Whistleblower Suit Filed Over Baby Formula Worries

CHICAGO (CN) – A former Mead Johnson compliance director claims in court that she was fired for urging a full investigation of potential contamination of its Enfamil infant formula.

Linda O’Risky, former global product compliance director for Mead Johnson Nutrition Co., says in a lawsuit filed Thursday in Chicago federal court that she was “marginalized and eventually terminated after she began raising and escalating concerns about serious safety issues related to defects in the manufacture of Mead Johnson’s ready-to-use infant formula.”

Her complaint describes the corporate culture at Mead Johnson as one that prioritized profits over infant safety.

O’Risky says she first learned about problems with Mead Johnson’s Enfamil infant formula in March 2015, when the company rejected one million units due to leaking seals. She allegedly became worried that there could be more products with a similar problem, and urged the company to investigate.

Mead Johnson touts its hermetically sealed liquid formula as safer than powdered formula.

However, “the individuals assigned to investigate the problem falsely claimed that a defective seal did not constitute a food safety or [Food and Drug Administration] compliance problem, since any spoilage resulting from a defective seal would be obvious to a consumer,” the complaint states.

O’Risky claims she provided management with FDA regulations and examples of prior enforcement actions showing that the contamination threat must be reported to regulators, but they did not want to face the issue.

“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,” she claims.

O’Risky says she began to be excluded from meetings and shunned by co-workers, which made it difficult for her to do her job.

She was ultimately fired, purportedly as part of a company-wide layoff, but of all the laid off employees, only O’Risky had her computer confiscated and was immediately escorted off the premises, according to the complaint.

She seeks punitive damages for retaliation, reinstatement to her former position and double back pay.

Mead Johnson spokesman Chris Perille said in a statement, “The packaging matter cited in the suit was thoroughly reviewed by the U.S. Food and Drug Administration, and no action was required.” He did not directly address O’Risky’s retaliation claims.

O’Risky is represented by Debra S. Katz with Katz, Marshall & Banks in Washington, D.C.

On Friday, England-based Reckitt Benckiser announced that it is buying Mead Johnson for $16.6 billion, based on $90 per share.

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