A class action lawsuit has been filed against GranuFlo producer Fresenius USA Inc. in California state court, claiming that the company knowingly concealed the health risks of its dialysis drug GranuFlo Dry Acid Concentrate. The plaintiff class, which is comprised of patients who received the drug during dialysis treatment since 2000, alleges that Fresenius USA continued to promote GranuFlo despite knowledge that it “can cause an increased risk of death and serious injuries, including sudden cardiac death, cardiopulmonary arrest, heart attack, heart failure, cardiac arrhythmias, and stroke.”
The plaintiffs are bringing claims for violations of California’s false advertising and unfair competition laws, and seek an undisclosed amount of damages. Specifically, the complaint alleges that “despite knowing the serious risk factors associated with GranuFlo, and in efforts to increase sales of GranuFlo, Defendants [including Fresenius USA] embarked on a comprehensive and carefully-orchestrated scheme to promote the safety, and effectiveness of GranuFlo through a fraudulent and deceptive marketing program to Plaintiffs, class members, their respective physicians, and the public.”
FDA Recall and Investigation
This action, and other lawsuits against dialysis giant Fresenius Medical Care, the parent company of Fresenius USA, come on the heels of the June 2012 FDA Class 1 Recall of GranuFlo. In addition to manufacturing dialysis products, such as GranuFlo, Fresenius Medical Care also owns over 3,100 dialysis clinics worldwide and is the world’s leading provider of dialysis machines, according to the complaint. In March 2012, the FDA received a leaked internal memo addressed to Fresenius-owned clinics about the danger GranuFlo presented to patient heart health. The FDA is now investigating whether Fresenius’ breach violated federal regulations by failing to inform patients and doctors of these dangers.
Injured by GranuFlo?
Our GranuFlo lawyers represent people nationwide who suffered injuries or lost a loved one following treatment with GranuFlo. If you believe GranuFlo caused or contributed to the development of heart problems in you or a loved one, including a sudden heart attack or cardiac arrest, cardiopulmonary arrest, stroke, or arrhythmia, you may want to speak to a GranuFlo lawyer. Free and confidential consultations with our GranuFlo attorneys are available by filling out the form to your right or calling toll-free: (866) 981-4800.