Similac Recall Update - August 2022
Just as the Similac baby formula plant in Michigan is finally resuming operations, it is now being reported that a former Abbott employee filed a whistleblower complaint about the facility with OSHA back in February 2021. The complaint reported various concerns about the plant and claimed that records about the Similac Recall were being falsified. More significantly, it shows that federal authorities were on notice of the problems at the Sturgis, MI facility over a year before those conditions eventually led to a Similac recall and an acute shortage of baby formula.
In early June 2022, the FDA finally allowed production operations to restart at Abbott’s formula manufacturing plant in Sturgis, MI, following the previous Similac recall. A dangerous bacteria outbreak was linked to the facility and a subsequent investigation by the FDA identified numerous violations and unsanitary conditions. This prompted an emergency shutdown of the entire plant and Similac recall which lasted several months before operations finally resumed last week.
The Similac recall and other powdered infant formula shortages were starting across the U.S. even before the issues at the Michigan facility arose, but the shutdown made things worse and became the focal point of public outrage. The Sturgis facility is being allowed to reopen under the terms of a strict consent decree between Abbott and the FDA.
What's the Problem?
Premature babies do best on breast milk or human donor milk for a balanced diet. However, breastfeeding is not always possible in NICUs. Many low birth weight infants also need additional calories, so many NICU medical professionals use natural milk with a Similac baby formula.
Unfortunately, most baby formula products are cow's milk-based, which is difficult for premature babies to digest properly, leading to a severe and often deadly gastrointestinal disease known as necrotizing enterocolitis NEC.
Numerous studies have found that cow milk formula can increase the risk of premature babies developing NEC. The risk of sepsis increased in preemies by nearly 18% for every 10% increase in formula.
Unfortunately, Similac Baby Formula is used in NICUs across the U.S. Similac Human Milk Fortifier Special Care is specially designed for newborn preemies. In addition, NeoSure and Human Milk Fortifier are both made by Similac. When preterm babies feed on them, these baby formula products may increase the risk of NEC.
FDA Warns Against Abbott Baby Formulas After Infant Dies
US health officials are warning parents not to use 3 popular powdered baby formula products manufactured at an Abbott plant in Michigan that investigators recently linked to bacterial contamination .
The FDA it is investigating 4 reports of premature infants who were hospitalized after consuming the baby formula, including 1 who died. The agency said 1 of the cases involved salmonella and 3 involved Cronobacter sakazakiim, a rare but dangerous germ that can cause blood infections and other serious complications.
“As this is a product used as the sole source of nutrition for many of our nation’s newborns and premature infants, the FDA is deeply concerned about these reports of bacterial infections,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include powdered infant formula products at this facility, while we work to resolve this safety concern as quickly as possible.”
What is Similac Baby Formula?
Similac (for "similar to lactation") is a brand of infant formula products that were developed by Alfred Bosworth of Tufts University and marketed by Abbott Labs. The product is a manufactured food designed and marketed for feeding to preterm babies and premature infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water).
Is Similac Baby Formula FDA Approved?
No. The U.S. FDA does not approve premature infant formulas before they can be marketed. However, all formula marketed in the United States must meet federal nutrient requirements  and infant formula manufacturers must notify the FDA prior to marketing a new formula.
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Which Products Use Other Cow Milk Formulas?
About 80% of baby formulas are cow’s milk-based formula, and almost every major brand (and store brand equivalent) offers a bovine-based formula, including:
- Similac Baby Formula
- Similac Special Care
- Human Milk Fortifier
- Earth’s Best
- Happy Baby
- Go & Grow
- Parent’s Choice
- Baby’s Only
What is Necrotizing Enterocolitis NEC?
NEC is a serious gastrointestinal problem that mostly affects premature babies. The condition inflames intestinal tissue, causing it to die.
A hole (perforation) may form in the intestines of babies with NEC. Bacteria can leak into the abdomen or bloodstream through the hole. NEC usually develops within 2 to 6 weeks after birth.
In some preterm infants, NEC is mild. Others experience severe, life-threatening symptoms.
- A swollen, red, or tender belly
- Abdominal Distension
- Feeding Intolerance
- Hypotension (low blood pressure)
- Bradycardia (slow heart rate)
- Temperature Instability
Necrotizing enterocolitis may require medication, but severe cases will require surgery – and even the surgery may pose serious risks of permanent injury to premature babies.
In some cases, scarring and narrowing of the bowel may develop and can lead to future intestinal obstruction or blockage.
Another residual problem may be malabsorption (the inability of the bowel to absorb nutrients normally). This is more common in young children who require multiple surgeries for NEC and lose a large segment of the intestine.
Still, there are some preterm infants who lose so much intestine from the infection that they do not have enough intestine left to survive. These infants may end up requiring a bowel transplant to survive.
Similac Infant Formula Side Effects
In addition to an increased risk for necrotizing enterocolitis, cow's milk-based formula products have been linked to more moderate side effects including constipation, diarrhea, and upset stomach. These effects are usually temporary and may disappear as the baby's body adjusts to the medication.
