As the number of lawsuits involving Fresenius Medical Care’s Granuflo and NaturaLyte dialysis products continue to mount, a group of plaintiffs’ attorneys have been appointed to serve in various leadership roles in the federal multidistrict litigation (MDL), which was established to coordinate pretrial proceedings in the cases.
In April, the U.S. Judicial Panel on Multidistrict Litigation ordered that all Fresenius dialysis treatment lawsuits filed in U.S. District Courts throughout the country will be consolidated for coordinated management, as part of an MDL.
Since the centralized proceedings were established, at least 188 complaints filed in the federal court system have been transferred to U.S. District Judge Douglas P. Woodlock in the District of Massachusetts.
All of the complaints involve similar allegations that Fresenius Medical Care failed to adequately warn about the potential side effects of Granuflo and Naturalyte dialysate solutions, which have been linked to an increased risk of sudden heart problems or death if doctors do not carefully monitor bicarbonate levels during hemodialysis when the products are used.
In a case management order (PDF) issued on July 16, Judge Woodcock established a Plaintiffs’ Executive Committee of six attorneys, and a Plaintiffs’ Steering Committee consisting of 11 attorneys. These lawyers will take certain actions that benefit all plaintiffs who have filed a lawsuit involving cardiac arrest, heart attack or sudden death was allegedly caused by Granuflo or NaturaLyte.
Fresenius GranuFlo and NaturaLyte Dialysis Problems
Fresenius Medical Care is one of the largest providers of dialysis treatment in the United States, owning and operating thousands of clinics nationwide. However, the company also manufactures and sells many of the products used during dialysis treatments at other clinics, including solutions known as Granuflo and NaturaLyte.
NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate. Both products contain sodium acetate, which lawsuits allege converts to bicarbonate at a higher-than-expected level for most doctors.
Complaints brought on behalf of individuals who have suffered heart problems or family members of dialysis patients who died during or shortly after treatment now allege that Fresenius failed to adequately warn doctors about the importance of monitoring bicarbonate levels while these products were used.
Fresenius sent an internal memo to doctors at their own clinics in November 2011, following an internal review that identified at least 941 instances where individuals suffered sudden cardiac arrest during dialysis treatments. Although the company warned their doctors about the importance of monitoring bicarbonate levels, they failed to provide this warning to federal safety regulators or to other dialysis clinics that were using Granuflo or 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.
Granuflo and NaturaLyte Litigation
As individuals and family members continue contact Granuflo and NaturaLyte attorneys to pursue legal action for heart attacks or cardiac arrest events occurring during or shortly after dialysis treatments, the number of lawsuits against Fresenius is expected to continue to grow. Some estimates suggest that thousands of complaints will ultimately be filed throughout the country.
The centralized proceedings in the federal court system are designed 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.
Although each plaintiff will still have their own lawyers representing them in the litigation, the attorneys appointed to leadership roles will conduct various pretrial discovery that is common to all claims, coordinate responses to questions from the court, communicate on behalf of all plaintiffs during hearings, negotiate stipulations or potential settlements and perform other tasks that apply to common issues in the litigation.
Following the coordinated pretrial proceedings and any early “bellwether” trial held to help gauge how juries are likely to respond to evidence that may be repeated throughout the litigation, if a Fresenius dialysis injury settlement is not reached to resolve the cases, individual lawsuits may be remanded back to the U.S. District Courts where they were originally filed for separate trial dates.