Thousands of lawsuits over Fresenius dialysis treatments involving the use of Granuflo or NaturaLyte dialysate solutions are pending throughout the federal court system, with a small group of claims involving sudden cardiac arrest or wrongful death are being prepared for early test trials.
Since April 2013, all cases filed in U.S. District Courts throughout the country have been centralized for coordinated pretrial proceedings before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, as part of a federal multidistrict litigation (MDL).
According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) earlier this week, there are now at least 2,220 complaints consolidated before Judge Woodlock, which all involve similar allegations that side effects of Granuflo or NaturaLyte caused dialysis patients to suffer heart attacks or cardiac arrest during or shortly after treatment.
Granuflo and NaturaLyte are solutions that were used at both Fresenius dialysis clinics, as well as other treatment facilities that purchased the products from Fresenius.
The lawsuits claim that Fresenius failed to adequately warn that Granuflo and NaturaLyte convert to bicarbonate at higher levels than most doctors realized, which required that patients be closely monitored during treatment to avoid a risk of sudden heart problems.
Although Fresenius was aware that a large number of hemodialysis patients were suffering cardiac arrest at clinics throughout the U.S., plaintiffs allege that the company withheld information about the importance of monitoring patient bicarbonate levels and continued to sell the dialysis products as safe and effective.
Fresenius Granuflo and NaturaLyte Problems
Concerns about the link between NaturaLyte, Granuflo and heart problems surfaced in early 2012, after an internal Fresenius memo was leaked to the FDA.
Although the company indicated in the internal memo that it was aware of at least 941 instances where patients suffered sudden cardiac arrest during dialysis treatment in 2010, Fresenius failed to take actions to ensure that all doctors using Granuflo or NaturaLyte were aware of the problems.
Fresenius issued warnings to doctors at their own clinics in November 2011, indicating that doctors should closely monitor bicarbonate levels during treatments. However, they failed to provide the same information to other clinics that used their products. In addition, lawsuits allege that the manufacturer knew or should have known about the risk of problems long before the internal memo was issued.
In March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA classified as a GranuFlo and NaturaLyte recall.
Dialysis Treatment Litigation
Since information about the problems became public, the number of complaints filed by individuals and families throughout the U.S. has been slowly increasing, with the number of federal cases now exceeding 2,000. In addition, hundreds of cases are also pending in Massachusetts state court.
As part of the coordinated pretrial proceedings in the federal court system, a small group of lawsuits are being prepared for early trial dates, Known as “bellwether” cases, these early trial dates are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.
Judge Woodlock has scheduled the first GranuFlo lawsuit to go to trial against Fresenius on January 11, 2016, with a second bellwether trial set to begin on February 16, 2016.
Following these early trial dates in the MDL, if Fresenius fails to reach Granuflo settlements to resolve a large number of the cases pending in the MDL, Judge Woodlock may begin remanding hundreds of cases back to U.S. District Courts nationwide for individual trials.