Guidant Corporation recently received more bleak news from the FDA. Citing concerns about the manufacturing practices of the company, the FDA informed Guidant that it would not approve any more company devices for sale, nor will the FDA approve new contracts to export Guidant heart devices manufactured in its Minnesota plant.
This news comes at a time when the company is still reeling from several product recalls, based on sometimes fatal design defects. A number of problems cited in the FDA warning letter, were first identified by the FDA in a September inspection of the Guidant manufacturing plant. In the recent warning letter, the FDA indicated that Guidant had failed to address all of the significant manufacturing violations.
It is unfortunate that this FDA inspection and notification of manufacturing violations came after many people have suffered injuries, sometimes fatal, from defective Guidant heart devices. Guidant was aware of design flaws for several years and continued to sell defective devices. Guidant has joined the ranks of companies that turn a blind eye to safety concerns, once they have received initial FDA approval for a product. Sheller, Ludwig & Badey is currently investigating injuries resulting from recalled Guidant heart devices.
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