Granuflo Lawsuits Continue to Progress in Federal MDL

As Granuflo lawsuits continue to mount nationwide, the coordination of federal cases against Granuflo manufacturer Fresenius continue to move forward. The judge overseeing multidistrict litigation in Massachusetts recently issued an order outlining details of the discovery process. This step follows the initial status conference for the MDL that was held at the end of September.

Discovery in process, bellwether selection to come

The federal MDL involving Granuflo and Naturalyte litigation was established in U.S. District Court for the District of Massachusetts in April, 2013. Multidistrict litigation is used to streamline numerous cases with similar allegations, for the convenience of all parties involved. Plaintiffs filing complaints against Fresenius allege the dialysis product led to heart problems and even death for some dialysis patients. Plaintiffs further state that Fresenius failed to warn the medical community and general public about the potential risks associated with their dialysis products.

Currently, there are around 230 lawsuits pending in the multidistrict litigation, with more cases filed in local courts across the country. It is expected that the number of Granuflo lawsuits in the MDL could rise to the thousands before these cases are settled or tried in court. The judge overseeing the MDL, U.S. District Judge Douglas P. Woodlock, issued the order for discovery proceedings with the intent of beginning those proceedings in late October. Deadlines for various points of the process have also been set in this order, including the selection of bellwether trials to begin in January, 2014.

Bellwether trials are common in multidistrict litigation. These trials, selected by both plaintiffs and defendants, provide a look at how juries will respond to evidence and testimony during trial. In some cases, decisions made in bellwether trials could set the stage for future settlement negotiations.

History of Granuflo lawsuits

Granuflo and Naturalyte are Fresenius products used during hemodialysis treatment. The formulas work to neutralize acids by mixing with bicarbonates in the blood. However, the unique formulation of Granuflo and Naturalyte has resulted in high levels of bicarbonate in some patients’ bloodstreams, which have led to heart irregularities, heart attack and death in some of those patients.

In March, 2012, the FDA issued a class I recall of both Granuflo and Naturalyte, stating the concentrations in the formulas could lead to excessively high levels of bicarbonate in the bloodstream. Class I recalls are the most serious type of recall the agency issues, indicating there is reasonable probability the product in question could cause serious injury or death. Since the recall was issued, the number of dialysis injury lawsuits has been steadily growing, as patients harmed by Granuflo side effects seek legal compensation for their injuries.

In addition to the dozens of complaints currently pending in multidistrict litigation, another 300 Granuflo lawsuits have been coordinated into Massachusetts state court. A smaller number is also pending in California Superior Court. The number of cases is expected to continue to rise, as more dialysis patients become aware of the potential risks associated with these Fresenius products.  Progression of the federal MDL could also prompt more plaintiffs to file federal cases in the coordinated proceedings, in hopes of pursuing a positive jury verdict or Granuflo lawsuit settlement from Fresenius Medical Care.