What Do Ulcerated Colitis, Crohns Disease and Acne Have in Common?

The short answer is Accutane.  The generic name is Isotretinoin.  The brand names went under the following: Accutane, Amnesteem, Claravis, Decutan, Izotek, Oratane, Roaccutane, and Sotret.

Background on Accutane

Accutane came into general use in the early 1980s.  It was accidentally found to help in the treatment of acne but originally designed to be used as a type of chemotherapy to treat certain types of cancer.  It is a form of Vitamin A, which reduces the amount of oil released by the oil glands in your skin and helps renew the skin more quickly.  When it was discovered that it helped with the treatment of acne, the manufacturer, Hoffman-La Roche, launched an aggressive marketing campaign promoting the drug across the country. It then came into wide spread use with teenagers.  The only real warning that was promoted was that girls should not take any Accutane if they were pregnant.  Some doctors insisted that girls go on birth control to prevent the known side effects of birth defects.

Depression also became a known side effect, leading in some cases to suicide.

Warnings were put in place by the U.S. Food and Drug Administration this decade because of the large number of reported psychiatric disorders in those exposed to Accutane.  According to the FDA, Accutane ranks high in reports connected to depression compared with all drugs listed in the FDA’s Adverse Event Reporting System (AERS). There have been numerous reported cases of depression and suicides of people who were taking, or had taken, isotretinoin. Some of these suicide cases occurred within three months after the patient had stopped using Accutane.

Other Accutane Side Effects

Very little was made of the other side effects.  Very little, if any, warnings were made as to Inflammatory Bowel Disease (IBD).  This became a known side effect. There were studies conducted that confirmed the link to some IBDs.  Some of the studies have been ignored, or discounted, and in some cases, the courts have not allowed for the introduction of these studies into evidence.

Accutane and Ulcerated Colitis, and Crohns disease

The typical Inflammatory Bowel Diseases that are linked to Accutane are Ulcerated Colitis, and Crohns disease.  Ulcerated Colitis is a form of IBD that affects the large intestine (colon) and rectum.  In some cases a person’s colon and rectum are removed and replaced with a bag that collects the waste. This is a life long issue.  Cases with similar results have resulted in very large jury verdicts for the plaintiff.

Symptoms with Ulcerated Colitis

The symptoms associated with Ulcerated Colitis are stomach pain and cramping, stomach sounds such as gurgling, diarrhea, fever, rectal pain, and weight loss.  There may also be bleeding, joint pain, and nausea.

What is Crohns Disease?

Crohns Disease occurs when the lining and walls of the intestines become inflamed, and ulcers develop.  It can occur in any part of the intestine, but it frequently occurs in the lower part of the small intestine, generally where it joins the colon.  When this inflamation occurs, it often bleeds, and thereby prevents the rest of the body from absorbing the nutrients from digested food.  The associated symptoms are similar to those with Ulcerated Colitis. That is, one has stomach cramps/pain, diarrhea, fever, and weight loss.  A person then seems to tire easily, and loses their appetite.  People may also develop problems in other parts of their body, such as joint pain, skin rashes, and eye problems.  They may also be susceptible to infections, and may develop abscesses in their intestines.  Treatment can be significant.

Convincing a Jury is not easy with Accutane

Linking the use of Accutane to these problems is not always an easy task.  The first problem is convincing a jury or the defendant that you took Accutane in the first place.  This is not as easy as one may think.  Although a person’s testimony may be enough, it is preferable that records from the doctor be obtained.  Or one might get the records from their insurance company, if insurance was available, or perhaps from the drug store, where the Accutane was obtained.  The next hurdle is linking the use of Accutane to the health problem.  In general it is helpful if the onset of the symptoms occurred within 5 years of the consumption of the Accutane.  Here again the records from the treating doctors are helpful.

Accutane was pulled off the market in or around 2009.

Since much of the use of this drug occurred in the 1980s, 1990s, and early 2000s, getting records from many years ago can present problems.  Doctors don’t always keep records going back decades, thus presenting problems in not only proving the use of Accutane, but also in proving the onset of the symptoms.
Finally, and perhaps the most significant issue is proving the link of Accutane to the IBD, and other issues.  This is where experts are used, along with medical studies, etc.  This is not always an easy task, and some courts create significant problems for the plaintiffs.

Failure to Warn

The primary theory of recovery against the manufacturer is the failure to warn.  That is, did the manufacturer provide adequate warnings of what it knew, or should have known about potential side effects.  This again can be a problem for those cases where the use was very early on, perhaps in the very early 1980s.  Cases where the consumption was after 1992 are easier to prove knowledge on the part of the manufacturer.

As is generally the case, the retention of an Accutane Attorney early on is important.  There can be statute of limitation issues, discovery issues, and problems in the obtaining of records, etc.