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Baby Formula Lawsuits and Settlement Claims

Enfamil and Similac are facing baby formula lawsuits from parents of premature infants diagnosed with necrotizing enterocolitis (NEC) across the US. These parents claim Mead Johnson (Enfamil) and Abbott Laboratories (Similac) didn’t warn that their cow milk-based products could result in necrotizing enterocolitis in premature infants.

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Baby Formula Lawsuits and Settlement Claims

Enfamil and Similac are facing baby formula lawsuits from parents of premature infants diagnosed with necrotizing enterocolitis (NEC) across the US. These parents claim Mead Johnson (Enfamil) and Abbott Laboratories (Similac) didn’t warn that their cow milk-based products could result in necrotizing enterocolitis in premature infants.

What Is Necrotizing Enterocolitis (NEC)?

Necrotizing enterocolitis is a gastrointestinal infection that leads to intestinal tissue decay and failure. It can occur in the small or large intestine. However, while NEC typically has mild cases, about 50% of infections end up as fatalities.

The fatal symptoms of NEC include inflammation and perforations in the intestine. Perforations in the intestinal system typically occur when the condition isn’t detected and treated early. 

Intestinal bacteria leak through these resulting pores into the blood or abdomen to cause blood infections and other deadly conditions.

Why Are Parents Filing Baby Formula Lawsuits Against Enfamil and Similac Manufacturers?

Baby formula lawsuits against Similac and Enfamil claim that the manufacturers of these products failed to warn against the toxic nature and potentially fatal health risk of the cow milk-based formulas. 

Parents who have filed these lawsuits claim that Abbott Laboratories and Mead Johnson (manufacturers of Similac and Enfamil, respectively) were aware or should have had prior knowledge of their products’ dangers to the health of premature infants. 

Instead of providing warnings about the potential risks and guidelines regarding their products’ use, both companies promoted their baby formulas as healthy for consumption by premature babies. 

However, decades of scientific studies has shown that a cow milk-based baby formula puts infants at higher risk of NEC. Interestingly, the Journal of Pediatrics discovered that premature babies fed with breast milk had significantly lower chances of NEC infection than those given a mix of baby formula and breast milk. 

As such, the American Academy of Pediatrics has warned against using cow milk-based products, such as Similac, Enfamil, and other similar formulas to feed infants.

Enfamil and Similac Manufacturers Intentionally Refused to Warn Parents About Their Products' Potential Risks

The baby formula lawsuits against Abbott Laboratories and Mead Johnson claim that, as companies, both manufacturers knew about the scientific studies on the impact of cow milk-based formulas but failed to provide warnings for parents regarding their products. 

These baby formula litigations also accuse Abbott Laboratories and Mead Johnson of deliberately refusing to warn consumers about the dangers of their formulas to avoid any impacts on their patronage and market share. 

As such, affected parents are suing for emotional distress and financial losses due to their infants’ medical condition and death. 

Products Mentioned Under the Enfamil and Similac Lawsuits

Similac is a portfolio of cow milk-based baby formula manufactured by Abbott Laboratories. The collection comprises a range of products for full-term and preterm infant nutrition.  

Enfamil is also the brand name for a wide range of premature infant cow milk-based baby formulas produced by Mead Johnson. Both brands have a significant number of their products mentioned in the baby formula lawsuit, including: 

  • Similac Special Care 24
  • Similac Human Milk Fortifier Concentrated Liquid 
  • Similac Alimentum Expert Care 
  • Similac Special Care 20
  • Similac Special Care 
  • Similac Special Care 24 High Protein
  • Similac NeoSure 
  • Similac Human Milk Fortifier Protein
  • Similac Special Care 30
  • Similac Alimentum
  • Enfacare Powder 
  • Enfamil Premature 24 Cal
  • Enfamil 24 and DHA & ARA Supplement
  • Enfamil Milk Fortifier Liquid Standard Protein
  • Enfamil Human Milk Fortifier Powder
  • Enfamil Premature 24 Cal/fl oz HP
  • Enfamil NeuroPro Enfacare
  • Enfamil Human Milk Fortifier Liquid High Protein
  • Enfamil Premature 24 Cal
  • Enfamil Human Milk Fortifier Acidified Liquid

Has Abbott Laboratories and Mead Johnson Recalled Similac and Enfamil Baby Formulas?

