Dialysis patients treated with the recently recalled Naturalyte and Granuflo Acid Concentrate could qualify to file a legal claim. The risks posed by the treatment conducted at Fresenius dialysis centers and other clinics using Fresenius dialysis machines include low blood pressure, cardiac arrhythmia, and other threats that could lead to cardiac arrest, and patients who have experienced these adverse events might be entitled to legal restitution. Please see below for a brief history of this potentially deadly turn of events, and find out how a drug recall lawyer can help you.
The German-based Fresenius Medical Care is America’s largest operator of dialysis centers. Out of 400,000 people estimated to be receiving treatment, over one third obtain their medical care from Fresenius. Not only does the company operate their own treatment centers, but they supply many other clinics across the nation with dialysis equipment and products.
Dialysis machines work by carrying out the functions normally conducted by kidneys. When kidneys are compromised, a dialysis machine can be used to remove toxic materials from a patient’s bloodstream and offset the danger of renal failure. Fresenius uses Naturalyte and GranuFlo Dry Acid Concentrate to induce the necessary processes. These products contain ingredients that the human body can convert into the acid-neutralizing substance known as bicarbonate.
“In November 2011, Fresenius circulated an internal memo warning that GranuFlo could increase the risk of cardiac arrest in a patient sixfold. A shocking 941 patients sustained cardiac arrest at such centers in 2010 alone.
Why did this happen? GranuFlo and Naturalyte can lead to heightened levels of bicarbonate if doctors do not take precautions when administering dialysis. Medical professionals can underestimate the heightened amounts of bicarbonate produced by sodium diacetate and acetate in these substances. They might thus prescribe supplemental bicarbonate in amounts in excess of what would be considered safe. Researchers have found that high levels of bicarbonate can cause numerous heart problems.
Although Fresenius circulated an internal memo to medical staff at their own clinics, they did not provide such information to the numerous other dialysis centers across the country that use their products. This equates to an estimated 125,000 patients whose doctors may not have received a warning concerning these potentially injurious products, despite the fact that the internal memo contains language which clearly states, “This issue needs to be addressed urgently.”
The matter only came to light once the Food and Drug Administration received a copy of the internal memo from an anonymous source. A recall on GranuFlo and Naturalyte was issued shortly thereafter, but the damage may have already been done. Fresenius denies any wrongdoing, but numerous medical professionals believe that the company acted in a manner not consistent with promoting public safety.
If you have experienced cardiac arrest or any other adverse event related to GranuFlo or Naturalyte, or if you lost a loved one who was receiving dialysis, then it’s imperative that you review your legal options. A qualified drug recall lawyer from the Stampfle Law Firm can assist you with putting forth a legal claim.
Call us today to receive a free consultation. We are in the process of reviewing cases related to Fresenius dialysis machines, and if your family has been harmed, contact us at once. A member of our expert legal team can help you figure out if you qualify to file a claim.