Following several years of litigation over an increased risk of cardiac arrest of death linked to side effects of GranuFlo and NatruaLyte dialysis treatments, Fresenius Medical Care has agreed to pay $250 million to resolve thousands of claims filed by individuals throughout the U.S.
There are currently at least 4,300 Fresenius dialysis lawsuits pending in the Federal court system, with hundreds more pending in Massachusetts and other state court systems.
Each of the complaints raised similar allegations that the dialysis treatment provider failed to adequately warn doctors about the importance of closely monitoring patients receiving GranuFlo or NaturaLyte diaysate solutions, which have been found to raise bicarbonate levels and increasing the risk of sudden cardiac arrest or death during or shortly after hemodialysis.
In a press release issued February 17, a Fresenius settlement was announced that may resolve the litigation if 97% of all plaintiffs agree to accept the offer by July 2016.
Fresenius is offering to pay $250 million to settle NaturaLyte and GranuFlo lawsuits, with the medical provider’s insurance carrier funding about $220 million of the cost.
The agreement in principal reached with plaintiffs’ lawyers appointed to leadership roles in the litigation, calls for the settlement to be funded by August 2016 if the required threshold of claims are resolved.
Since April 2013, the federal Fresenius dialysis litigation has been centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, as part of an MDL or multidistrict litigation, where a series of cases were being prepared for “bellwether” trials, which were designed to help the parties gauge how juries may respond to certain evidence and testimony that would be repeated throughout the cases. However, with the Fresenius settlement offer pending, those trials are likely to be deemed unnecessary.
Fresenius Dialysis Problems
All of the lawsuits stem from a March 2012 recall issued after federal health regulators discovered that Granuflo and Naturalyte solutions may increase the risk that dialysis patients suffer sudden cardiac arrest or die during or shortly after treatment. The complaints allege that Fresenius failed to adequately warn doctors about the importance of monitoring bicarbonate levels when using Granuflo or Naturalyte.
While Fresenius is the largest operator of dialysis centers in the U.S., it also manufactures products used at other clinics as well, including GranuFlo and NaturaLyte dialysate solutions.
According to allegations raised in the lawsuits, Fresenius knew or should have known that Granuflo and NaturaLyte convert to bicarbonate at higher rates than other products, but failed to warn doctors about the importance of monitoring levels during treatment. As a result, during the years before the recall, many patients suffered sudden cardiac arrest or died at dialysis clinics due to side effects of the products..
Concerns about the link between NaturaLyte, Granuflo and cardiac arrest reports first 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 at their own clinics in 2010, Fresenius failed to take actions to ensure that all doctors using Granuflo or NaturaLyte were aware of the problems.
In November 2011, the company issued warnings to doctors at Fresenius clinics, indicating that doctors should closely monitor bicarbonate levels during treatments. However, the same warnings were not provided to other clinics that used GranuFlo and NaturaLyte. In addition, lawsuits allege that the manufacturer knew or should have known about the risk of problems long before the internal memo was issued.
Fresenius finally provided a warning letter to all healthcare providers in March 2012, which the FDA classified as a recall of GranuFlo and NaturaLyte.
As is noted in the press release announcing the Granuflo and NaturaLyte settlement, the Fresenius products remain on the market and unchanged, but doctors are now aware of the importance of monitoring bicarbonate levels.