GranuFlo, NaturaLyte Kidney Dialysis Allegations Lawsuits Update: Resource4thePeople Reports New Order on Federal Court System Petition to Consolidate Lawsuits

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U.S. panel of judges grants plaintiffs' petition seeking consolidation before a single judge of numerous lawsuits alleging Fresenius dialysis products were linked to kidney failures. Resource4thePeople offering free legal consultations.

Resource4thePeople reports today an update of the progress of numerous lawsuits* in the federal court system alleging that NaturaLyte and GranuFlo kidney dialysis products have caused deaths and life-threatening health problems for some patients.

The United States Panel on Multidistrict Litigation has granted a petition filed by plaintiffs in these lawsuits to consolidate the cases before a single judge in U.S. District Court, District of Massachusetts.**

"We are providing this update in response to the growing number of inquiries from patients about the status of these lawsuits and whether they might eventually become class-action lawsuits," said Resource4thePeople.

"Now that this special multidistrict litigation has been approved Resource4thePeople is also now providing free legal consultations to consumers who are inquiring about their legal rights over claims involving NaturaLyte and GranuFlo kidney dialysis products."

Here is part of the judicial panel's order:**

"On the basis of the papers filed and the hearing session held, we find that these actions involve common questions of fact, and that centralization of all actions in the District of Massachusetts will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All the actions share common factual questions arising out of allegations that plaintiffs suffered injury or death caused by the use of GranuFlo and/or NaturaLyte products during hemodialysis, which allegedly may cause metabolic alkalosis in patients resulting in low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, or cardiopulmonary arrest.
"All the actions involve factual questions relating to whether GranuFlo and NaturaLyte were defectively designed or manufactured, whether Fresenius, the manufacturer of these dialysate products, knew or should have known of the alleged propensity of these products to cause injury, and whether it provided adequate instructions and warnings with these products. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary."

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 asked 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.

Resource4thePeople also is providing free legal consultations to 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, U.S. District Court of Massachusetts, Judge Douglas P. Woodlock
***Williams vs. Fresenius USA, Inc., Case # 2:12-vc-02576, U.S. District Court of Northern Alabama, Southern Division

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