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The U.S. District Judge presiding over all federal dialysis treatment lawsuits involving Fresenius Medical Care’s Granuflo and NaturaLyte solutions will hold an Initial Status Conference with the lawyers involved in the litigation tomorrow.
In April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated federal proceedings for all product liability lawsuits filed in U.S. District Courts throughout the country on behalf of dialysis patients who suffered sudden cardiac arrest or other health problems after receiving Granuflo or NaturaLyte during hemodialysis.
The cases have been centralized for coordinated pretrial proceedings before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, as part of an MDL or Multidistrict Litigation.
The Fresenius dialysis treatment lawyers involved in the cases are scheduled to meet with Judge Woodlock on September 27, at which time the organization and structure of the coordinated proceedings will be discussed, including an initial scheduling order and discovery plan that will likely involve the eventual selection of a small number of lawsuits for early trial dates, known as bellwether cases. These trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout a large number of cases, and may ultimately facilitate potential Fresenius settlement agreements.
Fresenius Lawsuits over NaturaLyte, Granuflo Dialysis Treatments
According to a Joint Status Report (PDF) submitted by the parties in advance of the conference, there are currently more than 300 lawsuits pending in the NaturaLyte and Granuflo MDL.
All of the complaints involve similar allegations Fresenius Medical Care failed to provide proper warnings and instructions to doctors about the risk of sudden heart problems or death following use of Granuflo or NaturaLyte, which were the subject of a recall last year.
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 NaturaLyte and GranuFlo Litigation
In addition to the federal litigation against Fresenius that is consolidated before Judge Woodlock, a number of Granuflo lawsuits are currently pending in various state courts.
According to information provided in the Joint Status Report filed last week, there are currently another 297 cases centralized in Massachusetts Superior Court, where the litigation has been specially assigned to Judge Maynard M. Kirpalani for pretrial purposes. There are also at least five lawsuits against Fresenius consolidated in California Superior Court, which are assigned to Judge Lee Smalley Edmon.
In Massachusetts, Judge Kirpalani held a status conference earlier this month to review the different positions of the parties regarding initial discovery in the cases and a follow up telephone conference was tentatively scheduled for 5:00 p.m. today. In California, a stay on the proceedings remains in place while the parties finalize a discovery plan, with the next status conference scheduled for October 22.
In the federal Granuflo MDL, Judge Woodlock appointed a small group of attorneys to serve in various leadership roles in July, charged with taking actions that benefit all plaintiffs in the litigation. The parties have indicated that they hope to coordinate as much as possible between the state and federal GranuFlo and NaturaLtye litigation to avoid duplicative discovery and efforts.
In complex product liability litigation where a large number of cases are filed over the same or similar products, it is common for the courts to coordinate pretrial proceedings and discovery on common issues between the cases, limiting case-specific discovery to a small number of complaints. However, following a series of bellwether trials in the federal MDL, if Fresenius does not reach agreements to settle lawsuits or otherwise resolve cases, the company could face hundreds of individual lawsuits scheduled for trial in U.S. District Courts throughout the country.