A lawsuit filed on September 20 in federal court claims that a Louisiana infant developed necrotizing enterocolitis (NEC) and died because she was fed Enfamil infant formula and fortifier. The lawsuit names Mead Johnson & Company, LLC, and Mead Johnson Nutrition Company as defendants.
According to the complaint, the infant was born prematurely on June 21, 2009, at 27 weeks gestation, weighing 1 lb 5 oz. The infant was fed Enfamil formula on or about June 22, 2009, to June 24, 2009, and was fed breast milk fortified with Enfamil fortifier on or about July 16, 2009, to July 18, 2009, according to the complaint.
The infant started displaying symptoms of NEC on July 18, 2009, including portal venous air, pneumatosis, abdominal distension, and high-volume gastric residuals. That day, the infant was diagnosed with NEC, ischemic intestine, and pneumatosis intestinalis.
According to the complaint, the infant died on July 20, 2009, due to NEC after an exploratory laparotomy, which determined her intestines were not salvageable. The complaint claims that the Enfamil formula and fortifier “caused or substantially contributed to” the infant’s NEC and “catastrophic and preventable death,” describing NEC as “a horrific and deadly disease.”
NEC is a potentially fatal intestinal disease affecting premature and very low birth weight infants. The symptoms of NEC can include:
- Poor feeding
- Failure to thrive
- Bloody stools
- Increased gastric residuals
- Decreased activity
- Abdominal distension
- Abdominal discoloration
- Vomiting of bile
- Intestinal perforation
- Multiorgan failure
- Bowel death
- Systemic hypotension
About seven percent of infants born prematurely develop NEC, and about one-quarter of infants who develop NEC die.
Those who survive NEC, which necessitates surgery, may experience long-term complications such as neurodevelopmental disability, short bowel syndrome, or narrowing of the intestines.
NEC and Infant Formula
The use of infant formula has been linked with NEC by science and research, and science and research have found that feeding infants human breast milk has a protective effect against NEC.
A 1990 study involving 926 preterm infants concluded that infants who were fed only formula were six to ten times more likely to develop NEC than infants who were fed only breast milk. The study also found that infants who were fed only formula were three times more likely to develop NEC than those who were fed formula and breast milk.
The study found that babies born past 30 weeks gestation rarely developed NEC if breast milk was included in their diet and that those fed only formula were 20 times more likely to develop NEC.
A 2007 study involving 202 very low birth weight infants found that 10.6 percent of infants whose diets consisted of less than 50 percent human milk developed NEC and that only 3.2 percent of infants whose diets consisted of over 50 percent human milk developed NEC.
After adjusting for gestational age, the study concluded that a diet consisting of at least 50 percent human milk in the first 14 days of a very low birth weight infant’s life lowers the infant’s risk of developing NEC by more than six times.
A 2009 study found that extremely premature infants who were exclusively fed human milk were 50 percent less likely to develop NEC than those who were fed diets that included products based on bovine milk.
The study also found that extremely premature infants who were exclusively fed human milk were almost 90 percent less likely to develop NEC that necessitated surgery than those who were fed diets that included products based on bovine milk.
The study estimated that a 50 percent reduction in NEC diagnoses would prevent between 1,300 to 1,850 cases of NEC every year.
In 2011, the Office of the Surgeon General published The Surgeon General’s Call to Action to Support Breastfeeding. This report stated that formula feeding is linked with higher NEC rates. This report also noted that premature infants who are never breastfed are 138 percent more likely to develop NEC.
A 2011 study found that infants who received cow’s milk-based formula saw significantly higher rates of NEC necessitating surgery.
In 2012, the American Academy of Pediatrics published a policy statement reaffirming its recommendation that all infants be exclusively breastfed for six months. The policy statement noted that meta-analyses of four clinical trials found that feeding human milk to preterm infants reduced the rate of NEC by 58 percent.
The policy statement stated that “all preterm infants should receive human milk” and that pasteurized donor milk should be fed to infants when a mother’s own milk is not available.
A 2014 study stated that “it is well established” that infant formula administration increases NEC risk and that breast milk administration decreases NEC risk. The study recommended that all preterm infants be exclusively fed human breast milk, which is linked to “a significant decrease” in NEC incidence.
Another 2014 study found that infants who were fed cow’s milk-based formula were over three times as likely to develop NEC than infants who were exclusively given breast milk.
A 2016 study found that over twice as many extremely premature infants who were fed formula or breast milk fortified with cow’s milk-based fortifier developed NEC than infants who were only fed breast milk.
The study concluded that a diet consisting of solely human breast milk has “many benefits” for extremely premature infants and that such a diet led to “multiple improved outcomes.”
A 2018 article noted that complex sugars found in human milk known as oligosaccharides might reduce the risk of NEC development.
Lawsuit Claims Enfamil Products Were the Subject of ‘Misleading’ Marketing Campaigns
The complaint claims that Enfamil formulas and fortifiers were the subjects of “systematic, powerful, and misleading marketing campaigns” meant to convince parents and doctors that:
- Bovine milk-based fortifiers and formulas are safe
- Bovine milk-based products are equal to or even better than breast milk
- Doctors consider bovine milk-based products to be the first choice
The complaint claims that Enfamil formulas and fortifiers were marketed as necessary for the growth of preterm infants and completely safe for preterm infants, despite the manufacturers knowing that the products posed an extreme NEC risk to preterm infants.
