Fresenius Facing GranuFlo Lawsuits

Boston, MAGranuFlo lawsuits filed against Fresenius Medical Care allege patients suffered severe injuries and were not warned about the risks associated with GranuFlo. Although many lawsuits involve concerns about GranuFlo, Fresenius has also faced a lawsuit concerning procedures at one of its medical centers.

According to court documents related to the lawsuits, a judicial panel has transferred pending cases concerning Granuflo and Naturalyte Dialysate products to US District Court Massachusetts under MDL 2428. Those lawsuits allege personal injuries and wrongful death linked to the use of the dialysis products.

“The plaintiffs in these cases are dialysis patients or their survivors alleged to have suffered cardiopulmonary arrest and other injuries resulting from dialysis treatment with Fresenius’ dialysate products Naturalyte GranuFlo Acid Concentrate and Naturalyte Liquid Acid Concentrate (‘GranuFlo’),” lawyers for the plaintiffs wrote. The plaintiffs allege that the use of GranuFlo causes a rapid increase in bicarbonate levels, which could increase the risk of cardiopulmonary arrest by six to eight times.

Plaintiffs further allege that Fresenius either knew or should have known about the increased risks associated with the products, due to a case-control study conducted by Fresnius. That study reportedly found that around 940 patients who were treated with GranuFlo suffered cardiopulmonary arrest and sudden cardiac death. Plaintiffs claim GranuFlo was designed, developed and marketed without adequate warnings about proper use and risks.

Fresenius is also accused of warning its own medical centers about the risks associated with GranuFlo but not warning external medical centers about those risks. The company has not admitted liability, with a spokesperson reportedly telling the New York Times (6/12) that Fresenius did not consider the findings conclusive enough to be published in a journal.

Approximately 5,500 lawsuits have now reportedly been filed.

One lawsuit filed against Fresenius resulted in a seven-figure settlement, although exact terms of the lawsuit are confidential, according to NBC (4/26/12). That lawsuit involved 65-year-old Teresa Gaytan who died after becoming unresponsive while receiving her third dialysis treatment at a Fresenius center in Chicago.

The Gaytan lawsuit did not involve allegations about bicarbonate levels. Rather, it alleged that due to a lack of proper care at the site, Teresa Gaytan suffered “substantial blood loss through a disconnected catheter line, resulting in flow of blood onto her clothing and her chair, as well as significant pooling of blood on the floor of the dialysis center.” The lawsuit alleged multiple alarms went off but were not properly responded to, patient checks were not properly conducted, an oxygen tank that could have supplied oxygen to Teresa was empty and CPR was not provided by medical center staff.

Although Fresenius settled the lawsuit, it did not admit liability.