Duragesic Patch Recall Lawyers

Harvey Kirk

By Harvey Kirk
Posted January 5, 2009

ADD YOUR COMMENTS 15

Johnson & Johnson has issued another Duragesic patch recall for one lot of their name brand pain patch and one lot of generic fentanyl patch which were sold by Sandoz, Inc. The fentanyl lawyers at Saiontz & Kirk, P.A. are investigating potential Duragesic patch lawsuits on behalf of users or caregivers who suffered a fentanyl overdose death that may have been caused by a leaking patch.

Since Johnson & Johnson subsidiaries, Janssen Pharmaceutica, Inc. and Alza Corp. introduced the Duragesic patch in 1994, they have faced continuing manufacturing defects which have allowed patches to leak the powerful fentanyl gel, resulting in hundreds of serious or fatal injuries.

On December 31, 2008, PriCara, a unit of Johnson & Johnson announced a recall for one lot of Duragesic 50 microgram per hour patches (lot number 0817239) and one lot of Sandoz 50 microgram per hour patches (lot number 0816851). The recall involves 410,000 pain patches which were manufactured by Alza Corp., a Johnson & Johnson company.

The Duragesic patch recall was issued because some of the patches from these lots may contain cut defects, which would allow the powerful fentanyl gel that is supposed to be delivered in a regulated manner over 72 hours, to come out of the patch and directly contact the skin.

According to Bloomberg News, Johnson & Johnson expects six defective patches from the lot to be leaking fentanyl gel.

While this latest recall only applies to the two 50 microgram per hour fentanyl pain patch lots, prior recalls have involved a variety of different strength products. The continuing manufacturing problems associated with the fentanyl patch, more than 14 years after Duragesic patch was first introduced, signify the inherent problems with the design and manufacture of the product.

Johnson & Johnson’s subsidiaries have been found liable for the deaths of at least four users of their patch, and another sixty users have Duragesic patch lawsuits pending. In November 2008, a Chicago jury awarded $16.56 million to the family of a 38-year old mother of three who died in 2004. In October 2008, a Florida jury awarded $13.3 million to a mother of five.

DURAGESIC LAWYERS

The Duragesic patch lawyers at Saiontz & Kirk, P.A. are continuing to review and investigate new cases on behalf of individuals who have suffered fatal injuries caused by a fentanyl overdose while using the Duragesic or generic fentanyl pain patch. To review a potential case for a friend or family member, request a free consultation and claim evaluation.

15 Comments • Add Your Comments

  • Karen says:

    I wanted to comment about another angle on defective Fentanyl patches. I treated with Fentanyl and started with 25mcg/h, I ended up on 175mcg/hour patches. After being on the patch for about 5 months I came to realize that every third day my pain would go through the roof and I would begin to get the signs of opiate withdrawal. I found out from my doctor that there is a certain patient population that the patches need to be changed every two days instead of the usual three. I was having to pay cash for my patches as I was in the Medicare Part D coverage gap at the time and there was no way I could pay more than the 800 that I was paying, so I was switched to morphine and I don’t have that every third day escalation of my pain or withdrawal issues.
    I think that every third day when my patch failed me I would complain to the doctor that the meds weren’t working so they kept upping it.
    I feel that this has caused my body to “get use to” higher doses of opiates and this just complicates my whole pain management issues and that I paid good money for a product that only worked about a two thirds of the time. It would seem that the third day was hell and then it would take half of the first day to “catch up” and feel better.
    The thought I wanted to throw out was perhaps a class action suit to address this issue could be a possibility.

    Posted on January 6, 2009 at 11:59 pm

  • Mara says:

    Hi Karen,
    I had a very similar experience. By day the third day my body was sick ,sick,sick!! I am very glad I switched doctors because the first doctor kept trying to up my dose also. I’m glad you brought this up as I have never read about anyone else that had the same problem as me. Thank you!

    Posted on January 22, 2009 at 1:55 am

  • Laura says:

    I too have had the same difficulties with the third day problem. My doc chose to have me change the patch every 48 hours instead of 72 as manufacturer advises. This seems to work quite well and has for the past 3+ years.

    Now we come to the newest issues of recalls on the gel type because of so much misuse and blatant “druggie” type behavior associated with the gel patches. This is shortly going to involve ALL
    gel patches regardless of its brand – i.e. generic or not.

