Fresenuis, a German company with offices under the name Fresenius Medical Care North America in Waltham, MA, is the largest operator of hemodialysis centers in the US, and processes more than a third of the nearly 400,000 Americans who receive dialysis treatment each year. An investigation by the Food and Drug Administration (FDA) showed that doctors were administering NaturaLyte and GranuFlo at too high a level for healthy human consumption.
Both NaturaLyte and GranuFlo products can produce high serum bicarbonate level in patients undergoing hemodialysis. Dosage errors 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, possibly resulting in death.
It is thought that thousands of patients may have suffered a heart attack, cardiac arrest or sudden death as a result of inappropriate prescription of NaturaLyte and GranuFlo products during dialysis at a Fresnius Medical Center.
While an MDL is often confused with a class action because they both represent large groups of plaintiffs. However, an MDL differs because each lawsuit in the litigation remains an individual claim. Recently Fresenius settled a wrongful death case for seven figures to the surviving children of Teresa Gayton, a mother of five who died during a dialysis treatment at a Fresenius Medical Care facility in Illinois. She was taken off life support and died on March 10, 2009. According to the lawsuit, Teresa Gaytan "sustained massive blood loss as a result of hemorrhage from the dialysis circuit during dialysis treatment at the center".