GRANUFLO

GranuFlo
Naturalyte

Sodium diacetate

Hemodialysis

Sudden cardiac arrest
Cardiopulmonary arrest
Cardiac arrhythmia
Cardiovascular death

Fresenius is the largest dialysis services and products company in the United States, operating approximately 1,800 dialysis clinics domestically and shipping their products to facilities nationwide. Since 2003, Fresenius has manufactured two products, GranuFlo and NaturaLyte, used in the treatment of acute and chronic renal failure during hemodialysis. Both products have been linked to causing metabolic alkalosis due to an excess of alkaline bicarbonate or acid deficiency. The resultant electrolyte imbalance leads to an increased risk of cardiovascular death and injury.

A Fresenius internal memo acknowledged the increased risk of injury and death from cardiac events following exposure to GranuFlo and Naturalyte, yet the company did not alert the FDA. The memo was anonymously leaked to the FDA, which then issued a Class 1 recall of Granuflo in March 2012. The FDA later issued safety communications to healthcare providers and dialysis clinics warning them of the higher risk of injury and death Fresenius’ products may cause in hemodialysis patients. Fresenius responded by announcing in June 2012 that it would place updated labels on its Granuflo and Naturalyte products. The products are still being used in clinics across the country.

In March 2013, a multi-district litigation (MDL) was formed for federally filed cases in the District of Massachusetts. Trials in the MDL are tentatively set to begin in early 2016, and Missouri state court cases begin fall 2015.