Stevens-Johnson Syndrome Lawsuit Over Generic Dilantin Use Filed

A lawsuit over Stevens-Johnson Syndrome has been filed against Mylan Pharmaceuticals by a Texas man who says that side effects of generic Dilantin caused him to suffer a life-threatening skin reaction. 

The lawsuit was filed by Juan Morales on April 22 in Kanawha Circuit Court in West Virginia. Morales developed Stevens-Johnson Syndrome from generic Dilantin (phenytoin) he was prescribed in April 2008. He was hospitalized at Corpus Christi Medical Center by May 22, 2008, after developing a severe rash that covered most of his body.

Stevens-Johnson Syndrome (SJS) is a severe skin reaction that can occur as a side effect of several medications. It is highly debilitating and causes the skin to burn from the inside out, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.

Dilantin (phenytoin) is an antiepileptic drug manufactured by Pfizer. Mylan makes a generic version called Phenytek which is considered bioequivalent. In November 2008, the FDA issued a warning that Dilantin and Phenytek carried a risk of Stevens-Johnson Syndrome.

Morales is suing Mylan for failing to warn of the dangers and for selling a defective product. He claims in his lawsuit that had he known there was a risk of Stevens-Johnson Syndrome he would not have taken the medication. He is seeking compensatory and punitive damages of an unspecified amount.

Along with Mylan, the lawsuit lists unknown corporations and several “John Does” as defendants.