The U.S. District Judge presiding over all federal lawsuits involving heart attacks and deaths associated with Fresenius dialysis treatments is scheduled to meet with parties involved in the litigation tomorrow, to discuss the next phase for discovery in a small group of cases being prepared for trial.
There are currently more than 2,700 Fresenius dialysis treatment lawsuits pending in a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts to reduce the risk of duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and to serve the convenience of the witnesses, parties and the courts.
All of the complaints involve similar allegations that dialysis patients suffered a sudden cardiac arrest or died during or shortly after treatments involving Granuflo or NaturaLyte dialysate solutions. The products were recalled in March 2012, due to inadequate warnings about the rate at which the products convert to bicarbonate. Plaintiffs allege that if proper instructions had been provided about the importance of monitoring bicarbonate levels during treatment, hundreds of sudden heart problems and deaths during dialysis treatment may have been avoided.
As part of the coordinated proceedings, a group of 10 cases are being prepared for early trial dates, known as “bellwether” cases. These lawsuits will go through case-specific discovery before a series of trials go before juries to help gauge the strengths and weaknesses of certain evidence and testimony that is likely to be repeated throughout the litigation.
The parties are scheduled to meet with Judge Woodlock for a status conference on May 15. According to a joint status report (PDF) submitted this week, competing proposals regarding the completion of deposition discovery in the bellwether cases will be reviewed with the Court
Bellwether Discovery Plan
While attorneys for Plaintiffs and Defendants have agreed on most aspects of the phase II discovery plan, they disagree on the ability to retake depositions of several key witnesses who have already been deposed. Plaintiffs maintain that the Defendants are attempting to retake depositions without agreement of the parties and without a showing of good cause.
“Preparing and sitting for a deposition takes a great deal of time and energy – and can cause significant expense,” Plaintiffs’ attorneys said in an April 28 memorandum (PDF). “Recognizing this, Plaintiffs do not believe non-parties to these actions – namely, the victims’ physician(s) – should be subjected to a second deposition without an agreement by the parties or a showing of good cause to this Court that further questioning is warranted.”
Defense attorneys said in a April 28 memorandum (PDF) that further depositions are needed because the doctors cannot be compelled to testify in-person at trial.
According to a prior case management order, a series of Fresenius dialysis lawsuits are expected to go to trial between January and March 2016. A specific plan will be established by the end of August 2015 for identifying which of the 10 bellwether cases will go before juries and the sequence of trials.
While the outcomes of these early trial dates will not be binding in other cases, they will be closely watched by those involved in the litigation, as it may influence eventual negotiations to reach settlements with Fresenius.
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.