Breast Milk vs. Formula: How Similar Are They?
There are ways in which formula is similar to breast milk: they both provide energy, healthy foods, hydration and nutrients, so your baby will grow whichever milk he is given.
However, despite advances in how cow's milk based formula is formulated and manufactured, it doesn’t come close to matching the health benefits of human breast milk.
Human milk fortifier has evolved over millions of years to be the perfect health food for human babies. It’s much more complex than other mammals’ milk, as it builds our more complex brains and unique digestive and immune systems.
In contrast, cow’s milk, from which most formula is made, meets the specific needs to be fed to calves. It’s not safe for human babies to drink, so has to be processed intensively when made into formula to be fed to infants.
Abbott Baby Formula Linked to 2nd Infant Death
The CDC announced on Feb. 28, 2022, that Abbott Laboratories Similac Human Milk Fortifier PM 60/40 baby formula product has been linked to a second infant death. The baby formula was produced at Abbott Laboratories Sturgis, Michigan facility, where four cases of Cronobacter sakazakii and one case of Salmonella are linked to as of the announcement. The CDC said the Cronobacter infections may have contributed to the two infant deaths.
The particular lot of baby formula named in the expanded Similac recall was distributed nationwide and to Isreal, with those aforementioned cases coming from Minnesota, Texas and Ohio.
Lawsuit Filed After Newborn Died From NEC
The parents of a child who died of NEC have filed a wrongful death lawsuit against the makers of Similac, alleging the infant formula caused the serious intestinal disease.
The complaint was filed in the U.S. District Court for the Eastern District of California on May 14, 2021, by Alicia Restad and Daniel Renteria-Hernandez, alleging Abbott Labs and Mead Johnson & Company, LLC are responsible for the death of their child, Daniel Renteria-Hernandez.
According to the Similac lawsuit, baby Daniel was born on April 29, 2019 at Dignity Hospital in Merced, California. He was born premature, with a birth weight of only two pounds and two ounces after only 31 weeks of pregnancy and was put in the Neonatal Intensive Care Unit (NICU) at Valley Children’s Hospital.
At only 16 days, Daniel died from NEC, which the parents blame Similac fed to him during his short life, according to the Similac lawsuit against Mead Johnson.
Lawsuit Claims Abbott Laboratories Deceptively Marketed Similac
Abbott Inc. is facing a proposed class action lawsuit alleging that Similac Go & Grow toddler drink are defectively manufactured in a way that offers minimal nutritional needs to children while maximizing sales for the company.
New York caretaker Giovanna Smith claims Abbott fraudulently advertises its so-called “transition Similac formulas” by claiming they’re suitable for toddlers and an appropriate next step in their development. However, Smith says Similac Go & Grow toddler drink are essentially identical to the cow's milk formula.
The baby formula lawsuits state that Abbott Laboratories is adapting to a shift in how mothers are feeding their babies, citing findings from the American Academy of Pediatrics showing an increase in breastfeeding since 2003.
The resulting drop in infant Similac formula sales led Abbott to re-brand their products, creating a “transition Similac formula” category, including the Similac Go & Grow toddler drink, according to the class action. Other products in this category are labeled as “follow-on formulas,” “weaning formulas,” “toddler milks” and “growing-up milks.”
As evidence of the branding effort, Smith points to U.S. Nielsen data between 2003 and 2015 that shows advertising on these transition formulas quadrupled. The complaint further elaborates on Smith’s claims of how Similac formula and the Similac Go & Grow toddler drink are the same by comparing the labels.
The label on the toddler drink doesn’t indicate how it’s different, according to Smith. Similac Go & Grow and the infant formulas are labeled similarly, with parallel design choices.
Additionally, Smith claims advertising on these products has created a false impression that Similac Go & Grow are needed by growing children. Smith cited research conducted by the University of Connecticut’s Rudd Center for Food Policy and Obesity that looked at public opinion on toddler formula products.
What are Baby Formula NEC Lawsuits Alleging?
If your baby received Similac in a hospital or NICU, or if your child developed NEC after taking Similac, you can file baby formula lawsuits against the manufacturers of Similac with the help of our attorney.
These Similac Recall Lawsuits allege that Abbott knew about the risk of developing NEC, but failed to warn of this risk.
If your child suffered harm from NEC after being fed Similac, he or she may require a lifetime of care and professional medical advice to deal with complications of the disease. Tragically, you may even have experienced a death from this condition. When this occurs, you need someone on your side who can fight for justice and help file baby formula lawsuits.
Get a Free Similac NEC Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Similac Recall Lawsuits. We are handling individual litigation nationwide and currently handling Similac Recall Lawsuits in all 50 states.
If your baby or other loved one received Similac in a hospital / NICU, or if your premature baby was diagnosed with NEC after he or she was fed Similac, you should contact our Similac Recall Attorneys immediately. You may be entitled to a settlement by filing a Similac Recall Lawsuit and we can help.