September 27, 2012 – This month, a Georgia man filed a wrongful death lawsuit against Fresenius Medical Care (FMC) on behalf of his mother, who died following dialysis treatment with the company’s GranuFlo and NaturaLyte acid concentrates. The complaint alleges that the death was caused by the side effects of FMC’s dialysis treatments, and that the company was negligent in failing to warn both the public as well as the medical communities about the risk of cardiac arrest associated with its products. The new lawsuit is the latest to join a growing number of similar claims filed in courthouses around the country on behalf of individuals allegedly injured by GranuFlo and NaturaLyte side effects.
July 2013 – Attorney Michael Schmidt Elected to Plaintiffs’ Steering Committee For Granuflo and Naturalyte For Injury Claims Nationwide
GranuFlo / NaturaLyte Lawsuit Update 3/12/13: At least four separate GranuFlo and NaturaLyte class action lawsuits have been filed against DaVita Healthcare, alleging that the company should have known about the dialysis products’ potential to cause severe, potentially life-threatening side effects. The complaints seek class action status to include all patients who underwent hemodialysis treatment with GranuFlo or NaturaLyte at a DaVita clinic. Click here to learn more.
Free GranuFlo / NaturaLyte Lawsuit Evaluation: If you or a loved one has been injured by NaturaLyte or GranuFlo dialysis treatments, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Fresenius Medical Care and we can help.
What’s the problem?
The lawsuit, which was filed on September 14 by Waddell Bishop in the U.S. District Court for the Southern District, seeks wrongful death benefits against FMC and its various subsidiaries for the death of his mother, Frances Carol Bishop. Miss Bishop suffered a cardiovascular event and died in September 2010 after dialysis treatment that allegedly included the use of GranuFlo or NaturaLyte.
NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate, both of which are used as fundamental components of the dialysate solution during hemodialysis treatment procedures. According to complaints, both GranuFlo and NaturaLyte contain sodium acetate that converts to bicarbonate at higher-than-expected levels for most prescribing physicians, which requires close monitoring to reduce the risk of significant cardiovascular events.
According to Bishop’s complaint, “Fresenius is responsible for ensuring (through adequate training, instructions, monitoring and hiring principles) that it’s clinicians, nurses, contractors, employees and physicians know how to properly use all hemodialysis products in a manner that is safe and effective for the recipients.” However, when NaturaLyte and GranuFlo were used during his mother’s dialysis treatment, Bishop says that no adequate warnings were provided with the products regarding the importance of patient monitoring.
More than a year after the death of Frances Bishop, FMC circulated an internal memo regarding the risk of serious side effects associated with NaturaLyte and GranuFlo. The memo instructed physicians in their own clinics about the importance of monitoring pre-dialysis bicarbonate levels, and to adjust dialysate prescriptions to avoid the risk of cardiac arrest and death during dialysis treatment procedures. At the time the memo was circulated, FMC indicated that at least 941 patients treated at its own clinics had suffered cardiac arrests during dialysis treatments in 2010 alone.
Although Fresenius was clearly aware of its products’ ability to cause adverse health complications, the company chose not to share this information with other clinics that purchase GranuFlo and NaturaLyte until after a March 2012 inquiry by the U.S. Food & Drug Administration (FDA). In response to the inquiry, FMC decided to send a warning to other dialysis treatment centers, which the FDA subsequently classified as a NaturaLyte and GranuFlo recall.
Two months after the inquiry by the FDA, the administration issued a safety communication warning the medical community about the importance of proper dosing during hemodialysis procedures with GranuFlo and NaturaLyte. The communication urged prescribing doctors to consider the impact of acetate levels in the products when ordering or administering dialysis treatments.
Bishop’s wrongful death lawsuit is seeking compensatory damages, as well as punitive damages to punish FMC for its alleged reckless actions and inactions, which exposed his mother and other dialysis patients to unnecessary life-threatening risks.
Do I Have a GranuFlo / NaturaLyte Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in GranuFlo & NaturaLyte lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free GranuFlo / NaturaLyte Lawsuit Evaluation: If you or a loved one was injured by GranuFlo or NaturaLyte dialysis treatments, you should contact our law firm immediately. You may be entitled to compensation by filing a GranuFlo / NaturaLyte injury suit and we can help.