The family of a woman from Port Arthur, Texas has filed a product liability suit in Jefferson County, Texas alleging that the anti-seizure medication she took caused a fatal reaction.
Court papers say that phenytoin, a generic version of the drug Dilantin, was prescribed to Agnes Davis, who suffered a severe adverse reaction after taking the drug which allegedly resulted in her death on August 8, 2006.
Ten companies that make, label, test, market, or distribute phenytoin were named as defendants by the suit Willie Davis, Jr. and Alice Washington filed on August 8, 2008.
Davis and Washington claim that the defendants were negligence by misleading and failing to adequately warn users of phenytoin’s life-threatening side effects.
According to the suit, Davis began using the drug in June of 2006 and broke out with a high fever and skin rash that caused blisters to form on her face and body sometime later. She required hospitalization for several weeks at the Medical Center at Southeast Texas and was diagnosed with Stevens-Johnson syndrome.
MayoClinic.com describes Stevens-Johnson syndrome as a rare, serious skin and mucous membrane disorder. It typically starts with several days of flu-like symptoms, followed by inflammation of the mucous membranes and a painful red or purplish rash that spreads and blisters and eventually causes the top layer of skin to die and shed. The site says that it typically is a specific type of allergic reaction to medication or infection.
The plaintiffs alleged that the defendants were in violation of the applicable code of federal regulations through their failure to include a warning of SJS as a possible side effect.
Mylan Inc., Mylan Bertek Pharmaceuticals Inc., Mylan Pharmaceuticals Inc. Actavis Mid Atlantic, Morton Grove Pharmaceutical Inc., Taro Pharmaceuticals USA Inc., VistaPharm Inc., Barr Pharmaceuticals Inc., Ivax Pharmaceuticals Inc., Elkins-Sinn Inc., Hospira Inc., Hospira Worldwide Inc., and Baxter Healthcare Corp. were all named as defendants in the suit.
The suit alleges failure by the defendants to perform adequate testing that would have revealed the serious side effects phenytoin possessed and failure to take appropriate measures to ensure the defectively designed product not reaching the stream of commerce.