Suit claims improper warning on seizure drug caused woman's fatal skin disorder

By Marilyn Tennissen | Aug 11, 2008

Keith Jensen

The family of a Port Arthur woman claims the anti-seizure medication she took caused a fatal reaction, a recent lawsuit filed in Jefferson County states.

According to court papers, Agnes Davis was prescribed phenytoin, a generic of the drug Dilantin, and after taking the drug suffered a severe adverse reaction that allegedly caused her death Aug. 8, 2006.

The lawsuit, filed by Willie Davis Jr. and Alice Washington on Aug. 8, 2008, names as defendants 10 companies that make, label, test, market or distribute phenytoin.

The plaintiffs allege the defendants misled and failed to adequately warn the users of life-threatening side effects from the ingestion of phenytoin.

The suit states that Davis began taking the drug in June 2006 and sometime later broke out with a high fever and skin rash that resulted in blisters on her face and body. She was 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. Often, Stevens-Johnson syndrome begins 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. SJS usually is a specific type of allergic reaction in response to medication or infection, the site states.

Defendants violated the applicable code of federal regulations by failing to include a warning that SJS was a possible side effect, the plaintiffs allege.

"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.

In addition, the plaintiffs claim 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."

While concealing the hazards, the drug companies "have reaped huge profits," the complaint states. Defendants named in the suit 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 Corp.

The defendants failed to perform adequate testing that would have shown that phenytoin possessed serious side effects, and should have taken appropriate measures to ensure that its defectively designed product would not be placed into the stream of commerce, the plaintiffs allege.

The suit claims 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.
The drug makers knowingly and deliberately failed to remedy the known defects "for the purpose of increasing sales and enhancing its profits," the suit states.

"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," court papers say.

In the 32-page original complaint, plaintiffs' attorney Keith Jensen of Jensen, Belew & Gonzalez PLLC in Fort Worth outlines the responsibility of generic drug manufacturers to conduct post marketing safety surveillance and the companies' authority to unilaterally change its labels with additional warning information.

Causes of action in the complaint 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 plaintiffs are seeking damages for Davis' emotional distress including justifiable fear of disease, loss of enjoyment of life, physical and mental pain and suffering, inconvenience, mental anguish, physical pain and suffering and medical expenses.

As individuals and representatives of Davis' estate, the plaintiffs are also seeking damages for her pain and suffering, mental anguish, impairment, disfigurement, medical expenses, funeral expenses, lost earning capacity, loss of consortium, pecuniary loss, loss of companionship and society and mental anguish.

They are also suing for punitive damages, interest, expenses, attorneys' fees and other just and proper relief.

According to a Jensen Web site,, in 2006 Jensen obtained 12 settlements on behalf of his clients in SJS and Toxic Epidermal Necrolysis.

"In 2007, Mr. Jensen resolved five major SJS/TEN cases against one of the largest drug companies in the world," the site states. "These five clients are the first known people to ever recover from the manufacturer on SJS/TEN claims for the culprit drug involved."

The site also mentions that Jensen was set to start a trial in Boston in January 2008 when the case settled for a "very significant confidential sum."

The case has been assigned to District Judge Gary Sanderson.

Case No. B182-194

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