San Diego, CA (PRWEB) August 16, 2013
Resource4thePeople today announced a key update for consumers about lawsuits alleging that Fresenius NaturaLyte and GranuFlo kidney dialysis products caused life-threatening heart problems for patients.
The federal judge who has been selected to coordinate consolidated federal lawsuits* involving these allegations against the manufacturer, Fresenius Medical Care, has scheduled an important hearing in which he will meet with lawyers for plaintiffs and defendants, according to the court file.
"The judge has asked the attorneys from both sides in the case to meet and discuss the progress of the litigation and how the cases should proceed," said Resource4thePeople.
"This meeting is called a status conference and will be one of several such hearings in which the public will learn details about these NaturaLyte and GranuFlo dialysis lawsuits as they move through the court system."
Resource4thePeople will continue to provide updates about the progress of these consolidated lawsuits and others that are filed across the country involving allegations of life-threatening heart problems from the use of these dialysis products.
"We are also announcing in response to inquiries from consumers who are not involved in this litigation but may have suffered similar alleged heart problems that our national network of attorneys will continue to offer free consultations and accept cases as this litigation progresses," said Resource4thePeople.
The status conference has been scheduled for Aug. 30, 2013 by Judge Douglas P. Woodlock at the Joseph Moakley Courthouse in Boston, Mass. in the U.S. District Court for Massachusetts.
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 in U.S. District Court for the Southern District of West Virginia 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.
The man's lawyers are claiming in their allegations 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 docket of the multidistrict litigation in the U.S. District Court of Massachusetts summarizes the specific allegations involved that plaintiffs who used NaturaLyte and GranuFlo claim they should be compensated for:
“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.”
At least 300 federal NaturaLyte and GranuFlo lawsuits from across the country alleging serious heart problems and deaths from the use of these products have been consolidated before Judge Woodlock, according to the court docket.
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.
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.
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 are not in conformity with current federal good manufacturing requirements.
“The FDA’s warning letter further calls into question the quality of products that Fresenius is producing for kidney patients,” said Resource4thePeople.
In the warning letter to Fresenius Medical Care, the FDA wrote that it had three times previously expressed its concerns and found Fresenius’s responses to be inadequate. FDA officials also warned of possible strict penalties:
“Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties."
*In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation 13-md-02428, U.S. District Court of Massachusetts, Judge Douglas P. Woodlock
**Case # 2:13cv20858, Harris v. Fresenius, U.S. District Court for the Southern District of Virginia, Judge Paul Zakaib Jr.