Plaintiffs argue that Abbott Laboratories, Similac’s manufacturer, did not adequately warn healthcare providers or parents about the risks of necrotizing enterocolitis (NEC), and potentially contributed to severe and sometimes fatal outcomes.
Written by :
Gregory Parker
Edited by :
Grace Johnson
Judge Rebecca Pallmeyer issued an order requiring all plaintiffs to provide evidence that the injured infants consumed Enfamil or another Mead Johnson product before naming the company in a lawsuit. This decision aims to prevent indiscriminate naming of defendants and streamline the litigation process for cases involving Mead Johnson. Currently, no similar order exists for plaintiffs involving Similac products.
Judge Pallmeyer scheduled hearings on sealed and private motions for several plaintiffs involved in MDL 3026. These hearings were set to take place in March 2024, focusing on procedural and preliminary issues in the multidistrict litigation concerning NEC baby formula cases.
As of November 2023, the litigation was still in its early stages with no approved settlements or jury verdicts. The cases are primarily focused on establishing the foundation for future proceedings and gathering essential evidence.
The multidistrict litigation saw an influx of cases transferred from various jurisdictions across the country, indicating a growing number of plaintiffs seeking justice for alleged NEC-related injuries linked to baby formulas.
Parties involved in the litigation were required to submit briefs addressing outstanding discovery issues to the court by April 25, 2023. This step was crucial for resolving procedural disputes and ensuring that the discovery process could proceed efficiently.
The court scheduled Science Day proceedings for May 3, 2023, allowing parties to present an overview of scientific and medical theories relevant to the case. This event aimed to educate the court on the complex scientific issues underlying the NEC claims.
Defendants selected four cases for bellwether test trials. The cases chosen were Clarke, Cresap, Inman, and Mar. These trials are intended to serve as representative cases that can provide insight into how juries might respond to evidence and arguments in the broader litigation
Plaintiffs chose four cases for bellwether test trials. The cases selected were Brown, Diggs, Lopez, and Koeth. Additionally, four randomly selected cases, which were McCarthy, Jacobs, Kelton, and Donaldson, were also identified. These trials are intended to gauge the strengths and weaknesses of the plaintiffs' claims and facilitate potential settlements.
NEC is a significant health concern among premature infants, affecting up to 15% of preterm babies born weighing less than 1,500 grams. Adding to this concern, recent lawsuits highlight that certain baby formulas, like Similac, might worsen this already grave condition and increase the risk of NEC among the most vulnerable infants. [1]
The Similac baby formula lawsuits are primarily based on claims that cow's milk-based products significantly increase the risk of necrotizing enterocolitis in premature infants. The use of these cow's milk-based products has resulted in severe health complications for infants, including the death of intestinal tissue, life-threatening infections, and, in some cases, death.
Similac is a cow's milk-based infant formula produced by Abbott Laboratories. This product is designed to provide nutrition to infants, particularly those who may not be breastfed. However, research has shown that cow's milk-based formulas like Similac significantly increase the risk of NEC in premature infants.
One of the pivotal studies that highlighted this risk was published in the journal Pediatrics. This study found that premature infants fed cow's milk-based formulas had a six to ten times higher risk of developing NEC compared to those fed human breast milk.
Specifically, the research indicated that preemies fed exclusively on formula were significantly more vulnerable to this severe gastrointestinal condition, which leads to inflammation and death of intestinal tissue. [2]
Additionally, a study published in The Journal of Pediatrics in 2009 found that preemies fed an exclusively human milk-based diet were 90% less likely to develop surgical NEC compared to those fed with some bovine milk-based products. [3]
Furthermore, the US Surgeon General’s 2011 report, "The Surgeon General's Call to Action to Support Breastfeeding," stated that premature babies who are not breastfed are 138% more likely to develop NEC. [4]
All these findings highlight the severe risks associated with cow's milk-based formulas like Similac for premature infants.
The allegations against Abbott Laboratories focus on their failure to adequately warn consumers about these risks and their misleading marketing practices, which have led healthcare providers and parents to use the product without fully understanding its potential dangers.
As a result, numerous cases of NEC have occurred, causing significant harm to infants and emotional and financial distress to their families.
To gain a better perspective and understanding of the risks associated with Similac, we will need to take a look at the specific products involved in the lawsuits.
