Fresenius Medical Care operates 2,100 dialysis clinics in the United States, and they are also the nation’s leading supplier of dialysis machines and supplies. The company makes two products used during dialysis, GranuFlo® and NaturaLyte®. Most patients are unaware of the name of their dialysate, or the fluid used during dialysis. However, GranuFlo® and NaturaLyte® have been implicated by the Food and Drug Administration for contributing to elevated levels of bicarbonate in the blood.
Patients who receive excessive doses of these products may become victims of cardiac arrest, sudden myocardial infarction (heart attack), stroke, sudden death, or irregular heart beats (arrhythmias) that may be fatal.
In addition to these potential consequences, Fresenius patients may have suffered changes in their mental status, or confusion; very low blood pressure has also been linked to excessive amounts of these products. Extremely low blood pressure can lead to blackouts, or even stroke.
The underlying cause of these adverse effects is a dangerous swing in the body’s pH balance. During dialysis, toxic waste that would otherwise be eliminated from the body through the kidney is removed from the blood of people with renal (kidney) failure. Bicarbonate is an alkaline substance, and is administered during dialysis to neutralize the hydrogen ions, or acids, that have built up in the blood.
The kidneys, when functioning, maintain the body’s pH at 7.4. This balance is necessary for the proper functioning of body systems. A higher or lower pH is called wither alkalosis or acidosis, respectively. When cells operate in an environment of inappropriate pH, they are unable to perform their cellular functions, which depend upon complex balances of electrolytes within and outside of the cell. The heart is especially sensitive to pH, and derangements in the acid-base balance may cause irregular heart rhythms, which sometimes deteriorate quickly, leading to disorganized pumping of the heart, and cardiac arrest or circulatory shock.
Both GranuFlo® and NaturaLyte® are widely used in not only Fresenius Dialysis Centers, but in multiple clinics for dialysis throughout the country. Fresenius has long publicized that these products were among the most prescribed dialysis products in the country.
Multiple lawsuits have been filed against Fresenius since the FDA’s announcement. Some of these lawsuits allege that Fresenius was long aware of the risk associated with their 2 top-selling products. Boston attorneys uncovered an internal memo to its own network of clinics, reporting 947 cardiac deaths among only a third of the clinics they operate in the United States. However, although Fresenius sold GranuFlo® and NaturaLyte® to multiple independent clinics, they failed to notify those dialysis clinics until months later.
Many clinics owned by Fresenius are operated under local names. Even if you or a family member undergoes dialysis at an independent clinic, if you have experienced any of the above adverse events after dialysis, you may have been dialyzed with one of the Fresenius products. Many Americans are on dialysis as a result of end-stage renal disease. It is believed that thousands of kidney patients have been affected adversely.
If you have reason to think you may have suffered an adverse event or have knowledge of the death of a family member due to sudden cardiac arrest or stroke, you may have a case against Fresenius Medical Care North America. It is important to consider consulting a medical malpractice attorney to see if you have legal recourse to recovery of damages.
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