Mead Johnson; Image Courtesy of Mead Johnson Nutrition,

Baby formula is a basic necessity for babies all over the world, so the last thing parents should have to worry about is whether or not the formula they’re feeding their babies is safe. Unfortunately, a recent whistleblower lawsuit against Mead Johnson, whose “Enfa family of brands includes Enfamil infant formula” has shed some light on alleged packaging defects that could be leaving the company’s 8-ounce ready-to-use formula “vulnerable to spoilage.”

The lawsuit against Mead Johnson was filed by a “former Mead Johnson Nutrition compliance director” on Thursday in the U.S. District Court in Chicago. After working for 25 years as a consultant and employee at Mead Johnson, the former employee, Linda O’Risky, claims she was “fired after raising concerns about packaging defects” in a product that Mead Johnson touted as “safer than powdered formula” because it is “hermetically sealed.”

What kind of defect was she referring to? Well, according to O’Risky, “the seals on the 8-ounce product were prone to leaking, making it easier for microorganisms and other contaminants to enter the packaging.” She discovered the defect back in March of 2015 when “she was copied on an email stating that Mead Johnson planned to reject nearly a million units of 8-ounce ready-to-use formula.” In the months that followed, she tried to convince upper management to “comply with Food and Drug Administration regulations” and even “contacted the publicly traded company’s integrity concern hotline.” Her concerns were dismissed and she was “eventually excluded from meetings and shunned.”

Enfamil Formula; Image Courtesy of Terapeak,
Enfamil Formula; Image Courtesy of Terapeak,

O’Risky pressed on, though, because she was concerned for consumers who might end up with a defective, potentially spoiled product. After all, the last thing anyone wants is for the most vulnerable among us to accidentally be fed spoiled food. She also knew from “her role in analyzing consumer complaints” that customer complaints were already on the rise in relation to the formula. Eventually, Mead Johnson finally began an inquiry. However, according to the lawsuit, the company’s investigators “falsely claimed a defective seal didn’t constitute a food safety or FDA compliance problem since any spoilage resulting from a defective seal would be obvious.”

Unfortunately, according to the lawsuit, “it became clear that senior management’s hope was that the defective products would make their way through the marketplace without any major incidents of harm to consumers and without having to fulfill their legal obligations to report the known problem.”

As a result of everything, from the way she was fired and how she was treated after raising concerns about the packaging defect, O’Risky is “alleging retaliations in violation of the Food Safety Modernization Act, the Sarbanes-Oxley Act and the Dodd-Frank Wall Street Reform and Consumer Protection Act.” Additionally, she also wants her job back and “two times back pay and compensatory and punitive damages.”

In response to the lawsuit, a spokesman for Mead Johnson, Chris Perille, said: “The company’s main focus is — and has been for more than a century — the quality and safety of our products. The packaging matter cited in the suit was thoroughly reviewed by the U.S. Food and Drug Administration, and no action was required.” He added that the company “maintains an environment for its workers of openness and respect and didn’t retaliate against O’Risky.”


Mead Johnson Whistleblower Lawsuit Claims Baby Formula Packaging Defective

Ex-Mead Johnson Director Files Whistleblower Suit Over ‘Defective’ Baby Formula

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