GranuFlo lawsuits continue to rise amid the news that the manufacturer, Fresenius, did not inform the U.S. Food and Drug Administration (FDA) and the general public of serious health risks associated with its use. GranuFlo use has been shown to increase a kidney dialysis patient’s risk of cardiac death by six times. The issue in the GranuFlo lawsuits is when Fresenius knew that it was unsafe. Studies to monitor the safety of GranuFlo were performed by both Fresenius and the FDA and initially the drug was approved. However, after receiving an anonymous tip about a Fresenius internal memo, the FDA issued a Class 1 recall of the drug in March 2012. The internal memo, dated November 4, 2011, alerted Fresenius clinics about a study which examined the high risk of cardiac arrest in patients taking GranuFlo. The study found that 941 patients had died from cardiopulmonary arrest and although these deaths had been observed as early as 2010, Fresenius did not conclude the study until November 2011. Attorneys for the plaintiffs argue that the two page memo was filled with scientifically vague terms and failed to adequately warn of risks to patients. The memo did not convey the seriousness with which the problem needed to be addressed and subsequently put hundreds of thousands of dialysis patients at risk. And, while the memo was sent to doctors at their Fresenius Medical Care clinics, no warning was issued to doctors outside the network or to the general public.
Risks of Taking GranuFlo
During dialysis, a build-up of acid in the blood called lactic acidosis, takes place. This build-up can cause nausea, vomiting, lethargy, anxiety and other health problems. An acid neutralizer, such as GranuFlo is taken by most dialysis patients to relieve this problem. Use of GranuFlo has been shown to increase bicarbonate levels in patients. Elevated bicarbonate levels have been linked with a six-fold increased risk of heart problems, including cardiac arrest and cardiopulmonary death. Even after a patient has stopped taking the drug, the elevated bicarbonate levels may continue, putting them at a higher risk of health problems including, heart disease, stroke and low blood pressure. There are currently over 400,000 patients on kidney dialysis and many of these have taken GranuFlo. If a patient has taken GranuFlo, they are urged to talk to their doctor about monitoring for any of these potential health problems.
GranuFlo Lawsuit Attorneys
If you or someone you love has been injured by Fresenius Medical Care’s GranuFlo or NaturaLyte dialysis products, please contact one of our skilled national GranuFlo lawsuit lawyers today to protect your rights. To learn more about your rights and legal options, call the Phillips Law Firm today. Our experienced GranuFlo lawsuit lawyers have represented families across the country in their quest for justice. You may be entitled to compensation for your injuries. For a free consultation visit the Phillips Law Firm websitehttp://www.justiceforyou.com or call 1-800-708-6000.