According to a report in the New York Times, GranuFlo® and NaturaLyte® contain more acetate, and therefore add more bicarbonate, than other competing products. Failing to take this into account can lead to alkalosis.
(PRWEB) November 06, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, is continuing to investigate potential lawsuits on behalf of patients who allege injuries from Fresenius’ GranuFlo® or NaturaLyte® dialysis products. Fresenius Medical Care came under scrutiny over the acid concentrates when a report in the New York Times found that the company had failed to warn the public about serious, sometimes fatal events associated with the products.
Dialysis is a process used to filter toxins from the blood in patients who have lost kidney function. Bicarbonate, which is an alkaline substance, is used to counteract the acidity that builds up in the blood. GranuFlo® and NaturaLyte® both contain acetate, which gets converted into bicarbonate through the liver. According to a report in the New York Times, GranuFlo® and NaturaLyte® contain more acetate, and therefore add more bicarbonate, than other competing products. Failing to take this into account can lead to alkalosis.
Fresenius stated in an internal memo dated November 4, 2011 that alkalosis “is a significant risk factor associated with cardiopulmonary arrest in the dialysis unit”. According to the memo, 941 hemodialysis patients in Fresenius facilities had suffered from cardiac arrest in 2010. Although Fresenius warned its own employees about this, the information was never made available to the public until prompted by the FDA, the New York Times reported. Fresenius did not issue an Urgent Product Notification until late March. This notification, however, failed to mention the 941 patients who suffered from cardiac arrest along with other details specified in the internal memo.
The FDA issued a Class I recall on GranuFlo® and NaturaLyte® in June. A Class I recall is the agency’s most serious recall status; the designation means that exposure to the product presents a reasonable risk of serious injury or death. In recalling GranuFlo® and NaturaLyte®, the agency stated that the high levels of bicarbonate “may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest.” According to the FDA’s Safety Communication, “This product may cause serious adverse health consequences, including death.”
Parker Waichman LLP offers free lawsuit consultations to victims of Fresenius GranuFlo and NaturaLyte side effects. If you or a loved one experienced sudden cardiac arrest or sudden heart attack following dialysis with GranuFlo or NaturaLyte, please visit the firm's GranuFlo and NaturaLyte injury page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Fresenius GranuFlo and NaturaLyte lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney