San Diego, CA (PRWEB) June 04, 2013
Resource4thePeople reports today to consumers that even though a judge has been assigned to oversee the consolidated federal lawsuits* alleging that NaturaLyte and GranuFlo kidney dialysis products caused life-threatening problems new cases are still being accepted and filed.
“We are informing consumers that even though Judge Douglas P. Woodlock has been chosen to oversee over 161 lawsuits alleging serious cardiac problems as a result of the use of NaturaLyte and GranuFlo dialysis products new inquiries will still be accepted and additional cases continue to be filed,” said Resource4thePeople.
“A review of the docket* shows that the judge has not issued any order preventing the filing or addition of new cases to this multidistrict litigation and our national network of attorneys will therefore continue to offer no-cost consultations for consumers.”
In fact, notes Resource4thePeople, several new cases have been recently filed. Among them:
“Based on the number of inquiries being made by consumers there may be a large number of other dialysis patients who could be affected by this litigation and come forth to seek information about their legal rights,” said Resource4thePeople.
Judge Woodlock sits in the U.S. District Court in Massachusetts and was assigned the cases because they contain similar allegations that NaturaLyte and GranuFlo kidney dialysis products have caused life-threatening health problems for some patients. In his first order on the court docket April 5 he described the litigation, according to the court file:*
“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.”
In reviewing the judge’s summation of the cases Resource4thePeople is encouraged that the first group of lawsuits over allegations that dialysis patients died or suffered life-threatening health problems is moving forward in the streamlined multidistrict litigation designation.
“As it does, we will continue to provide consumers who may be affected by this litigation the latest information about the progress of the lawsuits,” said Resource4thePeople.
Resource4thePeople began providing complimentary legal consultations to patients after the Food and Drug Administration issued a Class 1 Recall** March 29, 2012 of the kidney dialysis products.
“The decision to offer referrals to these consultations was made because of an increasing number of inquiries that came after the FDA's action concerning the allegations of life-threatening side effects,” said Resource4thePeople.
In announcing the recall the FDA advised health care professionals and patients that the affected GranuFlo and NaturaLyte products when inappropriately prescribed or administered in dosing errors may cause life-threatening cardiac problems.
“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,” the FDA said in the announcement. “This product may cause serious adverse health consequences, including death.”
The FDA describes Class I Recalls as the most serious type of recall and involve 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.
The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
Resource4thePeople notes that the FDA said it received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.
When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.
The FDA said this can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.
Judge Woodlock was assigned the cases after the United States Panel on Multidistrict Litigation granted a petition filed by plaintiffs in these lawsuits to consolidate the cases before a single judge in U.S. District Court, District of Massachusetts.
Here is part of the judicial panel's order:***
"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. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary."
*In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation MDL # 2428, U.S. District Court of Massachusetts, Judge Douglas P. Woodlock