As GranuFlo Lawsuits Gain Steam, Fresenius Runs Into More Trouble with the FDA

Published on September 4, 2013 by Sandy Liebhard

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Already named in hundreds of GranuFlo lawsuit claims filed since its March 2012 recall of GranuFlo and NaturaLyte dialysis drugs, Germany-based Fresenius is having fresh problems with the U.S. Food & Drug Administration (FDA). This time, the agency is telling the company to improve its procedures at a Fresenius Kabi manufacturing facility in Puerto Rico that produces blood bags.

According to a statement issued by Fresenius late last month, the company was hit with an FDA Warning Letter after an inspection of the facility in question revealed issues with complaint-handling procedures and labeling. Fresenius says it’s handling the problems, and production at the plant is continuing.

News of the new warning letter comes a little over a year after The New York Times reported that another Fresenius entity, Fresenius Medical Care North America, was the subject of an FDA probe. That investigation was prompted by the March 2012 GranuFlo recall, which involved two dialysis products manufactured by the company – GranuFlo and NaturaLyte.

GranuFlo Recall Issued Due to Dangerous Heart Side Effects

Both GranuFlo and NaturaLyte were named in a Class I FDA recall – the agency’s most serious type – after they were found to be associated with unsafe levels of bicarbonate in the blood. Such an occurrence can lead to sudden and catastrophic heart side effects, including heart attacks, stroke and sudden cardiac death. According to a New York Times report published in June of 2012, the FDA began investigating the issue last year, after it learned that Fresenius Medical Care had issued a memo detailing these problems to dialysis clinics in its own network as early as November 2011. However, Fresenius did not send a similar warning to thousands of other clinics outside of that network that also used the products until March 2012, after the FDA started asking questions about GranuFlo and NaturaLyte

Now, more than 300 GranuFlo lawsuits are pending in courts around the country, including over 200 in a multidistrict litigation underway in U.S. District Court, District of Massachusetts. All of these claims were filed on behalf of dialysis patients who suffered heart attacks, strokes, cardiac arrest, and sudden cardiac death, allegedly due to either GranuFlo or NaturaLyte. Plaintiffs in the lawsuits all allege that Fresenius Medical Care failed to provide patients and the medical community with appropriate warnings regarding the issues that sparked the GranuFlo recall.

Dialysis patients who may have been harmed by either GranuFlo or NaturaLyte still have time to file personal injury claims against Fresenius Medical Care, while family members of those who may have died from side effects associated with these two drugs could be eligible to file a wrongful death lawsuit on their loved one’s behalf. To learn more, and for a free evaluation of your GranuFlo lawsuit, please contact Bernstein Liebhard LLP today, at .