The U.S. Food and Drug Administration (FDA) is warning the public that pain patches containing fentanyl—sold under the brand name Duragesic—might cause overdoses in users and accidental injuries and death in children, pets, and others if they come into contact with patches.
What Are Fentanyl Pain Patches and What Are They Prescribed For?
First discovered in 1960, Janssen Pharmaceuticals (now a member of Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson), received FDA approval to market fentanyl as Duragesic in 1990. It is now frequently sold as a generic drug.
Fentanyl is a powerful opioid painkiller meant to treat persistent, chronic pain continuously over the course of three days. Because it is so strong, fentanyl is sold in patches placed on the skin rather than tablets or injections. The patches release the opiate into the body at a slow but steady rate.
Fentanyl Might Cause Life-Threatening Side Effects
Starting in 2005, the FDA warned the public that some patients were inadequately using and disposing of their fentanyl pain patches. Because of the high amount of opioid drugs in each patch, applying too many patches might cause an overdose. Disposing of patches, particularly by throwing them into a wastebasket, is dangerous because children, pets, and others might come into contact with the discarded patches, which can cause a fatal overdose. Users are advised to fold the patches in half and flush them down the toilet.
In an advisory statement in 2012, the FDA renewed its warning about the potential for life-threatening accidental exposure to discarded pain patches. The FDA had received 26 reports of children being accidentally exposed to fentanyl patches over the previous 15 years. Ten children died, and 12 were hospitalized. The agency commented that children could come into contact in the following situations:
- Finding lost patches
- Taking improperly discarded patches from the trash
- Finding unused patches that aren’t properly stored
- Receiving a patch accidentally when being held by an adult wearing one
On September 23, 2013, the FDA issued a drug safety communication notifying the public that it was requiring a color change to the writing on fentanyl patches. With the new color, caregivers and patients will be able to more easily find patches on patients’ bodies and see patches that have fallen off.
In the year since the advisory statement, two more children had died from contact with a fentanyl patch, one due to improper disposal in the household trash and the other from a transfer of a patch from a parent to a nearby child.
Fentanyl Lawsuits Have Been Filed Against Manufacturers
Because of the possibility of overdose by the intended user, or accidentally by others, many patients have filed fentanyl lawsuits or Duragesic lawsuits against the drugs’ manufacturers. In October 2008, a Florida patient’s family received a $13.3 million verdict after a family member died of a Duragesic overdose. A month later, a Chicago jury awarded a mother’s family $16.6 million after she died from a Duragesic overdose.
In August 2008, Watson Pharmaceuticals, Inc. issued a fentanyl recall because one of its lots of the drug was found to be leaking fentanyl gel because the patch manufacturing machines were mis-calibrated, stamping fentanyl gel onto the patches’ perforated fold-over lines. In August 2012, the U.S. Judicial Panel on Multidistrict Litigation consolidated all Watson fentanyl patch recall lawsuits into a single multidistrict litigation (MDL) proceeding in the U.S. District Court for the Northern District of Illinois. In July 2012, Johnson & Johnson issued a Duragesic recall covering 53,000 patches because the fentanyl gel crystallized on the patches.
RLG’s Fentanyl Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a fentanyl lawsuit on your behalf if necessary. RLG will also keep you up to date on any fentanyl class action lawsuits, additional FDA fentanyl warnings, and additional fentanyl FDA recall announcements. If you believe a fentanyl patch caused you or a loved one an injury, contact RLG today.