hemodialysis-patient-300x200With more than 650 cases filed against Fresnius Medical Care the stakes are growing ever higher in what may soon become the Fresnius Dialysis Multi-District Litigation. These cases—all of which allege patients suffered cardiac arrest or death as a direct result of the problems with Granuflo or NaturaLyte dialysate systems—have been filed in federal courts throughout the U.S., which may initiate a “bellwether” trial program in order to streamline claims pursuant to a more efficient resolution of the proceedings.

The cases are not particularly diverse insofar as they all allege similar failures by Fresnius to warn patients of Granuflo and NaturaLyte acid concentrates used during hemodialysis treatment. That lack of diversity in their legal claims renders the cases more susceptible to consolidation before a single Multi-District Litigation panel, which can address the issues raised in one proceeding so that the same issues need not be addressed for the first time by various judges throughout the country. While the decisions of the first “bellwether” cases are not binding upon later cases (meaning the outcome does not have to be the same), they are instructive. Furthermore, the earlier bellwether cases can lead to global settlements that will avoid the costs of additional litigation. The MDL process also reduces the likelihood that similar cases will have different outcomes, a situation that can result in discord among the various decisions of the federal courts and forum shopping by litigants.

The circumstances surrounding the litigation are suspect at best. The allegations surrounding the Fresnius dialysis solutions were encouraged, if not initiated, by an internal Fresnius memorandum that was leaked to the Food and Drug Administration (FDA). In 2011 Fresnius conducted an internal review of the products at their own clinics in an effort to determine if and to what extent there were negative effects associated with the acid concentrates used in the dialysis systems. Fresnius identified 941 instances of cardiac arrest during dialysis treatment in 2010 alone, but failed to provide that information to non-Fresnius clinics using those products.

Now, patients that underwent dialysis at non-Fresnius locations but using Fresnius products are pursuing legal action against the company for failure to warn about the potential defects in its products. Although Fresnius did eventually provide a warning letter to non-Fresnius healthcare providers regarding the potentially negative effects of the drug in March 2012, for many that was too little too late. Nevertheless, the FDA determined that warning to constitute a recall of GranuFlo and NaturaLyte products, which only lends further credence to the plaintiffs’ claims in these proceedings.

The parties are currently discussing the possibility of proceeding with Multi-District Litigation, which involves selecting test cases that will likely proceed to trial, and will have the potential to determine the outcome of the cases not selected, whether by settlement agreement or persuasive precedent. Each side will be allowed to select a certain number of cases, and each party will likely select the cases they are most likely to win. That said, the parties remain deadlocked on which cases will go to trial first, an important issue when considering that later cases will be easily influenced by earlier decisions. While cases are often factually distinguishable, these cases all revolve around similar claims, and federal courts are typically not interested in disagreeing on the law lest they be reversed on appeal. As a result, the battle over which cases come first is not likely to end without a fight on either side.

Ultimately, it remains to be seen whether the bellwether program will go ahead as planned. Case management conferences to be held in the near future may determine the outcome of that battle, and will likely have an impact on the legal war to ensue.

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