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."

Heygood, Orr, Reyes, Pearson & Bartolomei is the leading law firm in litigation involving fentanyl transdermal pain patches. On June 20th, 2007, the New York Times reported a verdict in a case tried by our firm. Please read the article in its entirety at http://www.nytimes.com/2007/06/20/business/20drug.html
The $5.5. million jury verdict, awarded on June 19th, 2007, 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.

Jim Orr, Partner of HORP&B, was the lead trial attorney in the Hendelson case. In the New York Times article, he stated that "The patch was intended to deliver a controlled dose of the powerful painkiller fentanyl. If the fentanyl gel inside the patch escapes and comes in contact with a patient's bare skin, it can cause a rapid and potentially fatal absorption of the drug." Unfortunately, Adam Hendelson was one of the numerous people who received a fatal dose of fentanyl from the patch. Adam suffered chronic hip pain due to a car accident and wore the patch on his arm. Mr. Orr also said in the article that "tests showed that Adam 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 patches such as Duragesic®, Sandoz, Mylan, Watson and Actavis. We have advanced far in this litigation and have obtained thousands of documents related to fentanyl patches. We have also taken the depositions of numerous company executives, scientists, engineers, manufacturing employees and quality control personnel. 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

Actavis Recalls Certain Fentanyl Patches in the US as Precaution
2/17/08 - Actavis, Inc. Press Release
Read the article...

PRICARA™ Recalls 25 mcg/hr Duragesic® (fentanyl transdermal system) CII Pain Patches
2/12/08 - Johnson & Johnson Press Release
Read the article...

Second Safety Warning on Fentanyl Skin Patch
12/21/07 - FDA
Read the article...

$5.5 Million Award in First Federal Fentanyl Patch Trial
6/19/07 - PRNewsWire
Read the article...

Jury Deciding if Pain Patch Leaked, Killing Man, 28
6/19/07 - Palm Beach Post
Read the article...

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