San Diego, CA (PRWEB) May 09, 2013
Resource4thePeople reports today to consumers that a judge has been assigned to oversee the consolidated federal lawsuits assigned to U.S. District Court in Massachusetts over allegations that NaturaLyte and GranuFlo kidney dialysis products have caused life-threatening health problems for some patients.
Judge Douglas P. Woodlock has been chosen to oversee the litigation* in which common allegations from plaintiffs seeking compensation and damages for alleged serious side effects have been filed.
“We are encouraged that the first group of lawsuits over allegations that dialysis patients died or suffered life-threatening health problems is moving forward before Judge Woodlock,” said Resource4thePeople.
“We will continue to provide consumers who may be affected by this litigation or are considering joining in the latest information about the progress of the lawsuits and our nationwide team of attorneys will continue to offer free legal consultations to consumers inquiring about the legal rights they may have to seek compensation.”
Judge Woodlock in his first order*April 5 outlined the procedures that must be followed by lawyers for the plaintiffs and Fresenius Medical Care, manufacturer of the products and operator of dialysis clinics. The court also posted a summation of the cases:
“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. These cases have been assigned to Judge Douglas P Woodlock.”
Resource4thePeople began providing complimentary legal consultations to patients who might have been affected by treatment with GranuFlo and NaturaLyte 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.
"We are providing this update in response to the growing number of inquiries from patients about the status of these lawsuits and whether this action affects their right to file a lawsuit," said Resource4thePeople.
"Although every case is different, the answer to most consumers is no. The creation of this special multidistrict litigation does not affect most consumers but the best way to determine if a consumer is eligible to file a NaturaLyte and GranuFlo lawsuit is to contact us as soon as possible.”
Here is part of the judicial panel's order:***
"On the basis of the papers filed and the hearing session held, we find that these actions involve common questions of fact, and that centralization of all actions in the District of Massachusetts will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.
“All the actions share common factual questions arising out of 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. 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