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. 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."
We actively participated in and helped achieve a $5.5 million jury verdict, awarded on June 19th, 2007, which was the first ever in a federal case against the makers of any fentanyl transdermal pain patch. This case was against the manufacturers and marketers of the Duragesic® patch, and 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 pain 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."
Our firm is now pursuing 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.
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."
We actively participated in and helped achieve a $5.5 million jury verdict, awarded on June 19th, 2007, which was the first ever in a federal case against the makers of any fentanyl transdermal pain patch. This case was against the manufacturers and marketers of the Duragesic® patch, and 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 pain 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."
Our firm is now pursuing 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.
Fentanyl News
& Warnings
& Warnings
$16.5 Million Award in First Federal Fentanyl Patch Trial
Jury Verdict Awarded
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the article...
J&J Units Should Pay $25 Million for Death,
Jury Told
11/14/08 - Bloomberg
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the article...
Jury awards $13.3M to family in fentanyl
pain-patch death
10/30/08 - Orlando Sentinel
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the article...
J&J Fentanyl Pain Patch Gave Woman
Fatal Dose, Lawyer Jim Orr Tells Chicago Jury
10/30/08 - Bloomberg
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the article...
Actavis Recalls Certain Fentanyl Patches
in the US as Precaution
2/17/08 - Actavis, Inc. Press Release
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PRICARA™ Recalls 25 mcg/hr Duragesic® (fentanyl
transdermal system) CII Pain Patches
2/12/08 - Johnson & Johnson Press Release
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Second Safety Warning on Fentanyl Skin Patch
12/21/07 - FDA
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$5.5 Million Award in First Federal Fentanyl Patch Trial
6/19/07 - PRNewsWire
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Jury Deciding if Pain Patch Leaked, Killing
Man, 28
6/19/07 - Palm Beach Post
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