Fresenius Medical Care, the world’s largest provider of dialysis products and services, faces a false advertising lawsuit alleging improper instructions on its dialysis concentrates GranuFlo and NaturaLyte caused serious adverse events including heart attack, stroke and death. The lawsuit claims that Fresenius knowingly concealed the serious health risks associated with the products.
Plaintiffs allege Fresenius continued to market and profit from sales of GranuFlo and NaturaLyte even after it learned that the product had been associated with heart problems including cardiac arrhythmia and sudden cardiac arrest.
Fresenius also faces hundreds of wrongful death and personal injury lawsuits stemming from improper use of GranuFlo and NaturaLyte.
“Despite knowing the serious risk factors associated with GranuFlo, and in efforts to increase sales of [the product], defendants 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,” the complaint reads.
In November 2011, Fresenius issued an internal memo to doctors at Fresenius-owned clinics warning that dosing instructions could be confusing, which may have led to deaths due to bicarbonate toxicity. The company failed to warn doctors at non-Fresenius-owned clinics or patients who were being administered the drug. Only after the Food and Drug Administration (FDA) received an anonymous copy of the internal memo 16 months later did Fresenius issue a recall of the products.
The false advertising lawsuit was filed in the Superior Court of California, County of Los Angeles.