Fresenius Dialysis Bellwether Trials in Multidistrict Litigation

Due to the growing number of Fresenius Lawsuits in the federal court, parties involved are moving forward to proceed with bellwether trials. A bellwether trail is a way of grouping a number of Fresenius cases together to avoid repetition and help facilitate a possible Fresenius settlement agreement. Bellwether trials also allow parties to gauge how juries might respond to certain evidence and testimony that is likely to be repeated throughout the trial process. Currently there are over 600 product liability lawsuits filed against Fresenius Medical Care in the federal court system. All of the lawsuits claim dialysis patients suffered from cardiac arrest or death after treatments. Problems with Granuflo or NaturaLyte dialysate solutions have become a huge issue across the country.

As part of pretrial proceedings for Multidistrict litigation (MDL), the complaints filed in the U.S District Courts throughout the United States have been centralized before the U.S District Judge Douglas P. Woodlock in the District of Massachusetts. A status hearing for this coming Friday will allow attorneys and plaintiffs to review with the court competing proposals submitted for a bellwether trial.

All of the complaints involve similar allegations, claiming that Fresenius failed to provide adequate warning and instruction about Granuflo and NaturaLyte acid concentrates. Both of the dialysis chemicals have been linked to increased risk of cardiac arrest and death among patients. The lawsuits go into detail about how the solutions convert bicarbonate at higher levels than doctors were aware of. When levels are become too high, they require closer monitoring during treatment to avoid the risk of death.

The link between Granuflo and NaturaLyte with heart risks surfaced early of 2012 after an internal Fresenius memo was leaked to the FDA. Fresenius Medical Care conducted an internal review at their own clinics and found that in over 900 instances patients suffered from cardiac arrest during dialysis treatments. The company did issue a warning to doctors at the dialysis treatment centers they own, but failed to provide a warning to other clinics using the product.

Fresenius did however; issue an official warning in March of 2012 to all healthcare providers, which then led to an official FDA recall of Granuflo and NaturaLyte. Plaintiffs in the litigation claim that Fresenius knew about the potential risk of death and withheld important information from patients.

In litigation this big, it is common for a series of bellwether trials to be scheduled early in the process. Both parties agreed that 20 representative cases should be selected for the bellwether pool, with 10 chosen from each party. It is undecided how the cases will be prepared and narrowed down.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.