Dialysis Products Recalled after Reported Heart Problems
NaturaLyte Liquid Acid Concentrate and NaturaLyte GranuFlo, products widely used in dialysis treatments, were recalled by the US Food & Drug Administration (FDA) on June 27, 2012. Made by Fresenius Medical Care North America Company, these products have recently been linked to heart complications in patients that have received dialysis within 48 hours of completing the treatment.
As such, the FDA issued a Class I recall—a classification that is only used to get products off the market that yield a “reasonable probability that the use or of exposure to the product will cause serious negative health consequences or death.”
Unfortunately, it may be too late for the countless people that have already received dialysis treatments with the use of these products, however, as it has been reported that more than one-third of the 400,000 patients that receive this form of treatment across the country do so in one of Fresenius Medical Care Company’s facilities.
The reason that has been cited for the recall is because of the high level of serum bicarbonate that is present in NaturaLyte Liquid Acid Concentrate and NaturaLyte GranuFlo. When undergoing dialysis, blood is filtered outside of the body to neutralize the acid that has built up. When a high level of bicarbonate is used, however, there is a possibility that heart complications can follow.
This recall may not have come as a surprise to the company that manufactures the product, as an investigation has already shown that top officials at Fresenius Medical Care knew about the source of the problem, but failed to remedy it or notify the FDA.
An internal memo from the company that was dated November 4, 2011 shows this to be true. The company continued to put patients’ lives at risk by continuing the distribution of these dangerous products and by failing to notify anyone of the potential risks that they posed, and for this reason, innocent people have suffered heart attacks, cardiovascular death and various other catastrophic heart problems.
If you have received dialysis treatments from any of Fresenius Medical Care Company’s facilities, or you believe that you were treated with NaturaLyte Liquid Acid Concentrate or NaturaLyte GranuFlo, and you have subsequently suffered heart complications, it is imperative that you speak to an attorney immediately.
As a consumer, you should not have to worry that you will be exposed to dangerous or defective products, especially when they could directly affect your health, so it is your right to pursue compensation for the harm that you have suffered if the manufacturers have acted negligently in any way.
In this case, if it is decided that the makers knew about the dangerous side-effects of their product but failed to take any action to remedy it, they may be held liable under the law.
For this reason, you should not hesitate to speak to a lawyer from our firm immediately and explore your legal options if you have been made ill or have been injured by a dangerous or defective product.