Calloway v. Caraco Pharmaceutical Laboratories, Ltd.

800 F.3d 244, 2015 FED App. 0210P, 40 I.E.R. Cas. (BNA) 955, 2015 U.S. App. LEXIS 15058, 2015 WL 5023560
CourtCourt of Appeals for the Sixth Circuit
DecidedAugust 26, 2015
Docket14-2526
StatusPublished
Cited by12 cases

This text of 800 F.3d 244 (Calloway v. Caraco Pharmaceutical Laboratories, Ltd.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Sixth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Calloway v. Caraco Pharmaceutical Laboratories, Ltd., 800 F.3d 244, 2015 FED App. 0210P, 40 I.E.R. Cas. (BNA) 955, 2015 U.S. App. LEXIS 15058, 2015 WL 5023560 (6th Cir. 2015).

Opinion

OPINION

COLE, Chief Judge.

Defendant Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”), appeals the district court’s judgment in favor of the plaintiffs, former Caraco employees. Following a bench trial, the district court found that Caraco violated the Worker Adjustment and Retraining Notification (“WARN”) Act, 29 U.S.C. §§ 2101-2109, by failing to comply with the Act’s notification provision when it closed its drug manufacturing operation. The sole issue before us is whether the United States Food and Drug Administration’s (“FDA”) mass seizure of Caraco products was an unforeseeable business circumstance that would excuse Caraco from complying with the WARN Act’s requirement to notify employees at least 60 days prior to a mass layoff. We conclude that it was not and therefore affirm the district court’s judgment.

I. BACKGROUND

A. Factual Background

Caraco is a Michigan pharmaceutical manufacturer. James Calloway was an employee of Caraco at its Detroit facility from 2006 until he was laid off on June 29, 2009. He is a member and representative of a class of former Caraco employees certified by the district court.

As a drug manufacturer, Caraco was subject to the regulatory authority of the FDA. The FDA enforces its regulations through periodic inspections of facilities *246 under its jurisdiction. After an inspection, the FDA may issue a Form 483, which “is intended for use in notifying the inspected establishment’s top management in writing of significant objectionable conditions, relating to products and/or processes ... which were observed, during the inspection.” (FDA Invest. Op. Manual at 5.2.3, R. 23-5, PagelD 487.) A Form 483 is issued when an investigator believes that á drug has “been adulterated or ... prepared, packed, or held under conditions whereby [it] may become adulterated or rendered injurious to health.” (Id.)

More serious than a Form 483, a warning letter is “a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.” (FDA Regulatory Procedures Manual, R. 23-6, Pa-gelD 495.) “Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected.” (Id.) Alternatively, an untitled letter may be issued in order to “cite[ ] violations that do not meet the threshold of a Warning Letter.” (Id.)

Several years before the mass layoff in question here, the FDA issued two warning letters to Caraco, on July 6, 2000 and October 11, 2002. Both letters stated that the company’s failure to correct the violations promptly could result in enforcement action by the FDA without further notice. After the 2000 warning letter, the FDA conducted a follow-up inspection in 2001 and issued a Form 483 with 17 observations of violations. The 2002 warning letter dealt with only a single product.

The FDA issued another Form 483 to Caraco on May 11, 2005. Caraco’s new chief executive officer, Daniel Movens, responded on June 10, 2005, stating that the company had “determined that most of the observations presented in the FDA 483 were isolated events and not reflective of overall systemic failures.” (6/10/05 Movens Letter, R. 22-6, PagelD 215.) On August 5, 2005, Movens again wrote to the FDA to report that the company had taken corrective action on 10 of the 13 observations in the May 2005 Form 483 and to update the FDA on its progress in dealing with the other three observations. Judith Putz, an FDA compliance officer, responded on August 19, 2005, disagreeing with Movens’s characterization of most of the observations as isolated and not reflective of systemic failures. On August 10, 2005, the FDA also conducted a meeting with Movens, in which Putz urged Caraco to submit a more definitive timeline for its corrective actions. On September 9, 2005, Movens wrote to the FDA to describe further corrective actions to its handling and packaging procedures that it had taken or planned to take.

On September 16, 2005, the FDA issued a Form 483 with four observations to an independent company, Future Pak, Ltd., whose premises Caraco used as a packaging facility (where it was responsible for FDA compliance). On June 21, 2006, the FDA issued another Form 483 to Caraco with 22 observations. That same month, Caraco issued a recall of Midrin capsules. On July 20, 2006, and again on August 25, 2006, Movens wrote to the FDA to notify it that Caraco was taking additional corrective actions regarding the 22 observations from the June 2005 Form 483.

After an inspection in August 2007, the FDA issued a Form 483 and Caraco again responded. In February 2008, Caraco issued a recall of metformin tablets. The FDA issued another Form 483 on March 6, 2008, noting four significant deviations from current good manufacturing practices (“cGMPs”), to which Caraco responded on March 31, 2008. On June 11, 2008, the *247 FDA issued another Form 483 detailing 14 significant' deviations from cGMP. In his response to this Form 483, Movens admitted that these 14 violations were “not all inclusive and could represent broader issues.” (7/10/08 Movens Letter, R. 22-20, PagelD 290.)

In 2008, Movens hired Quintiles Consulting to conduct an independent audit of Caraco’s facilities. In an email to Movens on July 7, 2008, Maxine Fritz, a vice president at Quintiles, noted that “[i]t is our opinion that the company faces the real possibility of FDA enforcement action. We believe it likely that FDA will initiate some form of seizure action which may target individual products or, conceivably may be a ‘mass seizure.’” (7/7/08 Fritz Email, R. 23-10, PagelD 523.) Further, Fritz stated that “FDA’s recent enforcement strategy has been to favor seizure of product and resolution of such action with a consent decree of permanent injunction. ... We have been involved in many such actions and I can tell you they are to be avoided at all costs.” (Id.) Fritz further stated that “[a]t this point, we believe it will be very difficult to dissuade [the] FDA from the enforcement approach we believe it is pursuing,” but that if Caraco was “more aggressive and comprehensive in demonstrating to the FDA” that it was willing and able to take significant corrective action, the FDA might be willing to give Caraco another chance. (Id.) As part of this strategy, Fritz recommended an in-person meeting with the FDA to outline Caraco’s plan and receive feedback on it, and a response to the most recent Form 483 that would include not only specific responses to the most recent observations but also a “Quality Systems Enhancement Plan” with several elements. (Id.) These elements included a comprehensive approach to reach cGMPs, specific timelines, an emphasis on Caraco’s commitment to quality principles, and offers to the FDA to make periodic progress reports and get feedback. Fritz also wrote that if there was no seizure, a warning letter was still “a virtual certainty.” (Id. at 524.)

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800 F.3d 244, 2015 FED App. 0210P, 40 I.E.R. Cas. (BNA) 955, 2015 U.S. App. LEXIS 15058, 2015 WL 5023560, Counsel Stack Legal Research, https://law.counselstack.com/opinion/calloway-v-caraco-pharmaceutical-laboratories-ltd-ca6-2015.