Already facing uncomfortable questions in the wake of its GranuFlo recall earlier this year, Fresenius Medical Care has warned that it expected revenue and net profit for this fiscal year to fall about 2% below its original forecast. According to a report from Reuters, Fresenius Medical Care also reported a 3 percent drop in third quarter net income to $270 million, less than the analysts’ average forecasts of $285 million.

According to Fresenius, the disappointing results were the effects of a strong U.S. dollar on earnings outside the U.S. The Reuters report made no mention of the GranuFlo recall, including any impact it may have had on the company’s bottom line.

Since the recall, Fresenius has been named in a number of GranuFlo heart attack lawsuits alleging the company knew for years that two of its dialysis drugs, GranuFlo and NaturaLyte, posed risks for the heart that could be minimized or eliminated by reformulating the products. The complaints allege that rather than warn doctors or the public, Fresenius made a decision not to disclose these risks in order to protect revenue from the sales of GranuFlo and NaturaLyte.

Germany-based Fresenius is the largest dialysis services and products company in both the U.S. and the world, and operates thousands of dialysis clinics here. It also sells dialysis products, including GranuFlo and NaturaLyte, to thousands of other clinics around the country. 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 allege this formulation 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.

On March 29, 2012, Fresenius Medical Care issued an Urgent Product Notification to its customer clinics to warn them about the heart problems associated with GranuFlo and NaturaLyte. Later, the U.S. Food & Drug Administration (FDA) deemed that notification a Class I GranuFlo recall, its most serious recall category

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. Doctors at Fresenius clinics were advised to alter prescriptions for individual patients with excessive pre-dialysis serum bicarbonate level. That memo never went out to customer clinics, according to the Times. It wasn’t until the FDA learned of the November 2011 memo from an unnamed source that a warning was issued to Fresenius customer clinics. 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.

A number of GranuFlo heart attack lawsuits have already been filed in several courts throughout the U.S. If you or someone you love suffered a heart attack or other serious cardiac problem following a dialysis treatment with GranuFlo or NaturaLyte, you may be entitled to compensation for your pain and suffering. To learn more about GranuFlo heart attack lawsuits, please contact the lawyers at Bernstein Liebhard LLP today by call 1-877-779-1414 today.

Published November 9, 2012 by