Kidney Dialysis Heart Attacks
Cory Watson Crowder & DeGaris is actively pursuing claims against Fresenius Medical Care (Fresenius) on behalf of victims experiencing life-threatening cardiovascular injuries caused by the use of GranuFlo® and NaturaLyte® in kidney dialysis. GranuFlo and NaturaLyte have been associated with an increase in death, sudden cardiac arrest, cardiopulmonary arrest, heart attack, and other catastrophic cardiovascular injuries.
What You Need to Know
The New York Times reports that the U.S. Food and Drug Administration (FDA) is investigating whether Fresenius Medical Care (Fresenius) failed to properly inform some kidney dialysis patients of their risk of cardiac arrest. The concerns involve the use of Fresenius products GranuFlo and NaturaLyte which have been linked to alkalosis, a condition associated with an increase in death and sudden cardiac arrest in patients undergoing dialysis treatment.
Fresenius is the leading supplier of kidney dialysis machines and disposable kidney dialysis products and Fresenius operates kidney dialysis centers across the U.S. In addition, Fresenius supplies products used in kidney dialysis to dialysis centers operated by other companies.
On March 29, 2012, Fresenius issued an "urgent product notification" with "important prescribing information" highlighting the increased risk associated with improper use of GranuFlo and NaturaLyte.
An internal November 2011 communication confirmed that Fresenius was aware "patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of and additive to the risk of CP arrest associated with pre-dialysis hypokalemia."
Additionally, Fresenius indicated that in 2010 alone there were nearly 1,000 patients who suffered from cardiac arrest in dialysis clinics operated by Fresenius, an occurrence they said could be linked to bicarbonate levels in the body. Although the memo warning of the danger of improper use of GranuFlo was sent to clinics operated by Fresenius in November 2011, it is believed Fresenius did not first warn hundreds of non-Fresenius clinics which used GranuFlo and NaturaLyte of the possible problems tied to these products until months later in March 2012.
The FDA is now investigating whether non-Fresenius clinic patients were put at a greater risk based on the company's believed withholding of important safety information.
GranuFlo in Dialysis Treatment
Dialysis is often used to help patients whose kidneys have failed. During dialysis, the acid in a patient's blood is neutralized by bicarbonate, an alkaline substance. Products used in dialysis commonly contain ingredients that the body converts to bicarbonate, but the Fresenius product GranuFlo contains a larger amount of this ingredient. It is believed that this large amount can cause an excessive build-up of bicarbonate in the body, which can lead to heart problems—including cardiac arrest (heart attack) or death by sudden cardiac arrest.
Fresenius medical staff determined that the risk of cardiac arrest in patients with high levels of bicarbonate in their blood was six times higher than in patients with normal levels. The FDA issued an alert in May 2012 concerning this risk, and dialysis centers across the country are now checking patients' bicarbonate levels and adjusting their dosages as necessary.
If you or a loved one suffered serious heart problems within 48 hours of dialysis treatment, you may need the help of a dialysis heart attack lawyer. Call us at (800) 852-6299 or fill out our free initial consultation form.
Never stop kidney dialysis treatment without first consulting your doctor. GranuFlo® is a registered trademark of Fresenius Medical Care North America and is used here only for the purpose of identifying the product in question.
This law firm is not associated with, sponsored by, or affiliated with the New York Times, the U.S. Food and Drug Administration, or Fresenius Medical Care.
If you or a loved one suffered serious heart problems within 48 hours of dialysis treatment, you may need the help of a Birmingham dialysis heart attack lawyer at Cory Watson Crowder & DeGaris are ready to fight for you. Pick up the phone and call us at (800) 852-6299 or fill out our free initial consultation form.
As a leading national injury law firm, we serve clients throughout the country as well as locally, including Birmingham and Blount, Jefferson, Shelby, Tuscaloosa, and Walker counties. It takes just minutes to fill out the brief form and the initial conversation is free.