Accutane settlement

In a nutshell, back when I was 15 - 16 years old my occasional acne got worse so got an appointment with a Dermatologist recommended by acquaintances (private consultation). She prescribed Roaccutane after a blood test to verify that it wasn't risky for me (not sure what she was looking for in the blood results, but it was determined I was eligible). After very few days on Roaccutane my acne gets much more worse, so I get another appointment with the derma. When she sees me she cannot hide her horrified reaction (by when the consultation happened the acne had gotten much worse, my whole face was swollen and red and it was all pimples, barely unaffected skin). She determined it was a very bad reaction to Roaccutane but determined too that I should carry on taking the pills (of course, by then I had stopped). She recommended some additional care and treatment to apply on the skin, too. Looking for a second opinion went to a very good reputed clinic in Spain and they determined the same: the harm was already done, it was worth to keep taking Roaccutane and applying some palliative care over the skin.
Bottomline, I took Roaccutane for 6 months after that. It was after those 6 months that my face went more or less back to "normal" in terms of inflammation, redness and deep pimples. The result? deep scarring among my whole face and suicidal ideation during the treatment, probably fueled by the fact that I was looking like a monster during the whole thing and in the midst of my teenager years (still had to go to high school, so those months were horrible the least).
Didn't think about it a lot afterwards, but after coming across some press articles on Accutane lawsuits and settlements, I am wondering if there's actually something I can do about it now, more than 15 years later. The scarring is still very visible despite using AHA, Retinol and others during many years. As I mentioned above it all happened in Spain. Thanks for reading and any potential advise.

So I've done some research on litigation and it seems like the courts have maybe ruled in some states that the manufacturer of this drug is not liable for compensation to those that have also developed IBD issues, and it seems settlements have been reached too. The drug I took was called Claravis which is another drug that's generic name is called Isotrentinoin I think. Basically accutane.
I took is for like 8 months for accutane and about 2 months after at age 31 developed IBD. Presented at Ulcerative Colitis, but then due to perianal disease with fistulas and abscesses, changed diagnosis to Chron's Disease. Again anecdotal data, but seems like there have been many claims of linkages to IBD. The literature I've reviewed and lawsuits that's Roche, the maker of accutane, had dismissed, indicate there is no proven link. I think it falls short of statistically significant from the few data and studies out there.
So anyway, battles this for 3 years, have stopped working due to frequency and urgency in bathroom. Just got my colon out and will be living with colostomy forever. High chances will need revision to ileostomy at some point. Getting my rectum and anus out later this year.
I think I'll overcome this and get back to life eventually. I just feel that the warnings I was presented did not emphasize the IBD risk well. It might have just said possible gastrointestinal issues.
My question to you all is I'm having trouble figuring out best way to approach a consult to see if there might be anything worth considering to pursue. I do not want to go after my previous doctor at all. So should I just go to my state (SC) bar referral service, or is there a national law firm that is known for handling and possibly settling cases like these that you all are aware of?
When I research it, it seems like there's a lot of SEO and fake blog articles for law firms just to get you to contact them. I figure there's only a handful of players in this space worth talking to. I'd be willing to front some of my own money if a lawyer though I had a strong case if needed. Could probably afford up tp 50k. Thanks for the advice :)

