German Medical Giant Fresenius Medical Care (FMC) dominated the dialysis treatment segment in America and probably the world over. It is the largest manufacturer of all the medical dialysis equipments and has several clinics and physicians of its own who administer kidney failure treatments on patients day in and day out. This medical giant came up with GranuFlo and NaturaLyte in the early 2000's. The drugs received approval from the FDA in 2003 and started functioning as the most commonly used dialysate in the process of dialysis. FMS (Fresenius Medical Care) became the leading supplier and completely dominated the U.S market.
Class I Recall of GranuFlo and NaturalLyte
2010 onwards stories started circulating of cardiac arrhythmia, cardiopulmonary arrest and metabolic alkalosis and sudden strokes leading to death among patients who were getting
In response to the increasing incidences of cardiopulmonary arrests and deaths, Fresenius conducted a study trying to determine the possible adverse effects of their dialysate on the acute renal failure patients. The results were appalling. The study revealed that between January 1 and December 31, 2010 941 patients in 667 FMC facilities had cardiopulmonary arrests. The data further revealed that the patients' risk of cardiopulmonary arrest was up to six times higher if they had a heightened bicarbonate level pre-dialysis. This confirmed the worst fears that indeed GranuFlo was responsible for increased incidences of cardiac arrests and other symptoms in kidney failure patients.
FMC proved to be a completely profit motivated company and alerted about the developments only to FMC' own doctors and dialysis clinics. They chose to keep the non-FMC doctors and clinics using their products in the dark, although they were completely aware of the risks of cardiac arrest and death involved. They also knew that approximately 100,000 dialysis patients were receiving their products at non-FMC facilities.
However, this internal memo was leaked somehow and the FDA, USA got a whiff of it. Investigations regarding dosage and composition of the drugs in question were carried out and finally on March 29, 2012 the U.S Food and Drug Administration issued a Class 1 recall of GranuFlo and NaturaLyte (Fresenius'products).
It should be noted that Class 1 recalls are the most severe form of recalls and involves products that have ample scope to cause adverse and dangerous health consequences and death.
Cause of Recall and Dangers of GranuFlo
The severity of the recall obviously made it evident how dangerous GranuFlo was for cardiac health of patients. The reason it could cause cardiac arrest and death during hemodialysis treatments was because it contains acetate and sodium diacetate which leads to high bicarbonate levels during hemodialysis in the patient. Elevated pre-dialysis bicarbonate levels disturbs the pH balance of blood making it either too acidic or too alkaline (heavy on base) and this is what can cause the dangerous conditions mentioned.
A probability of six time increase in acquiring the condition of metabolic alkalosis which causes low blood pressure, hypokalemia, hypoxemia, cardiac arrhythmia (irregular heartbeat) in patients and in a severe stage can lead to cardiopulmonary arrest and death.
The internal memo FMC submitted to its own clinics on 4th November, 2011 stated action for patients with elevated pre-dialysis bicarbonate levels. The Recall by FDA was to check the dosage and composition of the drugs. Unaware physicians and medical staff had underestimated the potential of these drugs and was administering much higher dosages than required which were leading to the cardiac conditions.
The Importance of Dangerous Drug Lawsuits
Lawsuits are mounting against the nonchalant German giant FMC. The recall guidelines had come a little late and many lives were lost and injured till then. The patients and in many cases the practitioners were not aware of the dangers associated with the
If you have suffered much pain and anguish or seen a loved one suffer or lost a dear one due to these drugs of FMC, you must file a dangerous drug lawsuit to acquire compensation for all the body impairments and disabilities, lost wages, high medical bills incurred and the mental pain, suffering and anguish undergone.
The nonchalance of FMC is appalling. The way they have put their own personal and economic interests over a number of lives has laid the ground for many lawsuits they will have to deal with.
Moreover, even after all the safety concerns and lawsuits the company still aggressively markets its GranuFlo and NaturaLyte and sells them together with other FMC products giving high discounts.
The situation at present is such that the FDA recall did not make FMC products completely banned from clinics, but has prescribed guidelines regarding the correct dosage the physicians must administer. It also states the dangers of inaccurate dosing. The FDA also sent out a message to all dialysis medical professionals to administer dosages correctly and check the product manufacturer of dialysates as the levels of their components (like acetate and sodium acetate) vary from manufacture to manufacturer. Being alert and fighting for just compensation in such cases is extremely important and American people will do so.