Since August 2004 lawyers at MacDonald Rothweiler Eisenberg LLP have taken a national leadership role in the prosecution of civil wrongful death cases arising from defective or 'leaker' Duragesic/Fentanyl Pain Patches manufactured by Johnson & Johnson or its related subsidiaries. Cases filed by our firm in Atlanta Georgia, Salt Lake City Utah, New York City and Newark New Jersey in the period mid-2004 to date have all successfully been resolved in behalf of our clients and their families.

FENTANYL PATCH UPDATE: August 27, 2009 - After years of litigation and FDA scrutiny, Ortho-McNeil, a subsidiary of Johnson & Johnson, has removed the reservoir Duragesic pain patch from the market. Duragesic is one of Johnson & Johnson's top-selling drugs with over $2 billion in sales in 2005 alone. However, the reservoir design can leak which has led to numerous recalls over the years. Fentanyl is 100 times more potent than morphine and a leaking patch can be fatal. Our Fentanyl Patch Litigation Team has been succesfully prosecuting wrongful death cases throughout the United States on behalf of the families whose loved ones have died as a result of leaking reservoir patches. The FDA has looked into more than 120 deaths possibly caused by the dangerous patch. After nineteen years of selling the reservoir design to the general public, Johnson & Johnson has replaced the reservoir design with a "new" design that they allege does not leak. Johnson & Johnson's "new design", however, is not new. Johnson & Johnson has been using the technology in Europe for years. Additionally, generic fentanyl patch manufactures have been using the technology in the United States for years. If you suspect that a loved one may have died due to a leaking fentanyl patch, recalled or otherwise, contact us immediately to speak with a member of our Fentanyl Patch Litigation Team.

August 7, 2009 - Watson Pharmaceuticals has recalled one lot of 100 mcg/hr Fentanyl Transdermal System patches with the lot number 145287A. A number of patches leaking Fentanyl have been found in this lot that was shipped to consumers between April 2, 2009 and May 20, 2009. Direct contact with Fentanyl gel from a leaking patch can cause serious injury or death. The recalled patches have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc.

December 31, 2008 - Pricara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has recalled one lot of 50mcg/hr DURAGESIC® fentanyl patches with the lot number 0817239 and one lot of fentanyl patches sold by Sandoz Inc. with the lot number 0816851. Due to a manufacturing defect these lots may have a "cut" along one side of the patch. The result is a possible release of fentanyl gel from the patch, exposing patients or caregivers directly to the fentanyl gel causing serious injury or death.

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.

In June of 2007 a jury awarded $ 5,500,000 the family of a man whose death was caused by a defective Duragesic patch.

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

December 31, 2008 two more lots of fentanyl patches were RECALLED due to manufacturing defects that could lead to leaking patches that may expose patients, family members or caregivers to potentially fatal overdoses. The recalls includes two lots of 50mcg/hr patches.

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

February 2008 Recall

2008 Recall includes all 25mcg/h dose Duragesic patches sold in the United States.

December 2008 Recall

The lot number of the defective Duragesic patches recalled on December 31, 2008 can be identified by its Lot Control Number as follows: Lot Control nos. 0817239, 0816851

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.