Contact Solution Maker Failed To Report Problems
Stock quotes in this article:
ABT
Reichardt settled her case against the company out of court last month, but 220 other plaintiffs are pushing ahead with litigation in California against AMO, now part of Abbott. The next case is scheduled to begin go to trial in August in California Superior Court in Orange County.
At the center of the litigation is the FDA report. Medical manufacturers are supposed to report product complaints tied to serious injury within 30 days of the end of each quarter. But FDA inspectors uncovered nine reports of Acanthamoeba dating from 2006 that went unreported until they arrived to inspect the company's plant following the recall. "It confirms our suspicion that AMO knew, or should have known, that there was a significant increase in Acanthamoeba keratitis cases associated with Complete MoisturePlus," said attorney Michael Schmidt of Dallas. A swifter response could have even helped the government head off some infections, said Lurie, of Public Citizen. "A relatively small number of cases of something as serious as this could tip the balance between something that seems like background noise, and something that's a legitimate outbreak," he said.- Loading Comments...
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