Sandoz Fentanyl Pain Patch

Fentanyl is an opioid pain medication that is 100 times more powerful than morphine. It is used to treat patients suffering from moderate to severe chronic pain. The patch is most often prescribed for people with cancer. The fentanyl transdermal patch was approved by the Food & Drug Administration (FDA) in 1990 for people with persistent to moderate severe pain.

The Sandoz fentanyl patch is manufactured by Johnson & Johnson and its subsidiary Alza Corporation.  Sandoz is a transdermal patch that has a reservoir containing a 3-day dose of fentanyl gel. The FDA has received hundreds of reports of fatalities linked to Sandoz 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.

Patients and caregivers who come in contact with a leaking patch may experience severe side effects, or potentially be victims of a fatal overdose. 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."

The FDA’s warning to doctors and patients on the symptoms of fentanyl overdose included the following:
• Trouble with breathing, or slow or shallow breathing
• Slow heartbeat
• Severe sleepiness
• Cold, clammy skin
• Trouble with walking or talking
• Feeling faint, dizzy, or confused

According to the FDA, patients using the fentanyl patch who experience those symptoms should get medical attention right away. Additionally, patients or caregivers should call the patient's doctor immediately if the patient's temperature exceeds 102 degrees while wearing a fentanyl patch.

On June 19, 2007,we participated in and helped achieve a $5.5 million jury verdict that was awarded in a case against Johnson & Johnson and its subsidiary, Alza Corporation, the manufacturers of the Duragesic fentanyl transdermal pain patch. This case, the first Federal trial involving the Duragesic fentanyl patch, was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division. The verdict was achieved for the family of a 28-year-old Florida man (Adam Hendelson) who died while wearing a Duragesic fentanyl drug patch.

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."

If you or a loved one has suffered injury, or a family member has died as a result of using any brand of fentanyl transdermal pain patch, please fill out our case review form to the right of this page for a free consultation.

DURAGESIC AND SANDOZ RECALLS:
On February, 12th, 2008, all 25-microgram-per-hour patches that expire on or before December, 2009 sold in the U.S. were recalled by Johnson & Johnson. The recall includes Duragesic and Sandoz brands, both of which are manufactured by the Johnson & Johnson subsidiary Alza Corporation. This recall follows a 2004 recall of five lots of 75-microgram-per-hour patches for leaking defects. Many other lots, of all sizes, that were not recalled suffered from leak defects as well.
COMPLETE RECALLS & WARNINGS ARCHIVE>>

DURAGESIC TRIAL NEWS ARTICLES:
7/10/07 - The Legal Broadcast Network – Civil Action Radio Features Interview with Trial Team on Duragesic Fentanyl Patch $5.5M Verdict
6/19/07 - Bloomberg.com – J&J Units Ordered to Pay $5.5 Million in Patch Case
6/19/07 - MedaNews.com – Heygood, Orr, Reyes & Bartolomei and Gulas & Stuckey: $5.5 Million Award in First Federal Fentanyl Patch Trial
6/19/07 - Forbes.com – Jury Awards $5.5M in Drug Patch Case
6/19/07 - NYTimes.com – Companies Lose Drug Patch Suit
COMPLETE DURAGESIC TRIAL ARCHIVE>>