Generic Dilantin Lawsuit Filed Over Stevens-Johnson Syndrome Reaction

A Georgia man has filed a Stevens-Johnson Syndrome lawsuit over generic Dilantin, alleging that he developed the painful and debilitating skin reaction after taking the medication for treatment of a seizure disorder.  

The Dilantin lawsuit was filed by Charles Henderson of Rome, Georgia, on March 8 in the U.S. District Court for the Northern District of Georgia. The complaint names various generic drug makers, including Sun Pharmaceuticals Industries, Ltd., Caraco Pharmaceutical Laboratories, Ltd., Hospira, Inc., UDL Laboratories, Inc., and Mylan Pharmaceuticals, as well as some of those companies’ subsidiaries, as defendants.

Henderson alleges that he developed Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) after taking generic Dilantin and generic fosphenytoin, a prodrug that the body turns into Dilantin once ingested.

Stevens-Johnson Syndrome, commonly referred to as SJS, is a painful and debilitating reaction that has been linked to side effects of Dilantin. It can cause the skin to burn, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions from SJS affect more than 30% of the body, the condition is typically 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, which is also available as a generic. In November 2008, the FDA issued a warning about the potential risk of Stevens-Johnson Syndrome from Dilantin and Phenytek. Pfizer is not a defendant in the lawsuit, since the plaintiff only took generic versions of the drug.

According to allegations raised in the lawsuit, the FDA’s adverse event reporting system has logged more than 1,000 cases of SJS from Dilantin, including 139 Stevens-Johnson Syndrome deaths where Dilantin was the primary responsible drug and 188 deaths where it was the secondary or concomitant drug reported. The World Health Organization (WHO) has found that SJS and TEN have a mortality rate of between 30-80%. 

Henderson’s lawsuit argues that, given the high rate of SJS linked to generic Dilantin, the drugs should carry a black box warning about the risk of Stevens-Johnson Syndrome from Dilantin to properly warn consumers of the health risks. It also claims that the warnings on the label referring to the risk of skin reactions as rare is inaccurate. 

A number of similar Dilantin Stevens-Johnson Syndrome lawsuits have been filed by users of the drug who suffered from the horrible side effect. It was reported last year that one Dilantin wrongful death lawsuit brought by the family of a 9-year old girl who developed Toxic Epidermal Necrolysis resulted in a $3.78 million settlement with Pfizer, Inc.

Charges in the lawsuit include failure to warn, defective design, fraud, breach of warranties, negligence and seeks both compensatory and punitive damages against the companies.