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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Duragsesic (Fentanyl) Patch Recall Information

Posted in Duragesic / Fentanyl, Recalls

SAFETY ALERT: OVER 60 MILLION DURAGESIC (FENTANYL) PATCHES RECALLED

On February 12th of 2008, Pricara announced a recall of 38 million Duragesic and generic Fentanyl patches because they "may have a cut along one side of the drug reservoir within the patch."  (Duragesic is the brand name of a patch that contains the drug Fentanyl.)  Because of this cut, the Fenantyl inside the patch can leak out and cause an overdose to anyone who handles the patch.  The recalled patches are the 25mcg patches and will have an expiration date on or before December of 2009.  There are two types of patches being recalled: The brand-name Duragesic patches, and the generic Fentanyl batches.  The Duragesic patches will likely have a "Duragesic" label on them, while the generic patches will likely just say "Fentanyl."  The Duragesic patches are sold by Pricara, which is owned by Ortho-McNeil-Jannssen Pharmaceuticals, Inc.  The generic Fentanyl patches are sold by Sandoz, Inc.  All of the patches are made by ALZA corporation, which is why they have the same defect.

If you think you have a defective 25mcg Duragesic patch, call 1-800-547-6646.  If you think you have a defective 25mcg generic Fentanyl patch, call 1-800-901-7236.

On February 2nd and March 3rd of 2008, Actavis announced two recalls of all of their generic Fentanyl patches, which is estimated to be over 21 million patches.  Like the Johnson & Johnson Duragesic Fenatyl patch, the Actavis generic Fentanyl patch suffers from a manufacturing defect that can kill individuals who handle the patch. 

Actavis recalled all of their 25mcg, 50mcg, 75mcg, and 100mcg doses with expiration dates between May and December of 2009.  If you think you have a defective Actavis Fentanyl patch, call 1-877-422-7452.

If you accidentally touch one of these patches, wash your hands with water onlyDO NOT USE SOAP as this increases the likelihood you will be injured by the patch.

How do I know if I've been injured by a Duragesic or Fentanyl patch?

The most serious injury that can occur with a defective Duragesic or Fentanyl patch is death.  If an autopsy was performed, "Fentanyl overdose" or "Fentanyl toxicity" may be listed as one of the causes of death.

Other symptoms of Fentanyl Toxicity include: agitation, circulatory failure, coma, confusion, convulsions, hallucination, hypotension, myoclonic jerks, nightmares, pinpoint pupils, renal failure, respiratory depression, rhabdomyolysis, and vivid dreams.  If you think you’ve experienced an overdose of Fentanyl, get medical help immediately. 

Do I need a Duragesic or Fentanyl Lawyer?  Should I file a lawsuit?

If you or a family member were injured by a defective Duragesic or Fentanyl patch, you may want to consult with an attorney to see what your legal rights are.  I personally know several attorneys involved in Duragesic & Fentanyl litigation, and can put you in touch with one of them to see if you have a case.  The lawyers I know aren't paying me to refer them cases.  And I'm not getting a "cut" of any recovery you may receive.  All I ask from you is that you consider writing a letter to your elected representatives to tell them you oppose FDA preemption, which will prevent many injured citizens from filing lawsuits against manufacturers of defective drugs.

I'm not an attorney – I'm a law student.  So contacting me does not and can not create an attorney-client relationship.  And I will not give you any legal advice, either.  What I will do is listen to your story and put you in touch with an attorney I believe may be able to help you.  I can't promise that the attorney will win your case, if you have one.  All I can promise is that the attorney I put you in contact with will treat you and your family with dignity and respect, and that he or she will vigorously fight for your rights.

Over 60 million defective patches?  What happened?

Several problems contributed to all of these defective patches.  For one thing, it's only recently that the manufacturers implemented an electronic inspection program to verify the patches weren't defective.  Before then, they were relying on purely visual inspection.  This is a problem because the machine that makes the patches was spitting them out at a rate of 240 per minute.  That's four patches every second. No one can look at four patches every second.

Another problem is that the way the patches are made makes it impossible for there not to be leaking patches.  One of the manufacturers even stated that leaking patches are an inherent part of the manufacturing process.  The internal goal was for only 1/10th of 1% of patches each year to leak.    1/10th of 1% is still 8,000 defective patches per year, meaning that if everything went according to plan 8,000 people per year could be injured or die from defective patches.  Does that sound acceptable to you? Unfortunately, the defective lots had a rate closer to 20% of all patches being defective.

The recalled patches were defectively manufactured.  But there's also plenty of evidence that the design of the patch is defective, too.  If the manufacturers switched over to what's called a "Matrix" design, or to a "drug in adhesive" design, there would be little to no risk of leaky patches.  In fact, ALZA corporation even acknowledged to the FDA that a "Matrix" design would eliminate the risk of gel leakage.  In fact, Fentanyl patches sold in Europe do use the Matrix design.  You're probably wondering why we don't use the Matrix design here.  If you've been injured by a Duragesic or Fentanyl patch, perhaps the manufacturer will have to tell a jury why it doesn't use a safer design.