If you look at the docket of hundreds of GranuFlo and NaturaLyte dialysis lawsuits grouped together before a U.S. District Court judge you will find some frightening allegations:
“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.”
There are hundreds of these cases consolidated into what could eventually become a huge class-action litigation. Many more cases have been filed in other state and federal courts across the country.
One of these cases 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 products at issue on these cases were the subject of a Class 1 Recall by the U.S. Food and Drug Administration.
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.
FDA records also 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.