February 18, 2016 —Fresenius Medical Care has reached at $250 million settlement to resolve about 4,300 lawsuits involving heart attacks that occurred in patients who were given GranuFlo or NaturaLyte during dialysis.
According to a securities filing, 97% of plaintiffs must agree to the settlement by July 2016 to receive funding by August. The lawsuits are currently centralized in a federal Multi-District Litigation (MDL No. 2428) in Massachusetts.
GranuFlo and NaturaLyte are dialysates — liquid chemicals that balance blood-acidity for patients undergoing dialysis (mechanical cleaning of the blood). They were recalled in March 2012 to revise the instructions for use.
The problem was that unlike other dialysates, GranuFlo and NaturaLyte contained a chemical that was metabolized into bicarbonate by the liver. Because bicarbonate is also added during dialysis, doctors must adjust the dose of GranuFlo and NaturaLyte to prevent bicarbonate overdoses.
Unfortunately, the dose was often measured incorrectly and patients developed metabolic alkalosis, a condition that can cause low blood pressure, electrolyte imbalances, irregular heart rhythm, cardiopulmonary arrest, heart attack, and death.
An internal company memo (PDF) from November 2011 revealed that 900 patients experienced heart attacks at Fresenius clinical in the previous year. Fresenius concluded that patients with high bicarbonate levels were 6-times more likely to experience cardiac arrest than patients with normal bicarbonate levels.
The memo linked GranuFlo and NaturaLyte to elevated bicarbonate levels and heart attacks, but Fresenius did not warn the FDA or other dialysis clinics until after an anonymous source sent the memo to the FDA.
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