Two Years After GranuFlo Recall, Some Fresenius Clinics Fall Short in Medicare Rankings

Published on January 28, 2015 by Sandy Liebhard

Half of the U.S. dialysis clinics ranked lowest by the U.S. Centers for Medicare and Medicaid Services (CMS) are operated by Fresenius Medical Care, a defendant named in thousands of GranuFlo lawsuits pending in courts around the U.S. According to a report from Modern Healthcare, 259 Fresenius sites received a one-star rating, which signifies a clinic that is “much below average quality.” A total of 545 dialysis facilities around the country garnered the one-star rating.

Only 53 Fresenius dialysis clinics received a top, five-star ranking, according to the report.

According to Modern Healthcare, CMS posted the star ratings last week on its Dialysis Compare Website. The site is part of a broader initiative to boost transparency and help Medicare beneficiaries compare quality in healthcare settings. The CMS ratings use nine publicly reported quality measures, including ratios for transfusions, mortality and hospitalizations. They also reflect percentages of adult dialysis patients with high calcium levels.

Fresenius Recall Litigation

Fresenius Medical Care is one of the largest providers of dialysis products and services in the U.S. Among other things, the company manufacturers GranuFlo and NaturaLyte, two dialysis concentrates that were recalled in 2012 after they were linked to hundreds of cases of serious, and sometimes fatal, cardiac arrests at Fresenius clinics in 2010. The GranuFlo recall was given the U.S. Food & Drug Administration’s (FDA) highest Class I rating after the agency determined that the products posed a risk of serious injury and death.

Since then, thousands of people have filed dialysis lawsuits against Fresenius in an attempt to obtain compensation for serious cardiovascular events allegedly caused by GranuFlo and NaturaLyte. Among other things, plaintiffs accuse the company of concealing the risks associated with the two products in order to preserve their market share. The complaints cite a November 2011 internal memo Fresenius circulated to its own dialysis clinics informing them of the cardiac arrests that occurred at the company’s clinics the prior year. The memo also advised doctors to adjust dosage of GranuFlo to avoid a spike in the amount of bicarbonate in a patient’s blood that could lead to similar heart events.

The majority of GranuFlo recall lawsuits have been filed in a federal multidistrict litigation now underway in U.S. District Court, District of Massachusetts. Other Fresenius lawsuits have been consolidated in Massachusetts’ Middlesex County Superior Court.