    The non- gel comes from one source – Mylan. According to some who have tried it (myself included) the non-gel patch does not have as effective of coverage. Solution now- up the patch another level.

    I am angry that the people who abuse this rx and those who are not extra careful in examining the patch prior to adhering are making it hard on those of us who play by the rules. Of course if you change the dosage, costs go up, this raising insurance premiums which are already sky high.

    Thanks for letting me vent!!

    Laura

    Posted on February 4, 2009 at 6:24 pm

  • Belinda says:

    I am currently being treated with the patches and have used both the gel type and the Mylan. With both I have had the same third day problem but am unable to afford to pay for the extra that my insurance considers past the “quantity limits”. I had a severe allergic reaction to the adhesive surrounding the gel ones. This caused me to have to look all over my city to find a pharmacy that stocks the Mylan. I don’t seem to have a problem with that adhesive other than itching and some redness.

    The non-gel do seem to have less coverage and my doctor has had to increase the dosage and my break through medication is now taken every day. Its either that or increase the patch again.

    This recall has me concerned because of the difficulty in finding the Mylan. Morphine is not an option for me and my insurance is very limited in what they will cover.

    I agree with Laura above, first it was Oxycontin, now Fentanyl, pretty soon there will be nothing available to those of us who really need this type of medication.

    Posted on February 10, 2009 at 1:50 am

  • Kelli says:

    I agree with Laura and mine do not last 3 days either. I usually just spend the 3rd day laying down and taking breakthrough meds. I can’t help but wonder if some of the people who accidentally overdoses didn’t nip the pouch while opening the package. I always check mine for leaks and have never had a problem.

    Posted on March 20, 2009 at 2:42 pm

  • Ray says:

    Dear Belinda,
    In regards to the itching and allergic reaction to the patches, my wife’s dr. recommended spraying her arm with some nasal spray (I believe it was Nasonex or some other allergy prescription meds we had) letting the arm dry or wipe it off gently (she was wearing it on her arm) then apply it. Hope this helps. She’s been off of the patch for a while (she also applied it every 2 days rather than 3; however, might be getting a morphine pump and that’s why she isn’t on the patch or Dilaudid, Oxycontin, and Lortab as she was. Does anyone know how the morphine pump has worked for them? Heard horror stories re: the spinal cord stimulator that her pain dr. kept pushing her to get.

    Posted on April 23, 2009 at 4:11 am

  • Robert says:

    hello Ray, I am a pump user and also the patch (mylan). I am having my pump removed because the cathater at the interthecal space came loose. (hope I spelled that right) I had a pool of morphine near my spine and when I complained to my doctor and had to use to much of my break through meds. He took me off the meds all together. I was really upset then. I found another doctor who looked at the records and understood what happened. I take 50mcg but started on 25. As to the stimulator, I would not recommend it unless you have tried a tens unit with results. Just my opinion. Good luck in your quest for stability of pain.

    Posted on April 29, 2009 at 12:34 am

  • Shannon says:

    I was on the patch and had put one on and after awhile I totally passed out in my chair. My Wife thank goodness was there and told me that I had acted as if I was totally drunk really out of it and then just passed out so she came over and ripped that patch off of me and I have never used them since as it was a very scary experience. I myself think they are very very dangerous and I certainly didn’t have cancer.

    Posted on May 11, 2009 at 3:29 am

  • PAT says:

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’T RESTICK. I AM OVER 50 AND A HEALTH EDUCATION MAJOR AND EXTREMELY CAREFUL. I WRITE DATE AND TIME WITH LAUNDRY MARKER ONTOP BEFORE I PUT THEM ON. GREAT FOR SEVERE FIBROMYALGIA PAIN OF 24 YRS. BUT SIDE EFFECTS AWFUL. I SWEAT SO MUCH. LOSE APPETITE. BE CAREFUL EVERYONE!

    Posted on June 28, 2009 at 11:21 am

  • Kimberly says:

    It looks like there are several people who have had problems with using hese patches. Like everyone else they totally became worthless on the third day. To be honest with you they really didn’t work too good from the beginning. I am not sure if I overdosed myself and could be the reason for some long term side effects I notices I picked up after starting to use them. No one told me to stay out of the sun with them and I’d lay out every Saturday and Sunday trying to get a sun tan with them on. It sounds like I’m lucky to be alive.