So I want to have a consultation with a lawyer on my development of severe perianal Crohn's disease right around the time I was taking Isotretinoin (same thing as Accutane, but a different brand). I have no interest in medical malpractice against my previous dermatologist at this time, however I feel that the company that made the medication and the iPledge program/waiver may have not communicated the gastrointestinal risks well.
What type of lawyer should I reach out to? Do I need to stick to one in my state? I stopped taking the medicine about 3 years ago, my issues presented shortly after, and I was diagnosed with IBD about 2.5 years ago. My condition has continued to develop and get worse and I've had 2 surgeries already due to fistulas. I know correlation does not equal causation and the literature might suggest (i.e., approaches significance) but there hasn't been many studies showing statistical significance between Isotrentin.
I'd still like to get a consultation just in case I'm missing something where my case has merits as I approach potential statute of limitations. It gets messy I understand as when I started taking the medication, to when my symptoms first developed, to when the full extent/impact of my disease is known might all be considered when the clock starts ticking there. The latter I'm unsure when that will be as I may have issue returning to work if the surgeries don't go well or cause my anal fistulas and abscesses to get under control and be manageable. Still TBD obviously until after my surgeries.
I am at the end of medical therapy options and will likely get a colectomy with end ileostomy and then a proctectomy next year. I've had to stop working and have qualified for SSDI.
I'd prefer to reach out to a lawyer that has had success in these types of cases, but I can't find much information online on litigation. Some information on state/history of litigation on this topic I found:

• Accutane Lawsuit
• Accutane Lawsuits: What’s Happening Now?
• NJ Supreme Court Ends Accutane Cases in a Significant Opinion Addressing Adequacy of Warning in Pharmaceutical Product Liability Litigation
• Accutane Lawsuits
• Inflammatory Bowel Disease and Isotretinoin: Litigation Concerns

Anecdotes from Reddit:

• gardenshow - i regret taking accutane
• yael24 - [Acne] Confusion about accutane and crohns
• crhaxter - "My Gastroenterologist is convinced that the accutane is what started my GI issues"
• ElementK - "I took accutane, and I was diagnosed with Crohns a year after I got off it"
• milkyturtle - "My boyfriend got crohns from taking it"
• deleted - Well fuck. I may have found the cause of my UC.
• ohfaith - Diagnosed with Ulcerative Colitis after taking Accutane
• accucrap - I took Accutane for a year and now have Irritable Bowel Syndrome (IBS) AMA

Is there a way to search for litigation related to this drug and if anyone has had success at trial? What about records of settlements? I imagine they're not public so contacting a bunch of firms might be best? Perhaps I can join an existing or soon to be filed class action? It seems many of the cases were against Roche (maker of Accutane) and filed in NJ and have been appealed and dismissed up the chain -- so maybe I've missed any chance of litigation and most firms are turning away my types of case?
If it does, however, seem my case has merit and good probability of compensation after consultations, I'd prefer something on contingency, but would probably be willing to pay some now. If you do a Google search, you find a ton of firms that offer to take you on for Accutane and IBD links. I'd rather not rely on Google SEO and I wouldn't be confident of getting the best representation for my unique possible case from my state bar's referral service. Especially if I should be finding an out of state firm, joining an existing suit, etc.
Can you all point me in the right direction on my next steps, if there are big players I should contact, or if maybe pursuing this is likely futile? Not looking for legal advice at all, just hoping to get more advice than the generic contact the bar referal service. Thank you!

