Products Liability
This page is about the Accutane litigation which began with great promise but ended in disappointment for victims.
Accutane Litigation Updates
This Accutane litigation ultimately failed for victims. We know of no lawyers currently taking Accutane mass tort cases (although that does not mean they do not exist)
2024: In 2024, Clear Health introduced a Microdose Accutane Protocol, offering low-dose isotretinoin regimens for individuals with milder acne. This approach aims to provide effective treatment while minimizing common side effects associated with higher doses. Studies have indicated that low doses of isotretinoin can lead to similar levels of acne improvement as conventional doses, with a reduction in side effects by 16% to 35%.
2023: the FDA updated the iPLEDGE program for isotretinoin to improve accessibility while maintaining safety. Key changes include allowing home pregnancy tests, eliminating the 19-day lockout period for missed prescriptions, and reducing monthly counseling requirements for patients not at risk of pregnancy to a single session at enrollment.
2020: Speculation this is the final blow to the Accutane lawsuits.
2019: New Jersey high court dismisses 514 cases pending in New Jersey. This litigation is fading away fast. This litigation had some great verdicts but, sadly the science to make these cases still lags.
2018: 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.
2017: Several state courts, including those in Florida and New Jersey, dismiss large numbers of cases, ruling that plaintiffs failed to provide sufficient scientific evidence to link Accutane to Crohn’s disease and ulcerative colitis.
2015: Hoffmann-La Roche successfully appeals some large verdicts, including multi-million-dollar judgments for individual plaintiffs, by challenging the reliability of expert testimony and scientific causation.
2012-2014: Juries award several large verdicts to plaintiffs who alleged that Accutane caused severe gastrointestinal problems, including IBD and ulcerative colitis. The largest verdicts include awards exceeding $10 million, though many are later reduced or overturned on appeal.
2010: Roche pulls Accutane from the U.S. market, citing financial concerns and the mounting cost of defending lawsuits. However, the drug remains available under other brand names internationally.
2008-2009: Accutane mass tort litigation begins to build, with thousands of lawsuits filed across multiple jurisdictions. Plaintiffs allege that the drug caused IBD, Crohn’s disease, and severe psychiatric side effects, including suicide ideation and depression.
2005: The FDA issues updated warnings about the risks of psychiatric side effects linked to Accutane, including depression and suicidal thoughts. These warnings become a focal point of future litigation.
2002: The FDA adds a “black box” warning to Accutane regarding the severe risk of birth defects if taken during pregnancy, leading to the creation of the iPledge program to prevent use by pregnant women.
Accutane
Accutane was originally designed for the treatment of severe cases of acne. It worked. 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. 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 its 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. Studies have found other potential contributing factors 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. 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 that 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.
Other Side Effects of Accutane
Accutane, while highly effective for treating severe acne, has been associated with numerous severe and life-altering side effects. These side effects have been at the core of the litigation against Hoffmann-La Roche, as they raise concerns about whether the drug’s risks outweigh its benefits. Below are the primary categories of side effects linked to Accutane use:
- Psychiatric Side Effects
There is evidence connecting Accutane to psychiatric issues, including depression, anxiety, and suicidal ideation. These risks were not initially highlighted, and Roche faced criticism for delaying stronger warnings on the drug’s label. Over time, suicidality has become a well-documented concern for patients taking Accutane. - Teratogenic Risks
Accutane is highly teratogenic, meaning it causes severe birth defects if taken during pregnancy. This risk led to the FDA implementing the iPLEDGE program to prevent pregnancies in patients taking isotretinoin. However, even with safeguards, the risk of devastating birth defects remains a major concern. - Other Long-Term Effects
Patients have reported bone density loss, joint pain, and even severe conditions like pancreatitis and liver damage linked to long-term Accutane use. These risks were not adequately communicated in the early years of the drug’s use, contributing to its eventual removal from the U.S. market.
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 life. 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.
History of Accutane Lawsuits
As early as the 1980s, patients began filing lawsuits against Roche alleging that Accutane had caused them to develop IBD. Over time, the number of Accutane lawsuits increased, and by the early 2000s, close to 8,000 lawsuits had been filed against the company.
Accutane Class Action
To handle the growing number of cases, judges began consolidating them into multidistrict litigations (MDLs). In 2002, the Accutane MDL was created in the Middle District of Florida, under MDL No. 1626. This MDL ultimately numbered over 8,000.
Over the next several years, the MDL proceeded with pretrial proceedings, including discovery and expert testimony. However, in 2007, U.S. District Judge James Moody dismissed all the federal Accutane cases, ruling that the warning label on the drug was adequate. This decision effectively put an end to federal lawsuits against the manufacturer.
New Jersey Litigation
After the MDL dissolved in 2015, most of the remaining Accutane cases continued in multicounty litigation (MCL) in New Jersey under MCL No. 271. Initially, as we detail below, juries ordered Roche to pay millions to patients. Which made a lot of lawyers really bullish on the Accutane litigation. But appellate judges did not buy in and overturned those verdicts.
Plaintiffs got some momentum back in in 2017 when an appellate court reinstated more than 2,000 cases that had been dismissed by the New Jersey MCL judge two years earlier. But in 2018 the New Jersey Supreme Court ruled that two critical plaintiffs’ expert witnesses would not be allowed to testify. This made litigating the few remaining Accutane lawsuits impossible to litigate because the case needed an expert’s testimony connected the drug to IBD and Crohn’s disease.
Ultimately, the New Jersey Supreme Court dismissed 532 failure-to-warn cases in October 2018, ruling that the warnings provided physicians with adequate information to warn their patients of the risks of IBD. This decision effectively brought an end to the Accutane litigation.
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 a positive correlation between Isotretinoin use and the development of bowel diseases. As a result, there have 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.
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 20s 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 a $2.69 million verdict. Sometimes you have to be careful what you wish for. Of course, the $25 million 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)
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 didn’t like what they saw. But again, to get to a jury, you need judges will to let a jury hear the claim.
Filing an Accutane Lawsuit
Our law firm is not taking new Accutane claims and few lawyers are still taking Accutane lawsuits. Why? The first 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.
But, larger picture, by 2023 and 2024, it became increasingly clear that the scientific support for the plaintiffs’ claims remained insufficient to sustain large-scale litigation. Every law firm we know of has stopped taking on new Accutane lawsuits. A few generic isotretinoin-related claims have persisted when we last checked, but they face an uphill battle due to previous legal losses and the challenge of linking the drug to serious medical conditions like inflammatory bowel disease.