On Monday, the United States of America filed both a lawsuit and a proposed consent decree in the Western District of Michigan against defendants Abbott Laboratories and several employees in an effort to resolve the nationwide powdered infant formula shortage and ongoing health issues surrounding Abbott’s powdered infant formula.
Abbott Laboratories and two employees at its Sturgis, Michigan, facility, namely the Sturgis Director of Quality and the Sturgis Site Director as well as the Division Vice President of Quality Assurance were all noted as defendants in the suit. The complaint asserts that Abbott produced its powdered infant formula under conditions and practices that did not comply with “regulations designed to ensure the quality and safety of infant formula.” The compromised environment led to bacteria like Cronobacter sakazakii living in the powdered infant formulas. The bacteria, which was found in U.S. Food and Drug Administration (FDA) sample of the formula, is known to cause deadly sepsis and meningitis in infants.
A press release issued by the U.S. Department of Justice noted that “Abbott has agreed to resolve the complaint in a proposed consent decree of permanent injunction.” Abbott will plan to retain expert assistance in bringing their facility up to regulation and compliance with good manufacturing practice regulations. Specifically, the proposed consent decree outlines the requirements that Abbott must meet to continue manufacturing powdered infant formula safely in order to address the shortage of powdered infant formula.
U.S. Attorney Mark Totten explained that “parents who feed their babies formula must have confidence these products are safe. This proposed consent decree aims to protect one of our most vulnerable populations. My office is fully committed to supporting FDA and working with its partners at the Consumer Protection branch to ensure manufacturers in our district comply with FDA’s safety regulations.”
If the consent decree is entered by the federal court, Abbott Laboratories would be permitted to continue manufacturing its powdered infant formula in its Sturgis facility. However, Abbott would also be required to take measures that would increase safety and ensure the formula’s compliance with various federal statutes, significantly reducing the risk of compromised powdered infant formula.