Link to the blog
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Biopharma/Investing ————————– GSK acquisition of TSRO is very value-destructive and weakens faith in new GSK management. For $5bn, a drug that is a 50/50 to reach $500 million is quite the price tag.
GBT is probably a better long “up here” than before. The risk of an approval is gone. Commercial risks remain with Novartis’ drug seemingly superior in efficacy. A combination study would be wise. The market is big enough for both, though. I see GBT trading over $100 sooner or later.
DEEP DIVE – CELGENE – PRICE TARGET: $91.00 ——————————————————– Revlimid (lenalidomide) is 2/3rds of Celgene’s revenue, with $10 billion in revenue expected for this year. The composition of matter patents on Revlimid expired (the IND for Revlimid was filed in 2000), as Revlimid is simply a derivative of Thalomid (thalidomide). We will spend some time on the indole-pyridine scaffold of thalidomide. While the structure of Revlimid is very similar to Thalomid, the drug does have some advantages over its predecessor. Nevertheless, nearly 30 patents which “protect” Revlimid will likely be found invalid or not infringed by would-be generic entrants. The first entrant, NatCo (partnered with Teva), has settled with Celgene for a partial distribution deal starting in 2022. The strongest patent is the ‘800 polymorph patent, expiring in 2027. NatCo is allowed a full launch in 2025, with their 2022 “low-single-digits” participation in Revlimid growing to one-third in that year. This would have been a fairly good deal for Celgene if no further ANDAs were filed. But when you have the world’s second best selling drug, you can count on competition. Dr. Reddy’s is at the plate as we speak, with expert discovery concluding in the near future and a trial likely for late 2019 or early 2020. More importantly, their 30-month stay will expire in late 2019. So, how strong is a polymorph patent? I initially felt that Celgene would have a very low likelihood of prevailing at trial, and their Natco settlement indicates weakness. Further research revealed polymorph patents do occasionally prevail, and I believe Celgene has a roughly 50-50 chance of having the patent upheld. The details of the ‘800 fight are beyond the scope of this review, but take a look at the docket and some case law in polymorph patents–many white papers are available. After Dr. Reddy’s, 5 more ANDAs have been filed: Zydus, Cipla, Lotus, Apotex and Sun are all waiting in the wings. Ultimately, there isn’t enough Revlimid to go around for Celgene and the generics. The Natco settlement worked for one company, and there is enough room for Dr. Reddy’s, but ultimately Celgene will not be able to settle every generic as each subsequent filer finds each subsequent settlement offer less attractive than a trial. Imagine being the fourth ANDA here–do you really want the 3.5% of Revlimid starting in 2024 and up to 2025 but nothing if the patent is overturned in the future? Someone will break ranks and go to trial and overturn what is probably a flimsy patent. So, I have 2019 revenue of Revlimid at $11.5b, 2020 at $12.7b and 2021 at 50% of that: $6.3b, 2022 at $3.5b. Someone launches in 2021 is my best guess. One year later adds roughly $10 per share, so risk is weighted to the upside (probably) here. The three remaining points on Revlimid are the success of generics, replacement by the IMID portfolio and recent data. Revlimid generics may not do so well, commercially, from the outset. Somewhat like the dynamics of a biosimilar, I predict that the first generic entrants for Revlimid may not find the marketplace too easy. Revlimid’s REMS program has a lot of mindshare with doctors and their assistants–switching to a Dr. Reddy’s program may not be facile and the near 100% generic switch rates we see with oral solids may not take place here. See Clozaril and Accutane for historical reference. Revlimid is still alive, with the AUGMENT data showing remarkable efficacy. AUGMENT is actually a bad thing, I think, for Celgene, as it takes the wind out of potential NHL data for avodomide and iberdomide, the two named “IMID” follow-ons. If I wanted to transition revenue to those drugs, I’d delineate and differentiate them from Revlimid. Instead, we see Revlimid is potent in R NHL with Rituxan. So, where do we go with iberdomide and showing how it is different from generic Revlimid? It may not matter as clinical data you can see is better than hypothetical differences, but if I had my druthers I’d have saved non-MM/MDS for the follow-ons. I have no revenue at all in my model for the next-generation IMIDs. Part of the reason for that is they share the indole/pyridine scaffold. They are the same-old structure of thalidomide, which is really disappointing. A direct cereblon modulator should be doable at this point, and even Novartis has created such molecules. Again, I’m being conservative, but perhaps for good reason. Pomalyst is also a thalidomide derivative and is relying on a polymorph patent. I have it going away in 2023. It is remarkable that practically the entire company is disappearing in a few years. The pharmaceutical world has never seen such a dramatic patent cliff combination in its history. Otezla is also a thalidomide derivative, with a sulfonamide decoration which makes it a PDE4 inhibitor. It also relies on a weak polymorph patent, and there are many ANDAs on file, just like thalidomide, lenalidomide and pomalidomide. I suspect generics will enter in 2023, if not sooner. Abraxane is going generic soon too. Like I said, the entire company disappears in a few years.
