Two new lawsuits have been filed against Fresenius Medical Care North America, joining more than 300 lawsuits that allege two of the company’s dialysis products caused patients to suffer deadly heart attacks.
Fresenius, the world’s largest provider of dialysis services and products, manufactures GranuFlo and NaturaLyte, concentrates that are administered to patients prior to dialysis to balance electrolytes. The products are used both in Fresenius facilities as well as dialysis clinics owned by competitor companies.
GranuFlo and NaturaLye contain an ingredient that metabolizes into bicarbonate. However, these products contain more of the ingredient than competitor brands.
In March 2012, the products fell under the Food and Drug Administration’s most serious type of recall, known as a Class 1, in order to update dosing instructions on the products’ labels. Fresenius executives realized that the instructions could easily be confused, leading to an overdose of bicarbonate. Bicarbonate toxicity has been associated with serious health complications including heart attack and sudden cardiac arrest.
In an internal memo, Fresenius alerted doctors at Fresenius-owned clinics that it evaluated 941 patients in 667 of its clinics who suffered from cardiopulmonary arrest during or following dialysis treatment and found that patients with elevated bicarbonate levels were six to eight times more likely to suffer heart attacks and sudden cardiac death. The memo urged doctors to note that GranuFlo and NaturaLyte contain more of the bicarbonate ingredient than competitor products and that dosing instructions could have been misinterpreted, leading to elevated bicarbonate levels in dialysis patients. This memo was not shared with doctors at other clinics or patients until an anonymous copy was sent to the FDA.
As a result, Fresenius faces hundreds of lawsuits from patients and their families who allege that the dialysis giant was aware as early as 2005 of the dosing errors but failed to warn patients of this risk.
Source: Boston Business Journal