Pharmaceutical

Complaints allege Fresenius withheld information about deaths to minimize legal risks, keep market share

Fresenius sign Complaints allege Fresenius withheld information about deaths to minimize legal risks, keep market shareFresenius Medical Care, the world’s largest provider of dialysis services and products, is facing numerous wrongful death lawsuits claiming one of its products caused the deaths of dialysis patients. The company is fighting back, claiming it was not at fault. But sources say top management at Fresenius knew its dialysate product GranuFlo was contributing to serious health problems including deaths in patients but withheld this information in order to maintain the company’s market share as well as to minimize and diffuse its legal risks.

Dialysates, such as GranuFlo, are solutions used to clean the blood during hemodialysis. GranuFlo is the only marketed product that contains the dry powder form of acetic acid, sodium diacetate. This packaging allows dialysis clinics to mix their own acid concentrates using ultrapure water and packets of dry chemicals, which cuts down on shipping costs as well as storage space typically associated with traditional 55-gallon drums. Fresenius also sells a pre-mixed acid concentrate under the name NaturaLyte.

One of the ingredients in GranuFlo metabolizes in the body into a substance known as bicarbonate. Elevated levels of bicarbonate contribute to metabolic alkalosis, which is a significant risk factor for cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.

In 2010, Fresenius sent an internal memo to doctors at its clinics stating there was a significant increased risk of cardiac arrest and death in patients during hemodialysis treatments with GranuFlo. The memo urged doctors to consider this risk when prescribing dosing for GranuFlo.

The company chose not to share this warning with other clinics, many of which buy GranuFlo and NaturaLyte from Fresenius. The company also failed to warn its customers of this grave risk. Only after a copy of this secret memo was shared with the FDA did Fresenius notify others.

Fresenius was forced to issue a recall on its GranuFlo and NaturaLyte products in order to update their safety labels, and the FDA issued a separate warning to doctors urging them to consider dosing with these products. However, this does little to reassure family members of dialysis patients who died, allegedly due to Fresenius’ negligence.

Source: Nephrology News