July 7, 2010
Gerald Toner successfully defended a neonatologist and his practice group against allegations of medical malpractice related to the 2003 use of a powdered infant formula product in the neonatal intensive care unit (NICU). The plaintiffs, parents on behalf of their brain-damaged infant, alleged that the physician negligently entered an order for a phenylalanine-free diet in light of a significantly elevated level on a newborn screening test for phenylketonuria (PKU). Part of such a diet was the use of a specialty powdered formula product called Phenex-1, which was recommended to the physician by way of a genetics consult. Approximately 24 hours after the institution of the powdered formula to the baby, his twin brother began to develop symptoms of respiratory distress, and ultimately died of bacterial meningitis, later learned to be caused by the rare pathogen E. sakazakii. Several days after first receiving the formula, the original baby for whom the powder was ordered began to develop similar symptoms, and was ultimately diagnosed with E. sakazakii meningitis. Although he survived, he is severely brain-damaged.
Plaintiffs claimed that the powdered formula was the cause of both babies’ illnesses, and asserted that the formula should not have been ordered for a mere screening test for PKU as opposed to a confirmatory test. Moreover, Plaintiffs claimed that the genetics consultant had not actually recommended the formula, and that the neonatologist should have known in 2003 that powdered infant formulas were not commercially sterile and were prone to contain certain dangerous bacteria.
Toner defended the case by establishing that there were no warnings applicable to the use of powdered formula products in the NICU in such a situation in 2003, and that the use of Phenex-1 formula in this instance was particularly reasonable given the geneticist’s endorsement of the product. Moreover, they established that the formula had tested negative for E. sakazakii, and the fact that both babies contracted the disease in an unusual timeline made it more than likely that powdered formula was not the source of the babies’ illnesses. After a two and a half week trial, the jury deliberated for several hours before returning a verdict in favor of the defense.