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.
Shirley Johnson, Michael Shepherd and Lyndora Thomas Taylor on behalf of the recently deceased John Taylor filed a lawsuit against Pfizer, Parke Davis and Warner Lambert.
According to the complaint, the plaintiffs all developed SJS or TEN after taking prescription medications containing the substance Dilantin. One plaintiff, Lyndora Thomas Taylor, lost a relative John Taylor, to the severe skin reaction on December 31, 2009.
"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. The complaint states that even then, the drug should never have been approved as a safe treatment.
"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."
The complaint also states that the defendants knew of the drugs' dangers, but failed to adequately warn their customers of risks, and that 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. Further, the suit claims that while Pfizer included black box warnings in its Bextra products concerning risks of SJS, it did not for its drugs containing Dilantin.
"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.
Additionally, the suit allages that 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.
Despite mounting evidence of Dilantin's risks, especially to different populations, the defendants aggressively marketed their products and failed to report associated severe reactions. The plaintiffs allege that were unaware of how dangerous their prescriptions containing Dilantin could be. One plaintiff was originally prescribed a medication containing Dilantin over 10 years ago, but claims that the statute of limitations has not expired because he was not aware of the source of his 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.