There has been no Enfamil and Similac recall because of the baby formula and necrotizing enterocolitis lawsuits. However, there was an Enfamil recall in February 2022 due to a bacterial infection. 

The February recall occurred after incidents involving babies who got sick or died after consuming Enfamil baby formulas that caused a bacterial infection. However, the FDA declared the affected Enfamil formulas safe after testing. 

There has also been some store recalls on Enfamil formulas due to product tampering. Some mothers had claimed that the Enfamil products they purchased contained flour rather than baby formula. 

Furthermore, Abbott Laboratories issued a February 2022 recall for Alimentum, Similac, and Elecare formulas produced at the Sturgis, Michigan, facility. 

This recall came after one baby reportedly came down with Salmonella Newport, and another four suffered Cronobacter sakazakii infections after consuming Similac products. Two of these cases eventually ended up as fatalities.

FDA Investigations

In February 2022, the FDA announced an investigation of Similac products manufactured at the Michigan facility for bacterial contamination. This investigation came on the heels of the reports of Cronobacter sakazakii infections. 

The inquiry revealed that the infected babies had consumed Similac products manufactured at the Michigan plant. 

The FDA released a public notice warning against purchasing Similac products manufactured at the facility in Michigan. 

This regulatory body also inspected the plant and took environmental testing samples. 

These samples highlighted evidence of Cronobacter contamination at the facility and led to the Similac recall in February 2022. 

In March 2022, an FDA preliminary report also highlighted that Abbott lacked a process control system to prevent the adulteration of its formulas by microorganisms, such as Cronobacter sakazakii. 

In May 2022, FDA Commissioner, Robert Califf, testified before congress about the sanitary issues at Abbott’s Michigan facility that resulted in its shutdown. 

In June 2022, the FDA released another report concerning an infant’s death due to possible bacterial contamination. Abbott reopened its Michigan plant that same month due to a baby formula shortage resulting from the initial recall.

Cronobacter Sakazakii Infection in Babies

Cronobacter sakazakii naturally occurs in dry areas and food mediums, such as herbal tea, starches, powdered milk, protein shakes, and powdered baby formulas. It can lead to diarrhea, bowel discomfort, and urinary tract infections in adults.

However, it’s a more threatening condition for infants. Cronobacter sakazakii can lead to fatal systemic diseases, such as meningitis, in premature infants. It can also result in poorly developed gastrointestinal systems ill-equipped to deal with deadly bacteria. 

Some of the significant symptoms include fever and eating challenges. Affected infants may also show signs of lethargy. 

That said, while Cronobacter infections are rare, the majority of cases result from contaminated baby formulas since these products are an ideal environment for the bacteria to grow and thrive. 

Who Can File a Baby Formula Lawsuit?

  1. Parents of premature infants suffering from NEC after consuming Enfamil, Similac, or other cow milk-based baby formulas can file baby formula or NEC lawsuits. 

    While you may not have fed your baby Enfamil or Similac baby formulas, your baby may have consumed them at the hospital. Your lawyer can help you determine this incident’s possibility. However, you’ll need to provide the hospital’s name and location to your attorney. 

    If you have fed your baby Enfamil or Similac baby formulas, you’ll need to provide receipts, product boxes, or any other proof of purchase as they’ll serve as baby formula lawsuit information for your lawyer.

What Is the Status of Similac and Enfamil Lawsuits?

The Similac and Enfamil baby formula lawsuits are still in their early stages. However, more parents are still filing new cases against Abbott Laboratories and Mead Johnson across the US. 

Every case asserts product liability against Abbott and Mead Johnson based on the failure to warn about the potential toxicity of their products and strict product liability.

How Does Similac and Enfamil Class Action Work?

