Fresenius Medical Care, the world’s largest provider of dialysis services and products, is facing hundreds of lawsuits alleging that one of the company’s products caused sudden cardiac deaths in patients. Plaintiffs say that the company knew the instructions for using its dry acid concentrate GranuFlo were confusing and could cause life threatening toxicity to patients, but withheld this information from its customers and drug regulators.

GranuFlo is a product used to help balance chemicals in the blood during dialysis treatment. It contains an ingredient that metabolizes in the body as bicarbonate. GranuFlo has more of this ingredient in it than competitor products. Studies have shown that elevated bicarbonate levels in dialysis patients increases the risk of patient death.

A top executive of Fresenius was the first to suspect that the instructions for the company’s GranuFlo could be misunderstood. This led to an internal review during which it was discovered that 941 patients in 667 Fresenius dialysis clinics died from cardiovascular-related incidents between Jan. 1, 2010 and Dec. 31, 2010.

Fresenius sent a memo to doctors at its clinics warning them that the instructions for GranuFlo could be confusing and to consider this when prescribing the product to patients. Fresenius did not make patients aware of this risk, nor did the company inform doctors or other clinics who purchase and use GranuFlo. Fresenius also did not inform the Food and Drug Administration (FDA) of these serious adverse events, as it is required to do by law.

It wasn’t until someone anonymously sent a copy of the internal memo to the FDA three months later that federal drug regulators began to investigate the matter. Fresenius was required to notify patients and recall its products in order to update its labels.

There are more than 5,700 dialysis centers and about 400,000 dialysis patients in the United States. An estimated 3,300 clinics use GranuFlo formulations and approximately 260,000 patients are using the product. About half of these patients are using GranuFlo in non-Fresenius clinics.

Late last year, a group of plaintiffs filed a petition to form a federal multidistrict litigation and consolidate wrongful death lawsuits against Fresenius alleging that inadequate labeling and warnings for Fresenius dialysate concentrate product GranuFlo and its similar product NaturaLyte caused harm to patients.

Sources:
Nephrology News & Issues
Nephrology News
Renal Web



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