San Diego, CA (PRWEB) April 04, 2014
Resource4thePeople today announced important new information about how consumers inquiring about whether to file an action similar to lawsuits filed over allegations that GranuFlo and NaturaLyte dialysis products caused life-threatening heart problems.
Hundreds of such federal lawsuits* have now been consolidated before a U.S. District Court judge in Massachusetts in what is called a multidistrict litigation that is now in the preliminary stages of evidence-gathering and other legal procedures.
"The questions we have been receiving from consumers is whether they are required to join in this multidistrict litigation and be part of a huge litigation involving allegations that they developed serious heart problems as a result of dialysis treatment with GranuFlo and NaturaLyte treatments," said Resource4thePeople. "The answer is that each case is different and the decision whether to file in state or federal court or be part of this litigation depends on the facts involving each individual's circumstances. Therefore, we are urging that consumers with questions about their eligibility to seek compensation over these allegations take advantage of the free consultations that are being offered by our national network of attorneys."
These consultations can determine eligibility to file a claim or lawsuit and define what costs -- such as medical expenses and pain and suffering -- may be sought as compensation, said Resource4thePeople.
Resource4thePeople attorneys are focusing on allegations that mirror health concerns raised about GranuFlo and NaturaLyte dialysis products in a Class 1 Recall issued by the Food and Drug Administration** March, 29, 2012.
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.
The FDA warned in the recall about high serum bicarbonate levels that might contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia that could lead to fatal heart problems.
“There are now 650 such federal lawsuits consolidated before U.S. District Judge Douglas P. Woodlock, who is overseeing pre-trial evidence-gathering and other legal procedures in this multidistrict litigation,” said Resource4thePeople.
Court statistics*** provided by the U.S. Judicial Panel for Multidistrict litigation show that this figure for the reporting period ending March 13, 2014 is an increase of nearly 200 cases since the filing period ending in January.
“The increase in the number of cases corresponds to the increase in the number of consumer inquiries we are receiving in connection with the allegations raised in this litigation,” said Resource4thePeople.
In the Class 1 Recall** of GranuFlo and NaturaLyte products federal officials spelled out details of the recall:
“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.”
Resource4thePeople's national network of attorneys are answering questions from consumers alleging that they suffered cardiac arrest, heart attacks, strokes, sudden cardiac death and other side effects in connection with the allegations currently filed in the multidistrict litigation.
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.”
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.
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 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.