Dialysis Company's Failure to Warn of Product Risk Draws Inquiry
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Leading U.S. supplier of dialysis products, Fresenius Medical Care, is under fire from the U.S. Food and Drug Administration for failing to inform consumers that one of its products was connected to a potentially lethal risk. Last November, the company became aware of a possible link between GranuFlo and cardiac arrest. More specifically, Fresenius realized that prescribing the incorrect amount of GranuFlo could potentially result in an overdose of bicarbonate, which is reported to put patients at risk of cardiac arrest six times more frequently than patients with normal levels of bicarbonate in their blood.
Although the company sent an internal memo to all of the doctors prescribing the drug in Fresenius' dialysis centers last November, the company curiously decided not to spread the warning to all U.S dialysis centers that may be using their dangerous product until five months later. As of June 18, 2012, the FDA is examining whether Fresenius met its regulatory responsibilities. Even if Fresenius is not found to have violated anylegal obligations, it is likely that the business will continue to face public scrutiny due to their financially driven agenda. Why else would a company responsible for treating over a third of the estimated 400,000 Americans receiving dialysis every year not make it more of a priority to immediately inform everyone who could be in danger of this harm?