Mark Livingston vs. Wyeth Pharmaceutical
Livingston vs. Wyeth Pharmaceutical was filed in U.S. District Court for the Middle District of North Carolina under the whistleblower provisions of the Sarbanes-Oxley Act. GAP represents Mr. Mark Livingston in this action, which was one of the first cases filed in federal court involving the Sarbanes-Oxley claims. This case will be an important case to test the scope of protected activity under the Act.
Livingston was hired by Wyeth Pharmaceuticals in August 2000 as Manager, Training and Continuous Improvement, at Wyeth’s Sanford (North Carolina) Vaccine Site. He was promoted to Associate Director of Training and Continuous Improvement in April 2001. Shortly after he was hired, Wyeth entered into a Consent Decree with the Justice Department and the Food and Drug Administration (FDA) on October 3, 2000 to settle ongoing violations of Good Manufacturing Practices (GMP).
Livingston’s principle job responsibility was to improve compliance with the GMP Training System at Wyeth Sanford and to assure adequate training measures were in place for the safe and compliant manufacture of pediatric vaccines, particularly the new infant vaccine, Prevnar. In effect, Livingston was hired by Wyeth to ensure Prevnar’s safety. Prevnar is one of several early childhood vaccines recommended for every newborn infant by physician organizations, the Centers for Disease Control, and the United States government.
In the course of his tenure at Wyeth, Livingston made repeated complaints relating to lack of compliance with regulatory GMP. He complained that the company did not compliantly train new employees in critical manufacturing and quality assurance positions fast enough in the years 1999-2002 to keep pace with production and sales goals of Prevnar.
According to Livingston, Wyeth repeatedly announced both internally and publicly, that failure to meet Consent Decree and Good Manufacturing Practices (GMP) mandates would negatively impact the company's future. Instead, Wyeth Sanford management kept the production pipeline flowing despite the lack of compliance, therefore materially misrepresenting the true state of operating and financial performance in this fastest growing division of the Wyeth enterprise. The plaintiff spent two years sounding the alarm that those mandates were not being met.
Mr. Livingston was fired in December, 2002 for blowing the whistle on noncompliant training system practices. Shortly thereafter, he filed a whistleblower complaint under the whistleblower provisions of the Sarbanes-Oxley Act.
|
