Fentanyl Pain Patch Recall

On February, 12th, 2008, all 25-microgram-per-hour patches that expire on or before December, 2009 sold in the U.S. were recalled by Johnson & Johnson. The recall includes Duragesic and Sandoz brands, both of which are manufactured by the Johnson & Johnson subsidiary Alza Corporation. The recall occurred as a result of the potential for a cut along one side of the drug reservoir where fentanyl is stored in gel form, causing a leak of the gel. As fentanyl is a dangerous opioid drug, patients and caregivers who come in contact with a leaking patch may have difficulty breathing, or potentially be victims of a fatal overdose. This recall follows a 2004 recall of five lots of 75-microgram-per-hour patches for leaking defects. Many other lots, of all sizes, that were not recalled suffered from leak defects as well.

Gulas & Stuckey have been involved in Duragesic litigation since the first recall in January, 2004. We were co-lead counsel in the first and only Federal Court trial of a wrongful death case in June 2007. We represented Lee Hendelson for the tragic death of his son, Adam Hendelson, who was using a 75 mcg/hr patch. These patches are supposed to deliver a controlled dose of fentanyl through a rate controlled membrane. Unfortunately, due to problems with the manufacturing process as well as an inferior design, these patches can leak the gel out onto the patients skin and result in a an overdose that is usually fatal.

Adam Hendelson was found to have a fentanyl level of 3 times the accepted toxic level of fentanyl in his system. The latest recall suggests that many more families are going to continue to be victimized by this incredibly dangerous drug.

In addition to reports of leaking patches, the FDA has investigated deaths and life-threatening side effects in patients who never should have been prescribed the patch. Fentanyl pain patches are approved for moderate to severe chronic pain. They should be prescribed only to patients who are accustomed to powerful narcotic drugs. The reports of improper prescribing of the patch prompted. the FDA in December of 2007 to issue its second Public Health Advisory regarding fentanyl pain patches. The Public Health Advisory stated that "reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed."

Duragesic Recall Attorney
Contact us today

Additional Resources

• J&J Is Recalling a Pain Patch
• DURAGESIC® (fentanyl transdermal system CII) Recall Notice Product Photos
• PriCara(TM) Recalls 25 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches
• Fentanyl Patch Recall Expanded (25, 50 , 75 and 100 Mcg/hr patches manufactured by Actavis, Inc.)