Fentanyl Side Effects Lawsuit

Fentanyl is an extremely strong opioid pain medication that is 100 times stronger than morphine. Fentanyl is used during surgery for anesthesia. Fentanyl is also used to treat chronic pain patients. One way of delivering fentanyl for treatment of chronic pain patients is through use of a patch containing fentanyl. This method of delivering fentanyl was approved by the Food & Drug Administration (FDA) in 1990. Its approval is limited to treatment of persistent moderate to severe pain, that cannot be treated through the use of other, less powerful, medications. Initially, the fentanyl patch was most commonly prescribed for people with cancer. More recently, use of the patch for other types of pain patients has become widespread.

The Duragesic® patch made by Johnson & Johnson subsidiary Alza Corporation was, for many years, the only approved fentanyl patch. However, there are now numerous generic versions of the fentanyl patch, including Sandoz (manufactured by Alza), Mylan, Watson and Actavis. The patches all come in dosage strengths of 12.5, 25, 50, 75 and 100 mcg/hr. Each patch is designed to deliver a steady dose of fentanyl for 3 days. However, the amount of fentanyl contained within the patch can cause death if it is delivered in an uncontrolled manner such as occurs when the patch leaks or when the patch is defective in some other manner.

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. The FDA is currently investigating these deaths.

In 2004, Alza Corporation and Janssen Pharmaceutica (the Johnson & Johnson subsidiaries which manufactured and marketed Duragesic®) recalled 5 lots of patches because of "fold-over defects" leading to leakage of the fentanyl gel contained within the patches. Upon investigation by the FDA, numerous other defects were discovered including what is called a "stringer leaker" defect. Based on information from the FDA, it is clear that many other lots, of all sizes, that were not recalled suffered from leak defects.

Manufacturers of fentanyl patches continue to produce defective patches. In fact, on February, 12th, 2008, Johnson & Johnson recalled approximately 32 million patches because of possible leak defects. The recall includes Duragesic® and Sandoz brands. Then, on Monday, February 18, 2008, Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group HF announced that 14 lots of fentanyl transdermal system CII patches sold in the United States are being voluntarily recalled from wholesalers and pharmacies 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 February 12, 2008, the FDA announced that PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.has recalled all lots of 25 mcg DURAGESIC(r) patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc.in the United States were voluntarily recalled. The recalled fentanyl patches all have expiration dates on or before December 2009, and were manufactured by ALZA Corporation. The fentanyl patch recall was conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada were also recalled.

On November 17, 2008, a $16,560,000 verdict was handed down for the family of a Cicero, Illinois woman who died while wearing a Duragesic fentanyl transdermal pain patch. After a 3 week trial, a Chicago jury found two Johnson & Johnson subsidiaries liable for the death of 38-year-old Janice DiCosolo, a mother of three. On February 15, 2004, Mrs. DiCosolo died as a result of using a defective Duragesic patch that her doctor had prescribed to alleviate the intense pain she experienced from a neurological condition called "reflex sympathetic dystrophy."

There are several pending cases involving the manufacturers of all fentanyl patches such as Duragesic®, Sandoz, Mylan, Watson and Actavis. If you have lost a family member or a loved one as a result of using any brand of fentanyl transdermal pain patch, please fill out our questionnaire to the right of this page for a free consultation.

For a Free Fentanyl Case Evaluation Call 1-800-313-2546