Judge Reviews Bellwether Trial Proposals in GranuFlo Mass Tort

Attorneys involved in Fresenius GranuFlo lawsuits met with presiding U.S. District Judge Douglas P. Woodlock to review competing proposals regarding preparations for the first “bellwether” trials.

There are currently more than 1,500 GranuFlo lawsuits filed before the federal court system by dialysis patients or their loved ones alleging that GranuFlo caused sudden cardiac arrest or death after treatments using GranuFlo or NaturaLyte acid concentrates.

As of April 2013, the federal cases have all been consolidated as part of a multidistrict litigation (MDL) or a mass tort to ensure coordinated pretrial proceedings under Judge Woodlock. The first GranuFlo bellwether trials are expected in the second half of next year or early 2016.

At the heart of all the GranuFlo lawsuits is the allegation that Fresenius failed to provide adequate warnings abut the importance of monitoring bicarbonate levels during hemodialysis. The GranuFlo lawsuits also allege that Fresenius failed to inform doctors and dialysis centers on the increased risk of severe and potentially life threatening heart problems.

Early bellwether trials are important because they help the parties involved see how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

Overview of GranuFlo and NaturaLyte Complications

The MDL is composed of several different GranuFlo lawsuits alleging similar injuries against Fresenius Medical Care. Each of these cases involves either a life-threatening injury or a wrongful death GranuFlo lawsuit, allegedly caused by Fresenius’s dialysate mixtures GranuFlo and NaturaLyte. The injuries indicated in these lawsuits include:

• Cardiac arrhythmia
• Low blood pressure
• Low potassium
• Low blood oxygen
• Hypercapnia (too much carbon dioxide in the bloodstream)

In many cases, the complications caused from GranuFlo and NaturaLyte caused sudden cardiac death in patients, sometimes occurring during the dialysis procedures themselves.

Both GranuFlo and NaturaLyte were approved through the U.S. Food and Drug Administration’s 510(k) Premarket Notification process, which only requires manufacturers to prove that a product can work at an equivalent level with a product already released on the market. This has led to the public criticizing the FDA for allowing such dangerous products to pass, and Fresenius for putting patients at risk, despite knowing the possible consequences.

One key element in the Fresenius lawsuits is a 2011 memo from Fresenius that refers to earlier correspondence and studies which had found that these products could increase bicarbonate levels and cause cardiac arrests. This memo was not released to the public. Instead, the memo was only distributed to Fresenius-affiliated dialysis centers, though many other dialysis centers use these dialysis products. It was not until an anonymous whistleblower leaked the memo to the FDA that this information came to light.

The GranuFlo MDL is In re: GranuFlo/NaturaLyte Dialysate Products Liability Litigation, MDL No. 2428, in the U.S. District Court for the District of Massachusetts.

Join a Free GranuFlo Class Action Lawsuit Investigation

If you or someone you know suffered a heart attack or similar complication and were undergoing dialysis treatment, you may be eligible to pursue compensation for your injuries. Obtain a free legal review of your case by submitting your information now:

Oops! We could not locate your form.