More than 300 wrongful death and personal injury lawsuits have been filed against Fresenius Medical Care, the world’s largest provider of dialysis products and services, alleging the company did not adequately warn patients or medical centers about the risk of sudden cardiac arrest with its dialysis products GranuFlo and NaturaLyte.
GranuFlo and NaturaLyte are used during dialysis to remove impurities from the blood. Fresenius, which makes the products, uses them in its own dialysis centers as well as distributes them to other dialysis clinics across the country.
GranuFlo uses a formulation that the plaintiffs allege causes an unsafe elevation of carbonic acid salt called bicarbonate to build up in the body. An increased level of bicarbonate in the blood increases the chances of cardiac arrest and death by six to eight times, the lawsuits state.
An internal memo issued to doctors only at Fresenius clinics noted that that GranuFlo contains a higher level of the ingredient that metabolizes in the body as bicarbonate than competitor products. This could cause dosing errors that can lead to sudden cardiac arrest in patients. In 2012, Fresenius recalled Granuflo to update the dosing instructions. The formulation, however, remained unchanged.
Patients and doctors at other facilities that use GranuFlo were not warned of the potential for dosing errors nor the cardiac arrest risk until after the Food and Drug Administration (FDA) received an anonymous copy of the internal memo Fresenius sent.
The lawsuits allege that Fresenius was obviously aware of the serious risks involving its dialysis products but failed to adequately warn patients and doctors at other dialysis clinics.
Attorneys at Beasley Allen Law Firm are currently investigating cases of injury or cardiac arrest in dialysis patients who were given GranuFlo or NaturaLyte.
Source: Wicked Local