Calloway v. Caraco Pharma. Lab., Ltd., No. 14-2526 (6th Cir. 2015)Annotate this Case
In 2000 and 2002 the FDA issued warnings to Caraco, a Michigan pharmaceutical manufacturer, stating that failure to correct violations promptly could result in enforcement action without further notice. After follow-ups in 2005, the FDA sought a definitive timeline for corrective actions. The FDA issued notices of objectionable conditions in 2006, 2007, and 2008. A consultant audited Caraco’s facilities and stated that it was “likely that FDA will initiate some form of seizure action.” Caraco executives thought the consultant “alarmist.” Later, the FDA issued a formal warning, determining that Caraco products were adulterated and that its manufacturing, processing, and holding policies did not conform to regulations and noting its poor compliance history. The letter stated that failure to promptly correct the violations could result in legal action without further notice, including seizure. A new consultant warned of likely enforcement action. Caraco followed some of its suggestions. In 2009, Caraco issued a nationwide drug recall, constituting “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” The FDA filed a complaint, served Caraco, and seized products. Days later, Caraco began a mass layoff, indicating that it did not “reasonably foresee" the FDA action. A certified class of former Caraco employees alleged that Caraco violated the Worker Adjustment and Retraining Notification (WARN) Act, 29 U.S.C. 2101, by failing to provide 60 days notice. The Sixth Circuit affirmed that the FDA action was not an unforeseeable business circumstance that would excuse WARN Act compliance.