GranuFlo, NaturaLyte Lawsuits Consolidated

In the face of increasing NaturaLyte and GranuFlo lawsuits, a judicial panel has decided that the lawsuits will be consolidated into a federal court hearing.

The lawsuits accuse Fresenius Medical Care of deliberately concealing potentially fatal problems with its now-recalled GranuFlo and NaturaLyte products, which were approved to lower the acidity of patients’ blood during dialysis treatments. Recent lawsuits allege that 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.

The pre-trial proceedings for the federal lawsuits will be overseen by Judge Douglas P. Woodlock, according to the Judicial Panel on Multidistrict Litigation (JPML), said Injury Lawyer News. Fresenius Medical Care, is now facing hundreds of claims and many more are expected. Massachusetts is the chosen venue.

As we’ve written, lawsuits filed over the acid concentrate products allege that GranuFlo or NaturaLyte can lead to metabolic alkalosis, causing a number of potentially fatal complication. The lawsuits also allege that GranuFlo and NaturaLyte were defectively designed and that Fresenius Medical Care neglected to warn of the risks related to these hemodialysis products.

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.

Plaintiffs filed the motion to consolidate last December. The motion was accepted after judicial panel ruled there were sufficient similarities in the NaturaLyte and GranuFlo lawsuits to benefit from an MDL, said Injury Lawyer News.

The products received FDA approval in 2003.

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