Suit Over Phenytoin Names 10 Defendants in Woman’s Death

According to court papers, Agnes Davis was prescribed phenytoin and then suffered a severe adverse reaction- <"">Stevens-Johnson Syndrome – that allegedly led to her death.  Phenytoin is a generic version of Dilantin.  The lawsuit, filed by Willie Davis Jr. and Alice Washington—Davis’s family members—on August. 8, 2008, names 10 companies that make, label, test, market, or distribute phenytoin.  Among other issues, the defendents allege that the defendants misled and failed to adequately warn users of life-threatening side effects caused by taking phenytoin.

The complaint’s causes of action include strict product liability-failure to warn and defect in design or manufacture, fraud, breach of implied and express warranties, negligence and gross negligence.  The 10 companies named as defendants are:  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., Hospria Worldwide Inc., and Baxter Healthcare Corporation.

The suit also states that Davis began taking phenytoin in June 2006.  Sometime later, Davis broke out with a high fever and skin rash that resulted in blisters on her face and body.  Davis was then hospitalized for several weeks at the Medical Center of Southeast Texas where she was diagnosed with Stevens-Johnson Syndrome.  According to, Stevens-Johnson syndrome is a rare, serious disorder of the skin and mucous membranes and often presents 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, eventually causing the top layer of the skin to die and shed.  The syndrome is usually a specific type of allergic reaction in response to medication or infection, according to the Mayo Cinic’s Website.

The plaintiffs allege that the defendants violated the applicable code of federal regulations by failing to include a warning that Stevens-Johnson Syndrome is a potential side effect of phenytoin.  “Accordingly, Ms. Davis’ prescribing physician was deprived of the ability to fully assess the risks when making the decision to prescribe the drugs due to the defendants deficient and inadequate warning,” the complaint states.  The plaintiffs also claim that Davis would not have taken phenytoin had the risks and dangers been disclosed, and “would not have suffered her adverse reaction and its subsequent complications.”

The complaint states that because the drug hazards were hidden, the drug makers “have reaped huge profits”; that the defendants failed to perform adequate testing that would have shown that phenytoin possessed serious side effects; that the defendants should have taken appropriate measures to ensure that its defectively designed product would not be placed into the stream of commerce; that prior to manufacturing and distributing the drug, the companies “had knowledge from several sources” that the product presented substantial and unreasonable risks to the consumer; that the drug makers knowingly and deliberately failed to remedy the known defects “for the purpose of increasing sales and enhancing its profits”; and that “Defendants’ conduct was wanton and willful, and displayed a conscious disregard for the safety of the public and particularly of Ms. Davis, entitling her to exemplary damages.”

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