Mead Johnson’s Enfamil Recalls: An Extraordinary Measure or a Strategic Move?

Launched in 1959, Enfamil was Mead Johnson’s first-ever routine baby formula developed to replicate the nutritional composition of human breast milk. At the time, the company marketed it as “a low-protein duplication of the mother’s milk.”

Along with its formula cousin, Similac, Enfamil met the milk-feeding needs of infants whose parents chose not to breastfeed due to barriers like –

  • Excessive concerns regarding breastfeeding complications
  • Low or no milk supply
  • Health risks to the mother or the infant
  • Perceived inconvenience of breastfeeding
  • Poor familial or social support
  • Busy work schedule
  • Prior radiation treatment for breast cancer
  • Negative feelings about breastfeeding due to stigma, fear, or lack of confidence

The National Library of Medicine also revealed that some mothers chose to stop breastfeeding two weeks post-partum due to an incongruity between expectations and reality. Even during the infamous infant formula crisis, Enfamil tried filling the gaps left by Abbott Laboratories’ Similac recalls.

However, Mead Johnson (owned by Reckitt) had to face a similar fate in February 2023. What is the recall all about, and is it a strategic move on the company’s part? This article discusses these in detail.

Taking down 145,000 Cans amidst Cronobacter Concerns

“We are committed to the highest level of quality and safety, and it is for this reason that we have taken this extraordinary measure,” said Mead Johnson in a statement to the FDA. Formula manufacturers are not required to inform the FDA regarding a product recall by way of law.

However, Mead Johnson alerted the FDA this February that it was voluntarily taking down as many as 145,000 cans of Enfamil ProSobee Simply Plant-Based baby formula due to cross-contamination with Cronobacter sakazakii – the same bacterium responsible for Abbott Laboratories’ Similac recall last year.

It is interesting to note that Enfamil’s voluntary recall came six months after the initial discovery was made. The FDA inspected the Mead Johnson plant at the Zeeland, Michigan facility back in November 2022 after the bacteria was first found in September 2022. At the time, the first (contaminated) batch was completely discarded by the company.

Still, the FDA mentioned in a statement that Enfamil’s recalls were narrower in scope compared to Similac’s, which means only a few weeks’ worth of products were taken down. There were no additional facility closures, thereby ensuring a steady supply of infant formulas amidst supply chain bottlenecks.  

How Dangerous is Cronobacter Bacteria to Infants?

During the same month, the Centers for Disease Control (CDC) published a detailed report on Cronobacter sakazakii and its potential dangers to infants. It mentioned that infections caused due to this bacterium are the most common among infants (less than 12 months old) fed with powdered baby formula.

Since the bacterium thrives in extremely dry conditions, cross-contamination in powdered baby formulas is easy. Also, the bacterium can easily live on home surfaces, including sinks, kitchen counters, etc. But, how could it contaminate baby formulas in Mead Johnson’s processing facility? There could be two possibilities –

  • The company used contaminated ingredients to prepare the formula.
  • The formula came in contact with contaminated surfaces.

The CDC admits that Cronobacter infections among infants are rare, but almost always life-threatening. Around two to four cases are reported every year among infants as young as a few days to a few weeks old. Other risk factors include infants born prematurely and those with a compromised immune system (younger than two months).

The bacterium can lead to a dangerous blood infection called sepsis. Even the lining of the spinal cord and brain may swell, leading to meningitis. Common symptoms of a severe Cronobacter infection include –

  • Fever
  • Poor feeding
  • Excessive crying
  • Extremely low energy
  • Seizures in some cases

Is the Voluntary Recall an Attempt to Whitewash a Tainted Past?

On the surface, Reckitt’s move to recall batches of Enfamil infant formula appears to be an extraordinary measure on the company’s part to protect infants and parents. However, some believe the same could be a strategic move to cover up past damages.

Enfamil, along with Similac, has been accused of causing a potentially life-threatening gastrointestinal condition in infants (especially premature babies) called Necrotizing Enterocolitis (NEC). According to the National Institutes of Health (NIH), this condition causes symptoms like –

  • Inability to digest food
  • Swelling in the stomach or intestines
  • Diarrhea or constipation
  • Blood in stools
  • Bloating
  • Poor feeding tolerance
  • Discoloration of the stomach

Parents of affected infants are filing an Enfamil lawsuit, which is an active lawsuit in the US Federal Court. As many as 100 cases have been reported to date. Mead Johnson is accused of concealing crucial information regarding Enfamil’s health risks. The company provided no warning labels whatsoever to inform parents of NEC.

According to TorHoerman Law, three kinds of lawsuits can be filed against the manufacturer, including –

  • Product Liability Lawsuitbecause Mead Johnson failed to warn of the potential risks of NEC.
  • Wrongful Death Lawsuitin cases where the infant passed away due to NEC. The family of the deceased baby is eligible to file a wrongful death lawsuit.
  • Medical Malpractice Lawsuitcan be filed by an affected infant’s parents who were recommended Enfamil by a healthcare provider. This lawsuit is filed against the healthcare practitioner’s incompetence or negligence.

Enfamil Lawsuit Latest Updates

In April 2022, Enfamil lawsuits were consolidated into multi-district litigation (MDL) along with Similac lawsuits of similar nature. The Transfer Order issued by the US Judicial Panel for the MDL in the Northern District of Illinois stated that Enfamil and Similac showed a greater propensity to NEC than other safer alternatives, especially among premature infants.

The cases will be closely inspected till December 2023, after which the first Bellwether trial is scheduled to take place in early 2024. Hence, the exact value of payouts and settlements cannot be given right now, though personal injury attorneys speculate that the value could easily reach millions.

The Bottom Line

As per Pediatrics & Child Health, it was found that though formula-fed neonates showed good growth rates, they were also at increased risk of developing NEC and feeding intolerance. The study compared two groups of infants – one fed with pasteurized donor human milk (PDHM) and the other, with baby formulas.

At least 8.9% of formula-fed neonates were transferred to the NICU for suspected risks of NEC, as compared to only 3.1% from the PDHM group. As of now, no Enfamil recalls have been made due to the risks of NEC, but the upcoming Bellwether trial should help serve justice for affected infants and their parents.