Numerous lawsuits alleging personal injury and wrongful death have been filed against a major dialysis drug manufacturer regarding an increased risk of heart problems after receiving GranuFlo and NaturaLyte dialysis treatments. An Urgent Product Notification was sent out in March, 2012, by Fresenius Medical Care, the manufacturer of the dialysis drug, that reportedly discussed both NaturaLyte and GranuFlo. The notification was noticed by the U.S. Food and Drug Administration, which issued a Class 1 recall of GranuFlo several months later. Class 1 recalls are only issued when a significant risk of death or serious injury is posed by a medical product.
A Fresenius internal memo warned doctors about the drug’s risks and stated, “In light of these troubling findings, this issue needs to be addressed urgently.” The company did not, however, immediately warn external centers that use GranuFlo and did so only after a copy was anonymously sent to the F.D.A. who, in turn, questioned them about it.
Problems that may have resulted from the medications GranuFlo and NaturaLite include cardiac arrest and heart attacks. Allegedly, the increased risk of cardiac arrest and heart attacks is linked to elevated levels of bicarbonate. According to the FDA, increased levels of sodium bicarbonate “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.”
Court documents state that an order of the U.S. Judicial Panel on Multidistrict Litigation established GranuFlo lawsuit litigation on March 29. Allegations listed in these cases state that Fresenius Medical Care had knowledge of the heart risks associated with GranuFlo and NaturaLyte, but failed to adequately warn doctors and patients of the full scope of these risks. In one of the 161 cases already pending in Massachusetts, the plaintiff suffered a heart attack while driving and was involved in a fatal collision shortly after dialysis treatment.
Fresenius Medical Care is based in Germany and, in addition to being the leading supplier of dialysis products and machines, treats over one third of Americans receiving dialysis treatment.
If you or a loved one were a dialysis patient who suffered a heart injury that can be tied to GranuFlo and NaturaLyte within 48 hours of treatment, you may be able to receive compensation for medical expenses, lost wages, and pain and suffering by filing a personal injury or product liability lawsuit.