Katz, Marshall & Banks partners Debra Katz and Michael Filoromo are representing Linda O'Risky in a newly filed whistleblower retaliation lawsuit against infant formula maker Mead Johnson Nutrition Co. In the lawsuit, Ms. O'Risky, who worked as the company's global product compliance director, alleges that over the course of seven months in 2015, Mead Johnson failed to fully investigate, report to the Food and Drug Administration (FDA), and remove units of ready-to-use infant formula with defective seals, posing health risks to infants. Ms. O’Risky alleges that the company destroyed more than 1 million of its 8-ounce, ready-to-use infant formula units with leaking seals ealier in the year; however, these batches were made several months earlier, suggesting that other defective units could have entered the market in that time. According to the Complaint, Ms. O'Risky repeatedly argued that a defective seal could allow microorganisms and other contaminants into the packages after sterilization and that defective processes and incidents of spoilage in the market must be reported to the FDA. Ms. O'Risky alleges that she reported her concerns repeatedly to Mead Johnson management and on two separate occasions to the company's compliance department, prompting investigations. According to the Complaint, after reporting her concerns, Ms. O'Risky was marginalized, excluded from meetings, denied a promotion opportunity and ultimately terminated in November 2015.
The Complaint alleges that, in terminating Ms. O'Risky, Mead Johnson violated the whistleblower protections of the Food Safety Modernization Act (FSMA), the Sarbanes-Oxley Act (SOX), and the Dodd-Frank Act. Commenting on the case, Ms. Katz said, "It is unconscionable to allow infants, the most vulnerable among us, to be exposed to life-threatening risks. People like Ms. O’Risky, who speak up about these dangers, shouldn’t suffer as a result." Read the full complaint here.