CHICAGO – Less than a year after federal regulators established new rules under the federal Food Safety Modernization Act (FSMA), a whistleblower suit has been filed by an employee of Mead Johnson Nutrition Company, potentially signaling more attention for that company and others under the FSMA.

The suit was filed on Feb. 9 in U.S. District Court for the Northern District of Illinois by Linda O’Risky, a former global product compliance director for Mead Johnson. She had direct responsibility for regulatory compliance activities.

In the complaint, O’Risky alleges she was marginalized and eventually terminated after she began raising and escalating concerns about serious safety issues related to defects in the manufacturing of Mead Johnson’s ready-to-use infant formula, “as well as a culture and organizational structure that increasingly prioritized profits over safety and compliance.”

O’Risky alleges she continued to make her concerns known to compliance personnel at Mead Johnson, but faced ongoing resistance and hostility. Her managers began, “excluding her from meetings, withholding critical information from her and impeding her ability to do her job.”

The complaint also states that Mead Johnson’s handling of the ready-to-use formula resulted in fraud to consumers. O'Risky's action accused Mead Johnson of allegedly misrepresenting to the FDA the nature of defects that were discovered.

She was eventually terminated through purported cost-cutting layoffs at Mead Johnson.

“This lawsuit heralds a new kind of whistleblower litigation,” Diane Romza-Kutz, a partner with Thompson Coburn, LLP, told the Cook County Record. “The concept that the FDA and other federal agencies will work together on whistleblower allegations arising from regulatory requirements not being met provides fertile ground for new suits.

"Food and nutrition companies are struggling to meet compliance dates on this sweeping regulatory overhaul of the food industry as is and now, while struggling to meet these new demands, these companies face a new threat.  Once filed, these suits shine a spotlight on these companies, making them subject to potentially more inspections and enforcement actions by the FDA and its state agency counterpart.”

Romza-Kutz said employers need to be more responsive and thorough in meeting the new FSMA regulatory requirements. The new requirements apply to both food and animal companies.

“Employers need to have a process to understand what of these new rules they are subject to and have a plan for meeting the requirements set forth in those new rules,” Romza-Kutz said.   “As more and more companies are required to comply, more of these suits will occur. Companies that do not have an internal knowledge base of the FDA are particularly vulnerable."

O’Risky seeks to regain her position as global product compliance director with Mead Johnson, or an equivalent position, two times back pay, including lost benefits, compensatory damages for pain, suffering and emotional distress, punitive damages and attorney fees.

She is being represented by Stuart J. Chanen, of Valorem Law Group in Chicago.

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U.S. District Court for the Northern District of Illinois Valorem Law Group

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