GranuFlo Recall Update: More Legal Woes for Fresenius Medical Care
Fresenius Medical Care, the company at the center of the recent GranuFlo recall, is facing a new legal battle. According to a report published by Bloomberg News earlier this month, two pharmaceutical companies filed suit accusing Fresenius Medical Care of infringing three U.S. patents for a human blood-thinner made from rattlesnake venom.
Legal experts already expect that Fresenius could face thousands of GranuFlo heart attack lawsuits stemming from its March 2012 GranuFlo and NaturaLyte recall. 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. 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.
It was later learned that doctors practicing at Fresenius-owned dialysis clinics had received a warning about GranuFlo’s heart risks months earlier, via an internal memo sent to the clinics in November 2011. The U.S. Food & Drug Administration (FDA) is now investigating to determine if the delay in warning Fresenius’ customer clinics broke any laws.
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. Already several GranuFlo heart attack lawsuits have been filed against Fresenius over the recall. The complaints allege that rather than warn doctors or the public about GranuFlo’s heart risks, Fresenius made a decision not to disclose these risks in order to protect revenue from the sales of GranuFlo and NaturaLyte.
Now, Merck & Co. and a division of Takeda Pharmaceuticals have filed a patent infringement lawsuit against Fresenius alleging the company plans to market a generic version of anti-clotting Integrilin before their patents expire in 2015. Integrilin is used to prevent blood clots during angioplasty procedures. Takeda and Merck allege sales of the generic version will cause them irreparable harm, and claim Fresenius acted “without a reasonable basis for believing that it would not be liable for infringing on” their patents when it applied to the FDA for permission to sell the drug.