The number of dialysis patients who were put at risk of suffering fatal cardiac situations after being treated with GranuFlo or NaturaLyte acid concentrates may never be full tabulated.
Both products were the subject of a Class 1 Recall issued by the Food and Drug Administration in March, 2012 in which federal officials warned of life-threatening side effects that patients were put in risk of suffering.
If you were one of those patients, here is the specific language used by the FDA in announcing 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. 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.”
Class I recalls are the most serious type of recall made by the FDA and involve situations in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.
According to the court files of lawsuits filed by hundreds of dialysis patients and their loved ones many patients did suffer heart attacks, strokes, sudden cardiac arrest and other heart problems and some of them died.
The number of these lawsuits filed in state and federal courts across the country has shown a steady increase since the 2012 FDA Class 1 GranuFlo and NaturaLyte Recall.
There have been so many federal lawsuits with common allegations filed against the manufacturer of the products, Fresenius Medical Care, that they have been grouped together in what is called a multidistrict litigation.
Nearly 500 such federal lawsuits are now under the jurisdiction of a U.S. District Judge in Massachusetts who is overseeing pre-trial evidence-gathering and other legal actions in which lawyers for victims of NaturaLyte and GranuFlo life-threatening side effects will gain access to internal Fresenius Medical Care documents and other evidence as they press their cases.
Among their allegations against the manufacturers of NaturaLyte and GranuFlo are that the products caused patients to suffer the side effects documented by the FDA: heart attacks, strokes, sudden cardiac death, cardiovascular arrest and other serious heart problems.
The victims also are claiming that Fresenius Medical Care was negligent by not informing patients about the risk of these life-threatening conditions while undergoing dialysis.
In addition, according to court documents filed in the lawsuits, Fresenius officials became aware of these life-threatening risks and at first only warned health care professionals at Fresenius-operated dialysis clinics about these dangers at the expense of the health and safety of patients being treated at independent clinics.