Livingston v. Wyeth, Inc.

520 F.3d 344, 27 I.E.R. Cas. (BNA) 613, 2008 CCH OSHD 32,940, 2008 U.S. App. LEXIS 6088, 91 Empl. Prac. Dec. (CCH) 43,160, 2008 WL 756068
CourtCourt of Appeals for the Fourth Circuit
DecidedMarch 24, 2008
Docket06-1939
StatusPublished
Cited by47 cases

This text of 520 F.3d 344 (Livingston v. Wyeth, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Livingston v. Wyeth, Inc., 520 F.3d 344, 27 I.E.R. Cas. (BNA) 613, 2008 CCH OSHD 32,940, 2008 U.S. App. LEXIS 6088, 91 Empl. Prac. Dec. (CCH) 43,160, 2008 WL 756068 (4th Cir. 2008).

Opinions

Affirmed by published opinion. Judge NIEMEYER wrote the majority opinion, in which Judge HILTON joined. Judge MICHAEL wrote a dissenting opinion.

OPINION

NIEMEYER, Circuit Judge:

Relying on the whistleblower protection provisions of the Sarbanes-Oxley Act of 2002, 18 U.S.C. § 1514A, Mark Livingston commenced this action against his employer Wyeth, Inc., a pharmaceutical company, alleging that Wyeth unlawfully discharged him because of his complaints to Wyeth’s management about Wyeth’s inability to implement on schedule a training program at its Sanford, North Carolina facility, supposing therefore that local employees would likely misrepresent or cover up the deficiencies in progress to internal compliance auditors and to the Food and Drug Administration. The training program was designed to train employees in good manufacturing practices, and its implementation was required by regulations of the Food and Drug Administration. Livingston asserted that in making his complaints, he reasonably believed that Wyeth’s potential conduct in misrepresenting or covering up the deficiencies in timely implementation of the program would constitute violations of § 10(b) of the Securities Exchange Act of 1934 and Rule 10b-[346]*3465 promulgated under it, and therefore that his conduct was protected under the Sar-banes-Oxley Act.

The district court entered summary judgment against Livingston, concluding that his complaints were not protected activity under the Sarbanes-Oxley Act because Livingston could not reasonably have believed that Wyeth was violating the securities laws. The court also concluded that Wyeth had shown, by clear and convincing evidence, that it had discharged Livingston for insubordination in threatening to have the police remove Wyeth’s Director of Human Resources from a company-sponsored holiday party and that Wyeth would have discharged Livingston regardless of whether he had complained about the progress of the training program.

Because we conclude that no objectively reasonable basis existed for Livingston to have believed that Wyeth was violating the securities laws, we affirm.

I

On Thursday, December 19, 2002, following a brief investigation, Mark Livingston was discharged from his employment with Wyeth as Associate Director of Training and Continuous Improvement at Wyeth’s Sanford, North Carolina facility. The parties agree that the precipitating events occurred on the previous Friday, December 13, 2002, when Livingston held a company-funded lunch party for members of the training staff. David McCuaig, the Director of Human Resources at the Sanford facility, came to the party without an invitation from Livingston, allegedly to wish the group a happy holiday. According to Livingston’s own testimony, Livingston approached McCuaig as McCuaig came into the room and asked, “What are you doing here? ... You’re not invited. We have a gift exchange. You have no gift. We have limited food.” After some more discussion, Livingston then stated, “I need you to leave. I’m asking you to leave. If you do not leave, I’m going to ask the police escorting holiday traffic downstairs ... to escort you out.” Although there is a factual dispute about the manner in which Livingston told McCuaig to leave, it is undisputed that he threatened to have the police remove him. Wyeth suspended Livingston on the following Monday, December 16, 2002, pending investigation, and, following a three-day investigation, it terminated his employment.

Wyeth contends that this incident was the culmination of a long history of abusive and insubordinate conduct by Livingston, about which he had been warned numerous times previously. Livingston contends, however, that he was fired in retaliation for complaining about the insufficient progress in implementing a training program to teach employees good manufacturing practices, as required by the Food and Drug Administration (“FDA”), and about the potential that Wyeth could misrepresent the progress of the program or cover up its true status, in violation of the securities laws.

Wyeth, Inc., formerly known as American Home Products Corporation, is a publicly traded company that develops pharmaceutical and consumer health products worldwide. Its net revenue in 2001 was approximately $14.1 billion. Its Sanford, North Carolina facility is one of more than two dozen at which it develops and manufactures products.

From August 2000 to December 2002, Mark Livingston was employed at the Sanford site, first as a manager of Training and Continuous Improvement, and then as Associate Director of Training and Continuous Improvement. He reported to Bruce [347]*347Kaylos, the managing director of the Sanford site. During the period of his employment, Livingston oversaw audits of training programs at the Sanford facility to monitor their progress. The events which form the basis of Livingston’s complaint in this case occurred during July and August 2002.

Wyeth’s manufacturing operations are regulated by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et. seq., and the FDA regulations promulgated thereunder. Pharmaceutical products, such as the vaccine components produced at the Sanford facility, must be made in accordance with “current good manufacturing practice.” 21 C.F.R. § 211.1. In addition to specific mandates, such as requiring workers to wear clean clothing during drug production, see id. § 211.28(a), the regulations for good manufacturing practices require that “[ejaeh person engaged in the manufacture ... of a drug product shall have education, training, and experience” sufficient to perform the functions assigned to them. Id. § 211.25. The regulations do not specify what training is required, how it should be accomplished, or how it must be documented, but rather leave it to each regulated company to create and implement appropriate procedures, subject to FDA inspection. If a pharmaceutical product is produced in a facility that does not adhere to good manufacturing practices, including training for good manufacturing practices, the product is legally considered adulterated and is subject to seizure by the FDA. See 21 U.S.C. §§ 351(a), 334(a)(1).

Precisely for this reason — a failure to follow good manufacturing practices — the FDA seized allegedly adulterated products at Wyeth’s Pearl River, New York and Marietta, Pennsylvania facilities, leading to a Consent Decree in October 2000, directed at those facilities. While the decree did not apply to any other facility, it did require Wyeth to retain an expert consultant to conduct a “division-wide” assessment of its quality control programs at all sites, including the Sanford site, and to respond to the expert’s report, providing the FDA with a timetable for its responsive actions. As required, Wyeth did retain a consultant and, in May 2001, advised the FDA that it would revise its training guidance documents, setting September 30, 2002, as the date by which it would implement training changes and verify compliance with the new program. The FDA has never suggested that Wyeth ever violated the October 2000 Consent Decree.

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520 F.3d 344, 27 I.E.R. Cas. (BNA) 613, 2008 CCH OSHD 32,940, 2008 U.S. App. LEXIS 6088, 91 Empl. Prac. Dec. (CCH) 43,160, 2008 WL 756068, Counsel Stack Legal Research, https://law.counselstack.com/opinion/livingston-v-wyeth-inc-ca4-2008.