The FDA recall issued in March 2012 for GranuFlo and NaturaLyte, manufactured by Fresenius Medical Care, has brought to the public eye an issue that the medical community has been concerned about for many years —the mortality rate of dialysis patients.
Fresenius Medical Care is a large player in the dialysis market. Not only does the company make many products that are used in dialysis treatment such as dialysate products and machinery, it also owns and operates thousands of dialysis clinics across North American and Europe.
Fresenius conducted a study in 2010 of dialysis patients in its own clinics and noted 941 dialysis patients suffered cardiac arrest while receiving treatment. The results of the study were only released to Fresenius facilities and noted that patients were six times more likely to suffer from cardiac arrest within 48 hours of treatment with the use of GranuFlo and higher pre-dialysis bicarbonate levels were present. Fresenius did not disclose this information to non-company owned facilities, doctors, and home dialysis patients who used its products.
RenalWEB, a website that serves to aggregate web content regarding the dialysis industry and community, recently mentioned the use of GranuFlo had increased beginning in 2003 as oil prices and transportation costs began to increase. This was likely due to the fact that GranuFlo is a powder acid concentrate, which must then be mixed with liquids to form the dialysate solution used for kidney dialysis. The cost to ship and store the GranuFlo product would be less than that for the heavier and bulkier liquid acid concentrate formulas.
Fresenius Medical Care, which holds approximately an 80% share of the dialysis market, disclosed in its 2012 second quarter report that it treated over 164,000 dialysis patients– which was a 17% increase over the previous year for its North American operations. The company also reported that it realized a 12% increase in dialysis treatments, delivering more than 11 million dialysis treatments in North America alone during the first half quarter of 2012.
Concerns over patient health are mounting as more cases of cardiac arrest and other serious injuries such as stroke and dangerously low blood pressure are being reported. If you or someone you care about has suffered an injury after receiving dialysis treatment, contact us. Lawsuits have been filed against Fresenius Medical Care for its failure to warn patients of the risks associated with GranuFlo use in dialysis treatment. Our product liability attorneys are available to advise you of your legal rights and options.