Company’s Failure to Warn of Product Risk Draws Inquiry

A 2012 article in the New York Times reported that the FDA is investigating whether or not Fresenius violated any federal laws by failing to warn patients of a potentially lethal risk linked to one of its drugs. An internal memo from the company’s medical office to its doctors practicing in the company’s dialysis centers warned that failure to properly use one of the company’s drugs was leading to a sharp increase in patients dying from cardiac arrest. What was even more frightening is that the company did not warn other dialysis centers which were using Fresenius products.

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