Updated GranuFlo, NaturaLyte, Dialysis Heart Attack Allegations Help: Resource4thePeople Reports Big Increase in Lawsuits as Consolidated Federal Cases Move Forward

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Over 100 new cases filed in multidistrict litigation involving allegations of life-threatening heart problems. Resource4thePeople’s national network of attorneys continue to offer complimentary consultations to consumers responding to FDA's concerns about dialysis patients suffering heart irregularities.


Resource4thePeople today announced that there has been substantial progress in the consolidated federal lawsuits* involving allegations that that patients who underwent dialysis treatments with Fresenius NaturaLyte and GranuFlo products may have suffered heart attacks.

This report is the latest in a regular series of consumer updates about the latest developments in lawsuits involving allegations of NaturaLyte and GranuFlo life-threatening side effects that have been filed in both state and federal courts and in the availability of free consultations from our national network of attorneys for consumers who may have been affected by these allegations.

"The first important news is that the number of lawsuits alleging that consumers have suffered serious heart problems from treatment with these dialysis products has shown a significant increase from the last posting of U.S. court figures," said Resource4thePeople.

"As of the latest reporting period, Oct. 17, 2013, the U.S. Panel on Multidistrict Litigation reported** that there are now 312 cases before a federal judge in Massachusetts who is overseeing a multidistrict litigation involving GranuFlo and NaturaLyte cases."

The new figures show that the number of cases from across the country that are now before U.S. District Judge Douglas P. Woodlock has increased by over 100 cases since the Aug. 15, 2013 reporting period.

"As these cases continue to increase so do the number of inquiries we are receiving from consumers about their legal options to seek compensation in cases involving these allegations," said Resource4thePeople.

"Because we expect this litigation to progress over the next several months and possibly longer we will extend our offer of complimentary consultations to consumers making these inquiries about their legal rights over such allegations."

The docket of the multidistrict litigation in the U.S. District Court of Massachusetts summarizes the specific allegations involved:

“These actions share factual issues arising from 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.”

The court docket in the cases* before Judge Woodlock also shows that the court has begun the process of directing the lawyers in their pre-trial evidence-gathering and other legal requirements.

In addition to being named in the lawsuits in this litigation, GranuFlo and NaturaLyte were the subject of a Class 1 Recall*** issued by the U.S. Food and Drug Administration on March 29, 2012 in which federal officials spelled out details of why the recall was made over concerns about life-threatening heart problems for patients:

“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' NaturaLyte Liquid and GranuFlo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis,” the FDA said.

“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. This product may cause serious adverse health consequences, including death.”

Meanwhile, a group of state court cases**** containing similar NaturaLyte and GranuFlo allegations filed in Massachusetts have been consolidated in similar fashion before a single state court judge in Middlesex County.

Resource4thePeople also is informing consumers that as this litigation advances more lawsuits continue to be filed against Fresenius over similar allegations involving GranuFlo and NaturaLyte products.

One of the most recent was filed by the husband of a woman who, according to the allegations in the court file,***** died as a result of her dialysis treatment with NaturaLyte and/or GranuFlo.

His lawyers are claiming that Fresenius officials knew that serious heart problems might be a side effect of the treatment but failed to adequately warn consumers and health care providers, according to the court file.

The FDA describes Class I Recalls as 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.

Meanwhile, FDA records show that Fresenius was cited****** by federal regulators over deficiencies uncovered at one of the company’s facilities.

In a warning letter dated March 13, 2013, FDA officials informed Fresenius Medical Care officials that dialyzers manufactured at the company’s Ogden, Utah plant are not in conformity with current federal good manufacturing requirements.

“The FDA’s warning letter further calls into question the quality of products that Fresenius is producing for kidney patients,” said Resource4thePeople.

In the warning letter to Fresenius Medical Care, the FDA wrote that it had three times previously expressed its concerns and found Fresenius’s responses to be inadequate. FDA officials also warned of possible strict penalties.

*In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation 13-md-02428, U.S. District Court of Massachusetts, Judge Douglas P. Woodlock
****In re Consolidated Fresenius Cases, No. MICV2013-03400-O, Middlesex County Superior Court, Judge Maynard M. Kirpalani
*****Case # 2:13cv20858, Harris v. Fresenius, U.S. District Court for the Southern District of Virginia, Judge Paul Zakaib Jr.

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