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By: Irvin Jackson | Published: January 31st, 2013
A product liability lawsuit has been filed against Fresenius Medical Care, alleging that a Louisiana man suffered a stroke and heart attack following hemodialysis treatment where the company’s Granuflo or NaturaLyte solutions were used.
The complaint (PDF) was filed by Ronnie Glasper in the U.S. District Court for the Eastern District of Louisiana on January 25, alleging that he received the recalled hemodialysis solutions while undergoing treatment at a Fresenius clinic in Ferriday, Louisiana.
According to allegations raised in the hemodialysis lawsuit, Fresenius Medical Care knew or should have known about the potential risk of cardiac arrest and heart attack associated with the use of Granuflo since at least 2004, when a retrospective study found that the solution may result in an increase in metabolic alkalosis, which can increase the risk of sudden heart problems.
Problems with NaturaLyte and Granuflo Following Hemodialysis Treatment
GranuFlo is a dry acid concentrate and NaturaLyte is a liquid acid concentrate. The products have been commonly used during hemodialysis treatment at clinics throughout the United States in recent years.
Hemodialysis is a method of treating acute and chronic kidney disease, replacing the normal functions of the kidney by filtering waste and removing extra fluids and electrolytes from the body. During treatment, individuals are connected to a hemodialysis machine, which removes blood from the body.
The use of NaturaLyte and Granuflo during hemodialysis has been found to increase bicarbonate levels at a much higher rate than many doctors typically expect from treatment. Glasper alleges that Fresenius failed to adequately warn about the potential side effects of Granuflo and NaturaLyte, which could lead to death, cardiac arrest, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmias, heart attack, stroke and hypotension.
A growing number of similar product liability lawsuits have been filed against Fresenius over the problems with Granuflo and NaturaLyte hemodialysis solutions.
NaturaLyte and Granuflo Hemodialysis Lawsuits
Fresenius is the largest provider of dialysis services and products in the world, owning thousands of dialysis clinics and manufacturing many of the products used during treatment at clinics owned by other companies, including machines, dialyzers, blood lines, needles and dialysis concentrates.
Although it appears that information was available to suggest hemodialysis patients may be exposed to an increased risk of severe and life-threatening problems shortly after Granuflo and NaturaLyte were introduced, Fresenius did not provide warnings about the importance of doctors monitoring patient bicarbonate levels until November 2011. Even at that time, the company only issued an internal memo to medical providers at their own clinics warning about the risk of patients suffering sudden cardiac arrest during hemodialysis. However, they failed to provide the same information to other clinics that used NaturaLyte and Granuflo.
After the internal memo was leaked to the FDA, the company finally issued a global warning to the medical community in March 2012, which has since been categorized as a Class I recall for Granuflo and Naturalyte.
In December 2012, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate and centralize all Fresenius hemodialysis cases involving Granuflo or NaturaLyte before one judge for coordinated pretrial proceedings. At that time, there were at least 37 hemodialysis lawsuits pending in U.S. District Courts throughout the country against Fresenius, but it is expected that the number of cases will eventually grow into the thousands as additional people learn about the issues and contact product liability lawyers investigating the claims.