Duragesic Fentanyl Patch Litigation at The Lanier Law FirmThe Duragesic fentanyl patch manufactured by the Johnson & Johnson subsidiary Alza Corporation and Janssen Pharmaceuticals was the first fentanyl patch approved by the FDA. However, there are now numerous generic versions of the fentanyl patch available to consumers, including those made by Sandoz (manufactured by Alza Corp.), Mylan Laboratories Inc., Watson and Actavis.
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 that allow fentanyl to leak from the patch (also known as the "fold-over defect"), malfunction of the rate-control membrane, and other defects. The FDA is currently investigating these deaths.
The Lanier Law Firm is currently pursuing cases involving the manufacturers of fentanyl patches such as the Duragesic fentanyl patch. If you have lost a family member or a loved one as a result of using a fentanyl patch, please contact us at The Lanier Law Firm.
What is Fentanyl?Fentanyl is an extremely potent Schedule II opioid analgesic (pain relief) medication that is 100 times stronger than morphine. Fentanyl patches were approved by the FDA in 1990 for the management of persistent, moderate-to-severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other pain relief methods.
Fentanyl Side EffectsDirect exposure to fentanyl gel from damaged, broken or leaking transdermal patches may lead to serious adverse side effects, including respiratory depression and possible overdose, which may be fatal. Faulty manufacturing of pain patches has led to numerous recalls and sales of defective patches that are broken or leak, causing serious injury and death to users or their caregivers.
Duragesic Fentanyl Patch ProblemsAccording to the FDA, the problems with Duragesic fentanyl patches occur when a breach in the fentanyl patch membrane leads to leakage of the liquid reservoir and can cause fatal health consequences. An overdose of fentanyl can cause depressed breathing that can lead to unexpected death. Signs of an overdose include difficulty in breathing or shallow breathing, extreme sleepiness or sedation, an inability to walk or talk normally, and feeling faint, dizzy, and confused. People who experience these symptoms should seek emergency medical attention. Removing the fentanyl patch won't reverse the problem; the drug is still absorbed into the body for more than 17 hours after the patch is removed.
Fentanyl Patch FactsThe fentanyl transdermal system comes in strengths of 12.5, 25, 50, 75 and 100 mcg/hr. Fentanyl patches work by releasing fentanyl through the skin into body fats, which then slowly release the drug into the bloodstream over a 72-hour period. After applying the first patch, it can take 12 to 18 hours to reach the peak of pain relief, with some early relief occurring at 4 to 6 hours after the first administration. The resulting pain relief can last for 3 days from a single patch application.
Each fentanyl patch is made of five functional layers: (1) an impermeable backing, which serves as a barrier to assure the drug is delivered only on the adhesive side of the product; (2) a drug reservoir, which serves as the primary residence site for the drug during storage of the product; (3) a rate-controlling membrane, which regulates the rate of fentanyl delivery; (4) a skin adhesive, which attaches the patch to the skin of the patient; and (5) a protective liner, which protects the adhesive during storage in the package.
Duragesic Fentanyl Patch RecallIn 2004, Alza Corp. and Janssen Pharmaceutica (the Johnson & Johnson subsidiaries that 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 there were leak defects in many other lots of all sizes that were not recalled.
In July 2005, the FDA issued a public health advisory on the fentanyl patch that focused on improving education about the signs of an overdose, proper patch application, drug interactions, proper storage and disposal of the patch, and safeguards for children. On Dec. 21, 2007, the FDA issued its second safety warning about the fentanyl transdermal system.
Manufacturers of fentanyl patches continue to produce defective pain patches. On Feb. 12, 2008, Johnson & Johnson (PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) recalled approximately 32 million patches because of possible leak defects. The recall includes Duragesic and Sandoz brands. On Feb. 17, 2008, Actavis Inc. (formerly known as Abrika Pharms., Inc.), announced that 14 lots of its fentanyl patches sold in the United States were being voluntarily recalled from wholesalers and pharmacies because of the "fold-over defect" that may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. On March 3, 2008, Actavis widened its recall to include all remaining lots of its transdermal patches. Most recently, on Aug. 8, 2008, Watson Pharmaceuticals, Inc., announced the recall of one lot of 75 mcg/hr Fentanyl Transdermal System patches (lot number 92461850, expiration date Aug. 31, 2009). In each of these recalls, the manufacturers warned that exposure to the gel contained in the patch could lead to serious injury or death.