Hagens Berman Sobol Shapiro LLP, a law firm with extensive experience prosecuting negligence cases against the pharmaceutical industry, has filed a series of lawsuits against Fresenius Medical Care North America (FMC), a subsidiary of Fresenius Medical Care AG & Co. (NYSE: FMS), the largest hemodialysis company in the world, alleging the company failed to inform patients, the medical community or the Food and Drug Administration (FDA) of serious, life-threatening complications resulting from the use of its GranuFlo and NaturaLyte products in dialysis patients.
The plaintiffs in the suits claim that FMC’s products caused them to suffer heart attacks, strokes and brain aneurysms, risks the company was aware of far in advance of informing the FDA.
Steve W. Berman, managing partner of Hagens Berman and the attorney representing more than 30 alleged victims, expressed outrage at FMC’s behavior.
“We have an internal memo dated November 4, 2011 that shows FMC knew their products put patients at a much higher risk of catastrophic events including stroke, cardiac arrest and other life-threatening complications,” said Berman. “We intend to prove that rather than informing the FDA and seeking guidance, the company continued to aggressively market products it knew would put thousands of dialysis patients at risk.”
The memo also included instructions for FMC clinics designed to reduce the risk of life-threatening complications.
“We know that FMC thought the risks associated with its products were very serious, because it provided very clear advice to its own clinics on how to mitigate the issues,” said Mr. Berman. “In a stunning failure, however, FMC did not pass the word along to its other customers, a move that may have been good for short-term profits but risked thousands of patients’ lives.”
The FDA obtained a copy of the November 2011, internal memo and ordered a Class 1 recall, the most urgent type, of FMC’s GranuFlo product on March 29, 2012.