As a Dallas, Texas medical doctor and Fresenius GranuFlo and Naturalyte recall and catastrophic injury attorney I am providing this timely update for folks who have been injured by Fresenius GranuFlo and Naturalyte dialysate solutions.
As the number of product liability lawsuits increase significantly against Fresenius Medical Care over the use of GranuFlo and Naturalyte dialysate solutions, a motion has been filed to consolidate the federal litigation for coordinated pretrial proceedings. This is known as Multi District Litigation or MDL and this consolidation is very common in complex drug and medical device lawsuit claims where there is similarity of the claims and injuries.
The consolidation motion was filed with the U.S. Judicial Panel on Multidistrict Litigation on December 12, requesting that all Naturalyte and GranuFlo lawsuits filed in U.S. District Courts to be consolidated in the District of Massachusetts as part of an MDL.
GranuFlo and Naturalyte Deadly Side Effects
The plaintiffs allege that cardiac arrest is caused by side effects of GranuFlo or Naturalyte, two acid concentrate products sold by Fresenius that have been commonly used during dialysis treatments at clinics throughout the United States in recent years. GranuFlo can cause a rapid and unsafe elevation of bicarbonate, which creates an increased risk of cardiopulmonary arrest and death.
NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate, both of which are manufactured by Fresenius for use as part of the dialysate solution during hemodialysis.
The Fresenius products contain sodium acetate that can convert to bicarbonate at a higher levels, requiring close monitoring of dialysis patient’s bicarbonate buffer prescriptions to reduce the risk of cardiovascular problems. In other words too much alkali in the blood can lead to cardiac arrest and death during dialysis.
According to some experts, Fresenius knew or should have known about the risk of problems from GranuFlo dialysis treatments, but they failed to provide adequate warnings or instructions with their acid concentrate products.
Who is Fresenius?
Fresenius Medical Care is the largest provider of dialysis services and products in the world, owning thousands of clinics throughout the United States and manufacturing many of the products used at other clinics, including machines, dialyzers, blood lines, needles and dialysis concentrates.
Fresenius “Smoking Gun” Memo
According to the lawsuits, Fresenius issued a detailed internal memo in November 2011, warning about the risk of dialysis with Granuflo and NaturaLyte. The company advised their physicians about the importance of monitoring pre-dialysis bicarbonate levels and adjusting dialysate to avoid the risk of cardiopulmonary arrest and death during dialysis. The company revealed that an internal review of patients treated at 667 Fresenius clinics found at least 941 occasions where individuals suffered cardiac arrest during dialysis treatments in 2010.
Fresenius provided information about the risks associated with GranuFlo and NaturaLyte to their own clinics in November 2011, but they did not send the same warnings to other clinics that purchase the dialysis products until after an FDA inquiry in March 2012. The company then sent a warning to other dialysis centers, which the FDA has classified as a Fresenius NaturaLyte and Granuflo recall. In May 2012, the FDA warned the medical community about the risks of improper dosing with GranuFlo and NaturaLyte during hemodialysis treatments.