Fresenius Medical Care’s Granuflo and NaturaLyte dialysis lawsuits in the federal multidistrict litigation (MDL), are beginning to make progress. Recently in April, the U.S. Judicial Panel on Multidistrict Litigation ordered that all Fresenius dialysis lawsuits will be consolidated for coordinated management, as part of an MDL.
Approximately 188 complaints filed in the federal court system have been transferred to U.S. District Judge Woodlock in the District of Massachusetts.
Plaintiff Fresenius Allegations
The injured plaintiffs claim that Fresenius Medical Care failed to adequately warn about the potential side effects of Granuflo and Naturalyte dialysate solutions, which have been during hemodialysis.
The plaintiffs have filed a lawsuit involving cardiac arrest, heart attack or sudden death was allegedly caused by Granuflo or NaturaLyte. Complaints allege that Fresenius failed to adequately warn doctors about the importance of monitoring bicarbonate levels while these products were used.
Fresenius GranuFlo and NaturaLyte Dialysis Side Effects
Fresenius Medical Care is one of the largest providers of dialysis treatment in the United States. The company also manufactures and sells many of the products used during dialysis treatments at other clinics, including solutions known as Granuflo and NaturaLyte.
NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate. Both products contain sodium acetate, converts to bicarbonate at a higher-than-expected levels.
“Smoking Gun” Internal Memo
Fresenius sent an internal memo to doctors at their own clinics in November 2011, that identified at least 941 events where individuals suffered sudden cardiac arrest during dialysis treatments. The company failed to provide this warning to federal safety regulators or to other dialysis clinics that were using Granuflo or NaturaLyte.
The internal memo was leaked to the FDA in March 2012, and only then did Fresenius provide a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.
Granuflo and NaturaLyte Litigation
According to experts, the number of lawsuits against Fresenius is expected to continue to grow, and some estimates indicate that thousands of complaints will be filed throughout the country.
What is Fresenius MDL?
The centralized proceedings in the federal court system are set up to reduce discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties.
Following the coordinated pretrial proceedings and early “bellwether” trials, if a Fresenius dialysis injury settlement is not reached to resolve the cases, individual lawsuits will be remanded back to the U.S. District Courts where they were originally filed for separate trial dates.