Soon after the tragic deaths of one infant from a bacterial disease, the FDA investigated Abbott. Traces of the pathogen Cronobacter sakazakii were found at its Michigan plant, which prompted the FDA to recall several brands of formula and warned parents not to use or buy formula coming from the plant. Then, on February 28, another infant died: doctors said a Cronobacter was a “contributing cause of death”. But in Abbott’s first recall, the giant drug company insisted that Cronobacter sakazakii, a type of bacteria that is sometimes found in food, is nothing to worry about. Do a quick online search and first up is the CDC website, which states that “Getting sick from Cronobacter does not happen often, but infections in infants can be deadly. Cronobacter infections in infants less than 12 months old are often linked to powdered infant formula.”
Abbott denied that these babies’ infections were associated with formula from its Michigan facility. Lawsuits and the FDA say otherwise. The FDA’s inspection of Abbott’s Michigan plant found violations related to cleanliness and temperature control: the very conditions that would lead to an infectious disease outbreak, plaintiffs state in their lawsuits, and they also argue that Abbott failed to warn about these violations, which were found back in September 2021.
The shutting down of Abbott Nutrition plant in Michigan triggered a widespread infant formula shortage crisis, all because it had a leaking roof that caused water to pool on the floor and cracks in production equipment that welcomed bacteria in, and it stayed. Dr. Robert Califf, the head of the FDA, told members of the House Energy and Commerce Subcommittee on Oversight and Investigations that the inspections were “shocking… We had no confidence in integrity of the quality program at the facility,” and he also said his agency’s response was too slow in dealing with problems at the plant.
An Abbott spokesperson told the Chicago Tribune that the plant is expected to reopen June 4, with some formula expected to begin rolling out June 20. “Officials hope new shipments will reach store shelves within six to eight weeks, although resumption of full production at the plant will take longer.” CNN recently reported that the 31% sold-out rate of formula from April hit 40%, and some states reported a 50% or higher out-of-stock rate.
Abbott replaced the leaking roof. And its senior VP, Christopher Calamari, said he was deeply, deeply sorry” about the shortages. He might also be telling Abbott investors that he is deeply sorry about infant formula lawsuits and why the company took so long to recall its formula, given the potentially fatal risks to infants.