Popular Dialysis Products Linked to Heart Failure

Popular Dialysis Products Linked to Heart Failure

By Robert J. Boumis

Patients with kidney disease depend on dialysis machines to take over for their ailing kidneys. Often, these machines are people’s lifelines as they wait for a donor kidney or for their own organs to start function again. However, it has come to light that certain dialysis concentrates may have lead to serious health risks.

GranuFlo and NaturaLyte are two products produce by the medical supply company Fresenius Medical Care. These products were promoted over traditional dialysis concentrates because they required less storage space than traditional dialysis concentrates. However, problems with preparing these products may have lead to serious, heart-related problems.

A dialysis machine mimics the function of kidneys by drawing a patient’s blood through a series of semi-permeable membranes. Since a solute will always move down-gradient, these membranes allow biological waste products, like urea and urine to leave the bloodstream, much as the nephrons of the kidneys would in a healthy patient. To create this osmotic gradient, various concentrates like GranuFlo and NaturaLyte are used to produce preparations.

However, with GranuFlo and NaturaLyte, possible dosing errors seem to have caused other problems. These two products appear to have produced conditions where patients’ blood pH changes. Since many reactions in the human body are calibrate to function within a very narrow pH range, this situation can spell disaster for the patient. In particular, if blood pH is radically altered, it can cause various catastrophic heart problems. This includes sudden cardiac death and various types of heart attacks. This is caused when the ion channels of the heart act differently due to changes in the ambient pH.

In March of 2012, the United States Food and Drug Administration (FDA) issued a Class I recall for GranuFlo and NaturaLyte. This is the most urgent and serious level of recall the FDA can issue. It is reserved for products which present an immediate risk of death or serious injury to the general public.

It has also come to light that Fresenius may have been aware of these problems before going public. An internal memo from 2011 warned Fresenius-affiliated dialysis centers that GranuFlo and NaturaLyte could lead to heart problems if dosed incorrectly. This memo was not distributed to unaffiliated dialysis centers.

Dozens of GranuFlo injury lawsuits have been filed against Fresenius since the recall. These lawsuits allege that these products injured patients by altering their blood chemistry and causing heart attacks and other cardiac problems. The lawsuits further allege that Fresenius knew, or should have known about these risks, particularly in light of the internal memo from 2011. These GranuFlo lawsuits further allege that Fresenius downplayed these risks, preventing patients and physicians from having the information they needed to make an informed medical decision regarding their dialysis care.

If you or someone you love underwent dialysis and suffered serious heart problems, you may not be sure what steps to take next. You may feel overwhelmed. But you do have rights. You can start to regain control of your situation by visiting the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. Here, you can enter your information for a free legal review by drug injury lawyers specializing in this type of legal action. If you have a case, you will receive free advice on the best steps to take in your specific situation.