Accutane Sufferer Hopeful with Generic Isotretinoin Lawsuit

Walnut Creek, CALike countless teens, Brad was prescribed Accutane to treat acne. And like a small percentage of Accutane consumers, he is now suffering from Accutane Ulcerative Colitis, to the point where he was hospitalized on three occasions.

“Just a few months after I stopped the Accutane four-month treatment back in 2005, I slowly developed loose and bloody stool, which I later found out were the symptoms of ulcerative colitis,” says Brad (not his real name), age 28. “I called Kaiser Hospital and described my symptoms over the phone. They suspected that I had Crohn's disease, a form of inflammatory bowel disease (IBD).

"I guess getting stressed out over my final exams aggravated my condition. It was so bad that I couldn’t even stand in front of my class and do a presentation. I had to go to the bathroom several times a day, and I was losing a lot of weight and a significant amount of blood in my stool. I was emaciated and at the point where I was so skinny and frail. At one point I weighed 150 lbs—I am 5’ 11”. Everything I ate just flushed right through me and it came out a bloody mess. Then my skin turned pale.

"My parents were so upset that they talked to the doctor. I was first hospitalized in 2008, right after I got my BA degree.

"During my month-long stay I had a colonoscopy and I was diagnosed with ulcerative colitis. I asked the doctors if it could possibly be related to Accutane but they just said it happens ‘naturally’. I didn’t buy that reasoning. The dermatologist at Kaiser was the Accutane prescribing doctor so I don’t think they were being completely honest with me; I think they were afraid of a medical malpractice lawsuit.”

Brad now takes prednisone, an infusion of Remicade once a month, and a lot of herbal supplement vitamins. He is on a strict gluten-free and dairy-free diet. No sugar, caffeine, alcohol. (He had a severe attack from drinking one beer at a party). He rarely goes out to eat anymore. And he has to pay a monthly health insurance premium to Kaiser because he now has a pre-existing condition.

Accutane has affected every facet of his life, including work. “It prevented me from traveling overseas, which affected my work,” he says. “I was working at Sherwin-Williams, mixing and gathering paint. When I went on deliveries I had to go to the bathroom so often it would take a long time to get the deliveries done. Eventually they laid me off.

"Right now I am unemployed but working on getting my ESL teaching certificate so I can work online, from home. Having to commute is a problem: I just can’t eat breakfast in the morning and rush to work like a normal person. I’m in a lot of pain when I wake up.

"I used to be athletic and into extreme sports. After losing so much weight and having colitis, I decided that, since my body was so weak, I gave up sports. I couldn’t risk getting injured. Prednisone weakens bone density so I don’t even work out so much. No matter how many drugs I take, flare-ups always occur, and I never know when they are coming.

"Now I spend most of the time in my apartment. I even have accidents while driving. Most 28 year olds don’t shit their pants. It is so embarrassing.

"Needless to say, I’m pretty mad at the drug makers. They have made trillions of dollars. Why can’t they deal with people they have poisoned? It isn’t fair that the consumers suffer when they walk away and get on with their rich and healthy lives. I was never given any justice; I wasn’t given my day in court.”

During his month-long hospital stay, Brad spent a lot of time online, researching Accutane side effects. He found out that many Accutane and generic brand users started getting symptoms of ulcerative colitis, IBD and Crohn’s after being prescribed Accutane from various health care providers. “I put two and two together and found so many Accutane lawsuits,” he says. “I decided to contact an Accutane lawyer.”

Brad connected with a law firm in Newark, NJ. “They thought I had a case since so many people are suffering from colitis-- they had a huge mass tort against the generic makers,” he says. “They flew me to Newark to get my deposition. But a few months later, I was notified by the attorneys that all of our cases had been thrown out of the Supreme Court. There is a law stating that generic manufacturers cannot be held responsible for side effects and failure to warn.”

(In Mensing v Pliva-- , federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state-law tort claims.)

Brad was recently offered an Accutane lawsuit settlement. Unfortunately he was prescribed the generic version: a law firm in New Jersey offered a $3,000 settlement. Brad likens that amount to putting a band-aid on a massive wound. “I’m not sure how they arrived at that figure but I pay well over $3,000 per month just in medications,” he says. “To me that figure is an insult for a life of pain and suffering. And I might be losing my colon.”

Brad isn’t giving up. He argues that Sotret, made by Ranbaxy, the generic version he took, (others are Amnesteem (Mylan), Claravis (Barr) and Isotroin (Cipla)), is exactly the same formula as Accutane.

“I am still hopeful that I can get compensated; I believe this generic drug law is unjust and from what I have learned, attorneys are fighting both the original maker and the generic manufacturer,” he adds.

“Luckily my family and girlfriend support me. Without my mother and father I would have been in serious trouble financially.”

(In 2009 Roche pulled Accutane off the US market after juries had awarded millions of dollars in damages to former Accutane users over Accutane inflammatory bowel disease lawsuits.)

Since March 2006, the generic version of Accutane (isotretinoin) has been monitored and controlled by iPLEDGE, a website mandated by the FDA. According to wikipedia, dermatologists are required to register their patients before prescribing and pharmacists are required to check the website before dispensing the drug. A physician may not prescribe more than a 30-day supply—Brad was prescribed a four-month supply. And a new prescription may not be written for at least 30 days.