More consumers are filing GranuFlo lawsuits in courts throughout the country that allege  Fresenius Medical Care neglected to warn dialysis patients about dangerous risks associated with its GranuFlo and NaturaLyte dialysis drugs. Both products were recalled last year, after they were linked to dangerously high bicarbonate levels that can lead to serious heart side effects in some dialysis patients.

During a conference call held in April to discuss first-quarter earnings, Fresenius executives acknowledged the company had been named in a number of personal injury lawsuits related to the GranuFlo recall, but declined to discuss what those lawsuits might ultimately cost the company. They also declined to provide more detail on the pending Fresenius lawsuits when asked, other than stating the company intends to vigorously defend itself.

GranuFlo Recall Details

In March 2012, Fresenius issued an Urgent Product Notification to the thousands of clinics using GranuFlo and NaturaLyte, warning that use of the drugs had been associated with elevated bicarbonate levels, and advising physicians to adjust dosage accordingly. Elevated bicarbonate levels can lead to catastrophic heart side effects in dialysis patients, including sudden cardiac death, heart attacks and strokes. Shortly thereafter, the U.S. Food & Drug Administration (FDA) granted the notification Class I status, its most urgent safety recall. Products listed under Class I have the potential to cause serious health risks or even death.

Plaintiffs in Fresenius lawsuits allege the company was aware of the serious risks associated with GranuFlo and NaturaLyte, but neglected to provide adequate warnings in order to protect sales of the drugs. Last year, the FDA was leaked an internal memo circulated to Fresenius dialysis clinics that concluded that patients administered GranuFlo were six times more likely to die as a result of cardiopulmonary arrest. Among other things, the memo revealed 941 patients at Fresenius clinics died from cardiac arrest in 2010 that was likely caused by elevated bicarbonate levels.

Fresenius Lawsuits Consolidated in Massachusetts Federal Court

In March, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all federal Fresenius lawsuits stemming from the GranuFlo recall transferred to U.S. District Court, District of Massachusetts for pretrial proceedings. According to the Panel’s March 29th Transfer Order, the consolidated litigation consisted of 11 federal claims filed since the GranuFlo recall. However, dozens of potential tag-along GranuFlo lawsuits were also pending in a number of additional federal districts, the Panel said.

Dialysis patients who experienced serious heart problems within 48 hours of a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation. For more information about the GranuFlo recall, please call 1-877-779-1414 for a free Fresenius lawsuit consultation today.

Published May 9, 2013 by