Our experienced team of defective medical device lawyers is now offering free consultations for victims of serious health problems caused by their treatment with GranuFlo or NaturaLyte kidney dialysis products. These are side effects can be severe – such as cardiac arrest – and involve legal issues with which our lawyers are well versed and have a history of successfully litigating.
Please contact us as soon as possible so we can add you to the growing number of patients who are seeking aggressive legal representation for the devastating effects of products so dangerous that they were recalled by the U.S. Food and Drug Administration.
GranuFlo & NaturaLyte Kidney Dialysis & Serious Side Effects
Kidney dialysis is a critical treatment issue. Those who have suffered health problems as a result treatment may be eligible to file a GranuFlo or NaturaLyte kidney dialysis lawsuit and seek compensation for injuries. GranuFlo and NaturaLyte kidney dialysis victims are increasing in number as more information surfaces about serious side effects from these products that have lead to, in some cases, life-threatening cardiac arrests.
Nearly one-third of the estimated 400,000 patients undergoing kidney dialysis treatments in the United States were being treated with these types of dialysis products due to the dominant position of the products’ manufacturer, German pharmaceutical corporation Fresenius Medical Care (FMS).
The FDA and NaturaLyte and GranuFlo Dialysis
The NaturaLyte and GranuFlo lawsuits that have been filed by kidney dialysis victims contain the same allegations that have been registered with the Food and Drug Administration, which issued an FDA Class 1 Recall notice over issues of cardiac problems caused by use of these dialysis products. The FDA announced that it was taking action to make sure health care providers were aware of the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining a patients’ dialysate prescription.
The FDA said it was acting, in part, on data it received describing alkali dosing errors that occurred during hemodialysis in which dialysate concentrates containing acetic acid and acetate were used. FDA officials warned that when metabolized, these sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.
The FDA said that in this situation a condition known as metabolic alkalosis can develop and generate serious risks of:
- cardiopulmonary arrest
- low blood pressure
- cardiac arrhythmia
The FDA said that dialysate solution is prescribed for treatment of acute and chronic renal failure during the hemodialysis procedure in which the dialysate solution combines with the hemodialysis machine and dialyzer to remove wastes from the blood.
The FDA’s Class 1 Recall was issued in July of 2012, with the agency acknowledging the large number of adverse reports being received from victims and physicians. Class 1 Recalls are issued only when life-threatening conditions occur. The FDA also encouraged physicians and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Program.
A History of NaturaLyte and GranuFlo Dialysis Health Risks
Another important source of information about life-threatening heart problems linked to the use of GranuFlo and NaturaLyte kidney dialysis products has been found in the internal documents generated in the offices of Fresenius Medical Care.
These figures have become public and show that Fresenius officials were aware that cardiac arrests were suffered by over 900 patients who were being treated in 2010 in Fresenius clinics across the country. This figure could be substantially larger because the statistics in the internal Fresenius memo do not reflect a large number of patients receiving Fresenius dialysis treatments in independent clinics.
This information was among the evidence reviewed by our GranuFlo and NaturaLyte lawyers as we aggressively move forward toward settling these cases or presenting them to juries.
Please contact us as soon as possible for a free consultation about the possibility of you or a loved filing a GranuFlo or NaturaLyte lawsuit to seek compensation for the medical costs and other expenses you may have incurred.