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By: Irvin Jackson | Published: November 27th, 2012
The family of an Ohio man has filed a lawsuit against Fresenius Medical Care, alleging that the company’s dialysis solution Granuflo caused a cardiac arrest during treatment at a one of its own dialysis centers.
The complaint (PDF) was filed by Deborah Swigert on behalf of her husband, Charlse M. Swigert, in U.S. District Court for the Southern District of Ohio on November 13.
According to the lawsuit, Swigert was 56 years old when he suffered a cardiac arrest while receiving dialysis treatment at a Fresenius center in Washington Court House, Ohio. He was rushed to a local hospital, where he was later declared dead.
The family claims that the death was caused by Fresenius’ failure to provide adequate warnings about the potential side effects of dialysis treatment with Granuflo, which has been found to increase the risk of cardiac arrest if bicarbonate levels are not carefully monitored during treatment.
Although Fresenius has allegedly known about the potential problems for years, they failed to provide proper instructions about the use of Granuflo to their own clinics.
Many Similar Lawsuits Filed Over Deaths During Dialysis Treatment with Granuflo
Fresenius is the nation’s leading provider of dialysis treatment drugs and the company also owns and operates a large chain of dialysis centers nationwide. About 79,000 dialysis patients are treated nationwide in Fresenius dialysis clinics, according to the complaint.
The Swigert case joins a growing number of Granuflo lawsuits filed against Fresenius after dialysis patients died or suffered catastrophic injuries from a cardiac arrest, heart attack or stroke that occurred during or shortly after hemodialysis where the company’s acid concentrate products were used.
GranuFlo is a dry acid concentrate used as part of the dialysate solution during hemodialysis. It contains sodium acetate that allegedly converts to bicarbonate at a higher-than-expected level for most doctors, according to lawsuits filed against the company, requiring close monitoring of dialysis patient’s bicarbonate buffer prescriptions to reduce the risk of cardiovascular problems.
One year after Swigert’s death, Fresenius issued a detailed internal memo in November 2011, warning about the risk of problems during dialysis treatments with Granuflo. The company advised physicians in their own clinics about the importance of monitoring pre-dialysis bicarbonate levels and adjusting dialysate prescriptions to avoid the risk of cardiopulmonary arrest and death during dialysis.
The company’s own internal review of patients treated at 667 Fresenius clinics found at least 940 other instances where individuals suffered cardiac arrest during dialysis treatments in 2010.
Although Fresenius provided information about the potential side effects of GranuFlo and NaturaLyte to their own clinics in November 2011, they did not send that same warnings to other clinics that purchase the dialysis products until after an FDA inquiry in March 2012. The company then sent a warning to other dialysis centers, which the FDA has classified as a Fresenius NaturaLyte and Granuflo recall.