March 2018 Update: Plaintiffs' lawyers have taken a beating in this litigation. But the tide may be turning. Plaintiffs have won two critical appeals, reviving 2,500 claims involving Accutane and inflammatory bowel disease and Crohn's disease.
Accutane was originally designed for the treatment of severe cases of acne. It worked. In fact, it worked so well that doctors began prescribing Accutane to treat even mild acne and other skin problems. Developed by Hoffmann-LaRoche (Roche USA), Accutane brought in billions in revenue. But after growing critics and an ever-increasing fury of Accutane lawsuits, the drug was taken off the market in 2009/2010.
Roche would not call it an Accutane recall. Instead, it would say Accutane was withdrawn or pulled from the market. In fact, they wrote us a letter - which you are free to read if you want to hear the company's lawyers' version of things - telling us that Hoffman-La Roche never withdrew, pulled or recalled Accutane from the market. You call it what you want. Functionally, it is hard to distinguish an Accutane recall from an Accutane withdrawal. Suffice it to say, this drug that was making a fortune for Roche is no longer on the market. Feel free to add two and two together.
Why was the drug taken off the market and why do we have all of these Accutane lawsuits? While Accutane solved the problem for which it was designed to treat, the hidden risks of Accutane outweighed it’s easy to see benefits. Since then, juries have found a lot of problems with Accutane awarding whopping verdicts against Hoffmann-LaRoche. Background
Isotretinoin was marketed in the U.S. under the brand names Accutane, Amnesteem, Claravis, and Sotret. It is classified as an anti-acne product but was initially developed in 1985 by Hoffmann-La Roche for chemotherapy treatments. It was later discovered that it was effective in treating severe cases of acne and was eventually marketed by Hoffmann- LaRoche for this purpose. It has since been sold globally and is being used by millions of people all over the world as a popular anti-acne treatment.
Why does Accutane treat acne so well? No one knows the exact mechanism of how Accutane works. Roche serendipitously discovered that Accutane was effective in suppressing the production of oil and waxy material produced in the skin glands. Nodular acne is the result of building sebum under the skin, which bursts through the follicle wall, causing the inflamed nodule we call acne. Again, there is no question that Accutane worked and was a better drug for treating acne than others available on the market.
Isotretinoin, the active ingredient in Accutane’s formula, is a synthetic form of Vitamin A but studies later showed that people using it were exposed to numerous long and short-term medical complications. The most notable complication is Irritable Bowel Syndrome.Irritable Bowel Syndrome - Crohn’s Disease and Ulcerative Colitis
IBD primarily refers to two diseases characterized by inflammation of the gastrointestinal tract: ulcerative colitis and Crohn's disease. Both Crohn’s Disease and ulcerative colitis are permanent conditions in which gastrointestinal symptoms wax and wane over time. Both are serious gastrointestinal diseases that lead to problems in the patient’s digestive tract which include inflammation, the development of fissures, problems with the body’s intestinal walls, and lots of other things that are just incredibly uncomfortable to talk about, much less experience. Most of the Accutane lawsuits being filed against LaRoche today are those related to the development of Crohn’s Disease and ulcerative colitis.
Most often, these conditions are diagnosed during adolescence or early adulthood, a fact lawyers defending Accutane have pointed to time and time again in Accutane lawsuits. Roche's position in IBD Accutane lawsuits is that even if plaintiffs prove general causation, that is, Accutane is capable of causing IBD, they cannot show causation in their particular case, pointing to the fact that IBD is a condition that over a million Americans suffer from.
