Fresenius GranuFlo® & NaturaLyte® Dialysis LAWYERS
THE YANKOWITZ LAW FIRM
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WHO HURT CONSUMERS AND THEY WIN !!
Fresenius Medical Care, the Nation’s largest operator of dialysis centers, is under investigation by the FDA for failing to warn consumers of potentially deadly heart problems associated with the company’s GranuFlo® and NaturaLyte® dialysis products.
Dialysis is a procedure that replaces the function of the kidneys by filtering toxic waste products out of the blood. GranuFlo® and NaturaLyte® are products used in the dialysis process. Bicarbonate is a chemical that dissolves acid in the blood. The issue with GranuFlo® and NaturaLyte® is that they produce more bicarbonate than their competitors, which can lead to excessively high alkaline levels, or metabolic alkalosis. Metabolic alkalosis increases the risk of serious complications, such as:
- Sudden Cardiac Arrest
- Sudden Heart Attack
- Hemodialysis cardiac arrest
- Hemodialysis cardiopulmonary arrest
- Altered mental status (confusion)
- Low blood pressure
Physicians who were not aware of the extra bicarbonate resulting from GranuFlo® and NaturaLyte® may have prescribed even more bicarbonates, essentially giving patients an overdose. In June of 2012, The New York Times reported that 900 dialysis patients had experienced sudden cardiac arrest in 2010 while undergoing hemodialysis at hundreds of Fresenius clinics. An analysis conducted by the Fresenius medical staff concluded that patients with high levels of bicarbonate in their blood had (approximately) six times the risk of cardiac arrest as those with lower levels.
According to news reports, in November 2011, Fresenius sent an internal email , warning the doctors at its own dialysis centers that the use of GranuFlo® and NaturaLyte® contributed to an increased risk of death from cardiac arrest during dialysis. The memo also stated: “In light of these troubling findings, doctors should take corrective action.” Doctors were warned that they needed to address the matter “urgently.” However, a similar warning did not go to the FDA, other doctors, or consumers. A subsequent warning was finally sent in March 2012 after the FDA received a copy of the Fresenius internal memo from an anonymous source . Questions have arisen as to whether the company’s conduct put patients at risk and violated FDA regulations and ethical standards.
If you or someone you love suffered heart attack, cardiac arrest, stroke, sudden cardiac death or another serious heart problem that you believe may have been caused by GranuFlo® or NaturaLyte® , please contact the defective drug lawyers at THE YANKOWITZ LAW FIRM for a free consultation, by filling out the form or calling 1-800-LAW-3333.
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