San Diego, CA (PRWEB) September 23, 2013
Resource4thePeople today announced its latest consumer update involving lawsuits over allegations that patients who underwent dialysis treatments with Fresenius NaturaLyte and GranuFlo products may have suffered heart attacks.
The two products were the subject of a Class 1 Recall* issued by the U.S. Food and Drug Administration on March 29, 2012 in which federal officials spelled out details of why the recall was made over concerns about life-threatening heart problems for patients:
“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.”
In its latest update, Resource4thePeople is reporting that the number of federal GranuFlo and NaturaLyte lawsuits alleging cardiac problems that have been consolidated before a federal judge in a multidistrict litigation has increased to 201,** according to the latest figures provided by federal court officials.
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 said that as these cases continue to advance its national network of lawyers will continue to offer complimentary consultations for consumers who have sought help over dialysis problems allegedly caused by GranuFlo and NaturaLyte products.
“Consumers also may regularly check our website at Resource4thePeople.com in order to receive regular updates about the progress of litigation involving NaturaLyte and GranuFlo lawsuits alleging serious heart irregularities,” said Resource4thePeople.
The updates will include information about the federal GranuFlo and NaturaLyte lawsuits**** from across the country that have been consolidated before a judge in the U.S. District Court for Massachusetts.
Judge Douglas P. Woodlock has been holding monthly status conferences to assess the progress of the litigation in meetings with lawyers for plaintiffs and defendants, according to the court file.
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 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.”
Resource4thePeople began providing complimentary legal consultations to patients after the FDA issued what it called a Class 1 Recall* of the kidney dialysis products.
In the recall the FDA advised health care professionals and patients that the affected GranuFlo and NaturaLyte products may cause life-threatening cardiac problems.
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 Consolidated Fresenius Cases, No. MICV2013-03400-O, Middlesex County Superior Court, Judge Maynard M. Kirpalani
****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.