Lawyers Seek Leadership Roles in Fresenius Dialysis Treatment MDL

A group of lawyers have filed a request to be appointed to various leadership roles in the recently formed federal MDL (Multidistrict Litigation), which was established in the District of Massachusetts for all Fresenius dialysis treatment lawsuits filed throughout the federal court system on behalf of individuals who suffered sudden cardiac arrest or death after receiving Granuflo or NaturaLyte dialysate solutions.

In April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all lawsuits filed in U.S. District Courts throughout the country involving the recalled GranuFlo or NaturaLyte hemodialysis products will be centralized for pretrial proceedings before U.S. District Judge Douglas P. Woodlock.

Consolidating the litigation against Fresenius Medical Care is designed to reduce duplicative discovery in a large number of different lawsuits, avoid conflicting pretrial rulings from different judges and to serve the convenience of the witnesses, parties and the courts.

On June 21, a Motion (PDF) was filed by a group of six lawyers representing plaintiffs involved in the lawsuits, asking Judge Woodlock to schedule an Initial Case Management Conference and to establish an organizational structure and leadership positions for lawyers who will coordinate joint efforts that benefit all plaintiffs involved in the litigation.

The request asks Judge Woodlock to appoint a six-member Plaintiffs’ Executive Committee, an 11-member Plaintiffs Steering Committee and for two attorneys to be appointed as Liaison Counsel, to coordinate activities in the federal MDL with the litigation pending at the state court level in Massachusetts, California and other locations.

In consolidated MDL proceedings, it is common for a small group of lawyers to be appointed to various leadership roles to take certain actions during discovery and pretrial litigation that benefit all plaintiffs who have brought a lawsuit. The request asks that Judge Woodlock establish the leadership positions before the first conference in the MDL, to allow the parties to meet in advance and negotiate issues surrounding the structure of the proceedings.

Lawsuits Over Fresenius GranuFlo and NaturaLyte Dialysis Treatments

There are currently over 300 lawsuits filed against Fresenius Medical Care throughout the United States, which allege that dialysis treatment patients suffered a sudden cardiac arrest, heart attack or death during or shortly after hemodialysis involving Granuflo or NaturaLyte.

NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate.  Side effects of these dialysis treatment products may result in increased bicarbonate levels, as they both contain sodium acetate that converts to bicarbonate at higher-than-expected levels for most doctors. The lawsuits allege that Fresenius failed to adequately warn about the importance of monitoring bicarbonate levels during dialysis treatments involving Granuflo and NaturaLyte.

Fresenius Medical Care not only manufactures these dialysis solutions and other products used at clinics throughout the United States, but they also own and operate thousands of dialysis clinics throughout the United States.

Plaintiffs allege that Fresenius knew or should have known about the risk of these problems during dialysis treatment, but withheld that information from doctors at clinics nationwide who were using the products, exposing patients to a substantial risk of serious and life-threatening injury.

According to an internal memo sent to their own clinics in November 2011, Fresenius conducted a review of patients treated at 667 of their own clinics in 2010 and found at least 941 instances where individuals suffered cardiac arrest during dialysis treatment.  The memo warned physicians at Fresenius clinics about the importance of monitoring bicarbonate levels. However, the company failed to provide this information to other clinics that used Granuflo and NaturaLyte.

After the 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.

While the organizational structure of litigation is just being established, it is expected that thousands of lawsuits will ultimately be filed as Fresenius dialysis treatment lawyers continue to review additional cases nationwide involving individuals who suffered sudden heart problems or death after receiving the products.