Proposals Submitted for Fresenius Dialysis Bellwether Trials in MDL

As the number Fresenius dialysis lawsuits filed in the federal court system continues to mount, the parties involved in the litigation are moving forward with the selection of a small group of cases to be prepared for early trial dates in the multidistrict litigation (MDL).

There are currently more than 650 product liability lawsuits filed against Fresenius Medical Care in the federal court system, which all involve allegations that dialysis patients suffered sudden cardiac arrest or death following treatments due to problems with Granuflo or NaturaLyte dialysate solutions.

Complaints filed in U.S. District Courts throughout the United States have been consolidated for pretrial proceedings as part of the MDL, which is centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts.

A status conference is scheduled for Friday, at which time attorneys for Fresenius and plaintiffs are expected to review with the Court competing proposals submitted for a “bellwether” trial program, which would help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Fresenius Heart Attack Concerns

All of the complaints in the litigation involve nearly identical allegations, claiming that Fresenius Medical Care failed to provide proper warnings and instructions regarding their Granuflo and NaturaLyte acid concentrates, which are used during hemodialysis treatments.

Granuflo and NaturaLyte have been linked to an increased risk rate of sudden cardiac arrest and death among dialysis patients, which may occur during or shortly after dialysis treatment. The lawsuits allege that the solutions convert to bicarbonate at higher levels than doctors were aware, which requires much closer monitoring of levels during treatment to avoid the risk of injury or death.

Fresenius Medical Care not only manufactures the solutions, but also owns and operates many of the dialysis treatment centers in the United States. Concerns about the link between NaturaLyte, Granuflo and heart problems surfaced in early 2012, after an internal Fresenius memo was leaked to the FDA.

In November 2011, Fresenius conducted an internal review of the use of the acid concentrates at their own clinics, identifying at least 941 instances where patients suffered sudden cardiac arrest during dialysis treatment in 2010. While the company issued a memo to doctors at their own clinics, warning about the importance of monitoring bicarbonate levels during treatments, they failed to provide the same information to other clinics that used the products.

After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers on March 29 of that year, which the FDA determined constituted a GranuFlo and NaturaLyte recall.

According to allegations raised in lawsuits filed on behalf of former patients who have suffered injury or died, Fresenius knew or should have known about the risk of heart problems during dialysis treatment and withheld critical information from the medical community.

Bellwether Trial Program for Fresenius Dialysis Lawsuits

In complex litigation where a large number of cases have been filed by individuals who have suffered similar injuries from the same medication or medical device, it is common for a series of bellwether trials to be scheduled early in the process. While the outcomes of these test cases are not binding on other lawsuits, bellwether trials may help facilitate a possible Fresenius settlement agreement to avoid hundreds of individual trial dates being scheduled throughout the country.

On March 14, a plaintiffs’ proposal (PDF) and defendant’s proposal (PDF) filed simultaneously, outlining the parties’ respective positions regarding the Case Management Order that should be ordered by the Court for the bellwether trials.

Both sides have agreed that a total of 20 representative cases should be selected for the bellwether pool, with 10 chosen by each party. Following case-specific discovery on those claims, the parties agree that the pool should be narrowed down to 10 and the first trial dates will be selected from those remaining cases. However, the exact process of how the pool will be narrowed or how the cases will be prepared is still being debated.

Also in dispute is the number of depositions each side should be permitted to take in each bellwether case, with attorneys for Fresenius wanting between seven and 14 per case, and plaintiffs’ attorneys indicating that each side should only get five.

The parties were also unable to come to an agreement on the ultimate order in which the cases will go to trial, with Fresenius indicating that the Court should select the order of the cases following briefing by the parties. However, plaintiffs maintain that since they have the burden of proof in the litigation, one of their original selections should be the first to go before a jury, which is common practice in bellwether programs.

Another area of dispute is how the Court should handle cases that are voluntary dismissed by plaintiffs after they are selected for the bellwether pool. Attorneys for Fresenius indicate that those plaintiffs should be required to dismiss their claim with prejudice, which would not allow them to refile in the future.

Fresenius also indicates that it should be able to choose any replacements for those cases. However, plaintiffs maintain that such a process would unfairly penalize plaintiffs, as cases may need to be dismissed for a variety of reasons. Plaintiffs indicate that the party who originally selected the voluntarily dismissed case should be permitted to select the replacement.

According to a Joint Status Report (PDF) filed on March 25, the competing proposed case management orders filed by each side are likely to be the main subject of discussions at the status conference on Friday.