We’ve been following a series of lawsuits filed since January 1, 2013 that accuses Fresenius Medical Care of deliberately concealing potentially fatal problems with since-recalled GranuFlo and NaturaLyte.
The GranuFlo and NaturaLyte products were to lower the acidity of patients’ blood during dialysis treatments. A number of recent lawsuits allege that the patients’ treated with these products tested with a high concentration of acetone, which led to abnormally high levels of bicarbonate in their blood. This led to fatal heart problems and strokes, according to prior court documents.
Now, a transfer order filed on March 29, 2013 will enable the Fresenius Granuflo/Naturalyte Dialysate products liability litigation to be centralized in the District of Massachusetts. National law firm, Parker Waichman LLP, announced that it supports this centralization and feels that the motion was necessary based on common questions of fact.
“We feel that coordination was necessary based on commonality of allegations among the Plaintiffs,” said Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman LLP. “Overall, these cases allege that GranuFlo and/or NaturaLyte caused injury or death in patients who used the products during hemodialysis and alleges that Fresenius failed to warn about the risks.” According to the Transfer Order, lawsuits filed over the acid concentrate products allege that GranuFlo or NaturaLyte can lead to metabolic alkalosis, causing a number of potentially fatal complications, such as:
- Low blood pressure
- Cardiac arrhythmia
- Cardiopulmonary arrest
The lawsuits allege that GranuFlu and NaturaLyte were defectively designed and that Fresenius Medical Care neglected to warn of the risks related to these hemodialysis products. Parker Waichman LLP is available to answer any legal questions and is investigating cases on behalf of individuals who suffered an injury after being exposed to GranuFlo or NaturaLyte during hemodialysis.
According to a The New York Times article published last June, the U.S. Food and Drug Administration (FDA) began investigating Fresenius Medical Care to learn if they had or had not violated federal regulations by failing to warn consumers about the potentially fatal risks of GranuFlo and NaturaLyte. The Times reported that the GranuFlo and NaturaLyte dialysis products raised safety concerns following news about an internal memo dated November 4, 2011 that warned that 941 hemodialysis patients suffered from cardiac arrest in Fresenius facilities in 2010. That memo was issued to Fresenius facilities; however, the information was not made available to the public until the firm was prompted to do so by the FDA.
Last June, the FDA issued a Class I recall on GranuFlo and NaturaLyte, warning that the products may lead to high levels of bicarbonate in patients undergoing hemodialysis when inappropriately prescribed. The agency said that these increased levels can lead to metabolic alkalosis, a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. If not appropriately treated, cardiopulmonary arrest may occur. A Class I recall is the agency’s most serious designation and indicates that the recalled product may cause serious adverse health consequences, including death.