Were You Adversely Affected by GranuFlo or NaturaLyte?
Have you or a loved one recently undergone dialysis and suffered cardiac arrest? The Food and Drug Administration is currently investigating whether or not Fresenius acted in a negligent or reckless manner when the company failed to disclose the threat posed by GranuFlo and NaturaLyte, widely-available dry acid items used during the dialysis process. If you have been adversely affected by these products, then you might be entitled to legal assistance from Greenberg & Bederman.
History of GranuFlo and NaturaLyte
A brief background is in order. GranuFlo and Naturalyte were offered in Fresenius dialysis clinics and other dialysis providers across the nation, making them some of the most commonly prescribed dialysis products of their kind. However, Fresenius recently studied these items’ potential to increase the risk of a condition known as alkalosis, which involves bicarbonate in the blood increasing to potentially dangerous levels. Should this condition occur, the risk of a patient experiencing cardiac arrest increases by six to eight times.
941 patients in Fresenius clinics sustained cardiac arrest in 2010 alone, and last November, Fresenius told physicians at those medical clinics about the danger via an internal memo. This failed to curtail the danger, however, as GranuFlo and NaturaLyte have also been prescribed to 125,000 patients that were not being treated at a Fresenius facility. Neither these patients nor the public at large were informed of the threat, and it’s very likely that these dangerous substances continued to be prescribed despite Fresenius having evidence that they could lead to health complications.
The GranuFlo and NaturaLyte Recall
It wasn’t until an anonymous source leaked the internal memo to the FDA five months later that the danger was made known to the world. The New York Times recently detailed the questionable actions of Fresenius and the FDA’s ensuing investigation. The safety organization is currently looking into whether Fresenius’s actions constituted a breach in federal regulations.
In the meantime, GranuFlo and NaturaLyte have both been recalled because of the inherent threat posed to patients. The FDA has classified the action as a Class 1 recall, meaning that the usage of these products would constitute a markedly increased chance that an individual would have their health suffer or would die.
The GranuFlo and NaturaLyte Lawyers of Greenberg & Bederman Want to Hear From You
The personal injury lawyers of Greenberg & Bederman are keeping abreast of the situation and making themselves available to all persons who have been harmed by GranuFlo and NaturaLyte. If you or a loved one recently underwent dialysis and experienced an adverse health consequence such as a heart attack, arrhythmia, stroke, and more, or if you lost a loved one due to any of the above, then you might consider speaking with one of our GranuFlo or NaturaLyte attorneys.
Call today and receive a free consultation from a member of our expert legal team. We can inform you of your legal options and advise you on how best to move forward.