Insys Therapeutics, a pharmaceutical company based in Arizona, is on the receiving end of a lawsuit filed by Attorney General Josh Stein of North Carolina. The lawsuit accuses the company of pushing Subsys, a fentanyl-based cancer pain medication at clinics that treat individuals with headache conditions in the state.
Subsys is a type of spray containing fentanyl that is extremely potent – in fact, 50 times more potent than heroin and 100 times stronger than morphine.
Due to the power and addictive nature of the medication, the North Carolina lawsuit argues that Subsys is only intended to be prescribed to cancer patients who are experiencing extremely severe “breakthrough pain”, and only after other medications have failed to provide relief.
The lawsuit comes in the wake of a Centers for Disease Control and Prevention report revealing that overdoses resulting in death involving a synthetic opioid such as fentanyl increased by approximately 100 percent in one year to a staggering 19,000. Most of these fatal overdoses occurred from the consumption of illegally manufactured powder pills often laced with heroin or other substances.
The state’s claim against Insys
Attorney General Stein contends that, due to the limited marketplace for Subsys, Insys created a strategy to persuade doctors to put non-cancer patients on the drug. The AG bolster his assertion by pointing to comments that the Charlotte-based VP of sales for the company allegedly made at a 2015 at sales meeting prior to his indictment and arrest the following year.
The scheme, according to the state’s lawsuit involved Insys providing “illegal kickbacks — often in the form of speaking fees — to doctors who excelled at promoting and prescribing Subsys to non-cancer patients.” The lawsuit also accuses Insys of tricking health insurers into covering the costs of the prescriptions by leading them to believe the drugs were being provided to cancer patients when this was not the case.
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- Founder of Insys Therapeutics Has Been Charged with Racketeering
Dangers of improperly prescribed Subsys
Pain specialist Dr. Christopher Grubb offered insight into how Subsys works at the press conference announcing the lawsuit. He explained the addictive nature of the fentanyl contained in the spray. The fentanyl is quickly absorbed into an individual’s bloodstream and provides “immediate and euphoric effects.” As well, without a buildup tolerance to “round-the-clock opioids”, the dangerous spray can precipitate respiratory depression, or shallow and slow breathing, leading to an accumulation of carbon dioxide in the blood.
Grubb further stated that, “marketing Subsys for anyone other than those with terminal cancer needlessly puts patients at risk for unintentional overdose and drug addiction.”
The FDA previously authorized the use of Subsys for cancer patients with “breakthrough pain” that is not helped by standard pain medications. As a result, it is illegal for the company to market the spray to non-cancer patients. The exception is that doctors may prescribe the drug “off-label” for other purposes. (Read about the CDC’s guidelines for prescribing medication for chronic pain.)
The FDA required a label on the drug that prohibited its use for such conditions as headaches, migraines, and postoperative pain.
The lawsuit brought by the state contends that the scheme began in 2012 to pay bribes and speaker fees to medical personnel who would prescribe Subsys to non-cancer patients. The scheme, the lawsuit alleges, also included defrauding insurers.
The lawsuit asks the court to prevent Insys Therapeutics, its employees, and agents from “engaging in unfair or deceptive trade practices” in the marketing and promotion of pharmaceutical products. The Attorney General is seeking the imposition of civil penalties on the company, including the recovery of any revenue the company obtained stemming from these practices.
McGowan, Hood & Felder, LLC is proud to represent victims and their families. We are currently accepting clients who have suffered harm because of Insys Therapeutics, and from taking Subsys or other over-or-wrongly-prescribed opioid drugs. Call us at 803-327-7800 or email us through our contact form to schedule a free initial consultation.