBC that the company plans to vigorously defend the lawsuit. Off-label prescriptions can be legally written by doctors, but it is not legal for a manufacturer to market its product for off-label uses.
How Subsys is Intended to be Used
Subsys is a spray containing fentanyl that was designed for severe flare ups of pain in cancer patients. The product is sprayed under the tongue and can deliver effective pain relief for severe flare ups in about five minutes whereas pills would take much longer to absorb. The manufacturer of Subsys states that it is not for short term pain, such as pain resulting from surgery, headaches, migraines, or dental pain. Likewise, Subsys is not meant for chronic pain. Subsys has been described as being 100 times more potent than morphine. The FDA has only approved Subsys for late-stage breakthrough cancer pain.
Financial Gain for Dr. Lubin
Dr. Lubin was reported to have received over $100,000 from pharmaceutical companies in 2014 (Open Payments, which is a government site that keeps records of payments made to physicians). Most of those funds were received from Insys in exchange for things such as public speaking, travel, and meals. Even though off-label use is permitted, the off-label use is still subject to what is within the standard of care for medical malpractice. In other words, if the general consensus of the medical community is against the use of the drug for the off-label use, the prescribing physician may have to answer a medical malpractice lawsuit, particularly when there are damages to the patient. In cases involving painkillers, patients are at risk of getting hooked on the highly addictive effects of the drugs and can become prescription drug abusers. There are real world consequences for those addicted to "legal" drugs and the suffering can be tremendous to detox yourself from addiction to the medication.
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