Duragesic®® / Fentanyl Pain Patches Recalled
Fentanyl, an opioid pain medication 100 times stronger than morphine, is used during surgery for anesthesia and to treat chronic pain patients. The drug is usually administered to patients through the use of a patch, a method approved by the FDA in 1990, when a patient's pain becomes untreatable through the use of other, less powerful, medications. Initially, the fentanyl patch was most commonly used by people with cancer, but with generic versions of the patch making it more available to the public, doctors have been improperly prescribing the patch for many other common types of pain. It is now being reported that the amount of fentanyl contained within these patches can cause death if delivered in an uncontrolled manner such as when the patch leaks or when it is defective in some other way.
Over the last couple years, the FDA has received hundreds of reports of fatalities linked to fentanyl patch use. The cause of these deaths can be due to seal breaches allowing fentanyl gel to leak from the patch, known as the "fold-over defect," malfunction of the rate control membrane or other defects. In 2004, Alza Corporation and Janssen Pharmaceutica recalled 5 lots of patches because of the "fold-over defect". Upon investigation by the FDA, numerous other defects were discovered including what is called a "stringer leaker" defect. It is now clear that many other lots, of all sizes, that were not recalled also suffered from leak defects. Since the initial recall, manufacturers have continued to produce and distribute defective patches. In fact, on February, 12th, 2008, Johnson & Johnson recalled approximately 32 million patches because of possible leak defects including the Duragesic® and Sandoz brands. On Monday, February 18, 2008, Actavis Inc., voluntarily recalled 14 lots of its fentanyl transdermal patches because of leak defects. In each of these recalls, the manufacturers warned that exposure to the gel contained in the patch could lead to serious injury or death.
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. In December, 2007, reports of improper prescribing of the patch prompted the FDA to issue its second Public Health Advisory regarding fentanyl pain patches, which 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."
On June 19th, 2007 a jury awarded $5.5. million to the family of a 28-year-old Florida man who died while wearing a Duragesic® fentanyl pain patch. The trial was the first ever conducted in a federal court against the makers of any fentanyl transdermal pain patch. Tests showed that the victim, Alan Henderson, who suffered from chronic hip pain due to a car accident and wore the patch on his arm, had three times the lethal dose of fentanyl in his system at the time of his death.
Our firm is now pursuing cases involving the manufacturers of all fentanyl transdermal patches. If you have lost a family member or a loved one as a result of using any brand of fentanyl transdermal pain patch, contact us today.
If you, your family or someone you know has been injured, contact us now for a free, private consultation. Knowledge is power - we'd like to help you!
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