Fresenius Medical Care, the world’s largest dialysis services provider in the world and manufacturer of peritoneal and hemodialysis machines and equipment, expects sales to reach $14 billion for 2012.
While Fresenius is enjoying huge profits, the company is also working to dodge criticism and lawsuits from family members of patients who they allege suffered heart attacks and strokes from some of the company’s products. The lawsuits claim that Fresenius’s GranuFlo and NaturaLyte, dry acid products used during dialysis, were not properly labeled to inform doctors that the product contained more of a key ingredient than competitor products. This ingredient converts in the body to bicarbonate, an alkaline substance that neutralizes the acid in the blood.
An overdose of bicarbonate can cause cardiac arrest. In fact, studies have found that patients with elevated bicarbonate levels are six times more likely to have a heart attack or other cardiac event than patients with normal levels of bicarbonate.
Fresenius discovered this problem and apparently planned to handle the issue quietly. The company issued a letter to doctors that worked in its clinics, but purposefully did not warn patients. Nor did the company alert the Food and Drug Administration (FDA), which it is required to do by law.
Fresenius finally did warn patients of the dangers associated with its products but only after the FDA was anonymously notified of the problem. The company ultimately recalled GranuFlo and NaturaLyte to update the products’ labels.