As more and more families learn that the death or sudden cardiac arrest of their loved one during dialysis treatment may be linked to the use of Granuflo or NaturaLyte dialysate solutions, the number of product liability lawsuits against Fresenius Medical Care continues to increase nationwide.
Hundreds of Fresenius Granuflo and NaturaLyte lawsuits have been filed in state and federal courts throughout the country, alleging that the manufacturer failed to adequately warn medical providers about the importance of closely monitoring bicarbonate levels during use of their products and the risk that hemodialysis patients may suffer sudden death or heart problems during or shortly after treatment.
In April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated proceedings in the federal court system, with complaints filed throughout the country centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts for pretrial proceedings. A large group of cases are also proceeding forward in centralized litigation in Massachusetts state court, which is where the company is headquartered in the U.S.
According to an updated case list (PDF) released by the U.S. JPML on November 18, there are now nearly 400 lawsuits centralized in the federal Fresenius MDL, which represents a sharp increase from the roughly 229 cases pending in mid-September. Many Fresenius dialysis treatment lawyers who are reviewing potential claims for families believe that there will ultimately be several thousand complaints filed nationwide over Granuflo and NaturaLyte.
Dialysis Problems from Granuflo and NaturaLyte
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.
The product liability litigation involves reports of problems with Granuflo and NaturaLyte, which are dry acid and liquid acid concentrates that have been used during many hemodialysis treatments over the past decade. The solutions are used at Fresenius clinics, as well as at other dialysis centers owned by other companies.
Both products contain sodium acetate that converts to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in the complaints. Failure to closely monitor a patient during treatment with these products may increase the risk of cardiac arrest and death during or shortly after hemodialysis.
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 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.
The lawsuits allege that Fresenius withheld critical information from consumer and the medical community, causing thousand of individuals to experience problems during dialysis treatments involving Granuflo or NaturaLyte.
Fresenius Dialysis Litigation
In the federal court system, all product liability lawsuits against Fresenius have been centralized as part of an MDL to reduce duplicative discovery across a large number of cases, to avoid conflicting pretrial rulings and to serve the convenience of the parties, courts and the witnesses.
Early last month, Judge Woodlock issued an Initial Scheduling Order, establishing the process for exchanging documents and information during the discovery phase of the litigation. On November 15, additional case management orders were issued regarding the preservation of documents (PDF) and a protective order (PDF) regarding the confidentiality of certain items produced during discovery.
As part of the coordinated procedings, the parties are expected to begin the process of selecting a small group of test cases in January 2014, which will go through case-specific discovery in preparation for early trial dates, known as “bellwether” cases.
These cases will help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout a number of cases, and may help facilitate Fresenius Granuflo settlement agreements.