Gluckstein Lawyers investigates link between NEC, baby formula

By Tony Poland, LegalMatters Staff • The class-actions and mass torts team at Gluckstein Lawyers is investigating potential claims on behalf of premature infants suffering from serious long-term consequences after being diagnosed with necrotizing enterocolitis (NEC), says senior counsel Steve Rastin.

The litigation team, which includes Rastin, James Newland, Jordan Assrraf and Brian Moher, is looking into whether some cases of NEC may be the result of baby formula that was fed to premature babies in the neonatal intensive care units (NICUs) of hospitals across Canada.  

NEC is a devastating bacterial disease that invades the intestine. Research findings published by Oxford Academic suggests that it affects five to 12 per cent of very low birth-weight infants, leads to surgery in 20 to 40 per cent of cases, and is fatal in 25 to 50 per cent of cases.

Many factors can contribute to necrotizing enterocolitis, according to medical authorities, but the exact cause is not fully understood. In 2006, the World Health Organization (WHO) reported that there is “strong and consistent evidence” that baby formula containing cow-based milk is associated with a higher incidence of NEC in preterm infants than those fed with human milk-based formula, and that is concerning, says Rastin.

‘This has the potential to be a global issue’

“This has the potential to be a global issue that can impact babies and families all over the world,” he tells LegalMattersCanada.ca. “We are investigating this with respect to potential litigation against the manufacturers who provide this product at little or no cost to hospitals throughout Canada, United States and the world.

“The question is, were parents adequately warned of the risk to their babies before they were given baby formula containing bovine milk?” wonders Rastin.

According to studies, most cases of NEC occur in babies born before 32 weeks of gestation, generally developing it within two to four weeks of their birth. The newborn’s intestine can no longer hold waste, so bacteria can travel into the bloodstream and cause a life-threatening infection. Waste can pass into the baby’s stomach making it extremely ill.

Symptoms may include trouble feeding, a swollen, red or tender belly, a slowed heart rate, low body temperature, low blood pressure, apnea, diarrhea, constipation or vomit containing bile.

Most babies who develop necrotizing enterocolitis fully recover but, in some cases, the intestine is scarred, narrowed, or blocked and surgery may be necessary. 

Formula offered at hospital

Formula containing bovine milk is often offered at hospital when mothers cannot breastfeed or produce enough breast milk, Rastin says.

“There’s a fundamental difference between cow milk and human milk,” he says. “The real problem is that the human body is not well evolved enough to digest cow milk protein, even as an adult.”

Rastin says his firm is consulting with U.S.-based lawyers who are interested in pursuing claims against baby formula manufacturers.

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“One thing we are seeing from our American colleagues is that the babies who are suffering the most adverse outcomes appear to be disproportionately from racialized and economically disadvantaged groups. This may be because they do not have access to as robust medical care as others,” he says. “These parents get to hospital and are told their babies are premature. They are offered free formula they can try and start using it without realizing there may be a potential for harm.

“But there are other alternatives out there,” Rastin explains. “There is soy-based formula. There are predigested formulas. In Canada, there are donor banks of human milk at some hospitals.  The other issue we see is that mothers may give up on the concept of breastfeeding too quickly.”

Misleading marketing practices

He says he is concerned that there is a substantial risk of parents being misled by the marketing practices employed by baby formula manufacturers. Rastin points to a WHO report that states companies “run advertising that routinely mischaracterizes scientific findings.”

According to the WHO, some of the false claims used include:

• formula products with added ingredients improve brain development and immunity;
• formula products are needed after 12 months of age;
• breast milk is inadequate for the nutrition of older infants and children;
• formula keeps babies fuller for longer and therefore helps them sleep; and
• the quality of breast milk declines with time.

“We believe that misleading advertising campaigns create a danger,” Rastin says. “The interesting thing about this is that some manufacturers seem to give lip service to the whole concept of breast milk being the best for the baby yet their marketing materials show that every mother is a potential client.”

He says as cases progress in the U.S., manufacturers seem to be shifting the responsibility onto the doctors and hospitals.  

Baby formula is not medicine, it is food

“Some are saying it was given to the hospitals and the hospitals are the ones responsible for informing parents to help them make a decision, not us,” says Rastin. “But the important thing to remember about baby formula is that it is not medicine. It is food. I have never seen a case where somebody says, ‘If you are going to eat that food you better get informed medical advice first.’”

“And this is not just a medical issue. This is also going to be a question of the marketing issues and determining if the amount of information that was given to the parents was enough to allow them to make an informed choice,” he adds. “That is one of the reasons we are partnering with our American colleagues who have particular expertise in this. It is going to be a process in terms of building these cases. But I can tell you that in the U.S. there are thousands of these claims that are going forward.

Rastin says his firm believes that there are many people out there who have experienced problems but are not aware of the facts.

“To them, we say If you have concerns, especially if you have had a low birthweight premature baby and you had an adverse outcome, especially the gastrointestinal system, do not just accept what has happened,” he says. “Go out and get legal advice.”

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