More GranuFlo Lawsuits Added to Multidistrict Litigation

Boston, MAThe number of plaintiffs filing a Granuflo lawsuit continues to grow, as does the number of plaintiffs added to the multidistrict litigation set up in response to the lawsuits. Lawsuits against Fresenius Medical Care Holdings and other defendants were filed after a recall of GranuFlo and NaturaLyte was announced on March 29, 2012.


NaturaLyte and GranuFlo concentrate are used to treat acute and chronic renal failure during hemodialysis. On March 29, 2012, the US Food and Drug Administration (FDA), announced a Class I recall of the products, warning that “Inappropriate prescription of [the concentrates] can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” That can cause metabolic alkalosis, which is associated with a variety of health problems - including cardiac arrhythmia - which can result in death. The FDA issues Class I recalls when there is a reasonable likelihood that the use of the products involved will cause serious health problems or death.

Lawsuits alleging wrongful death have been filed against Fresenius, with approximately 600 reportedly pending in a federal multidistrict litigation in Massachusetts.

Among them is a lawsuit filed by Lari Parich, who alleges that her husband, Robert Parich, received GranuFlo during a dialysis treatment on February 3, 2012, and suffered a cardiac arrest and died on the same day.

Lawsuits filed against Fresenius allege wrongful death, negligent failure to warn and breach of warranty, among other claims. Some claims come from concerns that Fresenius warned treatment centers within its network about the risks associated with GranuFlo and NaturaLyte but did not notify treatment centers outside its network for approximately four months.

The US Judicial Panel on Multidistrict Litigation continues to add lawsuits to the multidistrict litigation, finding that there are similar questions of fact relating to whether the concentrates were defectively designed or manufactured and whether Fresenius knew or should have known about the risks associated with its products. In adding Tate v. Fresenius and Jennings v. Fresenius to the MDL (12/16/13), the panel found that both lawsuits “Involve virtually identical allegations that plaintiffs or their decedents suffered metabolic alkalosis as a result of the use of GranuFlo and/or NaturaLyte.”

The decision to transfer cases to MDL is not a ruling on the merits of the lawsuit; rather it is a ruling on whether the lawsuits have enough in common to be consolidated for pre-trial proceedings.

The multidistrict litigation is MDL No. 2428, US District Court, District of Massachusetts.