Fresenius medical healthcare group announced yesterday that it has been warned by the FDA that it needs improve procedures at a blood bag manufacturing plant in Puerto Rico, according to Reuters.
In question were the company’s labeling and complaint-handling procedures. The company made certain to assure interested parties that it did not foresee the issues with the Puerto Rico plant affecting sales or earnings and added that patients had not been put at risk.
This is far from Fresenius’s first brush with the law and the largest issue looming for the Germany-based healthcare giant revolves around safety issues associated with its dialysis product GranuFlo. Fresenius is currently facing hundreds of lawsuits alleging injuries and death by people arising out of the company’s failure to inform patients and healthcare providers of the risks associated with GranuFlo, a dry-powdered acid concentrate used to cleanse blood.
“These latest developments with Fresenius add more examples of patient safety shortcuts in an already long list of infractions and substandard services provided by Fresenius and other for-profit dialysis corporations,” commented Christopher Paulos, an attorney with the Levin, Papantonio law firm who practices in the areas of product liability and personal injury litigation. “Time and again this company’s conduct indicates a corporate culture that appears to put bottom-line profits before protecting the safety of patients.”
GranuFlo is a product used in dialysis to filter detrimental particulates from the blood of patients. Unbeknownst to patients and providers, GranuFlo carried with it a dangerous risk of metabolic alklalosis. While patients underwent their dialysis treatment, they were at risk of developing dangerously high pH levels in their blood. Doctors and clinicians administering the treatment were not aware that the product carried such a risk, and so were not aware of the need to adjust the amounts of GranuFlo used in dialysis. The increased pH levels put patients at a much higher-risk of major cardiac injuries like sudden cardiac death, heart attack and/or stroke. The issues of GranuFlo became public knowledge only after an internal Fresenius memorandum was leaked to the FDA in March of 2012
Now Fresenius finds itself in the crosshairs of another FDA correction and if past experiences are any indication of future performance, it won’t be the last time.