Duragesic™ Pain Patch
Over the past 4 years Johnson & Johnson has recalled almost 40,000,000 Duragesic fentanyl patches due to defects that can cause serious adverse reactions and death. The Duragesic™ Patch litigation in which MacDonald Rothweiler Eisenberg LLP has taken a leading role, involves re-called patches and other Duragesic patches that are suspected of leaking fentanyl leading to the death of our clients due to "fentanyl toxicity." Currently, MacDonald, Rothweiler & Eisenberg LLP has wrongful death cases pending against Johnson & Johnson in Federal and State Courts across the United States. Do You Have a Case?
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In June of 2007 a jury awarded $ 5,500,000 the family of a man whose death was caused by a defective Duragesic patch.
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History of Leaking Duragesic Patches
On February 17, 2004, Janssen Pharmaceutica Products LP ("Janssen") issued, with the approval of the U.S. Food & Drug Administration (FDA) a Class I RECALL of all units of its 75mcg/hr Duragesic™ product bearing a specific lot number. February 17, 2004 recall letter.
Later on April 5, 2004, Janssen issued another urgent RECALL to include additional lot numbers that also may have contained defective Duragesic™ patches. The April 5, 2004 recall brought the total amount of recalled patches to 2,200,000. Duragesic is manufactured for Janssen by Alza Corporation ("Alza"). Both Janssen and Alza are wholly owned subsidiary companies of Johnson & Johnson. April 5, 2004 recall letter
Duragesic™, known as a "pain patch," is an adhesive patch applied to the to the skin which is intended to deliver a steady dose of a powerful opioid pain medication known as fentanyl (100x more potent than morphine) through the skin over an extended period of time to persons suffering from chronic and/or debilitating pain.
The 2004 recalls applied only to specific manufacturing lots of the 75mcg strength product, which (according to recall notices) were manufactured with a faulty seal which permits full strength fentanyl to leak from the patch delivery system. If the leakage occurs while the patch is on the skin, patients are potentially caused to suffer an overdose of fentanyl which can result in fatal respiratory and/or cardiac arrest or other, serious physical reactions.
In July of 2005, a Johnson and Johnson wholly owned subsidiary, Janssen, and the FDA issued a Public Health Advisory and Information for Healthcare Professionals notifying Healthcare professionals and the public of a change of the Duragesic label to “include important safety information in the following areas of the labeling: Use Only in Opioid-Tolerant Patients, Misuse, Abuse and Diversion, Hypoventilation (Respiratory Depression), Interactions with CYP3A4 Inhibitors, Damaged or Cut Patches, Accidental Exposure to Fentanyl, Chronic Pulmonary Disease, Head Injuries and Intracranial Pressure, Interactions with Other CNS Depressants, and Interactions with Alcohol and Drugs of Abuse.” (emphasis added). Janssen's Notice to Doctors.
In December of 2007, the FDA expressed concern regarding the lethal risks of Duragesic, releasing an FDA Alert because the FDA “continued to receive reports of death and life-threatening adverse events related to fentanyl overdose”. December 21, 2007 FDA Alert.
In February of 2008, almost 38,000,000 Duragesic patcheswere RECALLED due to manufacturing defects that could lead to leaking patches that may expose patients, family members or caregivers to potentially fatal overdoses. The recall includes all 25mcg/h patches sold in the United States. February 12, 2008 Recall Press Release & Wall Street Journal Article
Identifying Recalled Patches
2004 Recalls
The lot number of the defective Duragesic patches recalled in 2004 can be identified by its NDC number and Lot Control Number as follows:
NDC no. 50458-035-05
Lot Control nos. 0327192, 0327193, 0327294, 0327295, and 0330362
To determine whether your Duragesic™ product is subject to the 2004 recall, please review these Duragesic™ photos provided by Janssen to the FDA, which will direct you to the proper place to look for your Lot Control Number. Recall Notice Product Photos
2008 Recall
2008 Recall includes all 25mcg/h dose Duragesic patches sold in the United States.
If you or a loved one has suffered a catastrophic injury which you believe is related to your use of a defective Duragesic™ patch, MacDonald Rothweiler Eisenberg L.L.P. is prepared to assess your potential legal claim.
Contact us today to see if we can help.