    Posted on August 29, 2009 at 2:16 pm

  • linda says:

    I have been on the phentanyl patches for almost a year. I started out with 25 and am now using 75. I agree with them not lasting for 3 days and I am also concerned about them coming loose without my knowing it and leaking. I am going to talk to my Doctor about taking me off of them together because there is a high risk wearing them and there has been a lot of recalls on different lot numbers. How do we know that we are wearing one now that may have a recall on it next week. I dont think it is worth wearing when there is so many risk involved. I want to see my grandchildren grow up. I still take percocet ever 6 hrs anyway so why risk dying from a patch that we are not made aware of all of the risk involved. When I was given the patches to wear no one bothered to explain the side effects and I was not given any information about recalls. the first I heard about recalls was on TV.

    Posted on December 14, 2009 at 4:06 pm

  • Brad says:

    My wife has had the same problem with the third day regimin. She was prescribed more and more patches until she was on 175 mcg every three days. On the second day she was constantly in pain and suffered tremendous pain for a day and a half. The real dilema is that she lost her Medicaid card when our oldest daughter turned 18. We could not afford to pay for the patches. I could not watch her suffer her pain so I started purchasing lortabs off the street for her. Yes i was finally arrested and jailed and i costed me several thousands of dollars and alot of my time on probation (not to mention the embarassment i had to handle due to the police telling the smalltownsfolk that i was a narc for them and was also “labeled” a dope fiend) Due to this unfortunate illegal act by me i have been forced out of town due to rumors and missunderstanding conceptions. Back to the problem at hand my wife is now in constant excruciating pain and can’t get medical doctors to even see her or prescribe prescription pain medications.(which we can’t afford) Due to the constant over prescribed Fentanyl patch by the doctors and the side effects from “the patch” she has become physically tolerant on high dosages of “OPIATE MEDS” but now has been “YANKED” off the treatment and left to hang in pain. Whats wrong with the picture? Is it me, the doctors, the pharmacuetical companies or the government cutbacks(she can’t get public assistance or SSDI Social security disability insurance) because she “doesn’t qualify???? Does anyone have any suggestions or feed back? She also now has “heart problems” that can’t be addressed (as i understand this is one of the many side effects of “the patch”!!!!

    Posted on March 6, 2010 at 2:12 am

  • Janell says:

    my sister was on the Sandoz 50 mcg patches and was out of them for four days she got her new ones and put one on and went to sleep cause she was having so much stomache pain.Needless to say she never woke up she was dead within 8 hours.We are waiting for the toxicology report..

    Posted on April 5, 2012 at 8:48 pm

  • Janell says:

    well alls I can say is I just lost my 51 year old sister to this dangerous drug I hope you all find a different pain relief before you are next
    .

    Posted on April 5, 2012 at 8:50 pm

  • Debbie says:

    I want to add to the latest of this patch. I have been on 100mg mcg.hr Gel and Apotex (band-aid type) I am not an abuser and my doctor started me out on the 50 then 75 and have been on the 100mg for right at 7 months now. None of them last 3 days. I think they do that for people who do abuse and in some its mind over matter, those of us that use them properly know what and how the pain effects them. “Mind over matter” meaning they think they are in pain as I was a medic for 13 years and same patients would call a ambulance at least once a week. We had what is called a minutes meeting and we decided to give her an IV with only sodium solution and a push which is clear and leaves a nasty taste in the mouth. The “Push” is what is called a flush to make sure the real medication for pain ect was gone in the lines into the body. That’s all it is and we found that they believed it was for pain! WE that are in real pain can tell the difference. I believe the ones that sued was abusing the patches, therefor need to have a lot of test done to prove they overdosed themselves. That being said only hurts us that really need them no matter what brand in which If your doctor knows you and he/she is a good doctor and not just write a script get you out of the office, which many do or they find a doctor known on the streets as a “easy” doctor just to make money! Myself I have a caring PCP doctor and if he was like that and didn’t have a one on one relationship with his patients, I personally would find one that does. These doctors that only cares about getting that patient in and out, have a relationship with your PCP if not you may overdue yourself, must listen and follow his/her direction and those whom like I do have this “Honest” communication with their PCP will get the treatment they need. I hope this helps you all and for you abusers get help now before you find yourself so far gone your parents are burying you! We don’t need to bury our children unless a real accident! Open your eyes or close them for good!

    Posted on September 7, 2013 at 5:47 pm

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