Parties involved in the federal lawsuits against Fresenius Medical Care over problems with Granuflo and Naturalyte dialysis solutions are scheduled to meet this week with the U.S. District Judge presiding over the litigation, with two bellwether test cases expected to go before juries early next year.
There are currently more than 4,300 Fresenius dialysis treatment lawsuits pending in the federal court system, which all raise similar allegations that the company failed to warn about the heart risks associated with their dialysate solutions used at clinics throughout the United States.
Since April 2013, the federal 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.
A status conference (PDF) is scheduled before Judge Woodlock on Friday, at which time the parties are expected to review the scheduled start for two initial bellwether trials that have been selected to help gauge how juries may respond to certain evidence and testimony that is likely to be presented throughout many of the cases.
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.
The first bellwether case is expected to begin in January 2016, involving a complaint (PDF) filed by Edward J. Lastorka in November 2013, following the 2010 death of his wife, Jackie, who suffered a fatal cardiac event during treatment at a Fresenius dialysis clinic in Mississippi.
A second case is slated to go to trial in February 2016, including a similar complaint (PDF) filed by Florella Dial, whose husband, Carley, died in February 2012 of a severe adverse cardiovascular event after NaturaLyte or GranuFlo treatment at a Fresenius clinic in Pembroke, North Carolina.
While the outcomes of these early trial dates will not be binding on other claims, they may help the parties reach Fresenius settlements over the dialysis treatments, avoiding the need for thousands of individual trials to be scheduled in U.S. District Courts nationwide.
Fresenius Dialysis Problems
GranuFlo and NaturaLyte are dialysate solutions that were manufactured and sold by Fresenius Medical Care North America for use at their own dialysis clinics, as well as facilities owned by other companies.
According to allegations raised in the lawsuits, Fresenius knew or should have known that Granuflo and NaturaLyte convert to bicarbonate at higher rates than similar products, but warnings were not provided about the importance of monitoring levels during treatment with these products. As a result, many patients suffered sudden cardiac arrest or died during hemodialysis treatments involving GranuFlo and NaturaLyte.
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 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 recall of GranuFlo and NaturaLyte.
Following a series of bellwether trials in the MDL, if the parties fail to resolve large numbers of claims, Judge Woodlock may begin remanding cases back to U.S. District Courts throughout the country for individual trials.