Fresenius Dialysis Lawsuits May Be Delayed as Litigation Mounts

As an increasing number of lawsuits continue to be filed nationwide on behalf of individuals who suffered cardiac arrest or a sudden heart attack following dialysis treatment involving Fresenius Medical Care’s Granuflo or Naturalyte products, the parties involved in the litigation have asked for additional time to establish the “bellwether” trial process.

In April 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all Fresenius dialysis lawsuits filed in U.S. District Courts nationwide over problems with Granuflo or Naturalyte dialysate solutions.

At that time, there were about 100 product liability complaints pending in the federal court system, which all involved similar allegations that the manufacturer failed to adequately warn about the risk of sudden heart problems that may develop following hemodialysis treatments where Granuflo or Naturalyte were used.

According to an updated case list (PDF) released by the U.S. JPML this month, there are now at least 433 complains included in the Fresenius heart attack litigation, and the number continues to increase each month as lawyers review and file additional cases on behalf of families nationwide.

Centralized Management of Fresenius Granuflo Litigation

The coordinated litigation is centralized for pretrial proceedings before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, as part of an MDL or multidistrict litigation. Judge Woodlock is presiding over the exchange of discovery in the cases and has indicated that a small group of representative cases will be set for early trial dates, known as “bellwether” cases.

In complex product liability litigation where a large number of lawsuits are filed over similar injuries associated with the same product, it is common for the federal courts to centralize the cases before one judge for pretrial proceedings, which are designed to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As part of the coordinated proceedings, the parties have been conducting depositions and the exchange of information surrounding generic issues that are common to all claims. In October, Judge Woodlock issued a case management order calling for the parties to submit proposals regarding a Granuflo bellwether trial process by January 6, 2014.

It is expected that a small group of lawsuits, known as “bellwether” cases, will be selected to go through case-specific discovery in preparation for a early test trials. The preparation and outcome of these cases are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of cases, potentially helping facilitate Fresenius dialysis settlement agreements to avoid hundreds of individual trials.

In a joint motion (PDF) filed by the parties on December 16, plaintiffs and defendants have asked Judge Woodlock for additional time to submit proposals for a bellwether case management order.

“Inasmuch as generic discovery is only beginning, the parties are not yet in a position to propose a realistic schedule for case specific discovery and the selection of bellwether cases,” according to the joint motion, which asks that the Court consider the appropriate timing of the submission at the next Status Conference scheduled in the Fresenius Litigation on February 3, 2014.

Heart Attacks, Cardia Arrest from Fresenius Dialysis

It is ultimately expected that several thousand lawsuits will be filed against Fresenius Medical Care in state and federal courts nationwide.

Fresenius is one of the largest providers of dialysis treatments in the United States, owning and operating thousands of clinics nationwide, as well as manufacturing many of the products used during dialysis treatment. The litigation centers on problems with two dialysate solutions sold in recent years by Fresenius, including NaturaLyte and Granuflo.

NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate, which are not only used during hemodialysis treatments at Fresenius clinics, but were also sold to other dialysis centers throughout the country.  Both products contain sodium acetate that converts to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in the complaints.

In November 2011, Fresenius conducted an internal review involving the use of Granuflo and NaturaLyte at their own clinics, identifying at least 941 instances where patients suffered cardia arrest during dialysis treatments in 2010. While the company issued a memo to doctors in their own clinics in late 2011, they failed to provide the same information or warnings to other clinics that used Granuflo and NaturaLyte.

After an internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.

The lawsuits filed against Fresenius allege that the company withheld information from consumers and the medical community about the risk of problems during dialysis treatment involving Granuflo and NaturaLyte, failing to warn about the importance of monitoring bicarbonate levels, which exposed patients to a substantial risk of sudden heart injury during or shortly after treatment.

In addition to the federal litigation, Fresenius currently faces at least another 300 cases that are centralized in Massachusetts state court, where the litigation has been specially assigned to Judge Maynard M. Kirpalani for pretrial purposes. There are also about five lawsuits against Fresenius consolidated in California Superior Court, which are assigned to Judge Lee Smalley Edmon.