Pfizer and others named in St. Clair County suit over Dilantin

Kelly Holleran Jan. 18, 2011, 2:50am


Residents of St. Clair County, New York and Louisiana joined to file a suit against the makers of drugs used to treat epilepsy, saying it caused them or their deceased relatives to develop a severe and potentially deadly skin disease.

Shirley Johnson, Michael Shepherd and Lyndora Thomas Taylor on behalf of the recently deceased John Taylor filed a lawsuit Dec. 28 in St. Clair County Circuit Court against Pfizer, Parke Davis and Warner Lambert.

Christopher Cueto of the Law Office of Christopher Cueto in Belleville, Robert L. Salim of Louisiana and Kenneth T. Fibich of Fibich, Hampton and Leebron in Houston will be representing them.

According to the complaint, the plaintiffs all developed Stevens Johnson Syndrome (SJS) or Toxic Epidural Necrolysis (TEN) after ingesting prescription medications containing the substance Dilantin. SJS and TEN are both skin disorders characterized by the discoloration or exfoliation of skin, the shedding of hair and nails, hives or burns to the body, loss of eyesight and/or damage to internal organs, the suit states.

One plaintiff -- Lyndora Thomas Taylor -- lost a relative -- John Taylor -- to the severe skin reaction on Dec. 31, 2009, the complaint says.

"Defendants' Dilantin drug products are the most dangerous and lethal drugs that cause deaths from SJS/TENS," the suit states.
Dilantin, the substance suspected to cause the skin disorder, has been used in drugs to treat epilepsy since 1939, but was not FDA-approved as a safe and effective way to treat seizures until 1976, the plaintiffs claim.

Even then, however, the drug should never have been approved as a safe treatment, according to the complaint.

"Post-marketing databases confirm that serious skin reactions have been reported in patients receiving Dilantin drug products," the suit states. "These databases include the US-FDA Adverse Event Reporting System, World Health Organization, Upsalla Monitoring Centre, and the Health Canada Adverse Event Database and demonstrated that SJS/TEN events associated with Dilantin drug products were not infrequent and exceeded other drugs on the market that have significant relative risks of SJS/TEN, including Bactrim and Tegretol."

To make matters worse, the defendants knew of the drugs' dangers, but failed to adequately warn their customers of risks, the complaint says.

In fact, Pfizer admitted in its submission on Bextra to Health Canada that drugs containing Dilantin substantially increased the risk of adverse skin reactions more so than other drugs on the market, the plaintiffs say. It even included black box warnings in its Bextra products concerning risks of SJS, but none for its drugs containing Dilantin, according to the complaint.

"Defendants could have chosen to enhance its SJS/TEN warnings since it had prior experience with adding warnings about SJS/TEN to their other marketed products," the suit states.

Certain ethnic and racial groups are more prone to developing SJS/TEN because of a variation in their metabolic rates, but the defendants also failed to warn of the increased risks to these groups, the complaint says.

Despite mounting evidence of Dilantin's risks, especially to different populations, the defendants aggressively marketed their products and failed to report associated severe reactions.

When the plaintiffs ingested their prescriptions containing Dilantin, they claim they did not realize how dangerous the medications could be.

As a result of their taking the drug, the plaintiffs incurred substantial medical costs, lost their ability to perform household services and suffered disfigurement, disability and pain, according to the complaint. In addition, they suffered physical impairment, mental pain and loss of a normal life, the suit states.

In addition, Lyndora Thomas Taylor claims she lost her relative's love, care, comfort, support, affection and society.

Although it has been more than 10 years since at least one of the plaintiffs was prescribed the medication causing his skin reaction, the plaintiffs claim the statute of limitations has not expired because they were not aware of the source of their injuries until within the last two years.

In their complaint, the plaintiffs allege strict products liability,
negligence, failure to warn, negligence in bringing Dilantin to market, negligent misrepresentation, misrepresentation by omission, negligence per se, fraud and misrepresentation, fraud by concealment, violation of the Illinois Consumer Fraud Act and wrongful death.

They seek damages sufficient to compensate them for their damages, compensatory damages according to proof, applicable statutory damages, a disgorgement of profits, prejudgment interest, costs and other relief the court deems just.

St. Clair County Circuit Court case number: 10-L-669.

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