Posted on behalf of Arnold Law Firm on March 7, 2013 in Defective Healthcare Products. Updated on February 24, 2022
The FDA has recalled popularly used dialysis products GranuFlo and NaturaLyte due to an increased risk of heart issues, specifically cardiopulmonary arrest and sudden cardiac death. The manufacturer of both these products, Fresenius Medical Care (FMC) is liable for a failure to warn doctors and patients of the risks associated with the pharmaceuticals until recently, despite documented evidence that the manufacturer was indeed aware of the risks.
If you have used either of these drugs as a part of your dialysis treatment, we urge you to speak with a lawyer as soon as you can.
To start exploring your legal options, contact our attorneys by completing our Free Case Review form on this page.
Both GranuFlo and NaturaLyte are chemicals used in dialysis equipment to help cleanse kidney patients’ blood. The formula in both products is designed for preventing dangerous acids that are usually filtered by a properly operating kidney from building up.
Patients using GranuFlo and NaturaLyte report side effects including:
GranuFlo and NaturaLyte were both recalled by the Food and Drug Administration (FDA) on March 29, 2012. The FDA issued a Class 1 recall. Class 1 recalls are the most severe sort of recall, involving scenarios in which the risk of adverse health consequences or death is substantial, as is the case with GranuFlo and NaturaLyte.
Fresenius Medical Care performed a case-control study between January 1 and December 31, 2010, evaluating the risk factors for patients on dialysis suffering from cardiopulmonary arrest in their facilities as compared to other patients in the facilities that were on dialysis.
The study revealed that 941 patients in a total of 667 FMC facilities using GranuFlo or NaturaLyte suffered from cardiopulmonary arrest and consequently died. The data from those patients established that the risk for a cardiopulmonary arrest reached up to 6 times higher in patients with elevated level of bicarbonate prior to their dialysis procedure.
An internal memo from FMC to its physicians and dialysis facilities alerted the recipients of the findings and recommended actions to take for patients presenting elevated levels of bicarbonite pre-dialysis. The company made no attempt to inform the general public or even those outside of the company. This knowledge was only made public after a copy of the memo was leaked to the FDA.
About 400,000 Americans receive dialysis treatment each year. Over 30 percent of these patients are prescribed either GranuFlo or NaturaLyte, leaving them at a six fold increased and unnecessary risk of cardiopulmonary arrest and sudden cardiac death.
At the Arnold Law Firm, we believe that manufacturers of dangerous pharmaceuticals should be held accountable for producing and marketing products that cause harm to consumers – especially when they did so while fully informed of the possible outcome. The manufacturers of GranuFlo & NaturaLyte knowingly put thousands of patients at risk.
An experienced dangerous drug attorney at our firm can help you assess the merits of your claim and take it to court, if necessary. Our staff has the skills and resources required to gather all the evidence and present the strongest case possible so that you may recover the maximum compensation allowed under the law to recover your losses.
Through our main office in Sacramento, we are here to help any California resident who believes that they may have a claim for a GranuFlo or NaturaLyte lawsuit.
For more info on your legal rights as a user of GranuFlo or NaturaLyte, or to schedule a 100% free and confidential consultation with one of our pharmaceutical litigation attorneys, simply complete the FREE form at the top of this page.