Firm Investigates Death Allegedly Caused by Acute Fentanyl Overdose
March 4, 2009
Fischer | Goldasich LLC has been retained by a client and is currently investigating potentially dangerous defects found in fentanyl pain patches. Fentanyl is an opioid medication used to treat moderate to severe chronic pain through various methods including an adhesive patch. Fentanyl is a strong prescription medication said to be significantly more potent than morphine, and as a result, it can be fatal in the event of an overdose. The strength of the fentanyl drug necessitates a prescription by a physician and requires a close monitoring of the drug. Produced in dosages of 12.5, 25, 50, 75, 100 micrograms per hour, fentanyl pain patches, when functioning properly, release controlled amounts of a fentanyl gel over a period of 72 hours.
Although approved by the Food and Drug Administration (FDA) in 1990 as a method for delivering pain medication, the pain patches possess a sorted history of defects. In 2004, fentanyl patches manufactured by Alza Corp. and Janssen were recalled due to "fold-over defects" that led to the leaking of the potent fentanyl gel. Recognizing the issues surrounding the patches, in July 2005, the FDA issued a public health advisory to alert individuals to the signs of overdose and to educate consumers on the proper handling. Similarly, the FDA issued a second safety warning concerning the fentanyl pain patches on December 21, 2007.
More recently, on February 12, 2008, yet another nationwide recall was performed on all lots of the 25 mcg/hr pain patches due to uncontrolled leaking of the dangerous drug. These recalls centered around a serious and potentially lethal defect in the patches that caused an accelerated delivery of the fentanyl gel. The accelerated and uncontrolled release of the medication upon bare skin could lead to a fatal overdose. This recall included the confiscation of 32 million patches produced by manufacturers affiliated with Johnson & Johnson. Only days later, another manufacturer, Actavis, recalled 14 lots of the fentanyl patches due to the "fold-over defect" that may cause a leak of the potent drug. On March 3, 2008, Actavis expanded its recall to include all remaining lots of its fentanyl patches. As recently as August 8, 2008, Watson Pharmaceuticals, Inc. recalled one lot of 75 mcg/hr due to the potential for overexposure to the drug.
Although approved in 1990, to this day, manufacturers continue to produce defective pain patches despite the devastating injuries and even death that may result. If you or a loved one has been injured due to a fentanyl overdose, please contact Fischer | Goldasich LLC for a free evaluation of your potential claim.