Kidney patients who have been injured in a hemodialysis procedure using GranuFlo may be eligible for a GranuFlo lawsuit.
GranuFlo is a powder-based acid concentrate made by Fresenius Medical Care. It is used during hemodialysis to reduce acid buildup in blood. Recent reports have linked the use of GranuFlo to serious GranuFlo side effects, including heart arrhythmia and cardiopulmonary arrest.
Fresenius Aware of GranuFlo Side Effects
Fresenius Medical Care is a leading provider of dialysis centers in North America. The company also manufactures and distributes dialysis products worldwide, including GranuFlo Dry Acid Concentrate.
According to an internal company memo dated November 4, 2011, Fresenius was aware of the risk of excess bicarbonate associated with GranuFlo. A Fresemius case-control study of 941 patients who died of cardiac arrest in company run dialysis centers revealed that elevated levels of bicarbonate in the blood was a significant risk factor for cardiovascular side effects.
The memo noted that doctors were failing to adjust prescriptions of bicarbonate when using GranuFlo, which can raise levels of bicarbonate more than other similar concentrates. High levels of bicarbonate can lead to a condition called metabolic alkalosis, a pH imbalance in the body that may cause low blood pressure, low blood oxygen, heart rhythm problems, and cardiac arrest.
Patients May Recover Costs in a GranuFlo Lawsuit
Patients who suffer from these GranuFlo side effects are likely to incur substantial medical bills, and may suffer life-changing injuries that require constant medical monitoring. A GranuFlo lawsuit may help recover these expenses.
Critics accuse Fresenius of failing to adequately warn physicians of the danger associated with GranuFlo. The company’s November memo warned their own doctors about GranuFlo, but failed to alert physicians in other medical centers. It was not until the FDA asked about the memo that Fresenius sent an alert to other medical centers and nursing homes on March 29, 2012.
A GranuFlo lawyer is likely to claim that Fresenius put thousands of patients at risk in dialysis centers across the country. Before the March 29, 2012 warning, many may have been subjected to increased bicarbonate levels.
FDA Warns Doctors of Dosing Errors
The FDA issued their own warning to physicians on May 25, 2012. The agency warned of potential dosing errors that could occur when using GranuFlo, and noted that GranuFlo side effects may include metabolic alkalosis. On June 27, 2012, the FDA issued a Class I recall of GranuFlo and NaturaLyte, another dialysis product made by Fresenius.
Considering a GranuFlo Lawsuit
Patients who suffered a serious cardiovascular injury after going through dialysis with GranuFlo may be eligible for recovering damages through a GranuFlo lawsuit. A thorough review of your case with a GranuFlo lawyer may reveal claims against the manufacturer. Contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-480-1123.