The settlement approval was filed Friday following a hearing before New York State Supreme Court Judge Judith H. Gische.
Jesse Nichols Jacobson died less than a month after receiving the Pfizer-produced drugs Dilantin and Flagyl. Dilantin is an anti-seizure drug and Flagyl is an anti-fungal medication. Shortly after the administration of the drugs, Ms. Jacobson developed a drug-induced condition known as toxic epidermal necrolysis or TEN, which causes a severe rash and leads to the loss of 30 percent to 100 percent of a patient's skin, often followed by infections, blindness or death.
A study compiled by 15 burn centers in the U.S. revealed that more than 20 percent of TEN cases are believed to be caused by Dilantin use, with deaths reported in approximately one of every four cases. Dilantin is one of the most commonly-prescribed anti-seizure drugs in the U.S., and has been marketed by Pfizer and its predecessor companies since 1936.
In Canada and other countries, Pfizer warns that patients with African ancestry have a higher risk for developing Dilantin Hypersensitivity Syndrome which can include TEN, but Pfizer has not bothered warning doctors and patients in the United States, said the lawyer for the estate and adoptive parents of Ms. Jacobson. He added that Pfizer's label does not advise clinicians that a drug-company sponsored survey of seizure clinicians concluded that Dilantin should virtually never be used as a first line anti-seizure drug for children.