Popular cow’s milk-based infant formulas, sold under the brand names Similac and Enfamil, may increase premature babies’ risk of developing Necrotizing Enterocolitis (NEC). NEC is a life-threatening digestive condition that affects the intestines and results in local infection and inflammation — ultimately destroying intestinal tissue and often causing permanent damage.1

“Necrotizing” refers to the process of tissue death; “enterocolitis” is inflammation of the small intestine or colon. Necrotizing enterocolitis, or “NEC,” develops when bacteria from food damages a baby’s intestines, causing tissue damage or death. When that happens, a hole may form in the intestines, leading to severe infection in the baby’s belly.

Symptoms of NEC can include:

• Bloating or swelling of the belly
• Bloody Stool
• Breathing that stops and starts Slow heart rate
• Sluggishness

Serious health impacts of NEC include intestinal perforation, intestinal infection, abdominal infection, sepsis, and death. ² Surviving infants may suffer from significant and lasting adverse health effects, including — serious neurodevelopmental conditions, short bowel syndrome, and growth failure.3

Risks of Cow Based Products

The primary concern when a baby is fed cow’s milk-based products is that the infant will develop NEC. For over two decades, research has shown that the risk of NEC increases when an infant consumes cow’s milk-based products.

As early as 1990, a study published in the medical journal The Lancet found that it may be 6 to 10 times more likely for NEC to develop among babies fed cow’s milk products like Similac or Enfamil, compared to breast milk. For preemie babies born at more than 30 weeks gestation, the NEC risk was 20 times more common with cow’s milk formula products. Another meta-analysis found a 2.7x increased risk of NEC from a diet including cow’s milk-based products versus an exclusively human milk-based diet – with an incidence rate of 2.4% for babies fed an exclusively human-milk-based diet and 6.7% for those exposed to cow’s milk-based products. The incidence rate also increased as the amount of cow’s milk-based products increased.

In 2011, a group of hospitals further wrote that very premature babies given human donor breast milk were less at risk for NEC than those given cow milk formula. Also in 2011, the U.S. Surgeon General stated, “For vulnerable premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis (NEC).” Then in 2012, the medical professionals representing the American Academy of Pediatrics proclaimed that premature babies should be fed only human milk because cow milk formula carried too great of an NEC risk.⁵ Over the past decade, countless studies have confirmed these findings.

Abbott Laboratories and Mead Johnson now face a growing number of Similac and Enfamil NEC lawsuits, alleging that they knew their products were unreasonably dangerous for premature babies, yet continued to sell and distribute the cow’s milk formula without providing adequate warnings to parents, hospitals and medical providers. In a 41-page opinion issued on August 19, 2021, District of Connecticut Judge Stefan Underhill rejected an attempt by Abbott laboratories to dismiss a wrongful death lawsuit brought by the family of an infant that allegedly developed NEC from Similac baby formula used in a hospital NICU. While Judge Underhill dismissed claims for negligent misrepresentation, intentional misrepresentation, breach of express warranty, and violations of the CUTPA, he allowed claims for failure to warn, design defect and negligence, and loss of filial consortium to survive.

Target Products

• Similac (Abbott Laboratories) o Similar Special Care 20 o Similac NeoSure o Similac Special Care 24 o Similac Special Care 30 o Similac Special Care 24 — High Protein o Similac Liquid Protein Fortifier o Similac Pro-Sensitive o Similac Human Milk Fortifier o Similac Pro-Advance
• Enfamil (Mead Johnson & Company) o Enfamil Human Milk Fortifier o Enfamil NeuroPro EnfaCare o Enfamil 24 Cal
• Formula-fed preemies at higher risk for dangerous GI condition than babies who get donor milk, Science Daily (May 1 , 2011)

MANUFACTURERS

• Abbott Laboratories o Headquartered in Abbott Park, Illinois o Principal place of business in Lake County, Illinois o Abbott sold more than a billion dollars worth of Similac in 2019
• Mead Johnson & Company

TARGET IN INJURY

• Necrotizing Enterocolitis (NEC)
• Premature babies (before 37 weeks)
• Infant diagnosed with NEC
• Infant given formula or fortifier (except Prolacta which contains human milk oligosaccharides – “HMOs” — that are complex sugars unique to human milk.) before being diagnosed with NEC (particularly looking for Similac or Enfamil use)
• Infant suffered specific serious injuries requiring medical treatment: (i.e. the child died, had one or more surgeries, has ongoing gastrointestinal or other bowel conditions, has cerebral palsy or other ongoing neurological conditions, or suffered other serious/lasting injuries.)
• Child born in/after 2000.

FDA ACTION AND VOLUNTARY RECALLS

None.

ADDITIONAL THINGS TO CONSIDER

• NEC IS RARE – it affects just one in 2,000 — 4,000 births. This equates to almost 9,000 infants/year developing NEC — 90% of which are premature, 25% of which will die, and over 1/3 of surviving NEC infants develop long-term neurologic or intestinal disabilities. This equates to approximately 2,000 NEC related infant deaths – and an additional 3,000 infants developing serious NEC related injuries – each year.
• Other formulas to keep our eye on (also cow’s milk based) — Earth’s Best, Happy Baby, Go & Grow, Gerber, Parent’s Choice, Baby’s Only, Loulouka, Holle, Kendamil, Bobbie, Lebenswert

DWM Lawyers are reviewing potential class action lawsuits and individual injury claims against the manufacturers of Gramoxone and other paraquat weed and grass killers, for failing to warn about the risk of Parkinson’s disease associated with the toxic herbicide.

Although manufacturers have known about the link between paraquat and Parkinson’s disease, as well as other serious health risks, the herbicide has been distributed and sold without adequate warnings, even for “certified applicators.”

Paraquat Is Unreasonably Dangerous Even For Licensed Applicators

Paraquat is a controversial herbicide used for weed and grass control. It is a cheap and fast-acting product, which has been credited with the growth of “no-tilling farming” in the United States. However, it carries serious risks that have not been adequately disclosed by the manufacturer for decades.

Since it was first introduced in 1962, paraquat-based products have been sold by Chevron Chemical Company, Syngenta and other companies under a variety of brand names, including:

• Gramoxone
• Paraquate Concentrate
• Blanco
• Cyclone SL 2.0
• Firestorm
• Helmquat 3SL
• Bonedry
• Devour
• Para-Shot 3.0

Due to the unreasonable risk of Parkinson’s disease from paraquat and other serious heath risks, at least 32 countries have entirely banned use of the herbicide. However, use of the product in the United States has actually increased, with a U.S. Geological Survey indicating a doubling from 2013 to 2017, when estimated use of paraquat reached 10 million pounds annually.