Fresenius Medical Care Announces Update on Dialysate Concentrate Product


WALTHMAN, Mass.—Fresenius Medical Care AG & Co. announced that on Wednesday, December 12,  a group of plaintiffs' counsel filed a petition to form a federal multidistrict litigation in the United States District Court for the District of Massachusetts and thereby consolidate wrongful death lawsuits against the company's North American subsidiary Fresenius Medical Care Holdings, Inc. and subsidiaries (FMCNA).

The complaints to be consolidated allege generally that inadequate labeling and warnings for FMCNA's dialysate concentrate products NaturaLyte and GranuFlo caused harm to patients. The company believes that these lawsuits are without merit, and intends to defend them vigorously.

“We have commented many times on our pride in our global team’s commitment to quality. One has to understand the nature of the medical status that influences the acid/base balance in dialysis patients. The company’s actions related to these products were appropriate and responsible. Both products are safe and effective and were reviewed and cleared by the Food and Drug Administration several years ago. I am confident of our position on this medical issue,”
Ben Lipps, chief executive officer of Fresenius Medical Care said.

On December 7  FMCNA received a subpoena from the United States Attorney for the District of Massachusetts requesting production of a range of documents relating to products manufactured by FMCNA. FMCNA intends to cooperate fully in this matter.

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