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Shezad Malik MD JD
Shezad Malik MD JD
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Granuflo and Naturalyte Dialysate Lawsuit Update

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Granuflo and Naturalyte Dialysate Lawsuits are progressing slowly in the consolidated federal court action, centered in Massachusetts.

The federal court is overseeing the multidistrict litigation that has been established for claims that dialysis patients suffered sudden heart problems from Granuflo or Naturalyte.

More than 300 Lawsuits in Federal MDL

More than 312 Granuflo and Naturalyte Dialysate product liability lawsuits are filed against Fresenius Medical Care and are consolidated for pretrial proceedings before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts.

Granuflo and Naturalyte Dialysate Injury Claims

According to lawsuits, patients suffered heart attacks, cardiac arrest or sudden death during or shortly after hemodialysis where Granuflo or Naturalyte dialysate products were used. Plaintiffs claim that Fresenius failed to warn about the risk of side effects with these products or the importance of doctors monitoring bicarbonate levels during treatment.

GranuFlo and NaturaLyte Side Effects

The Naturalyte and Granuflo litigation is in early stages, with no trials or settlements on the horizon. Discovery and exchange of important legal documents is just beginning to take place.

Who is Fresenius?

Fresenius Medical Care is the largest provider of dialysis services in the U.S., the corporation owes thousands of dialysis clinics and is involved in the manufacturer of dialysis products and equipment.

What is Naturalye and Granuflo?

NaturaLyte is a liquid acid concentrate and GranuFlo is a powder acid concentrate, which is used during hemodialysis treatments at Fresenius clinics.  Both products contain sodium acetate that converts to bicarbonate at higher-than-expected levels according to experts and Fresenius own internal documents.

Plaintiffs and their families allege that Fresenius company withheld information from patients and the dotors about the risk of problems during dialysis treatment involving Granuflo and NaturaLyte, failing to warn about the importance of monitoring bicarbonate levels. If a patient got too much bicarbonate, that would affect the acid base balance in the blood, which could lead to sudden catastrophic cardiac events including death.

Fresenius Internal Memos

In November 2011, Fresenius held an internal review involving the use of Granuflo and NaturaLyte at their own clinics, and identified at least 941 cases where patients suffered cardiac arrest during dialysis treatments in 2010.

At the heart of the complaints, allegedly the company issued a memo to doctors in their own clinics in late 2011, but they failed to provide the same information or warnings to other clinics that used Granuflo and NaturaLyte.

The internal memo was leaked to the FDA in March 2012, only then Fresenius provided a warning letter to all healthcare providers, which the FDA has deemed as a NaturaLyte and Granuflo recall.

Massachusetts State Court Action

Fresenius is exposed to 300 cases that are centralized in Massachusetts state court, where the litigation has been assigned to Judge Maynard M. Kirpalani for pretrial purposes.