Kidney dialysis is intended to save lives — not endanger them. Yet the health of thousands of U.S. dialysis patients was needlessly compromised by Fresenius Medical Care, the world’s largest provider of dialysis treatment, equipment and support services. The German company sold Naturalyte Liquid Acid Concentrate and Naturalyte Granuflo Acid from 2004 until 2012, even though it knew the products had life-threatening side effects. Dialysis patients injured by Fresenius’ negligence are suing the company for compensation.
In March 2012, the U.S. Food and Drug Administration (FDA) issued an urgent recall of Naturalyte and Granuflo, linking them to sudden, dangerous and sometimes fatal heart problems. The compounds, which neutralized acid build up in the blood during dialysis, caused dangerously high levels of bicarbonate resulting in:
Sudden cardiac death
Cardiac arrhythmia (irregular heartbeat)
Although Fresenius had evidence of serious problems with Granuflo as early as 2004, the company did not issue a warning until November 2011 — and then only to its own clinics. The notification advised Fresenius Medical Care physicians to “adjust the Granuflo dosage” because 941 patients had experienced sudden cardiac arrest. When the memo was leaked to the FDA in March 2012, Fresenius finally alerted physicians outside their network. As a result of the delay, thousands more patients, including many in Georgia, received the hazardous products.
The year of the recall, Fresenius posted assets of $35.5 billion. Lawsuits against the company seek to recoup medical costs, loss of wages or future earning capacity, funeral expenses and more.