GranuFlo, NaturaLyte Kidney Dialysis Allegations Lawsuits Report: Resource4thePeople Updates Consumers over Progress of Federal Court System Petition to Consolidate Claims

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Resource4thePeople continues to follow news of litigation in which attorneys for patients filing kidney dialysis claims are joined by the products’ manufacturer in seeking consolidation of dozens of cases before a single judge.

Resource4thePeople announced today that a special panel of federal judges* is considering whether to consolidate lawsuits* alleging that NaturaLyte and GranuFlo kidney dialysis products have caused deaths and life-threatening health problems for some patients.

"In response to a growing number of inquiries from patients about the status of these lawsuits and whether they might eventually become class-action lawsuits we are closely following this litigation," said Resource4thePeople.

"As soon as this special panel of judges decides whether to grant the petitions that have been filed by plaintiffs and the products' manufacturer, Fresenius Medical Care, we will pass this information along."

As of today the panel had not posted a decision on its web site.

Typical of the claims in these lawsuits are the allegations made in one suit** filed in federal court in Alabama in which according to court documents, the plaintiff claims "Fresenius had knowledge that there was a significant increased risk of cardiac arrest and death during hemodialysis treatments associated with their Granuflo dialysis concentrate product."

Lawyers for the plaintiff also said in their court filing that the use of Granuflo could "lead to significantly increased bicarbonate levels and the associated risks of heart attack, cardio pulmonary arrest, and/or death."

In a Dec. 13, 2012 article, Reuters News Service reported that Fresenius, the world's largest dialysis group, in its petition was denying allegations in the lawsuits that the two products carried inadequate labeling and warnings and caused harm to patients.***

“The company's chief executive Ben Lipps said in a statement that FMC's actions related to the products were appropriate and responsible,” said Reuters."Both products are safe and effective and were reviewed and cleared by the Food and Drug Administration several years ago."

Resource4thePeople notes that the petitions ask that more than three dozen pending lawsuits filed in at least 10 different states be designated as a multidistrict litigation and be assigned to a judge in either Alabama, Massachusetts or Mississippi.

“What will happen next is that the Panel on Multidistrict Litigation will consider this petition and decide whether the cases should be consolidated in the interests of judicial efficiency before a single judge to conduct pre-trial evidence gathering and other legal requirements," said Resource4thePeople.

Resource4thePeople also is providing free consultations to lawyers for patients who might have been affected by the Food and Drug Administration’s Class 1 Recall of GranuFlo and NaturaLyte kidney dialysis products.

The decision to offer referrals to these consultations was made because of an increasing number of inquiries that have come after the FDA's action, said Resource4thePeople.

In announcing the recall the FDA advised health care professionals and patients that the affected GranuFlo and NaturaLyte products when inappropriately prescribed or administered in dosing errors may cause life-threatening cardiac problems.****

“This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest,” the FDA said in the announcement. “This product may cause serious adverse health consequences, including death.”

Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

According to the FDA, the affected NaturaLyte and GranuFlo Dry Acid concentrates were manufactured between January 2008 and June 2012 and are used in the treatment of acute and chronic renal failure during hemodialysis.

The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.

Resource4thePeople notes that the FDA said it received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.

The FDA said this can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.

*In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL 2428 pending before U.S. Judicial Panel on Multidistrict Litigation
**Williams vs. Fresenius USA, Inc., Case # 2:12-vc-02576, U.S. District Court of Northern Alabama, Southern Division

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