Employees for regulatory agencies that deal with matters involving interactions with the public know that once any sort of incident has broken through into the national news cycle, the media attention can spur Congressional investigations, agency investigations, and public outrage. For example, recent controversy over an infant formula recall may lead to wide-ranging inquiries about the U.S. Food and Drug Administration’s (FDA) oversight practices, and potentially discipline or worse for the federal employees involved. If you are an employee at a federal regulatory agency like the FDA, would you be equipped to protect yourself and your career in the wake of such scrutiny? Read on to learn more, and about how FEDS Protection PLI can help.
In September 2021, the FDA was notified that a baby was hospitalized with Cronobacter sakazakii – a bacterial infection – after consuming infant formula that was manufactured at Abbott Nutrition plant in Sturgis, Michigan. The same week that the agency was notified, FDA inspectors were in the plant performing the first routine inspection in two years – an unusually long gap for plant inspections – but found nothing serious enough to warrant regulatory action. In the coming months, four infants were hospitalized and two died after consuming formula from this plant. After another delay, FDA inspectors returned to the plant in January 2022 and found no fewer than five different strains of Cronobacter on plant equipment that could come into contact with formula. These findings prompted a massive infant formula recall, which lead to widespread shortages of certain types of formulas.
This incident has raised questions about the efficacy and thoroughness of the FDA’s practices. Consumer advocates and other outside experts allege that issues at the plant were missed because FDA inspectors weren’t looking closely enough, which has raised questions about what else the FDA might be missing. While they recognize that it is the company’s responsibility to maintain their plant, advocates also believe that it is the FDA’s responsibility to ensure that maintenance happens. The FDA plans to conduct a review of how the incident was handled, but some legislators are insisting that the U.S. Department of Health and Human Services Office of the Inspector General (HHS OIG) conducts its own independent investigation.
Because of the public health impact this recall has had and calls for extensive investigations, FDA inspectors involved in this incident may face administrative and agency disciplinary action. Additionally, these inspectors, along with their supervisors, colleagues, and other FDA personnel may be required to participate in a congressional hearing as subjects and/or witnesses. FDA inspectors may even be exposed to civil suits from the families of those affected by the plant contamination. Regardless of an FDA employee’s level of involvement and even if they are ultimately vindicated, defending against allegations will take an emotional and financial toll. A FEDS Protection professional liability insurance (PLI) policy will defend you against allegations arising from acts, errors, or omissions made in the scope of your federal employment.
FEDS Protection offers federal employee policies with $1 million, $2 million, or $3 million in civil liability protection for attorney’s fees and indemnity costs in the event you are sued in your civil capacity. The FEDS policy also includes $200,000 of legal representation coverage per incident for administrative actions and $100,000 of coverage for criminal defense costs. Annual premiums for FEDS Protection PLI start at $290, which is less than it would typically cost to hire a federal employment lawyer for an hour. Additionally, federal managers and law enforcement officers are eligible for a reimbursement of up to 50% the cost of their PLI policy through their agency. Find out more about how a FEDS PLI policy can protect you and your career here,
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*This article is provided for informational purposes only and does not constitute legal advice.