Federal Judges Hear Arguments to Consolidate GranuFlo Lawsuits

Federal Judges Hear Arguments to Consolidate GranuFlo Lawsuits

By Courtney Coren

Due to a high number of lawsuits against Fresenius Medical Care, the maker of the dialysis products GranuFlo and NaturaLyte, a panel of federal judges heard oral arguments last Thursday, March 21, regarding the consolidation of drug injury cases against the company.

The arguments were heard by the U.S. Judicial Panel on Multidistrict Litigation in San Diego, California. There are currently at least 37 lawsuits against Fresenius pending in 11 different federal districts, all of which allege the drugs GranuFlo and NaturaLyte caused serious and sometimes fatal reactions in dialysis patients.

The drugs have been linked to an increased number of cardiac arrests, heart attacks, stroke, and sudden death in patients where the drugs were used in their dialysis treatments.

GranuFlo and NaturaLyte provide bicarbonate, an alkaline substance used during dialysis to neutralize acid in the blood. According to a report published by the New York Times, GranuFlo contains more bicarbonate than other products of its kind and is linked to a potential rapid increase of the substance, which can elevate the risk of catastrophic heart side effects and even sudden death.  

In November 2011, Fresenius sent out an internal memo to its own dialysis clinics regarding the potential risks associated with GranuFlo and NaturaLyte. In the memo, Fresenius claimed that GranuFlo was responsible for 941 deaths due to cardiac arrest at U.S. dialysis clinics in 2010. It was recommended that the problem “be addressed urgently,” and that doctors carefully monitor and adjust the dosage to decrease adverse side effects.

But Fresenius did not send the memo and product warning to all of the clinics that use GranuFlo until March 2012 when the U.S. Food & Drug Administration (FDA) was anonymously sent a copy of the memo, and the FDA began to question Fresenius.  

In March 2012, an “Urgent Product Notification” was sent out by Fresenius to all of their customer clinics warning of the potential risks linked to GranuFlo and NaturaLyte.

The FDA began to investigate whether Fresenius had violated the law by not issuing a warning to its clinics earlier. The agency issued a Class I recall of GranuFlo, which is the most serious recall they can issue–restricted only to medical products that may result in severe injury or death.

Since the GranuFlo recall, there have been an increased number of lawsuits against Fresenius and this number is expected to increase even more. A multi district litigation (MDL) would streamline the litigation process by allowing individuals to add their case with other plaintiffs.

If you or a loved one suffered a heart attack, cardiac arrest, stroke or other adverse side effect after dialysis treatment, you may have a legal claim. Visit the GranuFlo & NaturaLyte Recall Class Action Lawsuit Investigation for more details. Compensation specialists will review your claims for free and determine if you have a case to seek a GranuFlo wrongful death or drug injury settlement.