Master Complaint Approved for Granuflo Lawsuits Against Fresenius

New procedures have been adopted in the federal litigation for all Fresenius dialysis treatment lawsuits stemming from the use of Granuflo or NaturaLyte solutions, streamlining the process for filing future claims on behalf of individuals who suffered sudden cardiac arrest or other heart problems.  

There are currently more than 433 product liability lawsuits filed in U.S. District Courts throughout the United States against Fresenius Medical Care, all involving nearly identical allegations that the company failed to adequately warn about the cardiac risks of their Granuflo and NaturaLyte dialysis products.

As more-and-more families contact product liability lawyers after learning about the potential link between the Fresenius dialysis products and sudden cardiac arrests suffered by loved ones during or shortly after treatments, it is ultimately expected that thousands of cases will be filed nationwide.

In April 2013, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for all Fresenius cases filed throughout the federal court system, centralizing all lawsuits before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the witnesses, parties and the courts.

As part of the coordinated management of the Fresenius litigation, Judge Woodlock issued a case management order (PDF) approving the use of a master complaint and short form complaint to standardize the process of filing addition lawsuits against Fresenius.

The master complaint form outlines the common allegations raised in all of the complaints, indicating that Fresenius failed to adequately research Granuflo and NaturaLyte or provide sufficient information to doctors about the risk of heart problems during dialysis treatments and the importance of monitoring bicarbonate levels.

Following adoption of the master complaint, plaintiffs are now able to utilize the short form compliant to bring future lawsuits, outlining the specific allegations of that plaintiff’s claim, indicating the portions of the master complaint they are adopting, which product was used and case-specific information about their heart attack, cardiac arrest or other alleged injury.

Fresenius Dialysis Cardiac Arrest and Heart Attack Concerns

Fresenius Medical Care is the largest provider of dialysis services in the U.S., owning thousands of dialysis clinics nationwide and manufacturing many of the products and machines used at competing centers as well.

NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate, which have been commonly used over the past decade during hemodialysis treatments at Fresenius clinics, as well as at 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 inform doctors that the products increase bicarbonate levels and expose patients to a substantial risk of sudden heart injury during or shortly after treatment.

In November 2011, Fresenius conducted an internal review of 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.

In addition to the federal Fresenius litigation, the company also faces several hundred lawsuits that are centralized in Massachusetts state court, where the lawsuits have been specially assigned to Judge Maynard M. Kirpalani for pretrial purposes. There are also a growing number of lawsuits against Fresenius consolidated in California Superior Court, which are assigned to Judge Lee Smalley Edmon.