GranuFlo, NaturaLyte, Dialysis Heart Attack Allegation Lawyers: Resource4thePeople Continuing To Review Claims as Multidistrict Federal Cases Move Forward

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Federal court actions will not affect consumers’ rights to seek compensation over allegations of life-threatening heart problems. Resource4thePeople’s national network of attorneys maintains offer of free consultations to consumers responding to FDA's concerns about dialysis patients suffering heart irregularities.

Resource4thePeople today announced today a clarification of its offer of free consultations from its national network of attorneys to consumers over allegations that NaturaLyte and GranuFlo dialysis products may have caused heart attacks.

“The creation of a federal multidistrict litigation* in which federal cases from across the country have been placed under the jurisdiction of a single judge has caused some confusion among consumers who have been contacting us about their legal rights to seek compensation over these allegations,” said Resource4thePeople.

“We are today assuring consumers that the fact that there is such a consolidated litigation does not affect the right of consumers to seek consultations from our attorneys about whether to join in this action or to seek compensation by taking action in state courts.”

These options as well as others related to the merits of each individual case can be outlined when consumers take advantage of these complimentary consultations, said Resource4thePeople.

“These are very serious allegations involving cases in which heart attacks and other life-threatening cardiac conditions have been attributed to dialysis treatments with Fresenius NaturaLyte and GranuFlo products,” said Resource4thePeople.

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.”

There are now at least 312 cases in the consolidated federal litigation in U.S. District Court for Massachusetts, according to the latest posting on Oct. 17, 2013, by the U.S. Panel on Multidistrict Litigation.**

The latest figures document that the number of cases from across the country 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.

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 involving 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 did not meet current federal good manufacturing requirements.

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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