New Fresenius Recall Issued in Midst of GranuFlo/NaturaLyte Litigation

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Fresenius Medical Care is the world’s leading producer of dialysis supplies. The company produces dialysis machines and accessories, such as concentrates used to create dialysis fluid. Additionally, Fresenius operates its own “in-house” dialysis centers throughout the United States. However, in recent years, the company has been dogged by several recalls.

The latest recall was issued by the U.S. Food & Drug Administration (FDA) on Jan. 6, 2014. The recall was a class II recall, a classification used by the FDA for products that could have health consequences, but a relatively remote chance of serious complications. This recall was over an issue with saline bags that comprised part of the unit. The recall is intended as a precautionary measure; no serious injuries have been reported from this issue.

This recall follows a much more serious class I recall from June 2012. As a class I recall, this reflected concerns that the products in question could cause serious injury or death. Specifically, two similar Fresenius products, GranuFlo and NaturaLyte, were recalled due to concerns that they could alter blood chemistry and in turn cause cardiac arrest. Class I recalls are the most serious category of recall issued by the FDA.

Allegedly, GranuFlo and NaturaLyte could raise blood pH. These two products are used to create dialysis solutions, liquids used in dialysis machines to draw biological waste products out of blood through osmosis. However, evidence has emerged that these preparations can increase bicarbonate levels in the blood, which leads to increased pH levels, a condition called alkalosis. The reactions that run the human body depend on having a stable chemical environment, and increasing pH can disrupt many critical biological processes. Alkalosis can disrupt the electrical activity in the heart, causing cardiac arrest.

GranuFlo and NaturaLyte have allegedly been linked to hundreds of deaths. Legal action has ensued in the form of multidistrict litigation. Multidistrict litigation is a form of group lawsuit, similar to class action lawsuits. These lawsuits allege that Fresenius was aware of the risk of cardiac arrest and death associated with their dialysis products, and initially concealed these risks from the public.

The cases within the multidistrict litigation cite an internal Fresenius memo dated to November 2011, which acknowledges the risk of increased blood pH and cardiac arrest. The memo was only distributed to Fresenius-affiliated dialysis centers, even though many other companies use Fresenius products. This memo was leaked to the FDA which set off a chain of events leading to the recall—and legal action.

The GranuFlo/NaturaLyte multidistrict litigation is In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, MDL No. 2428, in the U.S. District Court for the District of Massachusetts.

Legal Help for Fresenius Recall Victims

If you or a loved one suffered a heart attack, cardiac arrest, stroke, metabolic alkalosis or other injury after undergoing kidney dialysis with GranuFlo and/or NaturaLyte, you may be eligible to take legal action against the manufacturer of the dialysis drugs. Filing a lawsuit may be the only way you’ll be able to obtain compensation for medical bills, pain and suffering and other damages. Learn more and obtain a free case evaluation at the GranuFlo/NaturaLyte Recall Class Action Lawsuit Investigation.