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. It is contended in these lawsuits that the company knew the instructions for using GranuFlo, its dry acid concentrate, 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 increase the risk of patient death.
It appears that 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. But Fresenius did not make patients aware of this risk. Neither did the company inform doctors or other clinics who purchase and use GranuFlo of the risk. Fresenius also failed to inform the Food and Drug Administration of these serious adverse events even though it’s required to do so by law.
It wasn’t until a person 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. Currently, 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 (MDL) 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.
Lawyers in our Mass Torts Section are investigating and evaluating potential claims involving GranuFlo. If you need more information on this subject contact Frank Woodson, a lawyer in the Mass Torts Section, at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.
Source: Alabama Journal of Medical Sciences
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