Fentanyl is an opioid pain medication that is 100 times more powerful than morphine. The fentanyl transdermal patch was approved by the Food & Drug Administration (FDA) in 1990 for people with persistent moderate to severe pain.
For many years, Duragesic was the only fentanyl patch. However, when the patent for Duragesic expired in 2005, the first generic brand was sold in the United States by Mylan Laboratories. The patch is called Mylan Fentanyl Transdermal System. The Mylan patch is different from the Duragesic patch in that it utilizes a matrix design as opposed to a reservoir design.
Matrix Patch Design vs. Reservoir Design
The reservoir design has a front and back and is sealed along the edges to create a “reservoir” where a gel containing fentanyl is placed. This design also utilizes a membrane, which regulates the amount of fentanyl that enters the skin. The matrix design of the Mylan patch does not have a reservoir or a rate control membrane. The matrix design utilizes only one sheet of film which has an adhesive attached to it, causing the patch to stick to the body. The fentanyl is contained within the adhesive.
Although a Mylan matrix patch cannot leak, numerous deaths from use of Mylan patches nevertheless have been reported. These deaths may have been as a result of defective patches.
FDA Warnings and Recalls
In July of 2005, the FDA issued a Public Health Advisory. This warning stated that “deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product.” The generic version of Duragesic is called Sandoz.
The FDA issued a second Public Health Advisory in December of 2007 as part of this continuing investigation. This alert stated, “The FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after people incorrectly used it.”
Cases Won on Behalf of Duragesic Victims
Heygood, Orr & Pearson is the nation’s leading law firm in litigation involving fentanyl transdermal pain patches.
On June 19, 2007, a $5.5 million jury verdict was awarded in a case against Johnson & Johnson and its subsidiary, Alza Corporation, the manufacturers of the Duragesic fentanyl transdermal pain patch. This case, the first Federal trial involving the Duragesic fentanyl patch, was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division. The verdict was achieved by Heygood, Orr & Pearson for the family of Adam Hendelson, a 28-year-old Florida man who died while wearing a Duragesic fentanyl patch.
On November 17, 2008, HO&P achieved a $16,560,000 verdict for the family of a Cicero, Illinois woman who died while wearing a Duragesic fentanyl transdermal pain patch. On February 15, 2004, 38-year-old Janice DiCosolo died as a result of using a defective Duragesic patch that her doctor had prescribed to alleviate the intense pain she experienced from a neurological condition called “reflex sympathetic dystrophy.” After a three-week trial, a Chicago jury found two Johnson & Johnson subsidiaries liable for the death of Mrs. DiCosolo, a mother of three.
If you or a loved one has suffered injury, or if your family member has died as a result of using any brand of fentanyl transdermal pain patch, please contact us for a free consultation.