When a fentanyl pain patch is not manufactured to exact standards it can leak onto a patient’s skin. When a fentanyl patch leaks, it can exponentially increase the amount of the drug that is introduced into a patient’s bloodstream. This increased level often results in an overdose, resulting in the death of the patient wearing the leaking fentanyl patch.
Several manufacturers of the fentanyl pain patch fail to utilize state of the art multi-laminate designs for their products, making them more susceptible to malfunctioning and allowing the person wearing such patch to receive a lethal overdose of fentanyl.
The Food and Drug Administration has received hundreds of reports of overdose deaths linked to the use of fentanyl patches. These fatalities can and have been attributed to a myriad of problems with the patches, including:
- seal breaches in patches that allow Fentanyl gel to leak from an unsealed channel in the patch (often referred to as a “stringer leaker”)
- seal breaches where an entire side of the patch was not sealed during the manufacturing process
- seal breaches that were caused by improper manufacturing processes (often called the “fold-over defect”)
- a variety of other manufacturing and design defects
A fentanyl overdose can also occur when patients are prescribed the pain patch in ways that have not been approved by the FDA, such as for headaches or short term pain. Overdoses can also occur when doctors prescribe fentanyl to patients who are not approved to be treated with the drug, such as patients who have recently undergone surgery or those who have not built up a tolerance to opioid medications.
Over the past 10 years, Fentanyl patch manufacturers under the FDA’s supervision have recalled millions of defective Fentanyl pain patches. Each time, the FDA ensured that public warnings were issued to notify health care providers and the public at large that using a defective Fentanyl pain patch could cause life-threatening consequences.
First Fentanyl Patch Recall Issued
In February 2004, Janssen Pharmaceutica Products, LP issued a Class I Recall for one lot of the Duragesic Fentanyl transdermal pain patch. This recall was initiated because a potential seal breach on one edge of the patch (known as a “fold-over defect”) could allow a leak of Fentanyl gel. Janssen estimated that up to 19,000 of the Fentanyl patches in this recall might leak Fentanyl gel.
During the investigation into these recalled patches, the FDA found extensive manufacturing defects in addition to the “fold-over defects,” including the “stringer leaker” defect, “cut corners” in the patches, “bubbles in the seal” and holes in Fentanyl patches. Based upon this investigation, it is clear that millions of additional patches were manufactured in other batches that were not recalled but nonetheless potentially suffered from leak defects.
According to Janssen (a Johnson & Johnson subsidiary) during the February 2004 recall, exposure to the gel from a Duragesic Fentanyl patch “could result in an increased absorption of the opioid component, Fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications.” In April 2004, Janssen expanded the February 2004 recall of defective Fentanyl patches to include more than one million additional Duragesic patches.
Additional Fentanyl Recalls
In February 2008, Johnson & Johnson was again forced to recall additional defective Duragesic Fentanyl patches. This time they recalled approximately 32 million patches due to possible leak defects. Included in this recall were millions of Fentanyl patches manufactured by Johnson & Johnson to be sold by Sandoz, Inc. as a generic of the Duragesic patch.
That same month, the international generic pharmaceutical company Actavis Group HF announced that millions of Actavis Fentanyl patches were being recalled from wholesalers and pharmacies because of concerns in the manufacturing process.
In March 2008, Actavis broadened its February 2008 recall to include all remaining lots of its transdermal Fentanyl patches. Also that month, the first recall of Watson Fentanyl patches occurred. According to the FDA, Watson Fentanyl patch Lot Number 92461681 was recalled because it was “super potent.”
In August 2008, a second Watson Fentanyl patch recall was announced in a press release by Watson Pharmaceuticals, Inc. In connection with this Fentanyl patch recall, Watson notified the U.S. Food and Drug Administration (FDA) that Fentanyl patches from Lot Number 92461850 were leaking Fentanyl gel, which could lead to potentially fatal respiratory depression and overdose for the patients using those patches.
In December 2008, additional Duragesic and Sandoz Fentanyl patches were recalled. Once again, a problem in the manufacturing process led to patches that may have a cut in the pouch exposing the patients directly to the dangerous Fentanyl gel. The companies cautioned that, if used, the defective patches could cause a fatal overdose.
In August 2009, Watson Pharmaceuticals, Inc. announced another recall of Watson Fentanyl patches — this time of all Fentanyl patches from Lot Number 145287A that were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. According to Watson’s press release, patches that leaked Fentanyl gel “have been detected in this lot, potentially exposing patients or caregivers directly to Fentanyl gel.” Watson Pharmaceuticals, Inc. further explained that “exposure to Fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.”
In October 2010, an additional recall of millions of Actavis Fentanyl patches was announced. The following month, an additional recall of Watson Fentanyl patches was announced for Lot Number 264085A. These Fentanyl patches were recalled by Watson because they suffered from a miscalibrated and/or defective delivery system.
FDA Warnings About the Fentanyl Pain Patch
Prompted by the many fentanyl recalls issued by manufacturers of fentanyl pain patches, the Food and Drug Administration has issued multiple warnings and health advisories about the risk of overdose associated with the use of fentanyl patches. The agency has also warned about the risk of overdose and death that can be caused by the inappropriate prescribing of fentanyl pain patches by a doctor or hospital.
In 2005, the FDA issued a warning to the public regarding the dangers and risks associated with Fentanyl patches. The advisory contained information about recognizing the signs of an overdose, proper patch application, drug interactions, safeguards for children, and correct storage and disposal of the patch.
In December 2007, another FDA safety warning was issued, this time directed at incorrect prescribing of Fentanyl by doctors. The agency stated that doctors and hospitals have sometimes prescribed the fentanyl patch to patients who are not eligible to use it, such as patients with mild pain or pain following surgery. The FDA warned that these patients could be at risk of a fentanyl overdose or death because their bodies may not be able to handle the extremely potent medication contained in the pain patch.
Johnson & Johnson recalled 32 million fentanyl pain patches in February 2008 over concerns that the gel inside the patch could leak, putting patients at risk of a fentanyl overdose. In their press release related to this latest recall, the sellers of the Duragesic and Sandoz patches again warned that these defective patches could cause “respiratory depression and possible overdose, which may be fatal.”
Lawsuits Filed By Fentanyl Overdose Victims
Despite the FDA’s warnings about fentanyl patches, hundreds of individuals have been severely injured or killed as a result of defecting pain patches or fentanyl products that were improperly prescribed by a doctor.
If you or a loved one was injured as a result of a defective fentanyl patch or because a fentanyl pain patch was inappropriately prescribed by a physician, you may be eligible to file a case and receive compensation for your injuries. To find out more about whether you may be eligible to file a fentanyl lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by filling out the free case evaluation form located on this page.