Watson Fentanyl Pain Patch

Fentanyl is an extremely strong opioid pain medication that is 100 times stronger than morphine. Fentanyl is used during surgery for anesthesia, and 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.

Watson Pharmaceuticals manufactures a generic version of the fentanyl pain patch. In March, 2008, Watson Pharmaceuticals recalled one lot, or about 28,000 units of its fentanyl pain patch because ingredient levels deviated from specifications. This recall resulted from a six-month stability test on products while on wholesaler and retailer shelves.

Transdermal pain patches have a reservoir containing a 3-day dose of fentanyl gel. The FDA has received hundreds of reports of fatalities linked to the use of fentanyl transdermal pain patches. 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.

Heygood, Orr, Reyes, Pearson & Bartolomei is the leading law firm in litigation involving fentanyl transdermal pain patches. On June 19, 2007, a $5.5 million jury verdict 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.

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 questionnaire to the right of this page for a free consultation.