Subsys Spray Lawsuit


Fentanyl is an extremely powerful opioid painkiller that is 80 to 100 times stronger than morphine. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of late-stage breakthrough cancer pain in adults who are opioid tolerant or who have developed a tolerance for opioid medications as a result of long term treatment.

Cancer patients would definitely be familiar with some medications, like: Actiq, which is in lozenge form; Duragesic, which is in the form of a skin patch; Abstral, a sublingual tablet or a tablet that goes under the tongue; Fentora, a tablet that goes between the gum and cheek; and, Subsys, a sublingual spray.

Subsys, the most recent fentanyl-containing medication placed under legal spotlight, is manufactured, and was introduced in 2012, by drugmaker Insys Therapeutics, Inc. During the first half of 2015, this drug netted a $147.2 million profit for Insys, making it one of the biggest selling highly-addictive painkillers in the U.S. and around the world.

Use of Subsys, however, like all other fentanyl-containing drugs, poses great risk due to the possibility of abuse, misuse, addiction and overdose; using it on children can be fatal too. Due to the risks it presents, the FDA has Subsys mandated that it can only be prescribed (by healthcare professionals) and acquired (by patients) by enrolling in the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program, a restricted program of the FDA.

It may be true that Subsys effectively and immediately controls breakthrough cancer pain; despite being effective, however, reports have surfaced which link this drug to about 203 deaths since it was introduced in 2012. This is besides the 52 Subsys-related deaths reported in the second quarter of 2015.

The risks, the deaths, plus allegations that Insys Therapeutics has illegally prescribed Subsys for off-label use (the major reason for the many cases of fatal overdose in individuals who are not suffering from cancer and, therefore, not opioid tolerant) has landed this drug in the “drugs of concern” list kept in the office of the U.S. Department of Health and Human Services’ Inspector General.

Patients who have been inappropriately prescribed with a powerful opioid medication, such as Subsys, can suffer serious and potentially fatal injuries, such as overdose. Seeking legal assistance from a highly-skilled Subsys spray attorney may be able to help the victim and/or his/her family pursue justice and the compensation he/she may be legally entitled to.

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