As GranuFlo Lawsuits Mount, Regulators Hit Fresenius for Conditions at Tennessee Dialysis Clinic
Already facing a growing number of GranuFlo heart attack lawsuits stemming from its recent GranuFlo and NaturaLyte recall earlier this year, Fresenius Medical Care is now taking heat for conditions at one of its dialysis clinics in Tennessee. According to a report from The Tennessean, state regulators recently determined that conditions at a Fresenius Medical Care dialysis facility in West Nashville were putting patients at risk. The clinic now faces the loss of federal funding.
According to The Tennessean, the Fresenius Medical Care clinic was issued a formal notice of expulsion from the Medicare and Medicaid programs, after Tennessee health inspectors uncovered conditions that “placed patients in immediate jeopardy, including serious injury or death.” The expulsion was to be effective November 17, unless Fresenius filed an acceptable corrective action plan prior to the deadline. A Fresenius spokesperson told The Tennessean that the facility was already working on such a plan, but there is no word yet whether the funding shut-off has been averted.
Overall, it hasn’t been a great year for Fresenius Medical Care. The Germany-based company is the largest provider of dialysis services in the U.S. and around the world. In addition to operating thousands of its own dialysis clinics, it supplies thousands of others with dialysis supplies. Fresenius Medical Care is currently facing several lawsuits over a GranuFlo recall it issued for its GranuFlo and NaturaLyte dialysis drugs earlier this year, after they were associated with serious cardiac side effects including heart attacks, strokes, and cardiac arrest.
Both GranuFlo and NaturaLyte are used in dialysis to remove toxins from the blood. But unlike rival products, they are formulated with sodium diacetate, rather than acetic acid. GranuFlo heart attack lawsuits claim that the way the two drugs are formulated increases the risk of a condition called alkalosis, which occurs when there is too much bicarbonate in the blood, and can increase the risk of cardiac arrest and other catastrophic heart events in dialysis patients.
The GranuFlo recall was originally announced as an “Urgent Product Notification” in March 2012, and later deemed a Class I recall by the U.S. Food & Drug Administration (FDA). Such recalls are the agency’s most serious type of recall, and are issued when there exists a real possibility that using a product could result in serious injury or even death.
Over the summer, The New York Times reported on internal documents that indicate Fresenius actually knew of the GranuFlo heart attack risk long before it issued its Urgent Product Notification. In November 2011, the company circulated a memo to Fresenius clinics warning that GranuFlo had been linked to a sharp increase in the risk of dialysis patients dying suddenly from cardiac arrest. However, the same memo was not sent to the thousands of independent dialysis clinics that also used GranuFlo and NaturaLyte, so doctors at those clinics were not made aware of the danger. Fresenius did finally send its “Urgent Product Notification” to those clinics in March, after the FDA became aware of the November memo. The FDA is now investigating to determine if Fresenius Medical Care’s delay in notifying those customers of the potential for GranuFlo heart problems violated federal law.