A Louisiana mother whose infant son died in Colorado is suing formula manufacturers, arguing they failed to adequately warn of increased risk of a severe intestinal condition, though doctors have known about that link for over a decade.
Octavia Patton-Ashley is suing Abbott Laboratories and Mead Johnson, alleging their formula contributed to her son’s death from necrotizing enterocolitis, a condition where part of the intestine dies. Abbott produces Similac formula, among other types, and Mead Johnson manufactures Enfamil.
The lawsuit doesn’t address the possible contamination at one Abbott plant, which resulted in a large formula recall earlier this year. Rather, it argues that formula is inherently dangerous for premature babies and should come with extensive warnings. The only warning required by the U.S. Food and Drug Administration is that parents should closely follow a doctor’s directions for using formula.
The baby, called S.A. in the lawsuit, was born in early February 2021 at Children’s Hospital Colorado at 34 weeks and died in mid-June 2021. Patton-Ashley alleges she wasn’t warned of an increased risk of necrotizing enterocolitis associated with using formula and would have obtained donated breast milk if she had known, instead of using the formulas recommended by a doctor.
She also alleged the formula manufacturers withheld information about the risks from doctors, preventing them from making a good recommendation. Multiple reports have highlighted some increased risk with formula feeding for over a decade, though. A Surgeon General’s report in 2011 recommended breast milk for premature infants for that reason, among others, as did the American Academy of Pediatrics in 2012.
Necrotizing enterocolitis affects about one in 1,000 premature babies, especially those who were fed through a tube or who were born especially small, according to Cleveland Clinic. Premature babies have weaker immune systems and may have sufficient blood flow to their bowels, though it’s not entirely clear what causes their intestinal tissue to die.
Full-term babies can get necrotizing enterocolitis, but it’s rarer. Some babies recover relatively easily, while others develop sepsis if a hole forms in their intestines and bacteria get into the bloodstream.
Research into the magnitude of the risk associated with formula has yielded mixed results, perhaps reflecting differences in how studies defined high-risk babies, as well as the underlying risk in different hospitals.
A 2014 study of babies born at 33 weeks of pregnancy or earlier found the risk of necrotizing enterocolitis after the first week of life was about 1% in infants given only human milk and 3.4% in those given at least some formula. A 2013 study found a much larger difference — 3% in the human milk group and 21% in the formula group — while a 2005 study found no statistically significant difference in risk between babies who drank donated human milk versus those who received formula.
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