Fresenius Dialysis Lawsuits Over Granuflo, NaturaLyte Top 2,000 in MDL

Fresenius Medical Care continues to face a growing number of product liability lawsuits throughout the country, which all involve similar claims that the company failed to warn doctors and patients about the risk that its dialysis solutions GranuFlo and NaturaLyte could cause sudden cardiac arrest during treatment. 

According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on September 15, there are now at least 2,089 complaints pending in the federal court system, which have been centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts as part of an MDL, or Multidistrict Litigation.

All of the Fresenius dialysis lawsuits involve injuries or deaths suffered during treatments involving the use of GranuFlo or NaturaLyte, alleging that insufficient warnings and instructions were provided about the importance of doctors monitoring bicarbonate levels.

The dialysis solutions convert to bicarbonate at higher levels than doctors were aware, leading to hundreds of sudden cardiac arrests, heart attacks and deaths that occurred during or shortly after treatments at Fresenius clinics and other dialysis centers throughout the U.S.

Fresenius Granuflo and NaturaLyte Problems

Fresenius Medical Care not only manufactures Granuflo, NaturaLyte and other dialysis products, but the company also owns and operates many of the dialysis treatment centers throughout the United States.

Concerns about the link between NaturaLyte, Granuflo and heart problems surfaced in early 2012, after an internal Fresenius memo was leaked to the FDA, where the company identified at least 941 instances where patients suffered sudden cardiac arrest during dialysis treatment in 2010.

Fresenius issued warnings to doctors at their own clinics in November 2011, indicating that doctors should closely monitor bicarbonate levels during treatments. However, they failed to provide the same information to other clinics that used their products. In addition, lawsuits allege that the manufacturer knew or should have known about the risk of problems long before the internal memo was issued.

In March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA classified as a GranuFlo and NaturaLyte recall.

Since that time, a growing number of complaints have been filed by individuals and families throughout the U.S., alleging that Fresenius withheld critical information from the medical community.

Dialysis Injury Lawsuits and Trials

The Fresenius dialysis litigation is centralized in the federal court system before Judge Woodlock to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and courts.

As part of the coordinated pretrial proceedings, a small group of lawsuits are being prepared for early trial dates, known as “bellwether” cases, since they are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

The parties met during a status conference (PDF) on September 19, when both the plaintiffs’ executive committee and attorneys representing Fresenius each submitted a list of 10 potential bellwether cases.

Judge Woodlock has scheduled the first GranuFlo lawsuit to go to trial on January 11, 2016, with a second bellwether trial set to begin on February 16, 2016.

Following these early trial dates in the MDL, if Fresenius fails to reach settlements to resolve the Granuflo lawsuits, Judge Woodlock may begin remanding hundreds of cases back to U.S. District Courts nationwide for individual trials.