Roche Wins Accutane Lawsuit On Court Reversal
6 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.