A jury in Chicago found two Johnson & Johnson subsidiaries liable in the death of a Cicero, Illinois, woman who died while using a fentanyl pain patch, and ordered the companies to pay her family $16,560,000. Fentanyl pain patches are marketed under the names of Durogesic, Duragesic, and Matrifen).
Fentanyl is an extremely strong opioid pain medication that is 100 times stronger than morphine. Fentanyl is used during surgery for anesthesia. Fentanyl is also used to treat chronic pain patients. One way of delivering fentanyl for treatment of chronic pain patients is through use of a patch containing the drug. This method of drug delivery was approved by the U.S. Food & Drug Administration (FDA) in 1990. Its approval is limited to treatment of persistent moderate to severe pain, which cannot be treated through the use of other, less powerful, medications. Initially, the fentanyl patch was most commonly prescribed for people with cancer. More recently, use of the patch for other types of pain patients has become widespread. It is not recommended for post-surgical pain.
There are numerous manufacturers of the fentanyl patch. The patches all come in dosage strengths of 12.5, 25, 50, 75 and 100 mcg/hr. Each patch is designed to deliver a steady dose of fentanyl for 3 days. However, the amount of fentanyl contained within the patch can cause death if it is delivered in an uncontrolled manner such as occurs when the patch leaks or when the patch is defective in some other manner.
The FDA has received
hundreds of reports of fatalities linked to fentanyl patch use. The cause of these deaths can be due to seal breaches allowing fentanyl gel to leak from the patch, known as the "fold-over defect," malfunction of the rate control membrane or other defects. The FDA is currently investigating these deaths.
In 2004, Alza Corporation and Janssen Pharmaceutica (the Johnson & Johnson subsidiaries which manufactured and marketed Duragesic®) recalled 5 lots of patches because of "fold-over defects" leading to leakage of the fentanyl gel contained within the patches. Upon investigation by the FDA, numerous other defects were discovered including what is called a "stringer leaker" defect. Based on information from the FDA, it is clear that many other lots, of all sizes, that were not recalled suffered from leak defects.
Manufacturers of fentanyl patches continue to produce defective patches. In fact, on February, 12th, 2008, Johnson & Johnson recalled approximately 32 million patches because of possible leak defects. The recall includes Duragesic
® and Sandoz brands. Then, on February 18, 2008, Actavis, Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group HF announced that 14 lots of fentanyl pain patches sold in the United States were being voluntarily recalled from wholesalers and pharmacies because of leak defects. In each of these recalls, the manufacturers warned that exposure to the gel contained in the patch could lead to serious injury or death.
If your family member or loved one died while wearing a fentanyl pain patch, please contact us online or call our pain patch lawyers at 1-850-444-9500 to discuss your legal rights.