Epilepsy is a debilitating disorder. For patients suffering from epilepsy, drugs such as Dilantin (phenytoin) can be a godsend. But some patients may suffer from lethal, debilitating and disfiguring side effects, such as Stevens Johnson Syndrome.

What is Stevens Johnson Syndrome?

Stevens Johnson Syndrome (SJS) is a type of autoimmune disorder. An autoimmune disorder is a reaction in which the immune system attacks the body’s own tissues, mistaking them for an invading germ. The reaction typically starts with a rash that escalates to blisters, then sores and ulcers. In some cases, the damage spreads to the eyes and internal organs. The worst of the reaction typically lasts weeks, though it may take months, or years to recover. Some patients have lifelong complications, including blindness, scarring, and permanent organ damage.

Much remains in question about SJS, since the disorder is relatively rare. It is known that the vast majority of cases appear to be triggered by medications. However, many people suffer from SJS after taking relatively common medications, including such drugs as Tylenol or Dilantin. A genetic component has been observed. It appears that certain genes can make a person more likely to develop SJS in response to a specific drug, but many people with these genes never develop SJS and many people without these genes develop SJS anyway.

Postmarket Surveillance Report

In 2008, the U.S. Food and Drug Administration put out a warning to patients and physicians. The warning was carefully worded, advising no one to suddenly stop taking their medication, since suddenly withdrawing from Dilantin can cause serious side effects in and of itself.

The FDA’s investigation was started by a paper published in the May 2008 issue of the journalEpilepsia. The article concluded that individuals with a certain allele were more likely to develop SJS in responses to Dilantin. An allele is a version of a gene. For example, everyone has genes for hair color. But the different versions of the gene — alleles — cause people to have different hair colors. For example, one allele could produce blonde hair and another could produce black hair. The gene researched in the Epilepsia study was called the human leukocyte antigen or HLA gene. The gene regulated microscopic features of a part of the immune system. Researchers found that one allele of the gene, HLA-B*1502 made people more vulnerable to developing SJS when exposed to Dilantin.

Follow-Up

Based on the FDA’s follow-up research and evaluation, they mandated changes to Dilantin’s labeling in 2011. The new labeling advised physicians to test patients for the HLA-B*1502 allele before using Dilantin. The FDA’s research also found that Dilantin carried a risk of several other autoimmune systems, including Eosinophilia and Systemic Symptoms (DRESS) and Multiorgan Hypersensitivity.

Legal Action

Patients who suffered from SJS have filed lawsuits against the manufacturers of drugs such as Dilantin. Such lawsuits allege that drug manufacturers were aware of these risks, and moved forward regardless, endangering patients’ lives.

This litigation may take the form of a group lawsuit, called a class action lawsuit. In a Dilantin class action lawsuit, a group of plaintiffs allege that they have suffered similar harm at the hands of the same defendants. A Dilantin class action lawsuit is intended to save time, money, and resources for all parties involved. For example, plaintiffs can pool their resources, the defendant only face a single lawsuit instead of dozens or even hundreds of individual suits, and the legal system only has to expend the time and money of hearing a single case.