Fresenius Medical Care, the world’s largest provider of dialysis products and services, says it believes wrongful death lawsuits waged against the company are without merit and it intends to defend them vigorously. A group of plaintiffs last month filed a petition to form a federal multidistrict litigation (MDL) and consolidate lawsuits against the company alleging that inadequate labeling and warnings for Fresenius dialysate concentrate products NaturaLyte and GranuFlo caused harm to patients.
“We have commented many times on our pride in our global team’s commitment to quality. One has to understand that nature of the medical status that influences the acid/base balance in dialysis patients,” said Ben Lipps, chief executive officer of Fresenius Medical Care in a statement. “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.”
Plaintiffs accuse Fresenius of not providing adequate dosing instructions for its products used during dialysis. The products contain an ingredient that converts to bicarbonate during treatment. GranuFlo and NaturaLyte contain more of this ingredient than competitor products.
Fresenius notified doctors in its dialysis facilities last March that they may not be taking this difference into consideration when prescribing dosing of the products to patients. High levels of bicarbonate have been tied to cardiac problems, including sudden cardiac death.
Fresenius has been subpoenaed by the U.S. Attorney for the District of Massachusetts requesting it produce a range of documents relating to products the company produces.
Source: Renal Business