GranuFlo and NaturaLyte are popular dialysis products that have been linked to an increased risk for cardiopulmonary arrest and sudden cardiac death. Fresenium Medical Care (FMC), the manufacturer of these products, knew about the dangers, yet they failed to warn the public about it until this year.
More than 50 percent of the dialysis patients in the United States are at an increased risk for cardiopulmonary arrest and sudden cardiac death.
If GranuFlo or NaturaLyte were used during your dialysis treatment, then you may be eligible for legal and financial recourse. Contact an experienced product liability attorney today to explore your legal options.
Side Effects of GranuFlo and NaturaLyte
GranuFlo and NaturaLyte are chemical products that are used in dialysis machines to help clean the blood of patients with kidney impairment. These ingredients are supposed to prevent the buildup of acids that are naturally removed from properly function kidneys.
Patients have reported the following health issues after using GranuFlo and NaturaLyte:
- Heart attack
- Cardiac arrhythmia
- Low blood pressure
- Sudden cardiac death
- Low blood pressure
- Cardiopulmonary arrest
Fresenium Medical Care Knew of Products Risks
In March 2012, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo and NaturaLyte. A Class 1 recall is the most serious type of recall and it involves situations where there is reasonable probability that the product causes adverse health consequences or death.
FMC conducted a study that evaluated the risk factors of dialysis patients who suffered cardiopulmonary arrest in FMC facilities compared to other dialysis patients in the same facilities between January 1 and December 31, 2010.
Researchers found that 941 patients at 667 FMC facilities had suffered cardiopulmonary arrests resulting in death.
Data from the study showed that these patients showed that their chances of cardiopulmonary arrest were six times higher if they had an elevated pre-dialysis bicarbonate level.
FMC was aware of the hazards associated with their dialysis products that contained sodium diacetate. The manufacturer sent a memo to the FMC's doctors and dialysis facilities that advised action for patients with an elevated pre-dialysis bicarbonate levels.
FMC only alerted the public after the internal memo was leaked to the FDA.
Contact a Defective Product Attorney
Each year, approximately 400,000 Americans receive dialysis treatments. Over 33 percent of those patients are given dialysis products GranuFlo and NaturaLyte during treatment. GranuFlo and NaturaLyte patients are at an increased risk for adverse side effects and death.
If you or a family member was given GranuFlo and NaturaLyte products during dialysis and suffered cardiac arrest, you may have grounds to file a lawsuit.
The attorneys at Greg Coleman Law believe that manufacturers should be held accountable for the harm that their products cause.
Our attorneys and staff have the knowledge and resources to handle GranuFlo and NaturaLyte lawsuits. We offer free case evaluations to injured individuals. After hearing about the details of your injury, our attorneys will advise you on the best course action to purse.
To schedule a no obligation legal consultation, fill out the Free Case Review form on this page.