Three years after Fresenius Medical Care was forced to recall Granuflo and NaturaLyte dialysis treatments due to concerns about a risk of patients suffering sudden cardiac arrest, preparations continue for a group of “bellwether” lawsuits to go before federal juries in early 2016.
There are currently more than 2,700 Fresenius dialysis treatment lawsuits filed throughout 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.
The cases stem from a March 2012 recall issued after federal health regulators discovered that side effects of Granuflo and Naturalyte solutions may increase the risk that dialysis patients may 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.
Since April 2013, the federal Fresenius litigation has been centralized for pretrial proceedings before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, where a small group of cases are being prepared for early trial dates that are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the lawsuits.
Following a status conference earlier this month, a proposed case management order (PDF) was filed by the parties regarding the process for determining the sequence of cases that are expected to go to trial between January and March 2016.
An initial pool of 20 cases were selected by the parties for early trial dates. However, after at least eight plaintiffs dismissed their cases, the parties are continuing to prepare 12 cases for early trial dates.
According to the proposed order, the parties have agreed that Fresenius will not replace the dismissed cases, and the bellwether trials will be selected from the remaining pool of 12 lawsuits.
By the end of this month, the pool is expected to be reduced to 10 cases that will be eligible for the first trial dates. Plaintiffs will identify two “protected cases” by March 20, following which, Fresenius will be allowed to strike two of the remaining cases. Those cases will then continue through case-specific discovery in preparation for trial.
It is expected that a plan will be established by the end of August 2015 to identify the specific cases and sequence of bellwether trials set for January to March 2016.
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.
While the outcomes of these bellwether trials will not be binding on other claims, they will be closely watched by lawyers involved in the cases as they may influence negotiations with Fresenius.
Following the bellwether trials, if Fresenius settlements for the dialysis treatment deaths and injuries are not reached, Judge Woodlock may begin remanding cases back to U.S. District Courts throughout the country for individual trials.