Lawsuits Against Fresenius Dialysis Drugs. Lawsuits filed over Fresenius’ GranuFlo and NaturaLyte dialysis drugs are not barred by a 2012 warning posted by the U.S. Food and Drug Administration (FDA), attorneys representing plaintiffs argued. According to Law360, Fresenius cited the notice as a reason for its efforts to prevent hundreds of lawsuits from being consolidated into a multidistrict litigation in the U.S. District Court for the District of Massachusetts. The company said the notice, posted on May 25, 2012, was posted beyond the three-year statute of limitations. However, plaintiffs countered there is no proof patients or physicians knew about the notification.
Dialysis is a treatment used in patients who have kidney failure; it filters wastes from the blood. In doing so, the balance of acid and base must be maintained at the appropriate level. Serious health problems can arise from fluctuations in blood pH. Lawsuits allege Fresenius knew GranuFlo and NaturaLyte could cause alkalosis (too little acid in the blood) which could cause the heart to stop beating.
FDA Safety Communication
“Defendants pin their hopes to a single FDA safety communication published on a website and directed to health care professionals, claiming this is sufficient to put all potential plaintiffs on notice of possible claims,” plaintiffs stated in a dismissal motion, according to Law360. “Defendants have not identified any media coverage of the FDA safety communication or the information contained therein. The ‘notice’ here defendants cite is virtually no notice at all.”
The court was told that the notice would have to have been sent to health care providers or patients in order for Fresenius’ argument to be valid. Furthermore, physicians would have to have specified which drugs to use instead of prescribing drug components. “It is more likely that, as is the typical case, the treating physician simply prescribed a level of various components, e.g. potassium, bicarbonate, etc.,” the opposition said, according to Law360. “The staff of the dialysis clinic then carries out the prescription by entering the values into the dialysis machine. Most nephrologists have no idea what brand of dialysate or acid concentrate is being used to treat their patients.”