So, to counter the record large simultaneous patent cliffs, you have to build the world’s best pipeline, right? Celgene has tried their best, but nothing will replace the nearly $20 billion in peak sales that will be lost to generics. Ozanimod, luspatercept, lis-cel, BCMA CART, and fedratinib make my model and only reach about $6 billion in revenue for “the new Celgene”. This is still enough, as its growing and promising revenue that is conservatively forecast (could be $10 billion if everything goes right). But make no mistake, there is absolutely no way Celgene survives the patent cliff as we know it. Ozanimod is the tortured S1P acquired from Receptos. I have it peaking at $1.6B and this is my most conservative forecast. It is possible ozanimod does far, far better than this. There are some other S1Ps, with Novartis actually having beaten Celgene’s refiling of ozanimod with their next-generation of Gilenya (fingolimod), siponimod. Still, with $4 billion of Gilenya sales despite a toxicity profile that shocks the conscience, it is blue skies for the fumbling ozanimod. Assuming approval in 2020, they won’t have much time to replace very much of Revlimid, but they might be able to soften the blow if they execute well, which I suspect they will. I model $1.5B in net revenues from all BCMA CARTS (Juno and Bluebird). This might be conservative as well, but with the rapidly changing environment, it is hard to be confident of any CART revenue projections. Competition abounds from all fronts, CART and non-CART, so who knows if the numbers are accurate or not. Again, I tried to keep risk skewed to the upside. There are many that feel this paradigm shift will be a $5 billion+ opportunity for EVERY player. It is possible. The 80% response rates seen at ASH are remarkable for such late-stage patients. The 50-50 with Bluebird limits some revenue potential, however. I model $1.0B for luspatercept, net of Acceleron’s share. This drug isn’t a miracle as the ASH data shows. It is still very good, and will change the lives of many MDS patients. Where can you price it though? You’re trying to wean people off of RBC transfusions and there are other options potentially coming. Some feel this will be far larger than I think, but the XLRN stock price is perhaps telling us something different. My numbers could be conservative here as well. I only model $900m peak for lis-cel. I am a CART bear and I think drugs like MorphoSys’ will be seen as preferable. CART reminds me of Zevalin. You can squeeze out a tiny bit more performance relative to the mab, but is it worth it? Plus, you have Allogene and others making better CARTs. I’m just not ready to have $3B+ forecast for no reason. If Yescarta puts up a few more good quarters, perhaps a revision to $1.5B may be necessary. Again, conservative in most places, but I think I’m right on here. Fedratinib: I don’t get this one. I see $400 million peak sales in the Jakafi-dominated myelofibrosis/PV indications. This isn’t going to be a blockbuster.
Celgene still has a few years before “impact” and that is really important. With $25B or so of high-margin Revlimid revenue prior to expiry to deploy, and $40B or so if you count pre-full cliff of Rev+Pom+Otezla, there is plenty of capital to do a few more deals. They passed on Tesaro, which is a good start. Celgene has generally been pretty good at BD. The Acceleron deal is a good example (signed for $25 million if I recall correctly). The Juno deal makes me nervous that they’re feeling desperate, but there is still plenty of firepower for acquisitions. A few smart deals will not save Revlimid, but they don’t need to. We’ve all digseted the impact of the cliff and what is important is to value the copious cash flows between now and then, and value the “stub” remainder that the pipeline represents. It’s worth a lot, more than the current fear-based stock price of $71. If you believe my nervous nature was too conservative on all the pipeline, the stock is probably worth $100 or $110 or perhaps more if they can execute Revlimid flawlessly. With Revlimid lasting a bit longer than I think and just one drug like ozanimod surprising to the upside, you could get $120 or $130 out of the stock. For such a big company, that is an attractive return. However, a dud of an acquisition (Tesaros abound) or further buybacks make the risk profile uncomfortable. Celgene has a gun against their head and most management teams are not known for patience during shareholder pain.
Papers I’ve Read ——————– Timing the Landmark Events in the Evolution of Clear Cell Renal Cell Cancer: TRACERx Renal. Thomas J. Mitchell, et al. Cell 173, 1-13, 2018. Workers here did serial biopsies of ccRCC progression and unveil some interesting findings. First, mutations in UTR region of TERT abound. Next, a tiny clonal population of the 3q deleted region found in this disease of just a few hundred cells can give rise to the visceral tumor decades later. Really cool work and likely to be therapeutically relevant as we screen for these chromothrpsis-bearing patients.
Activity-based E3 ligase profiling uncovers an E3 ligase with esterification activity. Kuan-Chuan Pao, et al. Nature 2018. Fancy footwork in this paper to discover an E3 ligase that ubiquitinates atypical substrates.
A direct link between MITF, innate immunity, and hair graying. PLoS Biol 2018. Harris ML, et al. Harris & colleagues do a nice job of showing the innate immune system impact on hair graying. We’ve seen similar work in alopecia and vitiligo, so here comes Rituxan for balding! Jokes aside, this was impressive work, using poly(I:C) to simulate infection. Actual infection would have been interesting, but probably not necessary. The MITF-inteferon connection is made plain here by the researchers.
Personal ———– My tooth abscess still bothers me from time to time. I am almost done with my course of amoxicillin. Fans, friends and family: Please give Trashy a good life if you don’t hear from me!

