One of the most recent lawsuits involving fatal consequences with the recalled GranuFlo and NaturaLyte dialysis products was filed in U.S. District Court in 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 the products.
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.
These products, which were used in treatments affecting a so-far undetermined number of dialysis patients, were the subject of a Class 1 Recall issued by the Food and Drug Administration March, 29, 2012.
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.
A number of GranuFlo and NaturaLyte lawsuits had been filed on behalf of victims had been filed before the FDA announced the nationwide Class 1 Recall but the filings significantly increased after the recall was announced.
There have been so many such lawsuits filed containing similar life-threatening allegations against the products’ manufacturer, Fresenius Medical Care, that the U.S. Panel on Multidistrict Litigation consolidated a significant proportion of them under the jurisdiction of a single federal judge.
Court records show that there are now 460 cases before Judge Douglas P. Woodlock in the U.S. District for Massachusetts, which represents an increase of 67 cases since the reporting period in November.
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.”
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 Medical Care 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 officials that dialyzers manufactured at the company’s Ogden, Utah plant did not meet current federal good manufacturing requirements.