Recent news and updates regarding GranuFlo lawsuits indicate that all federal claims have now been transferred to a federal court in Massachusetts. Most of these cases allege that the dialysis product contains an ingredient that may have contributed to a sharp increase in the number of patients who suffered from a heart attack. A number of these lawsuits even claim that GranuFlo has caused the deaths of some patients due to severe complications.
Dialysis is the process of removing waste products in the blood of patients with kidney problems. It acts as an artificial kidney, preserving the equilibrium of water and minerals. This process takes place externally with the use of a machine called a dialyzer. In order to cleanse a patient’s blood, the machine is used together with a certain solution, which consists of purified water and an acid concentrate.
GranuFlo is one such acid concentrate used in dialysis. It is a product of Fresenius Medical Care, one of the largest manufacturers of peritoneal and hemodialysis equipment. It was approved by the U.S. Food and Drug Administration (FDA) in the year 2003. Following its market approval, the dialysis product grew in popularity. However, reports of complications associated with use of the dialysis product began to circulate not long after its market release.
Sometime in 2011, the manufacturer of GranuFlo, Fresenius Medical Care, conducted a post-market surveillance study on patients who were administered with the product. During the study, the company discovered that the acid concentrate contains an ingredient that the body converts into bicarbonate. As a result, patients who are given this product may end up with a higher blood bicarbonate level than patients who are given a different acid concentrate. High levels of bicarbonate in the blood can potentially increase the risk of developing heart-related complications.
The company also found that a high percentage of the patients who were given GranuFlo suddenly died from cardiac arrest, according to online news reports. Thus, the company immediately sent a warning memo to all its dialysis clinics that are using the product. However, the company did not warn other dialysis centers regarding the urgent discovery. Nevertheless, an anonymous person sent a copy of the memo to the FDA, prompting the agency to take immediate action. In June 2012, the agency issued a Class I recall of GranuFlo.
The recall reportedly triggered numerous lawsuits involving GranuFlo and another dialysis product known as NaturaLyte, which is also manufactured by the same company. Due to the large number of filings, reports say that the U.S. Judicial Panel on Multidistrict Litigation has decided to consolidate all federal cases into a multidistrict litigation, which is going to proceed in a federal court in Massachusetts. Updates and information regarding the GranuFlo MDL may be found on the sites of personal injury law firms, such as the Rottenstein Law Group’s rotlaw.com.