Another wrongful death lawsuit has been filed against Fresenius Medical Care, the world’s largest provider of dialysis products and services. The lawsuit alleges that a woman died after using two products created by the company during her dialysis treatment.
Shirley Harris underwent dialysis treatment during which she received GranuFlo and NaturaLyte, two dialysate products made by Fresenius. The lawsuit alleges the products were improperly labeled, which caused her and other patients to experience significant health problems including heart attack, cardiopulmonary arrest, stroke, and/or sudden cardiac death.
The lawsuit was filed by Shirley’s husband, Phillip, who claims the company failed to adequately warn doctors and patients of the serious health risks associated with its products, and failed to properly train, instruct and monitor treating physicians, technicians and other staff.
GranuFlo and NaturaLyte contain an ingredient that metabolizes to a substance known as bicarbonate in the body. What the instructions failed to note was that GranuFlo and NaturaLyte contain higher levels of this ingredient than competitor products. As a result, patients were put at risk of bicarbonate toxicity, which has been associated with serious adverse health consequences including heart attacks and sudden cardiac death.
Fresenius faces hundreds of wrongful death lawsuits related to misleading prescribing information for GranuFlo and NaturaLyte. Recently, a Granuflo/NaturaLyte lawsuit was removed to federal court. The federal lawsuit alleges that Fresenius did not warn the Food and Drug Administration about the dangers associated with its dialysis products.
Source: West Virginia Record