Parents of premature and low birth weight newborns are filing baby formula lawsuits against Similac and Enfamil for failing to adequately warn that cow’s milk-based formulas could lead to Necrotizing Enterocolitis (NEC), a serious and potentially life-threatening gastrointestinal disorder. Rhine Law Firm, P.C. is currently seeking compensation and accountability from manufacturers who failed in their duty to develop a safe product and warn parents of known risks.
Are You Eligible to File a Toxic Formula Lawsuit?
You may require the services of a baby formula lawyer if you answer “yes” to the following:
- Was your baby born prematurely?
- Did your baby receive Enfamil, Similac, or another cow-milk-based formula in the NICU?
- Did your baby suffer adverse physical symptoms, leading to a diagnosis of Necrotizing Enterocolitis?
While there is no way to undo the damage done, toxic formula lawsuits hold manufacturers accountable to prevent future safety hazards, while also giving families the money they need to take care of medical bills, lost wages, and other related expenses.
What Is Necrotizing Enterocolitis?
Necrotizing Enterocolitis (NEC) is a rare bacterial disease affecting one in 2,000 to 4,000 births. Studies have found it is most common in premature babies fed cow’s milk-based formula. NEC occurs when bacteria invade the intestinal wall, causing inflammation and infection that can ultimately destroy the bowel tissue. Perforation and stool spillage into the abdomen can cause overwhelming infection and death.
What Treatments Are Available for NEC?
Mild intervention for NEC includes the use of probiotics, antibiotics, and limited feeding intervals to allow the bowels to rest. More invasive treatment may include the insertion of abdominal drain tubes, bowel removal surgery, or enterostomy that reroutes stool around the injured section.
What Is the Prognosis for Babies With NEC?
In most cases, babies can go on to live healthy lives, but a 2019 study published in the journal Current Pediatric Reviews found long-term complications included strictures, short bowel syndrome, gastrointestinal discomfort, failure to thrive, and neurodevelopmental impairment. The worst outcome is NEC infant death resulting from widespread infection that overwhelms the body.
What Does Research Say About Premature Babies and Infant Formula NEC?
Research linking cow’s-milk formula to an increased risk of NEC in premature babies dates back to the nineties, yet manufacturers failed to warn doctors of the dangers—and still haven’t to this day. The science clearly shows that whereas human milk is protective, reducing inflammation and bacterial invasion, cow’s milk may encourage the proliferation of damaging bacteria. Further, the lack of antibodies and other immune-boosting substances found in breast milk makes formula-fed babies especially susceptible to the risk of infection and bowel issues.
- A 1990 study published in The Lancet found that NEC was 6-10 times more common in exclusively formula-fed babies, and 3 times more common in babies receiving formula and breast milk. Scientists writing for The Lancet in 1990 estimated that “exclusive formula feeding could account for an estimated 500 extra cases of Necrotizing Enterocolitis each year. About 100 of these infants would die.”
- A later study of over 1,500 premature babies found those exclusively fed breast milk had a significantly lower incidence of NEC and mortality compared to those fed cow’s milk formula.
- In 2011, Johns Hopkins Medical Institution researchers found only one in 29 babies who received human donor milk developed NEC, recovering without surgery. By comparison, five out of 24 formula-fed babies developed NEC and four required surgical intervention.
- A 2012 animal study found that infant formula contains free fatty acids (FFAs)—not found in breast milk—that caused oxidation, cell damage, and cell death in the gut of the animals who ingested it. While human milk has protective effects in reducing inflammation and bacterial growth, cow’s milk may encourage the proliferation of harmful bacteria.
- Researchers reported that Necrotizing Enterocolitis affects 5-12 percent of very low birth weight infants in a 2017 study published in Advances in Nutrition. Surgery is required in 20-40 percent of cases and is fatal in 25-50 percent of cases. While the exact cause of NEC is not fully understood, scientists recommended specialty formulas that are easier to digest to reduce the risk of NEC.
- A 2021 report published in the British Medical Journal found that manufacturers like Similac and Enfamil have funded “biased and unreliable” clinical trials that lack independence, transparency, and published outcomes so they could downplay health risks associated with their formulas.
Should Parents Sue Their Doctors or Hospitals for Baby Formula NEC?
Some parents have already filed and settled NEC lawsuits for undisclosed sums as medical malpractice claims against doctors and/or hospitals. However, it has become increasingly clear that doctors have been largely unaware of the link between premature infant formula and NEC. Decades of research has done little to move the needle on formula safety, so it’s clear more must be done to punish manufacturers who care more about profit than infant health.
Did Premature Infant Death Prompt a Baby Formula Recall?
While there have been no baby formula recalls associated with NEC or premature infant death, manufacturers have a duty to rigorously test their products for safety and provide adequate warnings to consumers and medical professionals about any known risks.
Over time, researchers have found babies are more predisposed to NEC if they:
- Weigh less than 3.25 pounds
- Experienced a difficult delivery
- Receive infant formula by mouth or tube
- Have a gastrointestinal infection or other serious illness
- Have low oxygen or an overabundance of red blood cells
With adequate warning, NICU doctors may decide to feed babies the mother’s breast milk, donor milk, or specialized (non-cow’s milk-based) formula instead to reduce the risk of NEC.
Even without a product recall, parents are still eligible to file a baby formula lawsuit.
Which Baby Formula Manufacturers Are Being Sued?
Baby formula manufacturers that are facing NEC lawsuits include:
- Mead Johnson / Similac NEC Lawsuits
- Abbott Laboratories / Enfamil NEC Lawsuits
These formulas are most commonly used in NICUs, but many other brands are milk-based—from Earth’s Best, Gerber, and Go & Grow, to Happy Baby, Kendamil, and Parent’s Choice—so we are likely to see more claims against other manufacturers as time goes on and word gets out.
Free Consultation With Experienced Class Action & Product Liability Attorneys
For more than 30 years, Rhine Law Firm, P.C. has provided North Carolina residents with personalized, effective representation in defective product cases and other personal injury matters. If your baby was premature and developed gastrointestinal problems after being fed with cow’s milk-based formula, we invite you to contact a class action lawsuit attorney from our team for a free consultation.
Filing an NEC Toxic Baby Formula Lawsuit
If you or a loved one’s infant has been affected by toxic baby formula, you may be eligible to recover compensation for the disastrous consequences and adverse effects on your life. Our top-rated and accomplished product liability attorneys at Rhine Law Firm, P.C., are representing victims of this tragedy and are here to help.
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