Granuflo News

FDA Warns Granuflo/NaturaLyte Manufacturer Again

The U.S. Food & Drug Administration (FDA) has issued another warning to GranuFlo/NaturaLyte manufacturer, Fresenius Medical Care. And the U.S. Judicial Panel on Multidistrict Litigation has decided to consolidate dozens of lawsuits against the firm.

The FDA warning, issued in March 2013, states that Fresenius failed to conduct adequate design verification studies of its electron beam (E-beam) dialyzers. The FDA also asserted that the company’s design did not meet specifications.

Dialysis is a process of filtering unwanted fluids from the blood. Patients with kidney malfunction require dialysis to remove toxins, such as urea, from their systems. Physicians use dialyzers to strain such waste products from the bloodstream and return clean blood to the body. Consequently, dialyzers are crucial to a successful dialysis procedure.

Prior recall

The FDA’s warning follows a 2012 Class 1 recall of GranuFlo and NaturaLyte, both concentrates used to treat acute and chronic renal (kidney) failure during dialysis.  Class I recalls are the most serious type of recall, used only when a product poses risks of  serious health consequences and/or death.  The recall drew attention to such risks, resulting from dosage errors.

Thousands of dialysis patients at risk

Fresenius operates more than 3,000 dialysis clinics throughout the United States, and an estimated 125,000 patients have been treated for kidney failure with GranuFlo and NaturalLyte. Low blood pressure, hypoxemia, cardiac arrhythmia and low potassium levels, which can lead to heart attack, cardiac arrest, stroke and sudden death, are all reported effects of GranuFlo and NaturaLyte dosage errors.

Company knew of hazards

An internal Fresenius memo, leaked to the FDA, revealed the company’s knowledge of these life-threatening complications. The 2011 memo, directed only to Fresenius clinicians, warned of more than 940 incidences of cardiac arrest among patients who received either GranuFlo or NaturaLyte while being treated at Fresenius clinics.

Dozens of lawsuits consolidated

Since the 2012 recall, approximately 40 lawsuits have been filed alleging that Fresenius failed to warn consumers and physicians at large of potential dosage risks, and, according to court documents, another 700 victims are waiting to file suit. In March 2013, the U.S. Judicial Panel on Multidistrict Litigation heard arguments in San Diego, about where to consolidate dozens of multi-state suits and decided on the District of Massachusetts.

If you or a loved one has suffered an injury due to a Fresnenius E-beam dialyzer or to use of either GranuFlo or NaturaLyte, you need to seek legal advice immediately.  Contact us for a free consultation. There is no charge to you until we win your case.

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