Dialysis Recall Issued by Baxter International

Following the lead of Fresenius Medical Care, which issued a dialysis recall in 2012, Baxter  International Inc. is recalling its DIANEAL PD-2 (peritonea dialysis solution) due to the concern of mold contamination and injury reports.  The Baxter recall was officially announced on March 5 after some particles were discovered in the mixture, and were determined to be mold.

While the number of adverse patient events indicates that it is highly probable that this dialysis solution was harmful, Baxter claims that there is no official link or sufficient evidence  linking their product recall and the patients’ injuries.  In the company’s announcement, the specific number of injury reports were not specified. Baxter warned that the contaminated dialysate may contain a life-threatening fungal peritoneal infection.  As of now, the company believes that the contamination was caused by a leak in the container.

The affected products were distributed to dialysis centers, facilities, distributors and patients between May 2013 and January 2014.  This recall comes two years after the infamous recall of GranuFlo and NaturaLyte, dialysis concentrates manufactured by Fresenius Medical Care that are being investigated for possibly causing hundreds of deaths.  Baxter’s dialysate provided dialysis treatment for patients who suffered chronic renal failure, and were receiving PD treatments.

Currently, Fresenius is facing hundreds of product liability lawsuits filed in federal and state courts across the United States.  Each of these GranuFlo recall lawsuits alleges that Fresenius failed to fully disclose the side effects of the NaturaLyte and GranuFlo.

Overview of the NaturaLyte and GranuFlo Recall

The GranuFlo recall occurred in 2012, after an internal memo was leaked to the FDA.  The memo described an in-house study which observed the occurrence of sudden cardiac death in conjunction with the patients using both or either product.  Fresenius is facing hundreds of GranuFlo recall lawsuits over these sudden death side effects, and have taken a massive hit in public credibility.  Fresenius Medical Care is the largest dialysis provider in the country, and manufactures the most dialysis products internationally.

NaturaLyte and Granuflo are liquid acid and dry acid concentrates respectively, which both contain sodium acetate, which converts to bicarbonate during dialysis.  This causes the pH levels of the blood to rise significantly, which causes the blood to slow down; this allowed for blood clots, heart attack, stroke, sudden cardiac death, and other devastating side effects.  According to the evidence the plaintiff team has presented in court, Fresenius knew about this problem, but had failed to take any action to correct it, or warn the public.  Additionally, there were no special warnings or instructions to the administrator of the dialysate solutions.

GranuFlo and NaturaLyte Litigation Movement

In April 2013, the United States Judicial Panel on Multidistrict Litigation (JPML) consolidated all Fresenius cases filed in the federal court system, centralizing them in Massachusetts under U.S. District Judge Douglas P. Woodlock.

This action is meant to reduce duplicative discovery, avoid conflicting rulings from different judges, and to serve the convenience of the witnesses, parties and the courts.  There are currently more than 460 Fresenius product liability lawsuits filed under this MDL.

File a GranuFlo or NaturaLyte Lawsuit Today

If you believe that you or a loved one have been the victim of a GranuFlo or NaturaLyte injury, you have legal options.  Please visit the Kidney Dialysis Heart Attack GranuFlo and NaturaLyte Recall Class Action Lawsuit Investigation.  There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned GranuFlo or NaturaLyte lawyer will contact you for a free, no-obligation consultation.  You will be guided through the litigation process with no out-of-pocket expenses or hidden fees.  The GranuFlo or NaturaLyte attorneys working this investigation do not get paid until you do.