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
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
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
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.