Two very important functions of our kidneys are balance water, salt and electrolytes in our blood and eliminate waste products from our body by converting these to urine. Thus, when our kidneys fail to function, a medical procedure called kidney dialysis or hemodialysis should be performed in order to maintain the balance of fluids in our body, as well as to help our body continue excreting wastes (such as creatinine and urea) to keep our blood clean.
One very necessary component in dialysis is dialysate, the fluid that is placed in the dialysis machine and which helps in the removal of waste products from the blood and in correcting any imbalances that result from kidney failure.
In 2003, Fresenius Medical Care (FMC), which controls the dialysis market in the US, introduced GranuFlo, a powder acid (dialysate) concentrate which FMC advertised as the safest dialysate ever due to its unique formula of uniformly distributed minerals that would help ensure balance in a patient’s blood.
GranuFlo, it should be understood, contains acetate and bicarbonate, two ingredients that work together in neutralizing extra acids that gather in the blood which the failed kidneys’ could no longer filter out. When these ingredients go into the body during dialysis, the acetate is converted by the liver into bicarbonate, doubling the amount of bicarbonate in the process.
When these two ingredients enter the body during dialysis, the liver converts the acetate into bicarbonate. Now, a surplus of bicarbonate inside the body can cause complications, like myocardial infarction, stroke, cardiopulmonary arrest, low blood pressure, metabolic alkalosis, and, the most serious of which, heart attack.
GranuFlo had been used in thousands of dialysis treatments since it was released by FMC, and approved by the U.S. Food and Drug Administration, in 2003. In 2010, a study was conducted by Fresenius in its own clinics (in Fresenius dialysis clinics where doctors used GranuFlo and NaturaLyte, FMC’s liquid counterpart of Granuflo, in patients that underwent dialysis) and had as many as 941 patients suffering from cardiac arrest as a result. This result, however, was only communicated by Fresenius through a memo a year later (in 2011) and only to doctors in its own dialysis centers, leaving out the FDA and all other doctors outside its centers in the communication loop. The memo specifically informed doctors in Fresenius dialysis clinics that GranuFlo increased in patients the risk of sudden death from heart attack, stroke and other complications.
The memo, however, according to the website of the GranuFlo lawsuit attorneys at Williams Kherkher, found its way into FDA hands. After conducting its own investigation, the FDA issued a Class I recall (the most serious FDA recall) for both GranuFlo and NaturaLyte in May of 2012. Barely two months after this FDA recall, lawsuits begun to be filed either by injured patients or by the families of those who have already died due to the drug.
Obvioulsy, as early as 2010 (or maybe even earlier), FMC had already known about the possible fatal risks that the drugs can cause in patients, however, it chose to continue to market and sell them without issuing proper warnings to consumers and doctors.
FMC faces legal and moral responsibilities towards patients (and the families of patients), who have been harmed by its drugs.