Here’s the press release from the U.S. Attorney in Massachusetts: “The criminal information filed today alleges that SB Pharmco’s manufacturing operations (a Glaxo plant in Puerto RIco) failed to ensure that Kytril and Bactroban finished products were free of contamination from microorganisms. It is further alleged that SB Pharmco’s manufacturing process caused Paxil CR two-layer tablets to split. The splitting, which the company itself called a “critical defect,” caused the potential distribution of tablets that did not have any therapeutic effect and tablets that did not contain any controlled release mechanism.”
And here’s The New York Times’ take:
Altogether, GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant in Puerto Rico that for years was rife with contamination. Cheryl Eckard, the company’s quality manager, asserts in her whistle-blower suit that she warned Glaxo of the problems but the company fired her instead of addressing the issues. Among the drugs affected were Avandia, Bactroban, Coreg, Paxil and Tagamet. No patients are known to have been sickened by the quality problems although such cases would be difficult to trace.
Tony West, assistant attorney general for the Justice Department’s Civil Division, and Carmen M. Ortiz, the United States attorney for Massachusetts, announced the settlement in a news conference Tuesday afternoon in Boston. The outcome provides one of the highest whistleblower award yet in a health care fraud case.