A Chicago federal judge last week said she would allow expert testimony that a premature baby cow’s milk-based formula – made by Mead Johnson, a subsidiary of Abbott Laboratories and Reckitt Benckiser – can cause a fatal intestinal illness, as the companies face hundreds of lawsuits over the claims.
In a separate issue, US District Judge Rebecca Pallmeyer sided with Abbott in a lawsuit that was the first one slated to go to trial in federal court out of more than 700 similar cases that have been centralised in her court in multi-district litigation.
The judge said the family of RaiLee Mar, an infant who was born prematurely and died of necrotising enterocolitis (NEC) after being given some of Abbott’s formula, had failed to show that the company’s alleged failure to warn doctors and Mar’s family about the risks of the disease was the cause of the infant’s illness.
She also said they failed to show there was a reasonable alternative way the formula could have been made, reports Reuters.
Representatives for Abbott and Mead Johnson did not immediately respond to requests for comment.
Jose Rojas, in a statement on behalf of lawyers leading the litigation for the plaintiffs, said they were disappointed by the decision in the Mar case, but that the ruling on the expert testimony would let the other cases in the multi-district litigation go forward.
“We will continue to fight for the families whose children have been, and continue to be, harmed by the defendants’ cow’s milk-based preterm products,” Rojas said.
All of the lawsuits allege that the companies failed to warn that their specialised formulas used by newborn intensive care units in hospitals could cause NEC, a disease that almost exclusively affects premature infants and has an estimated mortality rate of more than 20%.
The companies have denied the claims, saying that while breast milk protects against NEC, formula does not cause it, and that the benefits of breast milk have long been known to clinicians.
In addition to the federal cases, both companies face hundreds of state court cases around the country, which have already resulted in verdicts of $60m against Mead Johnson and $495m against Abbott.
Both companies prevailed in the most recent trial in October. However, the judge in that case in March ordered a new trial, finding that lawyers for the defendants had acted improperly.
The litigation has alarmed many doctors. who say it could threaten the formulas’ availability or affect medical decisions.
The American Academy of Paediatrics recently filed a brief supporting Mead Johnson in its appeal of the verdict against it last year, saying that formula is part of the standard of care for premature babies.
US regulatory agencies and a working group of scientists convened by the National Institutes of Health said in a joint report last year that current evidence does not support the hypothesis that formula causes necrotising enterocolitis.
See more from MedicalBrief archives:
Most baby formula health claims not science-backed – global analysis
Formula industry continues to undermine importance of breast milk
Abbott Laboratories and AbbVie settle in TriCor kickback case