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

Background Information About Duragesic and Fentanyl Patches

Posted in Duragesic / Fentanyl

A man named Robert Gale led the development team for the Duragesic fentanyl patch.  He began working for ALZA Corporation in 1971, and began working on Duragesic in 1983.  He was granted Patent # 4,588,580 for “Transdermal administration of fentanyl and device therefor” on July 23rd of 1984, along with Victor Goetz, Eun Lee, Lina Taskovich, and Su Yum.  The patent expired in 2005.  The goal of the invention was to enable fentanyl to be delivered through the skin at a constant rate for a specific period of time.  ALZA Corporation submitted a New Drug Application to the FDA in 1987, and it was approved in August of 1990.  Here’s the entire Duragesic approval package from the FDA.  It’s a hefty 32mb download, so only grab it if you’re interested in scientific “nitty gritty.”

The following diagram comes from the FDA Duragesic approval package, and shows how the patch works:

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As the Duragesic diagram shows, there is a fentanyl drug reservoir in between several different layers of material.  The fentanyl gel slowly bleeds through one of the layers, and is absorbed through the skin.  This type of patch is called a “reservoir design” because of the fentanyl gel being in a reservoir.  Robert Gale, the lead inventor of the Duragesic fentanyl patch, has recently testified in a Duragesic lawsuit that if he were starting over today, he wouldn’t use the Duragesic design.  The matrix design doesn’t use a reservoir, but instead has the fentanyl gel mixed in with the adhesive backing of the patch.  Mylan Pharmaceuticals manufactures matrix-design patches, and I believe some other companies either do or are in the process of developing them.  Johnson &Johnson (who bought ALZA) tried to develop a matrix patch in the late 90’s, but it’s never come on the market.  I’m not sure if it ever will now due to patent issues.  The gel in the Duragesic patch is made up of about 1% fentanyl, 23% ethanol, and 76% water.

Duragesic patches come in four strengths, measured in micrograms-per-hour of fentanyl delivered.  They are 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr.  If a microgram doesn’t sound like a lot, you’re right.  But you don’t need a lot of fentanyl, as it’s between 80 and 100 times stronger than morphine.  And just like morphine, an overdose of fentanyl can kill you.  In fact, many fentanyl lawsuits allege that Duragesic or fentanyl patches are responsible for the deaths of patch users.

Most of the lawsuits over fentanyl patches allege that the patch was defectively designed, and that it was defectively made.  The defective design allegations stem from the fact that fentanyl patches can leak through a variety of different problems, especially problems introduced during the manufacturing process.  While ALZA argues that the Duragesic patch wasn’t defectively designed, even ALZA has had to admit that some of their patches were defectively manufactured.  There have been a series of recalls of Duragesic brand name patches and generic fentanyl patches due to manufacturing defects.  In all of the fentanyl lawsuits I’ve seen, ALZA argues that the person who died didn’t get a patch that was defectively manufactured.  My guess is that ALZA doesn’t want to risk going to trial in the cases where it can’t be disputed that the person received a defective patch, as that would virtually guarantee ALZA would lose at trial – at least on the defective manufacturing claims.  I’ve only seen the jury verdict sheets from a few Duragesic lawsuits, and the ones that I’ve seen have stated that the Duragesic patch was not defectively designed, but was defectively manufactured.  That’s not to say that no jury has ever ruled that Duragesic is a defective design – I have only seen a few jury sheets out of the many Duragesic trials.

Deaths occur from the Duragesic and fentanyl patches when someone is exposed to more of the fentanyl gel than they’re supposed to get.  ALZA was aware this could be a problem when they designed the patch, and even use the phrase “dose dump” to describe when the patch delivers too much fentanyl.  Duragesic patches are intended to be worn for 72 hours, so you can see how dangerous it could be for someone to get an entire 72-hour dose “dumped” on them at once.

The first Duragesic recall I know of occurred in 1993.  It seems that a purchasing agent at ALZA decided to buy one of the components of the patch from a cheaper vendor.  Initially, the cheaper part looked like it was going to work just fine, but after three months of sitting on the shelf, patches started to fail.  After investigating the problem, ALZA determined that the cheaper component was to blame. Just like in everything else in life, you apparently get what you pay for.  I’m not sure if there were any deaths or injuries caused by the defective patches in 1993.

Duragesic is the brand name of the original fentanyl patch.  But there are many generic patches that are virtually identical to Duragesic.  Some of the manufacturers of the generic patches include Sandoz, Novartis, and Watson Pharmaceuticals.  Some of those manufacturers actually have their patches made in the same factory as the Duragesic patches, while others make their own.  One of the important details to find out in a fentanyl lawsuit is who made the patch the injured person used.  The attorneys I know are very experienced in identifying the correct manufacturer of the patch. 

If one of your friends or loved ones died while using a fentanyl patch or a Duragesic patch, contact me and I’ll put you in touch with the right attorney.  I can’t promise you that my attorney friends will win your case, but I can promise that they’ll treat you with respect and give your case the attention that it deserves.  I don’t charge anything to you, or get paid anything by anyone for referring you to an attorney.  Because I’m not yet a lawyer it would be illegal for me to get a percentage of any recovery you may receive, and I’m not selling referrals.  Instead, I’ll put you in touch with an attorney that I would trust to handle my own case, or the case of any of my family members.