About 9 years ago I was prescribed Accutane haphazardly by a dermatologist. Other routes should have been taken before resorting to such a hardcore drug for cystic acne but being a 13 year old with only a pamphlet of the positives, and a few of the lesser negative side effects shown it sounded like a miracle drug. None of the rare side effects were shown or explained though...
At 20mg per day at two weeks I was beginning to see a decrease in acne pop ups but had began to feel a slight on and off gut ache. At the middle of week 4 I was experiencing bouts of dark bloody stool and eye irritation. I immediately stopped using the substance and contacted my dermatologist. I quit all acne medications after that mess.
The next 4 years I dealt with on and off heavy depression with slight suicidal thoughts throughout the first year. The depression would later come back again in my senior year as well as the beginning stages of college.
For about the last 5 years I have been experiencing a moderate accent into visual snow which has lead to mental fatigue and photophobia in heavily lit areas, as well as difficulty reading extensively on the computer. The most recent accession has added a residual fading rainbow plasma leftover of whatever I was just intently looking at.
I was looking at the visual snow wiki and noticed that inflamed optical nerve was one of the potential causes which sparked my interest in relation to my eye irritation. While there was nothing pointing to accustom there, on the photophobia sub page within the visual snow page Accutane was listed as a known cause of photophobia.
Knowing that eye irritation, bloody stools and depression can all be caused by systemic inflammation I knew I had to check the side effects of Accutane. Bingo. https://www.drugs.com/sfx/accutane-side-effects.html
Common -"burning, redness, itching, or other signs of eye inflammation" "scaling, redness, burning, pain, or other signs of inflammation of the lips" "skin infection or rash" "bleeding or inflammation of the gums"(correct me if I'm wrong. It the optic nerve runs through there yes?)
Rare-"Abdominal or stomach pain (severe)" high pain tolerance might have made it slight "blurred vision or other changes in vision" "pain or tenderness of the eye" "mental depression" "attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)" "rectal bleeding"
All among many other symptoms both common rare and rarer that all seem to revolve around hardcore inflammation of the bones, muscles, and organs including prominently the eyes, skin, brain, and the digestive systems at large....
I now believe that Accutane very well could have caused all of my symptoms. While visual snow remains a constant reminder of the dangers of such drugs that mimic complex bodily vitamins, I am extremely thankful I haven't contracted any form of ulcerative colitis or its lower counterpart irritabal bowl syndrome {of which are both heavily related to inflammation and both sides have led to numerous multi million dollar settlements against the manufacturer of Accutane.
TL;DR - Accutane a once common drug for severe acne was pulled from the main market for being too dangerous for causing various forms of systemic inflammatory issues leading to potential long term diseases. The eyes as well as the gums and jaw are some of the prominent areas for us since Inflamed optical nerves cause visual snow (among other causes)