San Diego, CA (PRWEB) February 05, 2014
Resource4thePeople today announced today that there have been several important developments in the progress of lawsuits that have been filed across the country over allegations that GranuFlo and NaturaLyte dialysis products caused life-threatening heart problems.
The federal judge presiding over hundreds of such lawsuits consolidated before him the U.S. District Court for Massachusetts was scheduled to meet with lawyers for the plaintiffs and those representing Fresenius Medical Care, the manufacturers of the products.
At the meeting, set for this week, according to the court file in the case, lawyers for both sides of the litigation were expected to brief the judge on the progress of the litigation and problems that might have arisen as pre-trial evidence gathering continues.
The judge also was scheduled to hear legal motions from both sides as they press their cases over allegations that GranuFlo and NaturaLyte could cause heart problems that, in some cases, may be fatal, according to the court file.
“The allegations in these GranuFlo and NaturaLyte lawsuits also were raised by the Food and Drug Administration** in a Class 1 Recall that was issued March, 29, 2012 involving these products,” said Resource4thePeople.
"We will continue to update consumers about the progress of this litigation and maintain our policy of providing free consultations to consumers seeking legal consultations involving heart attack concerns involving these products."
“The continued increase in the number of consumers inquiring about alleged GranuFlo and NaturaLyte side effects since the FDA issued a Class 1 Recall over heart attack concerns shows that there are a great number of affected consumers seeking experienced, aggressive legal help,” said Resource4thePeople.
Court records*** show that there are now 460 cases before U.S. District Judge Douglas P. Woodlock in the federal consolidated litigation, an increase of 67 since the reporting period in November.
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.”
"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 though our 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 are answering questions from consumers who are 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.
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.