Parents are filing a proposed class action lawsuit against Abbott Laboratories for Failure to Warn about its baby formula risks as the FDA investigates two baby deaths.
Detroit, MISeveral lawsuits filed in the U.S. District Court for the Northern District of Illinois over the last few weeks claim that Abbott Laboratories, which recalled lots of Similac, Alimentum and EleCare products mid-February, claim the pharma giant failed to warn consumers about the risk of feeding the formula to their babies before purchasing and that Abbott took too long to replace the recalled formulas. Several babies in Minnesota, Ohio and Texas became ill and at least two have died.
Baby Formula Recall
On February 17, Abbott voluntarily recalled lots of Similac, Alimentum and EleCare products—including almost 50 brands marketed under those names-- produced at its southwest Michigan facility. Then on February 28, Abbott expanded its recall to include one lot of Similac PM 60/40 made in the facility after the death of a baby who consumed the formula and tested positive for Cronobacter sakazakii. That case, like the others, is still under investigation.
“We are very sympathetic to families in these situations. We value the trust parents and caregivers place in us, and ensuring the safety and quality of our products is our top priority,” said Abbott spokesman Scott Stoffel and reported by the Chicago Tribune. Stoffel said that “all of Abbott’s infant formulas are tested for Cronobacter sakazakii, Salmonella and other pathogens and must test negative before any product is released, and that no distributed product from the company’s Sturgis, [MI] facility has tested positive for Cronobacter sakazakii or salmonella.
However, In an updated news release the FDA warned consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas produced at Abbott Nutrition’s Sturgis facility as they “have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Four reports of Cronobacter sakazakii infections were initially investigated: three complaints were reported to the FDA, another came from the CDC and a fourth complaint of an infant infected with Salmonella Newport. Investigators determined that Cronobacter “may have contributed” to the deaths of two infants.
"During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport," Abbott Nutrition said in a news release. "Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test."
Deadly Bacteria
Cronobacter bacteria can cause severe blood infections and other serious complications such as meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal body movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body. Cronobacter infections are rare but are especially high risk for newborn infants (see symptoms below).
Salmonella bacteria can cause diarrhea, fever and abdominal cramps. Severe cases can lead to lethargy, rash, blood in the urine or stool and even death.
The FDA is advising that people should avoid using Similac, Alimentum or EleCare powdered infant formulas if the first two digits of the code are 22 through 37; the code on the container contains K8, SH or Z2; the expiration date is April 1, 2022, or later. The agency advises that "Parents and caregivers of infants who have used these products, and are concerned about the health of their child, should contact their child's health care provider," the FDA said in the news release.
Abbott Lawsuit
A Michigan woman plans to file a lawsuit against Abbott after she fed her baby Similac after having problems breastfeeding. Her son suffered with digestion issues and skin rashes that she believes was caused by the formula. Wendy Jackson told Detroit News that all the symptoms went away when she switched to another brand of formula. Her attorney’s phone has been "ringing off the hook" with calls from parents whose babies were fed some of the recalled formula.
Another lawsuit filed February by a Florida father is seeking class action status. According to the Chicago Tribune, the father purchased Alimentum for his daughter in late January, and she developed diarrhea, abdominal pain, diaper rash with blisters and blood, dehydration and sleeplessness. Similar lawsuits involving Alimentum formulas includes a complaint by a South Carolina mother who said her baby had diarrhea for two weeks after drinking Alimentum formula. Five more Illinois lawsuits were filed by consumers in Maryland, Arkansas, Texas, Florida, Louisiana, Delaware, Pennsylvania and Indiana who bought the formulas and then were unable to use them because of the recall. They said they wouldn’t have bought the formulas if they’d known about the risks, and they are seeking damages.
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