A group of plaintiffs have filed a petition to form a federal multidistrict litigation (MDL) against Fresenius Medical Care Holdings, Inc. and its subsidiaries, for the wrongful deaths of dialysis patients who received toxic amounts of a dialysate concentrate that caused them to suffer cardiac arrest.
The MDL was filed in the United States District Court for the District of Massachusetts, and allege generally that inadequate labeling and warnings for Fresenius’ dry acid concentrates GranuFlo and NaturaLyte caused harm to patients. Fresenius contends that the lawsuits are without merit, and the company says that it will defend them vigorously.
In March, the company sent a memo to doctors in its clinics stating that one of its dry acid concentrates appeared to be contributing to a sharp increase in sudden cardiac death in patients. In fact, 941 patients in Fresenius clinics died in 2010 alone. The memo was designed to clarify dosing instructions for GranuFlo.
GranuFlo is used during dialysis treatments for various purposes. It also contains an ingredient that converts in the body to a substance known as bicarbonate. GranuFlo contains a higher percentage of this ingredient than competitor products and thus, the company deduced, doctors may not be taking this into account when prescribing the product. High levels of bicarbonate have been associated with serious cardiovascular events.
Fresenius received a subpoena from the U.S. Attorney for the District of Massachusetts requesting a range of documents relating to products manufactured by the company. Fresenius says it intends to cooperate fully with the request.
Source: Renal Business