San Diego, CA (PRWEB) March 19, 2014
Resource4thePeople today announced its latest update for consumers who have been following the progress of lawsuits* filed across the country over allegations that GranuFlo and NaturaLyte dialysis products caused life-threatening heart problems.
Many of these lawsuits were filed after health warnings were issued over GranuFlo and NaturaLyte dialysis products that were the subject of a Class 1 Recall issued by the Food and Drug Administration** March, 29, 2012.
In the recall notice the FDA warned 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.
Among the most recent developments in this litigation is the increase in the number of GranuFlo and NaturaLyte lawsuits* from across the country that have been consolidated before a federal judge in Massachusetts.
“There are now 650 such 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 filing deadline of 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.
“As a result we will continue to offer free consultations to consumers who are seeking information about their legal options to seek compensation over allegations of life-threatening heart problems stemming from treatment with these GranuFlo and NaturaLyte products.”
Resource4thePeople also notes that Judge Woodlock has scheduled a March 28, 2014 status conference at which he is scheduled to be updated by lawyers for the plaintiffs and those representing Fresenius Medical Care, the manufacturers of the products, according to the court file.
"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."
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.
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.