Lawsuits Allege Fresenius Knew of GranuFlo Health Risks

Lawsuits Allege Fresenius Knew of GranuFlo Health Risks

By Anne Bucher

Fresenius Medical Care is one of top suppliers of dialysis equipment around the world. Fresenius operates more than 2,000 dialysis facilities in North America. In fact, more than one-third of Americans suffering from kidney disease receive dialysis at a Fresenius facility. Fresenius also produces dialysis products that are used in other medical centers.

GranuFlo is the most widely-prescribed dry acid dialysis product today. It is marketed as a convenient alternative to liquid dialysis products because it is more concentrated. The higher concentration of product can save a dialysis treatment center valuable storage space.

Plaintiffs in GranuFlo and NaturaLyte lawsuits allege that Fresenius was aware of potentially fatal health risks associated with their products, but failed to disclose these risks to the U.S. Food & Drug Administration (FDA) or other health care providers that used Fresenius dialysis products. Fresenius has insisted that its products are not unreasonably dangerous. The company insists that proper training was offered to dialysis providers who use GranuFlo and NaturaLyte.

Internal Memo Warned of Dosage Risks

In an internal memo that was circulated within the company in 2011, Fresenius informed its doctors that GranuFlo and NaturaLyte can lead to alkalosis if improper doses were administered. Alkalosis is a condition that is associated with an increased risk of cardiac arrest or sudden cardiac death. According to this internal memo, more than 900 dialysis patients suffered cardiac arrest in a Fresenius clinic in 2010. Other centers did not learn about the dosage issue until the FDA began questioning the company’s safety practices.

On March 29, 2012, the FDA launched a Class I recall of both NaturaLyte and GranuFlo. Class I recalls are only issued for products that pose a threat of serious and potentially life-threatening health consequences.

GranuFlo and NaturaLyte Lawsuits Consolidated in Massachusetts

A large number of GranuFlo and NaturaLyte lawsuits that are pending in federal courts throughout the United States will be consolidated before a federal judge in Massachusetts. These cases were eligible for consolidation because the plaintiffs alleged that the drugs caused them to suffer severe side effects, including heart attacks and arrhythmia, while they received dialysis treatment. Cases that are consolidated into multidistrict litigation (MDL) are not the same as a class action lawsuit. In a class action lawsuit, the plaintiffs are treated as one class and any monetary awards will be shared among the plaintiffs. Within an MDL, only the pretrial processes are shared among the plaintiffs.

Get Legal Help

If you or someone you love has experienced serious GranuFlo or NaturaLyte side effects, contact a lawyer immediately. You may be eligible to receive compensation for your injuries. By filing a GranuFlo or NaturaLyte lawsuit, you can help to hold Fresenius accountable for their failure to warn others about the dangers of their dialysis products.

To learn more about filing a GranuFlo or NaturaLyte lawsuit, visit the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation page. If you submit information about your injuries, a GranuFlo lawyer will conduct a free case evaluation and let you know if you qualify to file a NaturaLyte or GranuFlo lawsuit.