As of May 2024, there is a long list of Similac products involved in the baby formula lawsuits, which are alleged to cause NEC in premature infants. These products include:
The prevalence of so many different Similac products in these legal cases underscores the need for greater transparency and caution in the marketing and use of infant formulas. Parents and healthcare providers rely on these products to support the growth and development of vulnerable infants, and the allegations suggest a significant breach of trust and safety.
As the NEC baby formula lawsuits progress, they may lead to stricter regulations and better safeguards to protect infants' health in the future.
Similac has been subject to several recalls, although not directly related to the NEC risk.
In February 2022, Abbott issued a voluntary recall for certain powdered formulas, including Similac, Alimentum, and EleCare, due to potential contamination with Cronobacter sakazakii and Salmonella.
The decision followed an investigation by the FDA, which detected the presence of Cronobacter sakazakii in environmental samples taken from Abbott’s manufacturing facility in Sturgis, Michigan. The recalled products were linked to reports of illness and death in infants, although no distributed product tested positive for the presence of these bacteria. [5]
Additionally, in October 2022, a proactive recall was initiated for specific lots of 2 fluid ounce ready-to-feed liquid products due to possible spoilage from incomplete sealing of bottle caps.
The affected products included various Similac formulations such as Similac Pro-Total Comfort, Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac NeoSure, and others. The recall was implemented because a small percentage of bottles in the recalled lots may not have been sealed completely, potentially leading to spoilage. [6]
Both these recalls highlight the critical nature of product safety and quality assurance in infant nutrition. Even though Abbott has faced significant scrutiny and legal challenges due to these product safety issues, it has yet to announce a recall related specifically to allegations of necrotizing enterocolitis linked to their products.
The following section delves into the specifics of the lawsuits filed against Abbott Laboratories regarding Similac, including details of the legal claims, the progress of the litigation, and any settlement information that has been disclosed.
As of May 2024, the litigation surrounding Similac infant formula related to NEC is still ongoing, with no final settlements or jury verdicts reported yet in the multidistrict litigation.
However, individual cases have seen significant verdicts, notably a $60 million award in a lawsuit against Mead Johnson over its Enfamil product, which has set a substantial precedent in terms of potential liability and compensation amounts for similar cases.
Legal experts estimate that NEC lawsuit settlements could potentially range between $5,000 to over $500,000, depending on the specifics of each case. These amounts are speculative but are informed by previous product liability lawsuits and the severe impact of NEC on infants, which can include fatal outcomes or long-term health complications for those who survive.
The size of the litigation and the number of cases continue to grow, with more than 400 complaints centralized in the MDL before the US District Judge. As the number of participants and legal scrutiny continue to grow, and more data emerges from trials and expert testimonies, we can expect to see either substantial settlements or further significant jury verdicts.
This ongoing process will not only shape the financial landscape for Abbott Laboratories and other manufacturers but will also significantly impact regulatory practices and safety protocols within the infant formula industry.
If you suspect that your child’s NEC condition might be linked to Similac baby formula, you are generally allotted a specific time frame to initiate a lawsuit, known as the statute of limitations. This period typically extends from two to three years from the date of the injury.
Additionally, many states apply a "discovery rule," which commences the statute of limitations at the point when the parents or guardians either discovered or should have discovered the potential connection between the formula and NEC. This provision is beneficial as the cause of the condition may not be immediately apparent.
It is essential to consult with a legal professional specializing in product liability without delay, to adhere to these deadlines and ensure your case is managed effectively. Product liability lawyers can provide tailored advice regarding the statute of limitations in your state and assist in gathering the necessary evidence to support your claim.
Several research studies suggest that cow's milk-based formulas, such as Similac, may increase the risk of necrotizing enterocolitis in premature infants and highlight a potential link between such formulas and the condition.
In 2021, Similac recalled specific lots of their powdered infant formulas, including Similac, Alimentum, and EleCare, during two separate incidents in February and October. These recalls were due to potential contamination with Cronobacter sakazakii bacteria. As of May 2024, Aboott has not recalled any Similac products because of NEC.
The NEC lawsuit involves several cow's milk-based infant formulas, particularly those marketed for premature babies. These formulas are alleged to have increased the risk of NEC in vulnerable infants. Notably, this includes products associated with major brands like Enfamil and Similac, which are at the center of the Enfamil baby formula lawsuit and similar legal actions.
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