A whistleblower lawsuit alerted Abbott and the FDA to questionable practices at the company’s formula manufacturing plant in Sturgis, Michigan one year before the recall of Similac, Alimentum, and EleCare powdered infant formula products that have been linked to a cluster of infant illnesses and two deaths. According to recent reports, the complaint was filed with the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) and passed onto Abbott and the FDA in February 2021, a full eight months before Abbott admits to being made aware of issues at the facility. The complaint reportedly detailed a number of quality control problems at the manufacturing plant, including issues with failing equipment and concerns about the safety of released infant formula products. If your child has suffered injuries due to contaminated Similac, Alimentum, or EleCare baby formula, you may have grounds to file a claim against Abbott. Contact Consumer Safety Watch today to find out how we can help.
The massive recall of Abbott’s Similac, Alimentum, and EleCare infant formula products in February 2022 exacerbated an already troubling nationwide infant formula shortage that had many parents across the United States questioning how they would feed their children. Revelations about a whistleblower lawsuit filed one year before the recall have raised additional questions about when Abbott and federal health regulators were first warned about contamination concerns and quality control issues at the plant, and why action wasn’t taken sooner to protect vulnerable infants. The delay in recalling the tainted infant formula is of particular concern for the families of babies who suffered Salmonella Newport and Cronobacter sakazakii infections and had to be hospitalized, including at least two infants who died from bacterial infections after consuming recalled formula.
Federal safety inspectors began investigating Abbott’s Sturgis plant in January 2022, amid concerns about the presence of Salmonella and Cronobacter bacteria, and found a history of contamination with Cronobacter as well as “egregiously unsanitary” conditions at the facility. Dr. Robert Califf, the head of the FDA, called the results of the inspection “shocking” during a Congressional hearing before the House Subcommittee on Oversight and Investigations, detailing serious issues like a leaky roof, standing water on the floor inside the plant, and defects in production equipment that allowed bacteria to enter the facility and persist. The FDA previously found sanitation issues at the same Abbott facility in September 2021, indicating in a report from that earlier inspection that the company “did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.” By February 1, 2022, the FDA had confirmed the presence of Cronobacter at the plant and the facility was shut down that same month.
The nationwide infant formula recall, while a necessary action, did little to help the families with children who consumed the contaminated formula and became ill and were hospitalized or died. According to the FDA, bacterial infections were reported in four infants from three states who were fed powdered formula manufactured at Abbott’s facility in Sturgis, Michigan. All four cases of illness were related to Cronobacter bacteria, which can cause severe, life-threatening infections (sepsis) or meningitis, an especially serious concern among newborns. All four infants had to be hospitalized and the bacterial infection may have contributed to death in two infants, the FDA reports.
The FDA is currently under audit by the Health and Human Services’ Office of Inspector General (HHS-OIG) for the agency’s response leading up to the baby formula recall and the shutdown of Abbott’s manufacturing plant, including whether FDA regulators followed proper protocol once Cronobacter was found inside the plant and if the agency upheld its duty to “safeguard the nation’s food supply, including infant formula and ensure all ingredients are safe.” If your child consumed a recalled Similac, Alimentum, or EleCare infant formula product manufactured at the Abbott plant in Sturgis, Michigan, and suffered a Salmonella Newport or Cronobacter sakazakii infection, contact Consumer Safety Watch as soon as possible. You may be entitled to financial compensation for your child’s injuries, which a knowledgeable infant formula recall attorney can help you pursue.