FDA Warning Insufficient to Stop Fresenius Dialysis Lawsuits, Court Hears

In the U.S. District Court for the District of Massachusetts, attorneys representing plaintiffs argued that a 2012 U.S. Food and Drug Administration (FDA) warning did not bar lawsuits filed over Fresenius’ GranuFlo and NaturaLyte dialysis drugs. Plaintiffs in the litigation asserted there was no proof that patients or physicians were aware of the warning, making it an insufficient reason to prevent lawsuits from proceeding.

The FDA posted a notice regarding Fresenius’ GranuFlo and NaturaLyte on May 25, 2012. In attempting to block hundreds of lawsuits from joining a multidistrict litigation, Fresenius argued that the notice was posted beyond the three-year statute of limitations. However, plaintiffs’ attorneys told the court that this argument is invalid because there is no proof physicians or their patients knew about the notification. The warning was simply posted on the FDA website and not sent to doctors or their patients.

“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.”

Plaintiffs told the court 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.”

Dialysis is used to filter a patient’s blood when their kidneys have failed. The treatment removes wastes and must maintain the appropriate pH balance; eliminating too much acid or leaving too much in the blood can lead to serious problems. According to the lawsuits, Fresenius knew its drugs could cause alkalosis (too little acid in the blood) which could cause the heart to stop beating.