Fresenius Medical Care, the largest provider of dialysis services in the U.S., recently settled a wrongful death lawsuit for some seven figures, after a 65-year-old mother of five died tragically after undergoing a treatment at a Fresenius dialysis clinic near Chicago. Now the company is facing new legal woes, as a growing number of patients are filing GranuFlo heart attack lawsuits, following Fresenius Medical Care’s recent recall of its GranuFlo and NaturaLyte dialysis drugs.

In addition to using these drugs at its own clinics, Fresenius also sells the two medications to thousands of independent dialysis clinics round the country. Both GranuFlo and NaturaLyte are used in dialysis to remove toxins from the blood. However, unlike rival products, GranuFlo and NaturaLyte are formulated with sodium diacetate, rather than acetic acid. According to GranuFlo lawsuits, this formulation increases the risk of a condition called alkalosis, which occurs when there is too much bicarbonate in the blood. Alkalosis is associated with heart attacks, cardiac arrest, sudden cardiac death, and other catastrophic heart problems in dialysis patients.

A GranuFlo warning was issued by Fresenius about the heart risks associated with GranuFlo and Naturalyte in March 2012. That warning was later deemed a Class I GranuFlo recall by the U.S. Food & Drug Administration (FDA), its most serious type of recall. But according to The New York Times, doctors at Fresenius Medical Care dialysis clinics actually got a heads up from the company months earlier, in November 2011. According to that GranuFlo warning, 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010, and the company’s medical staff had determined that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels. As such, doctors at Fresenius clinics knew to alter prescriptions for certain patients, while their counterparts at clinics supplied by Fresenius were left in the dark.

Apparently, the March GranuFlo warning was only issued to Fresenius’ customer clinics after an anonymous source forwarded the November 2011 memo to the FDA, and the agency started asking questions. The FDA has since opened an investigation to determine if Fresenius Medical Care violated the law by failing to warn its customers about the GranuFlo heart attack risks.

According to a lawsuit filed by the family of Teresa Gayta, the Illinois woman was rushed to the hospital in the midst of a dialysis treatment she was undergoing at a Fresenius clinic in Berwyn. The lawsuit claims a series of mistakes led to her death, including allowing a Fresenius patient care technician do a reversal of her dialysis lines (which he was not qualified to do), and not properly securing her lines. She began hemorrhaging, and later was taken off life support after being rushed to a hospital. Her family’s lawsuit was filed long before the GranuFlo recall, and doesn’t mention if Gayta was administered GranuFlo or NaturaLyte the day she underwent that fatal dialysis treatment. But despite settling their claim, the family says they have received few answers from Fresenius, which has not admitted to any wrongdoing.

Since the GranuFlo and NaturaLyte recall, a number of GranuFlo lawsuits have been filed by families who allege their loved ones died as a result of the medications. Such claims are currently pending in Florida, Alabama and Georgia. And considering how many dialysis clinics used these products, it’s highly likely more GranuFlo heart attack lawsuits will be filed in the coming weeks and months.

Published November 2, 2012 by