As part of the massive overhaul of food safety regulations under the Food Safety Modernization Act, Life Sciences Decoded reported in August on new whistleblower protections for food industry employees. On Feb. 9, six months since that post, the industry saw one of its first whistleblower suits invoking the new FSMA protections brought by a longtime employee of Mead Johnson Nutrition Company. This case signifies that food companies could be in for a bumpy and litigious road ahead.
In a 31-page compliant in the Northern District of Illinois, a former global product compliance director for Mead Johnson alleges she was marginalized and eventually fired after raising concerns about “serious safety issues” related to defects in the manufacturing of the company’s ready-to-use infant formula.
Her safety concerns pertained to spoilage and defective seals in batches of the formula. According to the lawsuit, in March 2015, the plaintiff learned that Mead Johnson planned to reject more than 1 million units of the formula due to the leaking seals. However, she suggested that additional products could have been affected. “Over the next seven months, [the plaintiff] diligently tried to persuade her managers to comply with Food and Drug Administration regulations and deal with this issue responsibly, to no avail.”
The plaintiff alleged that, after speaking up, she was excluded from relevant meetings, withheld from information and eventually terminated through a reduction-in-force, which was actually retaliatory. This claim was originally filed with the Occupational Safety and Health Administration, which according to the plaintiff, failed to issue a final decision in a timely manner.
In a Crain’s Chicago business article, a Mead Johnson spokesman denied the allegations:
The company's main focus is – and has been for more than a century – the quality and safety of our products. 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.
New FSMA protections
As discussed in our earlier blog, under the FSMA, employers may not retaliate against an employee who engages in actions that the employee reasonably believes violate the FSMA. The reasonable belief standard is subjective: a “good faith belief and/or an objectively reasonable belief” that an employer’s conduct violated the Federal Food, Drug, and Cosmetic Act (FDCA) or any rule, order, regulation, standard or ban under the FDCA is sufficient. (Citing to Sylvester v. Parrexel Int’l LLC, ARB No. 07-123, 2011 WL 2165854, at *11-12 (ARB May 25, 2011), discussing the reasonable belief standard under Sarbanes-Oxley Act whistleblower protections.) This standard is based on the “knowledge available to a reasonable person in the same factual circumstances with the same training and experience” as the employee at issue. Id. This is an interesting standard and is very fact dependent.
In order to defend against the allegations, it will be imperative that a clear understanding of the new FSMA regulations underlie any defense. In the case of Mead Johnson, the allegations of an unsafe food supply strike at the very purpose of the final rules promulgated under the FSMA. Therefore, at issue will be what actions the company undertook to comply with these regulations and what safety measures were in place. Further, it is likely a knowledgeable defense will include whether HARPC plans were in place and what hazards were identified that were being controlled under that written plan.
It will be difficult to successfully defend these suits not only because of the reasonable belief standard that will be applied, but because, to a large extent, the plaintiff can use the company’s food safety plan as a roadmap to food safety issues. On the flip side, a well-documented food safety plan can also be a defense tool to defeat the reasonable belief standard. A well-drafted, compliant food safety plan accounting for foreseeable risks and controlling for those risks demonstrate a reasonable approach to food safety and can go a long way to demonstrating that claims, similar to those brought in this new litigation, are unfounded.
Diane Romza-Kutz is a partner in Thompson Coburn’s life sciences practice where she focuses on FDA compliance, including FSMA matters and their impact on litigation strategy.