Case Info
GranuFlo and NaturaLyte’s Dangerous Side Effects
GranuFlo and NaturaLyte are acid concentrates used in dialysis treatments, manufactured by German company Fresenius Medical Care, the world’s largest provider of kidney dialysis equipment and services.
Several patients who used GranuFlo and NaturaLyte alleged it caused severe injuries including:
- Cardiac arrhythmia (irregular heartbeat)
- High levels of carbon dioxide in the blood
- Low oxygen in the blood
- Low potassium
- Metabolic alkalosis
- Sudden cardiac arrest or other adverse cardiopulmonary events
The use of these products been linked to an up to six-fold increase in the risk of cardiopulmonary arrest and sudden cardiac death. Fresenius Medical Care’s alleged failure to provide safe and reliable products may have put more than half of all dialysis patients in the U.S. at risk, potentially resulting in hundreds of deaths.
Leaked Fresenius Medical Care Memo
In 2012, an internal memo from Fresenius Medical Care was leaked to the FDA. In the memo, Fresenius acknowledged it was aware of at least 900 cases where patients experienced life-threatening cardiac events during treatment with GranuFlo or NaturaLyte.
As a result of the leaked memo, on March 29, 2012, the FDA issued a Class 1 recall of GranuFlo and NaturaLyte. The FDA identified the use of either product could lead to high bicarbonate levels resulting in metabolic alkalosis—a significant risk associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia, which may culminate in cardiopulmonary arrest and death.
Lawsuits Against Fresenius Medical Care
Thousands of patients and their loved ones filed lawsuits against Fresenius Medical Care over injuries or deaths that may be linked to use of GranuFlo and NaturaLyte in hemodialysis.
In 2016, Fresenius Medical Care agreed to settle approximately 4,000 GranuFlo and NaturaLyte lawsuits for $250 million.
Individual dialysis centers have also faced lawsuits for deaths caused by Fresenius Medical Care’s GranuFlo. The U.S. District Court for the District of Colorado awarded families of three deceased DaVita Kidney Care patients between $1.5 and $5 million and awarded $125 million to each family in punitive damages.