The FDA issued a Class I recall on dialysis concentrates GranuFlo and Naturalyte after it was found that the products could put patients at risk for cardiac arrest when not prescribed appropriately.   It is alleged that the manufacturer, Fresenius Medical Care, failed to adequately warn doctors that the products contain – when compared to similar products – more of an ingredient which the body converts to bicarbonate, an overdose of which has been linked to heart attacks and other serious cardiovascular problems.

The FDA is investigating whether Fresenius violated federal regulations in failing to inform patients and doctors of a potential lethal risk connected to its products.  An internal memo Fresenius sent to doctors working in its own dialysis centers in November of 2011 warned that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. However, Fresenius failed to warn other dialysis centers using its products of the same risk until March 29, 2012 after the FDA received an anonymous copy of the internal memorandum and questioned the company about it.  Only then did the company issue an Urgent Product Notification to warn of the risks associated with us of the products. It is likely that this failure to warn led to numerous additional preventable injuries and deaths.

Please contact the lawyers at Thornton Law Firm LLP today by telling us your story here, or by calling our toll free number: 1-888-341-1405. We can get you the help you deserve.

The risks associated with the use of GranuFlo and NaturaLyte include:

  • Sudden cardiac arrest
  • Sudden heart attack
  • Hemodialysis cardiac arrest
  • Hemodialysis cardiopulmonary arrest
  • Stroke
  • Death
  • Arrhythmia
  • Altered mental status (confusion)
  • Low blood pressure

Most patients receiving dialysis have the expectation that the products being used during dialysis are safe and, therefore, are generally unaware of the specific names of the products used during their treatment, such as GranuFlo and NaturaLyte. In addition, because many of the facilities use local names it is possible that dialysis patients do not know if they are receiving dialysis at a Fresenius Medical Care affiliated facility.

Fresenius Medical Care is based in Massachusetts and is the largest operator of hemodialysis clinics in the U.S. as well as the leading supplier of dialysis machines and disposable products and supplies.  GranuFlo and NaturaLyte are used at Fresenius’ own clinics, as well as other hemodialysis centers that purchase their dialysis supplies.

Thornton Law Firm in investigating on behalf of our clients to determine if their injury is related to the products GranuFlo and NaturaLyte of a Fresenius Medical Care affiliated facility.

If you or a loved one suffered cardiac arrest or any other cardiac injury while undergoing dialysis, GranuFlo and NaturaLyte products might be to blame.  For a free evaluation of your case, please contact the lawyers at Thornton Law Firm LLP today by telling us your story here, or by calling our toll free number: 1-888-341-1405.