Baby formula lawsuits are projected to grow in the US. As such, US federal courts have consolidated pending Similac cases into a class action multi-district litigation (MDL) under Northern District of Illinois Chief Judge Rebecca R. Pallmeyer. 

In other words, if you file a baby formula claim in any state in the US, the court will transfer your case to Illinois. That said, there are currently less than 100 baby formula claims in the Illinois federal court as of July 2022. Regardless, cases will likely increase in the coming months. 

Traditional class actions and MDLs in mass tort product liability lawsuits are similar. However, lawsuits for both cases are separate and consolidated for pretrial discovery. 

That said, class actions with significant damages and evidence of the responsibility of the defendant often have a history of a global settlement in the US. 

Federal Similac Class Action Litigations

NEC class action claims for Similac are numerous. Among them is a federal MDL class action that includes Enfamil and Similac, and it is undergoing. The MDL judge for this litigation is North District of Illinois Judge Rebecca Pallmeyer.

 Judge Pallmeyer began the MDL’s status conference and listened to suggestions for leadership appointments on May 19th, 2022. Currently, 52 NEC baby formula cases are pending and consolidated under Judge Rebecca Pallmeyer. However, this figure is likely to increase.

Illinois State Court Similac Class Actions

Plaintiffs have filed some baby formula lawsuits in Illinois state courts since Mead Johnson and Abbott Laboratories have their headquarters in Chicago; however, most of these filings happened prior to the federal class action. 

Attorneys for these cases filed for the Supreme Court of Illinois to consolidate all claims into a solitary baby formula class action litigation in Madison County. 

The companies consented to consolidation since handling the cases this way would be easier and more budget-friendly than defending multiple cases simultaneously.

What Is the Worth of Similac and Enfamil Baby Formula Lawsuits in Settlement?

Since there has been no settlement or trial for baby formula lawsuits involving Similac and Enfamil, it’s challenging to project the potential settlement value. 

However, we can make speculations based on payouts in previous medical malpractice cases that involve NEC in baby infants. While these projections may not be accurate, they provide insight into what’s possible in the baby formula litigation. 

The average settlement amount in some of the most recent medical malpractice claims was $3.5 million. The median amount in these lawsuits was $1.3 million.  

However, the settlement for the Abbott and Mead Johnson lawsuits may be higher than these since both companies are less sympathetic than the doctors in the medical malpractice litigations. 

That said, settlement amounts in class action lawsuits are lower than the trial value. Also, since these baby formula litigations are in their early stages, with considerable information and evidence still unknown,  there’s an average settlement value of $300,000 to $800,000 per person. 

However, this figure will likely depend on the baby’s medical condition.

What Will Be Abbott's and Mead Johnson's Defense in These Lawsuits?

Abbott and Mead Johnson are trying to avoid these baby formula lawsuits going to trial. As such, their lawyers are finding legal loopholes to avoid a court sitting. One crucial argument Abbott Laboratories has raised is learned intermediary. 

Abbott argues that the claim that the company failed to warn about the potential risk of its products is barred by the learned intermediary doctrine. In other words, the company did not have a legal obligation to warn the affected parents because that responsibility belonged to the infant’s doctors. 

This argument will likely stand for claims that involved Similac and Enfamil formulas used in hospitals; however, Abbott Laboratories still had a legal obligation to warn the doctors of their products’ potential toxicity. 

Furthermore, Abbott is using the preemption argument. The company claims that the US federal law preempts the baby formula lawsuits under the Infant Formula Act (IFA) 20 USC.

This act defines the manufacturing procedures and product labeling of baby formulas in the US. It also mandates baby formulas to pass through FDA tests before entering the market. 

Abbott argues that the IFA preempts the NEC lawsuits’ tort law claims because it is impossible to adhere to state and federal standards. According to Abbott, the claim that Similac has a defective design is precluded by the preemption law. 

Abbott also says it underwent the FDA test procedure, which involved reviewing cow milk as safe for infant consumption. However, baby formula lawsuits have never had a case of preemption in US history, so Abbott will likely lose this argument. 

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