GranuFlo, NaturaLyte, Heart Attack Allegation Attorneys: Resource4thePeople Comments on New Developments in Consolidated Federal Litigation

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Federal court litigation progresses as number of lawsuits increases over allegations that dialysis products caused life-threatening heart attacks. 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 its latest update for consumers following litigation* from across the country alleging that NaturaLyte and GranuFlo dialysis products caused heart attacks and, in some cases, deaths.

Among the latest developments is the release of figures from federal court officials that show the number of NaturaLyte and GranuFlo lawsuits that have been combined in a federal multidistrict litigation has increased.

There are now 393 such lawsuits being overseen by a federal judge in the United States District Court of Massachusetts, according to statistics compiled by the U.S. Judicial Panel on Multidistrict Litigation.**

The figures from the reporting period ending Nov. 18, 2013 show an increase of 81 cases over the last reporting period ending Oct. 17, 2013.

"This multidistrict litigation is still in the early stages but the increase in the number of cases shows that we can expect more such cases to be filed in the future," said Resource4thePeople.

"We will continue our commitment to assist consumers who have been affected by these allegations by maintaining our policy of free consultations that will enable them to determine what legal options they may have to seek compensation in such cases."

Resource4thePeople's national network of attorneys provides experienced, aggressive representation for consumers who may have suffered cardiac arrest, heart attacks, strokes, sudden cardiac death and other side effects in connection with the allegations currently filed in the multidistrict litigation.

“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.”

The latest figures document that the number of cases from across the country before U.S. District Judge Douglas P. Woodlock has increased by nearly 200 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 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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