A status conference will be held today in the federal multidistrict litigation established for all Fresenius dialysate solution lawsuits, involving claims that dialysis patients suffered sudden heart problems from Granuflo or Naturalyte. During the conference, it is expected that the Court will review pending motions in the cases, including requests that could send some of the lawsuits back to state courts where they were originally filed.
More than 312 product liability lawsuits filed throughout the federal court system against Fresenius Medical Care are currently consolidated for pretrial proceedings before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, and the number of claims continues to grow each month as dialysis injury lawyers review and file new complaints.
All of the cases involve similar allegations that patients suffered heart attacks, cardiac arrest or sudden death during or shortly after hemodialysis where Granuflo or Naturalyte dialysate products were used. Plaintiffs allege that Fresenius failed to adequately warn about the risk of problems with these products or the importance of doctors monitoring bicarbonate levels during treatment.
According to a docket entry earlier this month, a status and scheduling conference will be held today at 2:30 p.m. before Judge Woodlock and attorneys involved in the cases have been asked to be prepared to address any outstanding motions in the cases at that time.
In a Notice (PDF) filed October 31, attorneys for Fresenius notified the court of various motions pending in different cases where plaintiffs are seeking to remand the lawsuits back to state courts where the lawsuits were originally filed.
At least 22 complaints have been filed in California state court, and Fresenius has already removed at least 12 of those cases to federal court system based on diversity jurisdiction. According to a statement (PDF) filed October 11, at least another six cases in California state court are expected to be removed shortly.
Plaintiffs maintain that the cases were properly filed in state court and are attempting to have the cases returned back to California. While Judge Woodlock directed the parties to be prepared to discuss these outstanding motions, it is unlikely that any ruling on the motions will be issued at this time.
GranuFlo and NaturaLyte Heart Attacks
The Naturalyte and Granuflo litigation remains at the early stages, as the process for beginning the exchange of information and documents between the parties was just outlined last month.
At this time, the number of cases pending nationwide is continuing to increase at a fast pace, with more than 20% of the cases currently pending in the Fresenius MDL being transferred into the consolidated proceedings over the past sixty days.
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 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.
In addition to the federal litigation, Fresenius faces another 300 cases that are centralized in Massachusetts state court, where the litigation has been specially assigned to Judge Maynard M. Kirpalani for pretrial purposes. There are also about several lawsuits against Fresenius consolidated in California Superior Court, which are assigned to Judge Lee Smalley Edmon.