FDA Investigates Whether Dialysis Provider Failed to Warn Patients About Lethal Products

The U.S. Food and Drug Administration is investigating Fresenius Medical Center, the nation’s largest operator of dialysis centers, for potentially violating Federal Regulations by failing to inform its customers of a lethal risk of GranuFlo (powder) and Naturalyte (liquid) Acid Concentrate.

These Fresenius products have been causing dialysis patients to experience high bicarbonate levels in the bloodstream, which leads to a sharp increase in the risk of cardiac arrest.

In November 2011, Fresenius sent an internal memo that warned doctors in their own clinics about this risk. On March 29, 2012, the FDA sent an Urgent Product Notification to all the clinics using Fresenius’ products.They then issued a Class I recall of these products manufactured by Fresenius Medical Care North America between January 2008 and June 2012.

The attorneys at Eisenberg, Rothweiler, Winkler, Eisenberg & Jeck, PC have significant experience in handling the drug liability cases for clients throughout Pennsylvania, New Jersey, and nationwide. We are committed to protecting our clients’ rights and making drugs safer for the general public.

If you have a potential Fresenius, GranuFlo, or Naturalyte Acid Concentrate lawsuit, the Philadelphia law firm of Eisenberg, Rothweiler, Winkler, Eisenberg, & Jeck, PC can evaluate your claim. Contact us at info@erlegal.com or toll free at 877-638-0114 today.