An untold number of dialysis patients may have suffered life-threatening cardiac arrest, heart attack, stroke, or cardiovascular death after being administered Fresenius Medical Care’s GranuFlo or NaturaLyte products while undergoing hemodialysis. Fresenius Medical Care, a Germany-based operator of dialysis centers, may have violated federal regulations for failing to warn dialysis patients of a potentially lethal heart risk associated with its GranuFlo and NaturaLyte products. GranuFlo and NaturaLyte are used at dialysis clinics operated by Fresenius, as well as hundreds of independent facilities supplied by the company.
The leading law firm of Alonso Krangle LLP is currently investigating potential lawsuit claims on behalf of individuals who have experienced injury or loss due to a catastrophic heart event following administration of GranuFlo or NaturaLyte during dialysis treatment, including:
- Cardiopulmonary arrest
- Cardiac arrhythmia
- Sudden heart attack
- Hemodialysis cardiopulmonary arrest
Alonso Krangle LLP is offering free lawsuit evaluations to anyone who suffered cardiac arrest or other serious, life-threatening heart side effects during a recent dialysis treatment. If you or someone you love experienced a cardiac event during hemodialysis, you may have been treated with either GranuFlo or NaturaLyte. To discuss your legal options, please contact the defective drug lawyers at Alonso Krangle LLP today.
GranuFlo and NaturaLyte Heart Side Effects
Dialysis is a procedure that clears toxic waste from the blood in patients whose kidneys have failed. In dialysis, bicarbonate is administered to neutralize the acid that builds up in the blood. GranuFlo and NaturaLyte are alkaline products that contain acetate, which the body converts to bicarbonate. The products are administered to a patient in conjunction with bicarbonate. However, GranuFlo and NaturaLyte contain far more acetate than rival products, and thus result in more bicarbonate in the body. This can lead to alkalosis, a condition associated with an increase in cardiovascular events, including catastrophic cardiac arrest. In June 2012, The New York Times reported that more than 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 about six times the risk of cardiac arrest as those with lower levels.
In November of 2011, Fresenius Medical Care sent an internal memo to doctors who practiced in the company’s dialysis centers, warning them that failure to properly use GranuFlo appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. 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.”
Despite the apparent urgency, Fresenius did not issue a similar warning at that time to any of the independent dialysis centers it supplied with GranuFlo and NaturaLyte. The company only did so in March 2012, after the FDA received a copy of the Fresenius internal memo from an anonymous source and contacted Fresenius Medical Care to inquire about it. The FDA is now investigating Fresenius to determine if it violated federal safety regulations by failing to warn its customer clinics of the serious heart risks posed by GranuFlo and NaturaLyte.
In June 2012, the FDA declared Fresenius Medical Care’s warning for GranuFlo and NaturaLyte a Class I recall. Class I recalls are the FDA’s most serious recall classification, and are only issued in cases where a product poses a serious risk of injury or death.
Legal Help for Victims of GranuFlo or NaturaLyte Heart Problems
If you or someone you love suffered cardiac arrest, heart attack, stroke, sudden cardiac death or another serious heart problem during dialysis that could be associated with the use of GranuFlo or NaturaLyte, the defective drug lawyers at Alonso Krangle LLP would like to talk with you. For a free lawsuit evaluation, please fill out our online form, or call us.