Infant Formula Class Action Lawsuit Filed over Recalled Similac, Alimentum and EleCare

As Abbott Laboratories faces a growing number of necrotizing enterocolitis infant formula lawsuits brought by families of premature babies who developed a devastating intestinal injury after being fed Similac in the NICU, the company now faces a class action lawsuit over recalled versions of its powdered formula, which may be contaminated with Cronobacter sakazakii and other pathogens that are causing older babies to develop gastrointestinal distress.

A complaint (PDF) was filed in the U.S. District Court Southern District of Florida on February 18, by Luis Alfredo Suarez, on behalf of his minor child, identified only with the initials A.S., who developed gastrointestinal distress after being fed tainted Alimentum formula earlier this month.

The lawsuit comes only one day after Abbott Laboratories recalled Similac, Alimentum and EleCare formula, after confirming that the powder may contain Cronobacter sakazakii, Salmonella Newport or other bacteria that entered the products during the manufacturing process at a plant in Sturgis, Michigan.

According to an infant formula warning issued by the U.S. Food and Drug Administration (FDA) on February 17, parents and caregivers are being urged to stop using the recalled Similac, Alimentum and EleCare powdered products immediately, while the agency pursues an investigation into at least three confirmed injuries and one death that may be linked to contamination.

The FDA announced it has initiated an onsite inspection at the facility and has recorded several positive Cronobacter sakazakii results from environmental samples along with several adverse inspectional observations by investigators.

The infant formula lawsuit brought by Suarez seeks class action status to pursue damages for his child and other infants, indicating that Abbott Laboratories failed to put adequate quality control measures in place to make sure the products are safe and free of salmonella and cronobacter bacteria, which could cause gastrointestinal problems and difficulty feeding.

Suarez indicates that he purchased and fed the recalled Alimentum to his daughter. Shortly after, around February 8, A.S. began developing symptoms of gastrointestinal distress, including diarrhea, abdominal pain, severe diaper rash with blisters and blood, dehydration, sleeplessness, and other pain and injuries requiring immediate medical attention.

To date, Suarez states his infant still suffers gastrointestinal and bowel problems caused by the contaminated formula, causing A.S. to suffer pain, loss of enjoyment of life and medical problems. Suarez states he has incurred, and continues to incur, medical expenses to have his child medically treated as a direct and proximate result of Abbott’s negligence in failing to ensure its baby formula products were safe for human consumption and free of pathogenic bacteria or other substances injurious to human health.

The baby formula recall lawsuit is one of the first of what could be many filed against Abbott Laboratories Inc. in the coming weeks as the manufacturer scrambles to remove the potentially contaminated powdered formula from store shelves and alert customers of the possible dangers.

Similac and Enfamil Baby Formula NEC Risks

The reports of contamination came as Abbott Laboratories was already defending a rising number of Similac formula lawsuits brought throughout the federal court system, alleging that the company has withheld information about the safety of the cow’s milk product for premature infants, which has been found to greatly increase the risk of necrotizing enterocolitis (NEC).

A number of studies have highlighted a link between baby formula and NEC for preterm infants, resulting in gastrointestinal perforations that often develop while the infant is still in the NICU, allowing bacteria to leak through and cause abdominal infections and intestinal tissue to die off. Common symptoms of NEC include swollen, red or tender belly, difficulty feeding, constipation, dark or bloody stools, body temperature changes, green vomit,  apnea, bradycardia (slowed heart rate) and hypotension (low blood pressure), among others. It is often fatal and survivors often experience long term side effects from surgery to remove dead bowels, resulting in a lifetime of bowel complications.

According to allegations raised in the litigation, Abbott Laboratories withheld warnings and information from parents and medical providers for decades, placing desire for profit before consumer safety. Similar claims are also being pursued against Mead Johnson in Enfamil NEC lawsuits brought by families of babies who received this competing cow’s milk formula instead of breast milk.

Given common questions of fact and law raised in complaints filed in recent weeks throughout the federal court system, Abbott Laboratories filed a motion to create a Similac MDL, which would centralize the litigation before one judge for coordinated discovery and pretrial proceedings. The U.S. Judicial Panel on Multidistrict Litigation (JPML) is expected to schedule oral arguments on motion during an upcoming hearing session next month.