2008 Powdered Infant Formula – Cronobacter sakazakii

Powdered infant formula is not sterile and has been implicated in Cronobacter outbreaks. Cronobacter is a rare cause of infant blood infections and meningitis; it carries a 40% mortality rate. Two infants, in New Mexico, who were not related to one another, and lived 200 miles apart, developed infections with Cronobacter sakazakii. One infant developed severe brain injury and hydrocephalus. The other infant died. The New Mexico Department of Health determined that the only known risk factor for these illnesses was powdered infant formula. Cronobacter was not isolated from sealed canisters of formula, but it was isolated from an opened canister of formula in one of the infant’s homes. This Cronobacter was a genetic match to the Cronobacter found in the infant’s postmortem blood sample. The infants were infected with different strains of Cronobacter but had consumed the same brand of powdered infant formula.


2008 Spain Powdered Infant Formula – Salmonella

Consumption of infant formula that had been produced in Spain, and distributed widely throughout Spain, was linked to an outbreak of Salmonella Kedougou. The infant formula came in a powdered form. Outbreaks associated with infant powdered formula occur because these products are not sterile. The infant formula brand had been produced until March 2008; unfortunately, the outbreak was not detected until almost five months later. Adult cases that occurred during the outbreak were likely due to secondary transmission from infected infants who drunk the formula.


2007 Enterobacter sakazakii Linked to Enfamil Human Milk Fortifier for Premature/LBW Babies, Iowa – Cronobacter sakazakii

A premature infant was reported to the Iowa Department of Public Health as having Enterobacter sakazakii infection. Premature and low birth weight infants are susceptible to this infection. A link between illness and consumption of powdered infant formula had already been established. The infant was hospitalized for nearly five months, suffering multiple complications of E. sakazakii infection – seizures, respiratory distress, diabetes insipidus, and others. He underwent multiple surgeries for digestive and respiratory management. He remained on a ventilator and sustained significant, permanent, brain damage. He was placed in a care facility due to his extensive care needs. In 2002, the FDA advised that powdered infant formulas are not commercially sterile products. Powdered milk-based infant formulas are heat-treated during processing, but unlike liquid formula products they are not subjected to high temperatures for sufficient time to make the final packaged product commercially sterile. Although liquid sterile formulas are available for premature, or low birth weight infants, increasingly these infants are given powdered formulas as they are readied for transition to their homes. In light of the epidemiological findings and the fact that powdered infant formulas are not commercially sterile products, FDA recommended that powdered infant formulas not be used in neonatal intensive care settings unless there was no alternative available.


2001 Portagen Powdered Infant Formula – Cronobacter sakazakii

A premature baby became ill after consuming formula made from powder in a neonatal ward in Tennessee. A culture obtained by the hospital tested positive for Enterobacter sakazakii (now called Cronobacter sakazakii), a rare, invasive bacteria that often leads to death in neonates. The baby died nine days after infection was identified. The Tennessee Department of Health and CDC investigated the source of the infection. Forty-nine babies who had been hospitalized in the same neonatal intensive care unit (NICU) were enrolled in a cohort study. Nine of the babies were found to have E. sakazakii in their stool. The study showed a strong association between E. sakazakii infection and consumption of powdered infant formula, Portagen. Cultures from the Portagen tested positive for E. sakazakii. The NICU changed their policy and subsequently used only commercially sterile, ready-to use, liquid infant formula except in specific cases where powdered formula was needed. A designated formula mixing room was created.


2001 Children’s Hospital and Regional Medical Center Enteral Tube Formula Feedings – Salmonella

An outbreak of Salmonella Saintpaul occurred among children who had been hospitalized at Children’s Hospital and Regional Medical Center, Seattle, Washington, in mid-February. Case-patients were more likely than controls to have received enteral tube feedings using formula that had been mixed by hospital staff. Two nurses developed gastroenteritis caused by the same strain of Salmonella Saintpaul after caring for infected children.


1998 Enterobacter sakazakii in Belgian Powdered Milk Formula- Cronobacter sakazakii

An outbreak of necrotizing enterocolitis, a condition in which a section of the bowel dies, occurred in a neonatal unit of a hospital in Belgium. Twelve infants became ill, and two died. Enterobacter sakazakii, also known as Cronobacter sakazakii, was found in stool samples taken from six of the twelve infants. Ten of the infants had been fed orally with the same brand of powdered milk formula. Enterobacter sakazakii was isolated from the prepared formula milk as well as from several unopened cans of a single batch of powdered formula. The strains of Enterobacter sakazakii from the infants were partially similar to the strains that were isolated from the formula. No additional cases of necrotizing enterocolitis occurred once this formula was removed. Microbiologic contamination of powdered formula was suggested to be a contributive factor in the development of necrotizing enterocolitis, a condition encounter almost exclusively in formula-fed premature infants.


1994 Outbreak of Salmonella Virchow Linked to Powdered Infant Formula, Spain – Salmonella

Spain’s Salmonella surveillance system detected and halted an outbreak of Salmonella Virchow due to powdered infant formula. Most of the ill were infants less than seven months old. The outbreak lasted six months. Powdered formula samples were tested, and the same strain of Salmonella Virchow was detected in the product.


1993 Outbreak of Salmonella Linked to Soyalac(R) Powdered Infant Formula, Illinois – Salmonella 

Three infants developed Salmonella Tennessee infection after consuming Soyalac Powder(R) infant formula. Two of the infants lived in Canada and one infant lived in Illinois. The Food and Drug Administration investigated the Minnesota plant where the formula was manufactured. They found Salmonella Tennessee where the product had been dried and from cans of the powdered formula. Drying milk does not destroy Salmonella.


And, do not forget:

2008 Melamine in Chinese Milk and Powdered Infant Formula

For months, melamine was added to milk and powdered infant formula in China. Melamine is a chemical that is used to make plastics; it is high in nitrogen, which makes milk appear to have a higher protein content when tested. Addition of melamine into food was not approved by the FAO/WHO Codex Alimentarius (food standard commission), or by any national authorities. Almost 300,000 people were made ill by the milk and infant formula due to kidney stone formation(urolithiasis), and kidney failure. Sanlu was one of the companies that produced infant formula. There was evidence that the tainted milk had been used to make other products. The Chinese maker of White Rabbit Candy which was made from milk stopped sales of candy after finding melamine in its product. This product had international distribution. The World Health Organization was first notified of the toxic milk products on September 11, by then the products had been marketed to Chinese consumers for months. In 2007, melamine was found in wheat gluten and rice protein concentrate that was exported from China and used in the manufacture of pet food in the USA. This caused the deaths of many dogs and cats due to kidney failure. These outbreaks were examples of criminal action for short term gain leading to large scale health impact. Company officials were put on trial and ultimately were severely punished including two death penalty sentences. In December 2009, Chinese authorities closed the Shanghai Panda dairy after again detecting melamine in milk powder.


Cronobacter: Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Cronobacter outbreaks. The Cronobacter Attorneys and Lawyers have represented victims of Cronobacter and other foodborne illness outbreaks and have recovered over $800 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Our Cronobacter lawyers have litigation Cronobacter cases stemming from outbreaks traced to powered infant formula.

If your child became ill with a Cronobacter infection after consuming powered infant formula and you are interested in pursuing a legal claim, contact the Marler Clark Cronobacter attorneys for a free case evaluation.