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

A former longtime Mead Johnson employee alleges the Glenview-based company fired her for raising safety concerns, including not telling consumers about potentially spoiled baby formula.

Linda O’Risky, who spent more than 25 years at Mead Johnson, claims in a lawsuit filed today that the company attempted to “whitewash and downplay” the issue related to its popular ready-to-use infant formula.

“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 obligation to report the known problem,” according to the complaint O’Risky filed in U.S. District Court in Chicago (read the lawsuit below).

It’s not clear if any babies became ill, said O’Risky’s attorney, Michael Filoromo III, a Philadelphia, Pa.,-based partner at Katz Marshall & Banks.

O’Risky was not available for an interview. Mead Johnson is one of the top baby formula makers in the world, known for its Enfamil products. In a statement, Mead Johnson spokesman Christopher Perille said the company denies 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,” Perille said in the statement. “The packaging matter cited in the suit was thoroughly reviewed by the U.S. Food & Drug Administration, and no action was required. Mead Johnson also places a high value on maintaining an environment for our employees of openness, respect and high performance, and denies engaging in retaliation against the complainant.”

O’Risky, of Evansville, Ind., was the global product compliance director for Mead Johnson. She was responsible for making sure the company followed various government regulations, and she also reviewed consumer complaints.

In early 2015, according to the lawsuit, the company’s 8-ounce ready-to-use infant formula started to show signs that it was spoiling due to defective seals in batches manufactured in late 2014. The complaint says that O’Risky first learned of the issue on or around March 11, 2015, when she was copied on an email that said the company planned to reject three batches, or nearly 1 million units, of formula because of leaky seals. She then discovered that the formula was made two months earlier, suggesting there could have been more affected formula, and that it could have been contaminated during storage and shipping, the lawsuit says.

For several months, O’Risky tried to persuade her supervisors to comply with federal Food & Drug Administration regulations, and Mead Johnson’s chief scientific officer, Dr. Dirk Hondmann, expressed concern, too, the complaint says. The company started to investigate the issue, but employees assigned to the case falsely claimed, the lawsuit alleges, that the defective seal wasn’t a food safety or FDA compliance problem, because spoiled formula that stemmed from a defective seal “would be obvious to a consumer.”

O’Risky was persistent. She met with employees in compliance several times and reported her concerns to Mead Johnson’s “Integrity Concern” hotline, the lawsuit says. Among her concerns: “She was told to ‘consider only reports of death and serious illness from Health Care Professionals as credible and to consider all other consumer complaints … as not credible,'” the lawsuit alleges.

She claims in the filing that her managers began excluding her from meetings and withheld information from her, making it difficult to do her job.

O’Risky, who was fired in November 2015, reported her termination to the federal Occupational Safety & Health Administration in March 2016. Mead Johnson didn’t contact the FDA until after O’Risky complained to OSHA, the lawsuit says.

She is seeking unspecific damages, as well as back pay and possibly even her job back.

Source: www.chicagobusiness.com www.chicagobusiness.com

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