The complaint also notes that:
- The World Health Organization (WHO) Director once stated, “the campaign against bottle-feed advertising is unbelievably more important than the fight against smoking advertisements.”
- The World Health Assembly’s (WHA) International Code of Marketing of Breast-milk Substitutes prohibited the advertising of breast-milk substitutes.
- In 2018, the WHO stated that “far too many children are breastfed as recommended” and that “a major factor undermining efforts to improve breastfeeding rates is continued and aggressive marketing of breast-milk substitutes.”
The central claim of the lawsuit is that the defendants knew that its products were linked with an increased risk of preterm infants developing NEC, yet sold these products without warning about the NEC risk.
Lawsuit Seeks Compensation Based on Multiple Counts
The lawsuit seeks financial compensation for damages based on numerous counts, including:
Strict Liability – Design Defect
Strict liability means that negligence need not be proven for a defendant to be held liable. Companies that manufacture and/or sell products with design defects are strictly liable for any harm caused by the products.
If a product has a design defect, it means that the product is defective by design. Nothing went wrong during the manufacturing process to make the product defective. The product is unreasonably dangerous, even when manufactured and used properly, due to the design of the product itself.
The complaint alleges that:
- The defendants’ products are defective by design.
- Enfamil formula and fortifier are “not safe for use” in preterm infants because they “significantly” increase the risk of NEC, as well as death.
- The products are “defective and/or unreasonably dangerous,” noting that they don’t perform as safely as ordinary consumers would expect when used properly.
- The products are “manifestly unreasonable” because the risk of harm associated with them “clearly” exceeds the utility of the products, meaning that “reasonable” consumers, informed of the utility and risks, would not purchase them.
Strict Liability – Failure to Warn
The complaint alleges that not only are Enfamil formulas and fortifiers defective by design but also that the defendants knew or should have known they were defective by design yet failed to warn about it. Companies that know or should know their products are dangerous but fail to warn about them are strictly liable for any harm caused by the products.
The complaint claims that:
- Instead of providing adequate warnings about the link between its products and NEC in preterm infants, the defendants developed relationships including financial gain and incentives to facilities and healthcare providers for using its products, meaning that healthcare facilities and providers “had an incentive to withhold any instructions and/or warnings from the end user.”
- Through knowledge of scientific literature, its own experts and consultants, and its own studies and testing, the defendants knew that its products were linked with a higher risk of NEC and death in preterm infants yet failed to warn about this link.
Negligence is failing to uphold your duty to exercise reasonable care in order to prevent harm from occurring.
The complaint alleges that the defendant’s duty to exercise reasonable care includes a duty to hold the skill and knowledge of an expert, as well as a duty to be aware of scientific discoveries.
The complaint alleges that the defendants were negligent because they:
- Designed products that are defective by design
- Failed to collect data to find out if their products were safe for preterm infants to consume
- Failed to collect data to find out how and when their products could be safely used
- Failed to utilize research for the development of instructions
- Failed to develop or provide instructions or guidelines based on evidence in order to decrease the risk that their products could cause NEC or death
- Failed to deter or stop their products from being given to extremely preterm infants
- Failed to provide guidance or instructions based on evidence on how or when preterm infants should be given their products
- Failed to vigorously and continuously study their products to avoid NEC or death in premature infants
- Failed to utilize technically and economically available safer design and/or manufacturing alternatives for their products
- Failed to adopt a sufficient or adequate quality control program
- Failed to test or inspect their products with enough care
There are currently at least 120 cases listed in MDL 3026, the multidistrict litigation concerning preterm infant nutrition products litigation.
The lawsuits allege that the manufacturers of preterm infant formula and fortifiers, such as Enfamil and Similac, knew or should have known that their products were associated with an increased risk of preterm infants developing NEC yet failed to warn about this risk.
The product liability lawyers at Nadrich & Cohen have been representing victims of defective products since 1990, having obtained over $350,000,000 on behalf of our clients in that time. Some of our past case results involving defective products include:
- A $14,250,000 verdict plus interest for a girl who developed Stevens-Johnson Syndrome after being given Children’s Motrin
- A $5,000,000 settlement for a woman whose use of a diet drug led to her developing primary pulmonary hypertension
- $3,000,000 for a man who developed an infection after a heater-cooler device was used on him during a surgery
- $1,250,000 for a user of Fen-Phen who developed primary pulmonary hypertension
Contact Nadrich & Cohen for Representation
If your child developed NEC after being given Similac or Enfamil formula or fortifier, it’s not wise for you to take your choice of NEC lawyers lightly.
You need experienced product liability lawyers who have proven they have what it takes to successfully hold the manufacturers of defective products liable for any injuries caused by the products. You need battle-tested, experienced defective product attorneys like Nadrich & Cohen.
Call us, text us from this page, or contact us online today for a free consultation if your child developed NEC after being fed Similac or Enfamil formula or fortifier. You may qualify for financial compensation. We don’t charge our clients any fee unless and until we obtain a financial recovery for them. Our only fee is a percentage of any recovery obtained.