More GranuFlo Lawsuits Filed against Fresenius

Charleston, WVFive more GranuFlo lawsuits have been filed against Fresenius Medical Care, alleging patients were harmed by either GranuFlo- or NaturaLyte-related alkali dosing errors. Of the five lawsuits, linked to the NaturaLyte and GranuFlo Class I recall in 2012, four involve patients who died following dialysis.

The West Virginia Record (11/21/13) reports that the five lawsuits will likely be transferred to federal court for multidistrict litigation. The lawsuits involved in the MDL allege GranuFlo and NaturaLyte caused heart attacks and strokes in patients who were given the chemicals as part of their dialysis. Both GranuFlo and NaturaLyte were subject of a Class I recall in March 2012, during which time the US Food and Drug Administration (FDA) noted that there was a risk of inappropriate prescription of the products.

“This product may cause serious adverse health consequences, including death,” the FDA warned.

As of court documents filed at the beginning of 2013, attorneys said they had heard from thousands of patients across the US, concerned that they or their loved ones had been harmed by the use of NaturaLyte and GranuFlo.

“All of the claims seek damages based on allegations arising from the exact same misconduct; i.e., allegations of the Defendants’ intentional, reckless and/or negligent conduct related to the design, testing, manufacturing, marketing, advertising, promoting, labeling, selling and/or distribution of GranuFlo and NaturaLyte,” the documents, which were filed as a motion to transfer and coordinate the lawsuits, stated.

Meanwhile, court documents filed in June 2013 note that more than 300 lawsuits had been filed to that point against Fresenius entities.

“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 Natrualyte Liquid Acid Concentrate (‘GranuFlo’),” the documents state. The lawsuits seek damages for wrongful death and personal injury and allege Fresenius knew or should have known about the increased risk of cardiopulmonary arrest linked to the use of NaturaLyte and GranuFlo. That information, the lawsuits claim, was obtained by Fresenius during a study in 2010, in which one-third of 941 patients treated with GranuFlo suffered cardiopulmonary arrest.

The multidistrict litigation is MDL 2428: In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, before Judge Douglas P. Woodlock.