In June 2012, the FDA notified the public of a Class I recall for Fresenius Medical Care concentrates GranuFlo and NaturaLyte. Used during kidney dialysis procedures to reduce acid buildup in blood, these concentrates had been linked to reports of sudden cardiopulmonary arrest and death.
Since that time, patients injured by these products have been filing lawsuits across the country. Recently, a man who lost his wife to complications from these products filed a new GranuFlo lawsuit in Kanawha Circuit Court.
Plaintiff Claims GranuFlo Lead to His Wife’s Death
According to court documents, technicians used NaturaLyte and GranuFlo during Shirley Harris’ dialysis treatment at a local Fresenius Medical Care center. Her husband, Phillip Ray Harris, alleges that Shirley was seriously injured by these products, and later passed away because of her injuries.
Harris filed a lawsuit against Fresenius on June 19, 2013, claiming the company failed to provide appropriate warnings as to the health risks of the concentrates. He also blames the company for failing to train and/or monitor physicians and other healthcare workers using the products to be sure they were using them correctly.
Federal Lawsuits Consolidated in Massachusetts
On March 29, 2013, the U.S. Judicial Panel on Multidistrict Litigation ordered all federal GranuFlo and NaturaLyte lawsuits to be transferred into one court in the District of Massachusetts. The consolidation was expected to increase pre-trial proceedings and help preserve judicial resources as the number of GranuFlo lawsuits continues to increase.
As of July 10, 2013, there were nearly 200 actions pending against the manufacturer, all involving similar allegations that the use of GranuFlo and/or NaturaLyte caused serious complications, including heart rhythm problems and cardiopulmonary arrest. The first status conference for the MDL is scheduled to take place on August 30, 2013.
Company Failed to Warn of Dosing Changes
Doctors typically use concentrate products like GranuFlo and NaturaLyte to control acid buildup in the blood during a dialysis procedure. These products were made differently from previous concentrates, however, using a combination of ingredients that created a more concentrated dose. Plaintiffs filing lawsuits against Fresenius claim that the company failed to provide clear instructions on their products about the dosage that should be used, and also failed to provide clear and visible warnings about the serious consequences that could occur should doctors use too much.
Some patients who received a higher-than-necessary dose of these concentrates suffered from a condition known as metabolic alkalosis, in which the blood”instead of being too acidic”becomes too alkaline. The condition can then lead to problems like low potassium levels, low blood pressure, low blood oxygen, arrhythmia, and even seizures, heart attack, and death.
In May 2012, the FDA issued a warning to healthcare practitioners, stating it had received reports of dosing errors with these concentrates that lead to serious health consequences. Fresenius issued an internal memo to the doctors in their own dialysis centers in November 2011, warning them of the risks of metabolic alkalosis, but failed to issue a similar warning to outside medical centers using the products until after the FDA started asking questions, in late March 2012.
