Fresenius Settles Dialysis Drug Litigation for $250 Million
Fresenius Medical Care, a German medical company, has entered into a settlement agreement to resolve a landslide of cases brought against it involving its GranuFlo and NaturaLyte products used in dialysis treatments. Both of these products are dialysates and were used in thousands of dialysis clinics across the United States to treat patients experiencing kidney disease and kidney failures. Roughly one in every 500 Americans suffers from some illness that affects the kidneys and must undergo dialysis on a regular basis. Dialysis is a process that cleanses blood and eliminates toxins and wastes before returning it into the patient’s blood.
GranuFlo is a powder concentrate, and NaturaLyte is a liquid version of the same substance. The chemicals are used in dialysis machines to help neutralize the increased production of acid that can occur during the dialysis process.
In 2012, the U.S. Food and Drug Administration issued a Class I recall of both products after determining that the products posed severe threats to patients. Class I recalls are the most serious level of recall that the FDA can initiate and are appropriate when the product in question poses a substantial risk to patients, including the possibility of death.