Roche Wins Accutane Lawsuit On Court Reversal
19 CommentsBy Ed Silverman // October 28th, 2009 // 7:07 am
A three-judge panel has reversed a $7 million judgment against Hoffman-La Roche, which sold Accutane. A federal court ruled yesterday in favor of the drug maker and against a Pensacola, Fl., man who had most of his colon removed due to inflammatory bowel disease linked to the acne drug, the Associated Press reports.
The unanimous opinion said the patient, Adam Mason, failed to prove an allegedly deficient warning label was the proximate cause of his ailment. Mason had argued warning that Accutane was “temporally associated” with inflammatory bowel disease was too weak. But his dermatologist testified he would have prescribed the drug even if the warning had been stronger.
Last June, Roche withdrew Accutane, citing generic competition and the cost of product liability litigation for its decision. More than 500 lawsuits have been filed in federal and state courts claiming Accutane caused irritable bowel disease, and additional suits have been filed claiming the drug caused depression and suicide. The company has had mixed results in court. Fifteen federal IBD cases were consolidated and, in 2007, a court granted summary judgment in the lead case, which was upheld on appeal, The Pink Sheet wrote last June (here’s one example).
Disclosure: Ed Silverman is an editor at The Pink Sheet
Lichtstrasse 35
Sad to hear about anyone that has severe AEs with this drug, but I took 2 courses of it when it launched around 1983 and the results were excellent. It was $200 per month and you had to take it for 5 months. Luckily I had a good insurance plan and it only cost me $10 per month. Of course, today, recalcitrant cystic acne would probably be considered a “lifestyle disease”!
Stephanie
Lichtsrasse, this may have been an excellent drug for you, but unfortunately the doctors are prescribing it even for mild acne! My son really wanted to go on the drug, but luckily I was the wall between him and the doctor as the doctors were all ready to give the prescription even though he nothing even close to recalcitrant cystic acne.
Lichtstrasse 35
Hi Stephanie - My derm was a global KOL who was involved in the clinical trials, so when the drug was approved he was already experienced in its use. But at that time, I think I only needed to do a baseline LFT and another at the end of the course. There was no discussion of any psychological effects, no special requirements for female patients (I’m male), etc. I think that once the Roche marketing machine got rolling and many more patients were on the drug, the serious AEs starting coming in rapidly and you know the rest. I would be curious to know how your son found out about the drug to the point that he really wanted to go on it. The good news is that there are topical treatments now approved for mild to moderate acne that don’t present the risk profile of any systemic medication.
GAIL JONES
MY 36 YEAR OLD SON TOLD ME HAD A STOMACH THIS WEEK THAT KEPT HIM UP TIL 3 AM. HE ALSO HAS SHINGLES. SHOULD I BE CONCERNED AND MENTION THIS TO HIM. HE TOOK ACCUTANE WHEN HE WAS IN HIGH SCHOOL. HE WAS BORN IN 1973. WHAT SORT OF DOCTOR SHOULD HE GO TO IF HE WANTS TO GET CHECKED OUT.? THANKS
Renee
I have also lost my colon, rectum and anus due to Crohn’s (close relative of IBS) which developed shortly after completing a course of Accutane. No testing was done by my Dermatologist at the time presumably because I had never had any bowel issues before going on the drug. We always suspected that it was due to the drug as my bowel habits changed drastically.
If I were to do it again, I would not go on the drug.
Bill
Roche is in trouble. More and more studies are showing that accutane DOES cause IBD. They may have won one case, but time is not on their side. They have tried their best to drag these cases out, now that strategy us going to cost them big time. The longer they wait to settle the more incriminating info will continue to come out. I feel bad for the people who have suffered as a result of Accutane.
connie
I just heard about the connection between Accutane and IBD yesterday. I can’t believe it! I was diagnosed with ulcerative colitis 2 years ago and couldn’t understand how this happened to me. Now I know. I took Accutane 2 times once in 1997 and then again in 2000. I firmly believe this drug caused this desease. I’m 45 and now I have a future to worry about when I will lose my colon, will I get cancer? Can I make love with my hubby without worring I’ll have a humiliating accident, or ever get to travel? I will never be the same. Was it worth it? That depends on how vain I am. No acne today (but fatique, bloody stools and urgent diareah everyday). BTW - if you suffer from this, I found a wonderful remedy that lessens symptoms…tapioca flour - google it. I tried and it realy helps even better than my meds. What do I do now? Get involved in a lawsuit?
