Baby formula allegedly vulnerable to spoilage is at the center of a whistleblower lawsuit filed by a former Mead Johnson Nutrition compliance director who claims she was eventually fired after raising concerns about packaging defects.
Linda O’Risky, who was a consultant and employee for Mead Johnson for more than 25 years, claims in a lawsuit filed Thursday in U.S. District Court in Chicago that the Glenview-based maker of pediatric food products "touted its hermetically sealed liquid formula as safer than powdered formula," but in reality, she alleges, the seals on the 8-ounce product were prone to leaking, making it easier for microorganisms and other contaminants to enter the packaging.
The lawsuit says the Evansville, Ind., resident spent seven months in 2015 trying to persuade her managers to comply with Food and Drug Administration regulations and contacted the publicly traded company’s "integrity concern hotline," but it alleges she was eventually excluded from meetings and shunned.
The lawsuit says the company later fired her, claiming it was due to a cost-cutting restructuring, but the suit alleges that unlike the 50 other Evansville workers who also lost their jobs, O’Risky’s computer was immediately confiscated, she was told to leave the premises by noon, and she was escorted out of the building. 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.
O’Risky claims that she learned of defective seals in March 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. She realized that those manufacturing dates were nearly two months earlier — suggesting there could be more products with a similar problem, the suit says. O’Risky knew from her role in analyzing consumer complaints that there had been an increased rate of complaints about the ready-to-use formula, her lawsuit alleges.
Mead began an inquiry, but O’Risky’s lawsuit says that 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.
"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," the lawsuit says.
Mead Johnson, whose Enfa family of brands includes Enfamil infant formula, denied the allegations in the complaint.
"The company’s main focus is — and has been for more than a century — the quality and safety of our products," spokesman Chris Perille said. "The packaging matter cited in the suit was thoroughly reviewed by the U.S. Food and Drug Administration, and no action was required."
Mead Johnson also maintains an environment for its workers of "openness" and "respect" and didn’t retaliate against O’Risky, he said.
Perille declined additional comment, citing the pending litigation.
O’Risky, who lost her job in November 2015,
wants a jury trial and is seeking her job back, as well as two times back pay and compensatory and punitive damages, among other things.
Earlier this month it was reported that Mead Johnson might be acquired by Reckitt Benckiser for about $16.7 billion.
byerak@chicagotribune.com
Twitter @beckyyerak
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