NaturaLyte, GranuFlo Claims Update: Resource4thePeople Reports Federal Court System Is Petitioned to Consolidate Lawsuits

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Resource4thePeople updates web site with news of litigation in which attorneys for the plaintiffs 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 it is providing consumers an update of the progress of the growing numbers of NaturaLyte and GranuFlo that have been filed by patients who are claiming that they have suffered serious heart problems as a result of being treated with the products during kidney dialysis.

The latest news is that lawyers for the plaintiffs and lawyers for Fresenius Medical Care, the producer of NaturaLyte and GranuFlo, have both filed petitions with the U.S. Judicial Panel on Multidistrict Litigation seeking to have the lawsuits consolidated before a single federal judge.*

"We will be providing consumers with an update of this news on our web site and will continue to keep those who may be affected by litigation involving these products informed about the progress of that information," said Resource4thePeople.

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.

“We will continue to provide updates in response to the growing number of inquiries we have received from consumers about lawsuits filed over NaturaLyte and GranuFlo products by dialysis patients,” said Resource4thePeople.

“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.”

In its petition, Fresenius lawyers denied allegations that the company was aware of or should have been aware of allegations that the products could have caused such life-threatening problems such as cardiac arrest and heart attacks.

“The plaintiff’s claims will fail on their merits because the plaintiffs cannot show that Fresenius’s products are unreasonably dangerous or that Fresenius failed to provide adequate warnings and instructions to the intermediaries who used GranuFlo and NaturaLyte to treat dialysis patients,” the lawyers said in their petition.

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.”

Resource4thePeople said that dialysis patients who believe they allegedly may have suffered cardiac problems as a result of the administration of these products are invited to take advantage of these free legal compensations.

“These free consultations are available to inform those who may have suffered serious health problems as a result of their treatment with the products of the legal options that may be available to them to seek compensation for medical costs and other expenses attributable to their condition,” said Resource4thePeople.

Resource4thePeople said these free consultations also are available for those who may have lost a loved one as a result of a cardiac problem allegedly caused by treatment with these products.
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.

“The importance of consumers contacting the FDA about problems that they may incur with drugs and medical devices also is a factor in keeping the FDA abreast of problems as well as informing the public because such complaints are registered by the FDA,” said Resource4thePeople.

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.

Health care professionals may not be aware that the dialysate acid concentrates can contain acetic acid, acetate or citrate, and that these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis, according to the FDA.

These substances typically are found in acid concentrate in amounts ranging from 1.5 to 8 mEq/L. This potential exists for all currently marketed dialysate concentrate products containing acetate, acetic acid, or citrate, the FDA said.

*In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL 2428 pending before U.S. Judicial Panel on Multidistrict Litigation

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