A German medical device company that specializes in dialysis products is being investigated by the United States Food & Drug Administration after allegations that they were aware of an increased risk of death and complications related to their dialysis solutions: GranuFlo and NaturaLyte. It is also being alleged that Fresenius Medical Care (the company in question) was aware of these increased risks and chose only to inform doctors that used the products in their own clinics. Alarmingly, an estimated 125,000 patients are treated using Fresenius dialysis products in clinics outside of the company. Only in March of this year was this time-sensitive information made available to the public and other doctors using the products. It is believed that GranuFlo use resulted in heart attacks in 941 Fresenius center patients.
According to the FDA’s investigation of GranuFlo and NaturaLyte, these products substantially raise bicarbonate levels in patients receiving dialysis treatment. These Fresenius dialysis solutions are used both in FMC company dialysis centers as well as in other clinics that are not operated or owned by Fresenius. A high serum bicarbonate level can create a clinical cause for concern, especially when these levels result in metabolic alkalosis. Metabolic Alkalosis can result in all of the following dialysis side effects:
Earlier this year the United States Food and Drug Administration issued the most serious type of recall in regard to both GranuFlo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate, both of which are Fresenius Medical Care dialysis products. This recall, categorized as a class I recall, is only made in response to products with a high probability of resulting in irreversible adverse medical effects or death. The FDA’s analysis determined that the use of these dialysis products when administered improperly, greatly raise a patient’s risk of heart attack, cardiac arrest, and even death.
Has dialysis treatment with GranuFlo or NaturaLyte resulted in severe complications or the death of a loved one? If the answer is yes, you may want to consider the option of a Dialysis Lawsuit against the manufacturer of these products, Fresenius Medical Care. Call the Willis Law Firm today and we will evaluate your potential claim free of any monetary charge or further obligation. We always represent dialysis lawsuit clients on a contingency fee basis; this means that you will not be billed any legal fees unless we recover in your favor. Don’t hesitate to call; we are currently accepting claims in all 50 states.