Login Register Subscribe
Current Issue

Expert testimony in baby formula brain damage case was wrongly banned: Court


A federal court improperly refused to admit expert testimony in dismissing a product liability lawsuit brought on behalf of a baby who suffered brain damage after ingesting infant formula, says an appeals court.

Powdered infant formula produced by Glenview, Illinois-based Mead Johnson & Co. L.L.C. had been recalled both in 2002 and 2003 because of contamination with the bacterium Enterobacter sakazakii, also known as Cronobacter sakazakii or C. sak, according to Friday’s ruling by the 8th U.S. Circuit Court of Appeals in St. Louis in Scott Johnson as guardian ad litem of H.T.P., a minor v. Mead Johnson & Co. L.L.C.

The infant boy “H.T.P.” was born via cesarian section on May 4, 2005, and was later fed Mead Johnson’s Enfamil Lipil with Iron powdered infant formula by his mother, according to the ruling.

He was first brought to the hospital on May 20, 2005, because he was fussy, not eating well and had a fever. He later developed hydrocephalus, which is a buildup of fluid inside the skull and was diagnosed with “sustained severe permanent brain damage,” according to the ruling.

According to court papers, the boy cannot speak, has epilepsy and will require anti-seizure medication and a shunt for the rest of his life. He is also developmentally delayed, with a deficit that will magnify as he grows older. He will never be able to live independently, and will either have to live with his parents the rest of his life or be institutionalized, according to court records.

Mr. Johnson, who was appointed the baby’s guardian, filed suit against Mead charging products liability, negligence and failure to warn, alleging Enfamil was “defective or unreasonably dangerous” because of C. sak contamination.

The U.S. District Court in Minneapolis excluded Mr. Johnson’s expert’s testimony, concluding the experts’ opinions “were not sufficiently reliable/helpful” because they did not adequately rule out other possible sources of C. sak contamination. The court also awarded Mead Johnson $18,442 in costs.

A three-judge panel of the 8th Circuit unanimously overturned the ruling. The District Court violated “liberal admission standards by resolving doubts in favor of keeping the (expert) testimony out and relying upon its own assessment of the correctness of the expert opinions. By doing so, it disallowed the adversarial process to work,” said the ruling.

“Here, no one disputes that Enfamil can be and has been a source of C. sak,” said the ruling. “Thus, the major premise of Johnson’s experts does not remain unproven.”

“The district court abused its discretion in excluding Johnson’s experts. The methodology employed by Johnson’s experts was scientifically valid, could properly be applied to the facts of this case, and, therefore was reliable enough to assist the trier of fact,” said the panel, in reversing the District Court’s order to exclude the expert’s testimony, and its grant of summary judgment and costs in Mead’s favor.

The case was remanded to the lower court for additional proceedings.