Duragesic Fentanyl Pain Patch

Manufactured by Alza Corporation and Janssen Pharmaceutica Products, L.P. (Johnson & Johnson subsidiaries), Duragesic (fentanyl transdermal system) is a pain patch that contains an extremely strong opioid pain medication called fentanyl. Fentanyl is 100 times stronger than morphine, and thus the Duragesic pain patch is approved only to treat patients suffering from moderate to severe chronic pain. Each patch has a reservoir where a gel containing the fentanyl is placed. The patch also contains a rate control membrane that is designed to provide steady dosing of fentanyl over a 3-day period of time.

In February 2004, Janssen recalled one lot of Duragesic patches because of seal breaches which may allow the drug to leak from the patch. The recall notice warned that "exposure to the Duragesic hydrogel contents 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." Janssen also later recalled additional lots. For Duragesic product photos, visit FDA.gov.

The FDA issued a Public Health Advisory, which In July of 2005, the FDA is advised that "deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product." In December of 2007, as part of this continuing investigation, the FDA issued a second Public Health Advisory stating, "The FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after people incorrectly used it."

While the Duragesic product label was modified in 2005 to include new safety information, the drug is still available today and is causing serious concerns across the country. Reports claim the number of fatalities linked to fentanyl transdermal patch use runs into the thousands. The cause of these deaths can be due to seal breaches allowing fentanyl gel to leak from the patch, malfunction of the rate control membrane or other defects.

On June 19, 2007, a $5.5 million jury verdict was awarded in a case against Johnson & Johnson and its subsidiary, Alza Corporation, the manufacturers of the Duragesic fentanyl transdermal pain patch. This case, the first Federal trial involving the Duragesic fentanyl patch, was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division. The verdict was achieved for the family of a 28-year-old Florida man (Adam Hendelson) who died while wearing a Duragesic fentanyl drug patch.

On February 12, 2008, the FDA announced that PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.has recalled all lots of 25 mcg DURAGESIC(r) patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc.in the United States were voluntarily recalled. The recalled fentanyl patches all have expiration dates on or before December 2009, and were manufactured by ALZA Corporation. The fentanyl patch recall was conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada were also recalled.

On November 17, 2008, a $16,560,000 verdict was achieved for the family of a Cicero, Illinois woman who died while wearing a Duragesic fentanyl transdermal pain patch. After a 3 week trial, a Chicago jury found two Johnson & Johnson subsidiaries liable for the death of 38-year-old Janice DiCosolo, a mother of three. On February 15, 2004, Mrs. DiCosolo died as a result of using a defective Duragesic patch that her doctor had prescribed to alleviate the intense pain she experienced from a neurological condition called "reflex sympathetic dystrophy."

We have worked with many individuals and families who have been injured by dangerous drugs. If you or a loved one has suffered injury, or a family member has died as a result of using any brand of fentanyl transdermal pain patch, please fill out our questionnaire to the right of this page for a free consultation.

DURAGESIC NEWS ARTICLES:
7/10/07 - The Legal Broadcast Network – Civil Action Radio Features Interview with Trial Team on Duragesic Fentanyl Patch $5.5M Verdict
6/19/07 - Bloomberg.com – J&J Units Ordered to Pay $5.5 Million in Patch Case
6/19/07 - MedaNews.com – Heygood, Orr, Reyes & Bartolomei and Gulas & Stuckey: $5.5 Million Award in First Federal Fentanyl Patch Trial
6/19/07 - Forbes.com – Jury Awards $5.5M in Drug Patch Case
6/19/07 - NYTimes.com – Companies Lose Drug Patch Suit

INTERVIEWS AND APPEARANCES LINKS:
6/26/07 - Civil Action Radio – Jim Orr Podcast Interview regarding the June 19 Duragesic Fentanyl Settlement

DURAGESIC FENTANYL COMPLETE NEWS ARTICLE ARCHIVE:
Complete Duragesic Fentanyl pain patch news article archive