Drug Manufacturer Whistle-Blower Exposes Facility Failures
A segment on 60 Minutes discussed the story of Cheryl Eckard, who was the global quality assurance manager at GlaxoSmithKline (GSK). Her job was to inspect plants to make sure drugs were manufactured properly and met government standards for purity.
In 2002, Ms. Eckard was assigned to GSK’s important Cidra, Puerto Rico, plant where 900 employees manufactured 20 drugs for U.S. consumption. At the plant, Ms. Eckard observed water tainted with bacteria used to make tablets; failures on production lines that made some drugs too strong, some not strong enough; and the employees were contaminating products, including the anti-bacterial ointment Bactroban, which was made in a sealed tank to prevent contamination.
“It saved money,” said Eckard.
Among the drug mix up problems at Cidra, Ms. Eckard identified nine, including Avandia diabetes pills mixed in packages with over-the-counter Tagamet antacids and Paxil antidepressants, mixed with the Avandia diabetes drug. Currently, the Brandi Law Firm Avandia Attorneys are investigating defects in the design and formulation of the Avandia drug. But our investigations assume that all Avandia pills are identical. The possibility that different Avandia bottles may contain different drugs points to a whole new level of liability.
Eckard did her job and provided a summary to seven GSK executives that detailed nine high-risk areas at the plant, including the mix-ups, the water contamination, and the problems with sterility. She warned that if the FDA knew what the company knew, the government could seize the factory. Weeks later she was laid off due to “downsizing”.
Eckard then provided all of this information to the FDA and assisted in the prosecution of GSK for problems at the Cidra factory.