Fresenius Granuflo, NaturaLyte Dialysate Lawsuits Centralized in MDL

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has decided to consolidate all Fresenius Granuflo and NaturaLyte lawsuits filed throughout the federal court system before one judge for coordinated pretrial proceedings, as part of an MDL or multidistrict litigation.

According to a Transfer Order (PDF) issued on March 29, all product liability lawsuit filed over heart attacks or sudden deaths allegedly caused by the use of GranuFlo or NaturaLyte dialysate products during hemodialysis will be transferred to U.S. District Judge Douglas P. Woodlock in Massachusetts.

At least 119 complaints have been filed in 16 different U.S. District Courts throughout the country, all involving similar allegations that plaintiffs had their hearts suddenly stop during or shortly after dialysis treatment involving the use of Granuflo Acid Concentrate or NaturaLyte Liquid Acid Concentrate manufactured and sold by Fresenius Medical Care.

The lawsuits allege that Fresenius failed to adequately research the side effects of their dialysate products or warn about the potential risk of heart problems from Granuflo or NaturaLyte, including the importance of monitoring bicarbonate levels of patients receiving the products to avoid sudden cardiac arrest and death.

Centralizing the Fresenius litigation before one judge is designed to reduce duplicative discovery in a large number of cases, eliminate conflicting rulings from different judges and to serve the convenience of the parties, witnesses, and the courts.

Following discovery and any “test” trials in the MDL, if a settlement is not reached to resolve the Fresenius dialysate cases, the lawsuits may be remanded back to the U.S. District Court where they were originally filed.

Fresenius Failure to Warn Litigation

NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate.  Both products contain sodium acetate that converts to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in the complaints.

Fresenius Medical Care not only manufactures these dialysis solutions and other products used at clinics throughout the United States, but they also own and operate thousands of dialysis clinics throughout the United States.

Plaintiffs allege that Fresenius knew or should have known about the risk of problems during dialysis treatment involving Granuflo and NaturaLyte, but withheld that information from doctors at clinics nationwide who were using the products, exposing patients to a substantial risk of serious and life-threatening injury.

According to an internal memo sent to their own clinics in November 2011, Fresenius conducted a review of patients treated at 667 of their own clinics in 2010 and found at least 941 instances where individuals suffered cardiac arrest during dialysis treatment.  The memo warned physicians at Fresenius clinics about the importance of monitoring bicarbonate levels, but the company failed to provide this information to other clinics that used Granuflo and NaturaLyte.

After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.