Lawsuit blames improper marketing of potent opioid for woman’s death

IMO.. this family will probably win this lawsuit.  This drug allows the pt to administer the Fentanyl via a sublingual route. Which allows the drug to be absorbed at a rate similar to a IV injection.  Fentanyl administered like this has a rapid onset and a 30-60 minutes of pain relief.  Giving a pt this medication as their primary pain management opiate does nothing more/less than put the pt on a very violent “pain roller coaster”.  Depending on the pt’s CYP450 opiate metabolism status.. A pt could be using this medication every 30-60 minutes OR LESS in the attempt to maximize their pain management. On top of all this… the Subsys medication is EXTREMELY EXPENSIVE.

www.statnews.com/2017/03/24/opioid-insys-improper-marketing-lawsuit/

The family of a New Jersey woman who died after using a prescription version of the potent opioid fentanyl filed a wrongful death lawsuit Thursday against the drug’s maker, her doctor, and a specialty pharmacy that provided the drug.

The lawsuit, filed in a New Jersey state court, alleges 32-year-old Sarah Fuller was the victim of a nationwide push by Insys Therapeutics to entice doctors to prescribe its Subsys fentanyl spray for patients for which the drug was not suitable.

“Insys infiltrated the medical community with lies, misinformation, kickbacks and financial rewards which led to a large span of the medical community to prescribe Subsys for off-label indications for which there was no proven safe use,” according to the complaint. Insys did not respond to a request for comment.

Subsys is approved by the US Food and Drug Administration for patients with cancer who suffer from breakthrough pain that doesn’t respond to other treatments, though physicians are permitted to prescribe drugs for unapproved, or “off-label” uses. Fuller did not have cancer, and her doctor nevertheless prescribed it to her. At the time of her death, she was taking a heavy dose of the drug around-the-clock.

The lawsuit also accuses a specialty pharmacy company, Linden Care of Woodbury, N.Y., of abetting the effort by Insys to push the use of Subsys in patients who did not have cancer. The lawsuit claims the pharmacy company, which shipped Subsys to Fuller via FedEx, should not have dispensed the drug to her. Fuller’s family claims the pharmacy company did not have possession of the original prescription as required and was mandated by a special federal program to only dispense the drug to patients with breakthrough pain due to cancer.

“Insys needed a pharmacy to turn a blind eye to what it was doing and dispense Subsys throughout the country,” the complaint alleges. Linden Care declined comment.

Fuller became a patient of Dr. Vivienne Matalon in August 2014. At the time, Fuller was not taking any narcotic medications for the pain caused by two auto accidents. By October, according to the complaint, Matalon had Fuller on a regimen of oxycodone and OxyContin. In January 2015, Fuller and her father met with Matalon at her office. Also in the room was an Insys saleswoman, who was there to convince Fuller that Subsys would help treat her neck and back pain, the lawsuit charges.

She was prescribed the drug, and within three weeks, her dosage was tripled in strength. In October 2015, Fuller was admitted to the hospital, suffering from “hyper-sedation,” according to the lawsuit. She was immediately taken off Subsys and at discharge was told to discontinue use of it, along with weaning herself off OxyContin. Despite Matalon being notified by the hospital of the event and the instructions for Fuller, the lawsuit claims the doctor again prescribed Subsys for Fuller.

On March 25, 2016, Fuller died as a result of taking Subsys and the anti-anxiety medication alprazolam, the lawsuit charges. Both were prescribed by Matalon.

In the wake of the Fuller case, the New Jersey attorney general accused Matalon of “indiscriminately” prescribing Subsys and she agreed to a suspension of her medical license while her conduct is investigated by the state medical board. Attempts to contact Matalon’s attorney for comment were unsuccessful.

Filed under: General Problems