Medical Device:

Duragesic Pain Patch

In August 2009, Ortho-McNeil recalled the Duragesic reservoir pain patch from the market. Although the Duragesic pain patch was a top-selling item for the company, its faulty design warranted close scrutiny from the FDA over the past few years. Because the Duragesic pain patch contains fentanyl, which is 100 times stronger than morphine, a faulty or leaky patch can lead to serious injury or even death.

The FDA investigated cases of death and serious injury caused by the Duragesic pain patch and fentanyl, the generic form of the opioid made by Mylan Laboratories. Because of the strength of these medications, the FDA urged doctors to use the lowest possible dose. Signs of a Duragesic overdose include:

  • Difficulty breathing
  • Fatigue
  • Extreme tiredness or sedation
  • Inability to think, talk or walk normally
  • Dizziness
  • Fainting
  • Confusion

Before the removal of the Duragesic reservoir pain patch from the market, several lots of the pain patch were recalled due to a manufacturing defect. In August 7, 2009, the 100 mcg/hr Fentanyl Transdermal System patches with the lot number 145287A were recalled. These patches, which were shipped to healthcare facilities between April 2 and May 20, were susceptible to leaks. Likewise, on Dec. 31, 2008, the 50mcg/hr Duragesic pain patches with the lot number 0817239 and the fentanyl patches with the lot number 0816851 were recalled. These lots of the pain patches may have contained a cut along one side of the patch. This defective pain patch may have released fentanyl gel, putting patients or caregivers at risk for serious injury or death.

The Duragesic pain patch sticks to the skin and releases a steady dose of the powerful painkiller fentanyl. The Duragesic pain patch is intended for patients suffering from chronic or debilitating pain. If you or a loved one suffered an overdose from a Duragesic or fentanyl pain patch, you may be eligible for compensation. Fill out our free case review form on the right to speak to a Duragesic lawyer today.