What are the health problems most reported by dialysis patients who claim they have suffered life-threatening side effects after being treated with GranuFlo or NaturaLyte products that were the subject of a Class 1 Recall by the Food and Drug Administration?
Here are the main side effects as detailed in reports to the FDA and in allegations filed in GranuFlo and NaturaLyte lawsuits across the country: heart attacks, strokes, cardiac arrest, or sudden cardiac death.
It is not known how many GranuFlo and NaturaLyte patients may have died as a result of treatment with these defective products but the loved ones of some who did die are among the plaintiffs in these lawsuits.
The FDA issued a Class 1 Recall Notice of the products on 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.
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.
In the Class 1 Recall of GranuFlo and NaturaLyte products federal officials spelled out details of the recall:
“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.”
It was after this Class 1 Recall Notice was issued that the number of GranuFlo and NaturaLyte lawsuits multiplied. There are so many such lawsuits now that federal court officials have consolidated some of them before a judge in U.S. District Court for Massachusetts.
These cases are currently in the early stages of pre-trial evidence gathering and other legal actions and legal experts expect the number of such cases, which are now nearly 500 to significantly increase.
In addition, other victims affected by the GranuFlo and NaturaLyte Class 1 Recall may choose to not become part of this litigation and filed their own lawsuits in other federal courts or in state courts, these legal experts say.
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