Granuflo Dialysate Lawsuits Set for Trial Against Fresenius in 2016

The U.S. District judge presiding over all federal Granuflo lawsuits pending against Fresenius Medical Care indicates that the first bellwether cases will be ready for trial to begin in early 2016.

Fresenius Medical Care currently faces more than 1,800 product liability lawsuits involving problems with their Granuflo and NaturaLyte dialysate solutions, which are pendings as part of a federal multidistrict litigation (MDL) before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts.

All of the complaints involve similar claims that dialysis patients suffered sudden cardiac arrest or death following treatments involving Granuflo or NaturaLyte acid concentrates, alleging that Fresenius failed to provide adequate warnings about the importance of doctors monitoring bicarbonate levels during hemodialysis.

The cases are centralized 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.

In a case management order (PDF) on June 6, Judge Woodlock indicated that the first Granuflo dialysate lawsuit will be scheduled for trial on January 11, 2016, with a second bellwether trial set to begin on February 16, 2016.

Fresenius Granuflo Litigation

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.

In November 2011, Fresenius conducted an internal review of the use of the acid concentrates at their own clinics, identifying at least 941 instances where patients suffered sudden cardiac arrest during dialysis treatment in 2010.

While the company issued the memo only to doctors at their own clinics, warning about the importance of monitoring bicarbonate levels during treatments, they failed to provide the same information other clinics that used the products.

After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers on March 29 of that year, which the FDA determined constituted a GranuFlo and NaturaLyte recall.

According to allegations raised in lawsuits filed on behalf of former patients who have suffered injury or died, Fresenius knew or should have known about the risk of heart problems during dialysis treatment and withheld critical information from the medical community.

Following the bellwether trials, if Fresenius fails to reach settlements to resolve the Granuflo dialysate lawsuits, the company may face hundreds of individual trials throughout the country.