Certainly, they are correct that there are cases where people on Accutane were diagnosed with IBD that was not caused by the Accutane. In fact, studies have found other potential contributing factor to IBD, including smoking, family history, prior history of infections, and the use of birth control and antibiotics. But it is impossible to ignore the medical literature – that is still building – showing that Accutane use is a strong factor in causing IBD. In fact, it is more likely than not, some experts argue, that a patient with IBD who took Accutane developed the IBD from Accutane in the absence of any other evidence to support an alternative hypothesis.Stevens-Johnson Syndrome
Accutane is so effective in treating acne inflammation because of its profound effects on the skin. These changes are so drastic that it leaves people at high risk of developing serious skin conditions. Stevens-Johnson Syndrome is a severe skin reaction that results from exposure to medications. It is a fatal and debilitating skin condition which is characterized by burning sensations, blister formation, rashes and in some cases separation of skin from the body. (More on Stevens-Johnson Syndrome.)Suicide
In 1997 at the latest, Roche began discussions of a warning for suicide as a side effect of Accutane use. Roche's U.S. Marketing Division did not approve the idea of a label change because they knew it would scare doctors prescribing Accutane and decrease sales. They were right. And for a long time marketing won out. Eventually, a weak warning label was added to Accutane indicating that suicidality was a “rare” side effect.Accutane Alternatives
Accutane was first introduced in 1982 and has been the standard for acne treatment for people suffering from severe inflammatory acne. It has become the most popular choice for treatment due to the pace at which results can be seen. But, given the risks, a drug other than Accutane would have been a better choice for a lot of patients. There are alternatives to Accutane that are effective in treating severe inflammatory acne. They include benzoyl peroxide, antibiotics, and hormone therapy. They may not be as fast-acting as Accutane but they don’t have the same life-altering risks.Accutane “Recall”
Medical studies have confirmed the link between the development of severe side effects and Accutane treatment. These have prompted Roche Pharmaceuticals, makers of Accutane to issue an Accutane withdrawal/recall. Thousands of lawsuits have been filed and are currently under mitigation because Accutane use results in severe medical conditions that affect a person’s quality of living. These medical conditions include a high risk of suicide, seizures, bone degradation, heart attacks, and strokes. A majority of these lawsuits cover common serious side effects such as those seen relating to the digestive tract such as Crohn’s disease and Ulcerative Colitis.Accutane Lawsuit Settlements and Verdicts
Dozens of medical studies have reviewed the connection of isotretinoin in the development of Inflammatory Bowel Disease, Ulcerative Colitis, and Crohn’s Disease. Several medical studies have identified the positive correlation of Isotretinoin use and the development of bowel diseases. As a result, there has been a lot of personal injury Accutane lawsuits filed against Roche. The suits allege that Accutane treatment has resulted in serious medical conditions related to gastrointestinal disorders.
Candidly, lawyers have looked more closely at Accutane lawsuits because it is clear that juries are not happy with Accutane after hearing all of the evidence. Some of the cases have already gone to trial and have resulted in significant judgments. In February 2010, Roche got hit with a $25 million verdict in a case where the Plaintiff developed inflammatory bowel disease after undergoing Accutane treatment. The Plaintiff had taken Accutane for acne during his 20’s but later developed an inflammatory bowel disorder. He sued Roche Pharmaceuticals for failing to warn him of the possible side effects of Accutane. This case has been reversed on appeal but the point this jury and others have made is clear: to say the least, mistakes were made in the marketing and labeling of Accutane.
Here are some other sample Accutane verdicts:
- New Jersey: $25,160,000 - Interestingly, this result came after Roche appealed at $2.69 million verdict. Sometimes you have to be careful what you wish for. Of course, the $25 million dollar verdict has been overturned as well. What will the next verdict be?
- New Jersey: $!0.5 million (also reversed in August 2010)
- Florida: $7 million (also reversed)
Sure, these verdicts have been reversed on technical battles over the admissibility of evidence. But seven jury verdicts over $1 million? This is not an evidentiary problem. Juries simply don't like what happened here. (Oh, at Hoffman-LaRoche wants us to point out they won some of these cases too.)Filing an Accutane Lawsuit
Our law firm is not taking new Accutane claims and there are few lawyers who are still taking Accutane lawsuits. Why? Clearly, many of the pending lawsuits may well be viable claims. The problem is the statute of limitations. There are few remaining potential claims because the drug has been off the market for many years. There are exceptions to these laws so if you believe you have a potential Accutane lawsuit, you want to call a lawyer quickly.