Problems with Fentanyl Patch May Result in Death

Serious and potentially fatal problems have been associated with the Fentanyl Pain Patch (fentanyl transdermal). As a result of defects in the design, poor quality control and inadequate warnings, users could suffer fentanyl overdose resulting in a sudden death after putting the patch on their skin.

The fentanyl patch wrongful death lawyers at Saiontz & Kirk, P.A. previously reviewed potential lawsuits against the manufacturers of these products on behalf of individuals who have died as a result of problems with a pain patch. However, additional cases are no longer being accepted. This page is maintained for informational purposes only.


The Duragesic Patch and generic pain patch equivalents contain fentanyl in the form of a gel, which is designed to provide pain relief. A membrane on the sticky side of the patch is supposed to regulate delivery of the strong opiate painkiller through the skin.

Design problems and manufacturing defects have resulted in many cases where the gel leaked directly onto the skin or was released too quickly through the membrane.

Fentanyl poisoning caused by exposure to high concentrations of the medication could result in overdose or sudden death.

>>INFORMATION: Fentanly Patch Problems

The Duragesic Patch is manufactured by Janssen Phamaceutica, a subsidiary of Johnson & Johnson. The fentanyl patch was approved by the U.S. FDA in 1990 to treat severe and chronic pain which is not manageable by other drugs. It is only indicated for those who are already tolerant of narcotic pain medications and is not intended for post-operative or short term pain management. Generic fentanyl patch products are now available from a number of different manufacturers.


Defects in the design and production of the pain patch have exposed users to a risk of life-threatening complications. There have been hundreds of reports that individuals slipped into comas or suddenly died after placing the fentanyl patch on their skin.

The manufacturer issued a Duragesic Patch recall in February 2004, and again in April 2004. Certain batches were recalled due to faulty seals which could result in the gel leaking out onto the skin. Problems could result in potentially deadly doses of fentanyl being administered to unsuspecting users.

In 2005, the FDA issued a Public Health Advisory regarding an investigation into 120 Duragesic Patch deaths. Issues with the patch, combined with users who were not properly warned about appropriate use, have contributed to the Duragesic problems and continue to cause injuries for users.

Reports of death associated with the fentanyl patch continue to surface, yet the fentanyl patch remains one of the best selling products for pain management. Although the manufacturers claim that the product is safe when used as directed, many experts believe that the company should be doing more to ensure that the gel does not leak and that people properly use the patch to reduce the number of fentanyl patch deaths.


Lawsuits are no longer being reviewed by the fentanyl patch lawyers at Saiontz & Kirk, P.A.