GranuFlo and NaturaLyte Use Identification Process Outlined By Judge

The federal judge presiding over all Granuflo and NaturaLyte dialysis lawsuits pending against Fresenius Medical Care has approved a process that allows plaintiffs to obtain identification of the acid concentrate used during their treatment.

In April 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated proceedings in the federal court system for all product liability lawsuits involving Fresenius dialysis treatments, which plaintiffs allege that the side effects of Granuflo and NaturaLyte solutions caused dialysis patients to suffer a sudden cardiac arrest, heart attack or death.

There are currently more than 500 cases centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, as part of an MDL, or Multidistrict Litigation. The consolidated pretrial proceedings are designed to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As part of the coordinated management of the cases, Judge Woodlock issued an Order (PDF) earlier this month, which allows plaintiffs to seek confirmation about whether Granuflo or NaturaLyte were used during their last hemodialysis treatment at a Fresenius clinic prior to their injury or death.

Granuflo and NaturaLyte are dry acid and liquid acid concentrates, respectively, which were used by Fresenius at their dialysis treatment clinics throughout the United States. The product identification process was established to facilitate the discovery of which solution was used during a specific patient’s treatment, as such information is often not included in medical records.

According to the process approved by Judge Woodlock on March 5, plaintiffs may issue a request for the release of information from a Fresenius “Data Warehouse.” Within 14 days after the first Friday following the receipt of the request, Fresenius has been ordered to identify the last “acetate value” or “concentrate identifier” for the patient prior to the injury or death. The order only applies to cases where the last treatment was provided at a Fresenius Medical Care dialysis clinic.

Fresenius Dialysis Cardiac Arrest and Heart Attack Concerns

Use of Granuflo and NaturaLyte have been linked to a potential increased risk of sudden cardiac arrest or death, which may occur during or shortly after dialysis treatment. The lawsuits allege that the solutions convert to bicarbonate at higher levels than doctors were aware, which requires much closer monitoring of levels during treatment to avoid the risk of injury or death.

Fresenius Medical Care not only manufactures the solutions, but also owns and operates many of the dialysis treatment centers in 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 a memo 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 an 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.