It has been several months since a Food and Drug Administration recall was ordered on Fresenius Medical Care’s GranuFlo® or NaturaLyte® dialysis products but some victims of the failed treatments are still seeking justice.
The FDA ordered a Class I recall, its most serious, on the Fresenius dialysis products in June 2012. The recall was announced a considerable amount of time after it was learned that more than 900 patients who attended the company’s dialysis clinics nationwide in 2010 had suffered a cardiac arrest after receiving a treatment using the recalled products. The New York Times reported that the defective Fresenius dialysis products contained too much acetate – much more than competitive products – and that led to high levels of bicarbonate that contributed to the cardiac arrests.
The Class I recall status indicates that use of a drug or medical device included in it will likely result in serious injuries or death to patients. The recall on Fresenius Medical Care’s GranuFlo® or NaturaLyte® dialysis products was necessary when it was determined they had dangerously high levels of bicarbonate and that “may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest,” according to the recall notice.
The national law firm of Parker Waichman LLP is continuing to offer legal assistance to people who may have suffered adverse health reactions, including cardiac arrest, after they received one of these defective dialysis treatments.
The victims of these defective products likely could have avoided injuries had they been aware when Fresenius was aware that the dialysis treatments were causing widespread cardiac arrests at the company’s clinics.
Internal documents at Fresenius – dated Nov. 4, 2011 – show that the company had been aware of at least 941 patients receiving dialysis treatments with these products had suffered a cardiac arrest since 2010. In a press release from Parker Waichman LLP,, the internal documents state, “941 hemodialysis patients in Fresenius facilities had suffered from cardiac arrest in 2010.”
The company only warned its employees and executives of this development, failing to warn the public and federal regulators, as is required by law for any company responsible for a product that knowingly endangers people’s lives. Even though the company’s documents show that it was well aware of the problems linked to the GranuFlo® or NaturaLyte® dialysis products in November 2011, including the 941 cardiac arrests suffered by past recipients of these products, the Urgent Product Notification that Fresenius filed with the FDA a full five months later, in March 2012, made no mention of that serious and potentially life-threatening side effect.
