The parents of a 2-month-old girl who died in Allegheny County in 2011 are suing Abbott Laboratories, the makers of Similac baby formula, alleging a link between one of its products and severe bowel disease that can prove fatal.
Hundreds of other parents have made similar claims in lawsuits across the country, including one in which a Chicago jury in April awarded the plaintiffs $70 million.
The lawsuits allege Similac’s cow’s milk-based preterm infant formula causes necrotizing enterocolitis, a potentially fatal gastrointestinal disease that largely affects premature and low birth-weight babies.
Paris Wright of Pittsburgh and Demetrius Williams of Tarentum sued Friday in federal court in Pittsburgh alleging wrongful death; negligent misrepresentation; defective design; negligence; and failure to warn doctors, hospitals and parents the formula could increase the risk of the dangerous bowel disease.
Attorneys for the plaintiffs did not return a call Monday seeking comment. The lawsuit does not make clear why the parents filed their complaint so many years after their child’s death.
In an emailed statement, Abbott Laboratories, based in Illinois, said the company stands by the safety of its preterm infant nutrition products.
Abbott said the National Institutes of Health, Centers for Disease Control and Prevention, American Academy of Pediatrics, NEC Society and others agree that “these products are safe, they are necessary, and there is no reliable scientific evidence that they cause NEC.”
According to the lawsuit, a baby identified as A.W. was born in 2011 at 24 weeks gestation. At 4 weeks old, the complaint said, she was diagnosed with necrotizing enterocolitis.
She died at 2 months old.
According to the Cleveland Clinic, necrotizing enterocolitis, known as NEC, causes intestinal tissue to die, which can cause a hole in the intestine through which bacteria can leak.
It usually develops within two to six weeks after birth and is most common among premature babies or those with a low birth weight.
NEC affects 1 in 1,000 premature babies, the Cleveland Clinic said. Those at greatest risk weigh less than 2 pounds.
According to the lawsuit, scientific research has demonstrated strong links between cows’ milk-based infant formula and necrotizing enterocolitis in premature infants.
A study dating to 1990, the lawsuit said, showed the disease was six to 10 times more common in babies fed exclusively cows’-milk based formula than those who received breast milk alone, and three times more common than in those who received both.
“Notwithstanding strong scientific and medical evidence establishing the serious danger that cows’ milk-based formula poses for premature infants, defendant has long marketed its cows’ milk-based products as an equally safe alternative to breast milk, necessary for adequate nutrition and the choice for the modern, sophisticated mother,” the lawsuit said.
The complaint also criticized Abbott’s marketing of its Similac formula, alleging its advertising campaigns are misleading.
Among the allegations, the lawsuit asserts the company tries to convince parents that its formula is superior to breast milk and helps babies catch up on their growth faster than breast milk.
“In addition to perpetuating the myth that its cows’ milk-based products are ‘like breast milk,’ defendant has also deceived the public into believing that physicians believe Similac products are an ideal choice for babies,” the lawsuit said.
Hundreds of the lawsuits from across the country have merged into what is called “multi-district litigation” before a federal judge in Chicago. Mead Johnson, the makers of Enfamil, also is named as a defendant in similar lawsuits.
According to Reuters, Abbott Laboratories was ordered by a jury in Chicago in April to pay $70 million in a case in which four families claimed the company’s formula caused the disease in their infants.
In a statement after the verdict, Reuters reported, the company said, “Science was ignored in this case. This verdict, and the continued pursuit of a theory at odds with regulators and the medical community, risks eliminating vital options for doctors and the most vulnerable infants.”
In that case, while the babies survived, three required surgery, and all four have ongoing health problems, Reuters said.