Brain Injury to Child: $3.5 Million Settlement in Drug Product Claim Based on Defects in Instructional and Warning Materials

27 Jul 2007

New Jersey: Ocean County Superior Court Coddington v. Laser, Inc., et al Case No. OCN-L-321-93 Judge James P. Courtney

A $3.5 million settlement against two companies -- a drug manufacturer and a drug retailer -- was reported on behalf of a seven-year-old girl who suffered brain damage as a baby and now functions like a six-month-old.

The plaintiffs claimed that neither the manufacturer nor the retailer ever told pediatricians that a common medicine, theophylline, was potentially toxic to young children.

In fact, when the child suffered a seizure after a mild case of bronchitis, her doctors were baffled. They never realized the connection between the drug and her injuries.

It was the girl's family that finally figured it out seven years later. After watching an episode of "PrimeTime Live" on ABC, the family became suspicious that their daughter's brain injuries had been caused by theophylline, which was commonly prescribed to treat bronchitis and asthma.

Investigation and research showed that the defendants did not inform doctors of revised Food and Drug Administration guidelines for theophylline, including warnings that it was not safe for children under 5 years old. Other drug companies had added warnings to their packaging and had alerted their doctor/customers.

In 1984, pediatricians at a Colorado clinic diagnosed 22-month-old Cari Coddington with bronchitis and a possible case of the flu. They prescribed Theospan 65, a sustained-release form of theophylline, and told her parents to give her 65 milligrams three times a day.

A few days after she started taking the drug, Cari suffered a violent seizure; as a result, she was brain-damaged and spastic.

Doctors were unable to determine what caused the seizure and cited numerous possibilities, such as post-viral encephalitis. They measured her theophylline levels and found them slightly above the recommended range for a child her size but in an amount that they believed was insignificant to be dangerous.

However, doctors were never told by the drug manufacturer or the retailer that the toxicity for children was much more serious than originally believed. So the child's doctors never realized that the drug was the culprit.

Seven years later, the girl's parents, who had divorced after moving to New Jersey, alerted each other to a "PrimeTime Live" segment focusing on the dangers of theophylline.

The defendants contended that the doctors who treated the girl were at fault for the overdose. But her doctors asserted they had never been informed of theophylline's dangers.

It took almost five years of research before the case was ready for trial.

The critical evidence was two updates for theophylline-package inserts that were released by the FDA in 1982 and 1983. Despite the FDA's alert, neither the drug manufacturer nor the retailer updated their package inserts prior to the girl taking the medicine in 1984, the plaintiffs contended. However, other drug manufacturers and retailers had warned their customers about the problem.

The retailer, Laser, Inc., also had documents in its library that referred to the dangers of theophylline, including a paper from a 1978 symposium at which a speaker addressed the toxicity of the drug in young children. Laser officials had attended the symposium.