Fresenius Medical Care, the manufacturer of these pharmaceutical products has stated publicly that it stands by its products even as more lawsuits are being filed against the company by patients and families of those who have suffered cardiac problems after using GranuFlo or NaturaLyte. These two products are dry and liquid acid products used in dialysis procedures. The Food and Drug Administration (FDA) announced a Class I voluntary recall of these drugs in March of 2012. Class I recalls are applicable to drugs that pose an immediate health risk such as death.
A Multi-Prong Legal Attack
Lawsuits have been filed against the manufacturer in many states including Alabama, California, Georgia, Ohio, Nevada, and Texas. In December of 2012, two plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation seeking the establishment of a MDL in the district of Massachusetts to consolidate all the lawsuits over GranuFlo and NaturaLyte.
The two products are used to prevent acid buildup in the blood of patients whose kidneys can no longer perform this function. When used during dialysis these help clear the blood. Both products contain sodium acetate which is converted into bicarbonate in the body. High levels of bicarbonate can result in side effects like low blood pressure, heart attack, arrhythmias, and even cause death.
The lawsuits have been filed alleging that Fresenius was aware of these consequences of its products much before the FDA recall. The basis for this allegation is a leaked internal memo from the company issued in November of 2011, which warns its network of dialysis providers about the possible risks associated with GranuFlo and NaturaLyte. The memo also states that about 940 patients had died of cardiac arrest at Fresenius clinics since 2010 after being administered these products. Remember, if you or a family member or loved one has been injured by GranuFlo or NaturaLyte please contact Advocates for Justice for a free consultation.