Initial Conference Scheduled in MDL for Fresenius Granuflo Lawsuits

The federal judge presiding over all dialysis injury lawsuits against Fresenius Medical Care, which are consolidated as part of an MDL or multidistrict litigation, has scheduled an initial conference for the parties to meet with the Court late next month.

In April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all product liability complaints brought in U.S. District Courts throughout the country against Fresenius involving the use of Granuflo or NaturaLyte dialysis treatments.

The cases all involve similar allegations that plaintiffs suffered a sudden cardiac arrest, heart attack or death after dialysis treatments with Granuflo or NaturaLyte, which are manufactured and sold by Fresenius Medical Care.

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For coordinated pretrial proceedings, the lawsuits have been centralized in the District of Massachusetts before U.S. District Judge Douglas P. Woodlock, who recently appointed a group of attorneys to serve in leadership roles in the Fresenius Granuflo MDL, taking certain actions that will benefit all plaintiffs who have brought a case.

According to an order (PDF) issued July 29, the first scheduling conference has now been set for August 30, in the Joseph Moakley U.S. Courthouse in Boston, Massachusetts. At that time, Judge Woodlock will meet with the lawyers involved in the litigation to review outstanding issues and motions that are pending. It is also expected that the structure and organization for the MDL will be discussed.

Fresenius Problems with Granuflo and NaturaLyet

Fresenius Medical Care 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.

NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate, which have been used during hemodialysis treatments at Fresenius clinics as well as 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.

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 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.

Fresenius Granuflo Litigation

According to a case list (PDF) released by the U.S. JPML on July 10, there are currently at least 188 complaints centralized before Judge Woodlock in the District of Massachusetts.

The number of lawsuits is continuing to increase as product liability lawyers review lawsuits against Fresenius on behalf of individuals who suffered injuries over the past several years. It is ultimately expected that thousands of cases will be involved in the Fresenius Granuflo litigation.

The litigation has been centralized in the federal court system to reduce duplicative discovery across a large number of cases, 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 in the MDL, it is expected that a small group of cases will be prepared for early trial dates, known as “bellwether” cases. These cases will serve as test cases, allowing the parties to gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

The preparation of these cases and the outcomes of any early trial dates may influence eventual negotiations with Fresenius to settle Granuflo injury cases. If a settlement or other resolution is not reached following the MDL proceedings, each case may ultimately be remanded back to the U.S. District Court where it was originally filed for a separate trial date.


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