A leaked memo from Fresenius Medical Care has revealed details that make it clear the company knew of the dangers associated with its GranuFlo and NaturaLyte products months before it issued its GranuFlo recall in March 2012. The memo, which was sent to Fresenius-owned dialysis clinics, detailed the serious heart risks associates with the two products. However, the memo was never sent to the thousands of dialysis centers outside of the Fresenius network that the company supplied with GranuFlo and NaturaLyte.

A number of GranuFlo heart attack lawsuits have since been filed in the wake of the March 2012 recall. The existence of the Fresenius memo, which was issued in November 2011, would seem to lend credence to plaintiffs’ claims that the company knowingly concealed information about the dangers GranuFlo and NaturaLyte posed to the heart. All of the GranuFlo lawsuits allege use of the two products caused dialysis patients to suffer potentially deadly heart side effects, including:

  • Low blood pressure
  • Hypokalemia (lower-than-normal amount of potassium in the blood)
  • Hypoxemia (low blood oxygen)
  • Hypercapnia (high concentration of carbon dioxide in the blood)
  • Cardiac arrhythmia (abnormal heart rhythm)
  • Cardiopulmonary arrest/cardiac arrest
  • Heart attack
  • Stroke
  • Sudden cardiac death

GranuFlo and NaturaLyte are acid concentrates used during dialysis to remove toxins from the blood. The drugs are formulated differently than rival products in that they contain sodium diacetate, rather than acetic acid. As such, they have the potential to raise bicarbonate levels more than other dialysis concentrates. Excessive levels of bicarbonate can lead to a condition known as metabolic alkalosis, which has been linked to catastrophic heart side effects, including cardiac arrest and sudden cardiac death, in dialysis patients. Apparently, most doctors were not aware of this crucial difference, and were not accounting for the potential for a higher bicarbonate contribution when prescribing the dosage of GranuFlo and NaturaLyte.

According to the November 2011 Fresenius memo, more than 940 people at its dialysis clinics had died from sudden cardiac arrest in 2010. The patients had been treated with either GranuFlo or NaturaLyte, and all had elevated bicarbonate levels in their blood. A study conducted by the company’s medical staff concluded that high bicarbonate levels were associated with as much as a 6-fold increase in the risk of cardiac arrest. The memo advised doctors at Fresenius clinics to adjust dosage of the drugs to avoid this danger.

Doctors practicing at clinics outside of the Fresenius network received no such warning in November 2011. In fact, it wasn’t until March 2012 that the company finally issued an Urgent Product Notification to the thousands of facilities it supplied with GranuFlo and NaturaLyte detailing the potentially life-threatening heart side effects associated with the products. According to a New York Times report published over the summer, Fresenius issued the notification only after a copy of the November 2011 memo was leaked to the U.S. Food & Drug Administration (FDA), and the agency began asking questions.

The FDA has since declared Fresenius’ March notification a Class I GranuFlo recall, which means the products pose a significant risk of serious injury, and even death. According to the New York Times, the agency has also opened an investigation to see if Fresenius broke any laws when it failed to warn its customer clinics of GranuFlo and NaturaLyte dangers in November 2011.

Published December 11, 2012 by