Nicole
I just stumbled across all this info. I took accutane for five months (I had severe acne, got rid of it for two years but it came back even worse- started using proactiv and poof, all gone) and though I had the dry mouth, dry eyes, bloody noses, aching joints.. I didn’t think much of it. My doctor wasn’t concerned so I wasn’t either. Lo and behold, a couple years later.. sick sick sick sick sick- “digestive upset” is an understatement. Had my gallbladder removed. My poor digestive system has never been the same and has been an utter disaster. And along with that I’ve been diagnosed with fibromyalgia, Raynaud’s and neuropathy.. and all along I;ve been wondering why- why did my gallbladder stop working? why am I falling apart at 36? sadly this makes so much sense.
DK
Accutane ruined my life. I was on the drug 2 times (one time was generic form). I have bowel disorders, had my cecum (part of rectum) removed, had stomach surgery, and continue to have problems 8 years later. My skin is dry, my hair is dry, I’ve had skin disorders, massive polyps removed from my nasal cavaties, lower back pain and feel depressed/spacy/tired all the time.
I believe this drug ruined my life. Prior to taking the drug I was a healthy person. I am only 30 years old and feel my life is over. Fuck these god damned drug companies. I was only warned about depression when I took this drug, not that I would have my intestine removed and be in complete pain the rest of my life.
Julie Williams
After 27 years…finally some payback for Hoffman La-Roche. Not that they didn’t fill thier coffers plenty throughout this time. I took Accutane back in 1983. About 2 months into treatment, I ended up in the hospital with Type 1 diabetes. I always knew it was the accutane as nobody else in my family has diabetes. I filed a lawsuit by myself at 19 years old and had them talk down to me stating that I was just a confused teenager looking for someone to blame. I was pressured into settling for pennies because there wasn’t enough proof at that time. My dermatologist called me a year later to apologize for not truly believing me when it happened to another teenager in the same office. A lot of lives could have been saved if they just would have listened to the dumb teenager back in 1983.
Joe S
I took accutane on and off for many years from 1982 to 1989 for my cystic acne. It did help while I was on it, but once I went off the acne returned. Thus, was on it multiple times. About 3 or 4 courses. I have not experienced any bowel or colon problems, but I was recently diagnosed with Testicular Cancer. I am wondering if there is any connection to the Accutane here?
Chris r.
I also took Accutane as a teenager. 10 years later I was diagnosed with Testicular Cancer. I have no family history of TC. I have to wonder.
Barry
I, too, took accutane soon after it came on the market and developed testicular cancer years later. We should look into a connection.
Ian W
I took accutane around the age of 17 and I am 33 now. Was just diagnosed with testicular cancer two months ago. Anyone else?
Michele
My son took Accutane as a teen and was diagnosed with testicular cancer last year. If previous posters Ian W, Barry, Chris R, and Joe S would contact me we could perhaps look into a link and do something about it. My email address is itsmeudummy04@yahoo.ca. No this is not a joke, just an old email address that I made up without thinking how it might be perceived when dealing with serious matters. PLEASE contact me, my name is Michele.
Gerald
In reading some of the comments and the story about the law suit, by Mr. Mason, I can only put my head down. I think we put too much trust in the doctors and the medicines. I too have had some problems, but not with Accutane, I have had an almost fatal encounter with a blood pressure medication. It’s time we stepped back into time and look at the old holistic forms of treatment, and keep in mind that big pharma is about money, their mandate by law is to make their investors a profit and they will even it kills you.
Remember Vioxx killed about 60,000 people.
Remember also that your health is your own responsibility
aaron
I took acutane as a teenager and was diagnosed with testicular cancer a few years later.. I strongly believe that the two could be related… acutane messes with the reproductive organs. Im going to look into this and find a lawyer to help me. Anyone else interested please let me know.
Aaron
alphabeta1618@gmail.com
maria
My son took Accutane in 2006 and was diagnosed with Testicular Cancer in 2010. I’ve read a couple of other posts here (Michele, Aaron), and wonder if you heard from others who developed TC.
Gerald
Understanding the scope of the meds we take is way beyond me. We seemed to be a hypnotized people. I think we put a chemical in our bodies that cause injury and turn around and do it again and again. Look at the advertisements of the drug company’s “we can help you have longer prettier eye lashes with our chemical but you may die of cancer as a side effect”, but not to worry it only happens to a small percentage of the people and that’s surely not you. Right? The whole medical is founded on a false premis fostered by Louis Pasteur who on his death bed amitted he was wrong. We need to realize that our health is our own responsibility, and not the drug pushers. We get our english word pharmaceutical from a greek word pharmakia. (look up that word)