Fentanyl (fentanyl citrate) is classified as a schedule II drug under the Controlled Substances Act, meaning that it is dangerous and has a high potential for abuse. It is used to treat post-operative and “break-through pain” (pain common in cancer patients that overcomes standard medication), and is 100 times more potent that morphine. It works by blocking pain receptors in the brain.What Is The Fentanyl Pain Patch Used For?
The Fentanyl Pain Patches are used to deliver controlled doses of narcotic pain medication through the skin over a specified period of time (usually 24 to 72 hours). It is prescribed for patients who require around-the-clock pain control.How Do Fentanyl Pain Patches Cause Overdose Or Death?
The recalled Fentanyl Pain Patches are “reservoir” patches that all have some type of manufacturing defect which can cause the fentanyl gel to leak out at an uncontrolled rate. That gel then seeps into the skin of the patient or the person handling the patch, causing an overdose. Overdose of fentanyl, a controlled substance, may start with nausea, dizziness, difficulty walking, slow breathing, extreme weakness, cold and clammy skin, fainting and/or confusion. Too much fentanyl can be fatal. By August 2005, the FDA reported that they were investigating at least 126 deaths of patients using these Patches.
In other cases, patients suffer overdose or fatal effects not because of a defective patch, but because they should not have been prescribed fentanyl in the first place. Fentanyl is not for use by people with mild or infrequent pain and headaches.Who Makes Defective Fentanyl Pain Patch?
There are multiple types of Fentanyl Pain Patches that can be defective:
Duragesic (fentanyl transdermal system):
- Manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson (generic patches sold by Sandoz, Inc. also affected)
- Recalled on February 12, 2008 because of manufacturing defects
- Recall affects 32 million 25 microgram-per-hour patches
Fentanyl Transdermal System:
- Manufactured by Watson Pharmaceuticals, Inc.
- Recalled on August 8, 2008 because of leaking fentanyl gel
- Recall affects 75 microgram-per-hour patches from lot number 92461850, with expiration dates of August 31, 2009
Actavis Fentanyl Transdermal System:
- Sold by Actavis, Inc., and manufactured by Corium International Inc. (pouches containing the recalled patches may include a Abrika Pharmaceuticals Inc. label)
- Recalled on February 17, 2008 because of a fold-over defect that could cause leaking fentanyl gel. Recall was expanded on March 1, 2008.
- Expanded recall affects all Actavis Fentanyl Pain Patches (25, 50, 75 and 100 microgram-per-hour) with expiration dates from May 2009 to December 2009
Other Generic Manufacturers:
- Generic Fentanyl Pain Patches are manufactured by numerous companies, which may have defective products. Mylan Laboratories is one generic manufacturer.
The manufacturers of the Fentanyl Pain Patches sold defective patches to the public, and they are responsible in strict liability for their products. However, the companies were also negligent, perhaps willfully so, in not carefully monitoring their products. Fentanyl Pain Patches are lucrative products, and Duragesic sales reached $50 million in the second quarter of 2009 (compared to $70 million in the second quarter of 2008). They had a strong profit motive to delay warning and recalling their defective devices.
Furthermore, manufacturing defects have been apparent in Fentanyl Pain Patches since their inception in the mid-1990’s. The “classic” leaking defect came as no surprise in 2008, and the patches should have been better tested and quality controlled. However, the manufacturers refused to take appropriate steps to prevent distribution of defective patches, or to warn patients or doctors about the dangers.
Finally, there were safer alternatives to the defective pain patches. The defective patches use Fentanyl Gel in a “reservoir” design. However, Johnson & Johnson has been selling a “matrix” design patch through their affiliates in Europe since before 2008. That matrix design does not pose the same risks of leakage or overdose.What is the Current Status of the Fentanyl Pain Patch Lawsuits?
Fentanyl Pain Patch lawsuits are continuing to be filed around the country. There are at least 60 cases against Johnson & Johnson for their Duragesic patch. Plaintiffs have won every one of the first four Fentanyl Pain Patch cases to go to trial, with combined verdicts exceeding $36 million.