Granuflo Lawsuits | Fresenius Lawsuit

GranuFlo Lawsuits May Be Centralized in MDL

Staff Writer | January 18th, 2013

Granuflo Lawsuit Lawyer 2In early January 2013, Fresenius USA filed paperwork with the Judicial Panel on Multidistrict Litigation (JPML) to support the consolidation of GranuFlo lawsuits and formation of an MDL. On January 3, the defendant issued a statement that, while the company agrees with some Fresenius lawsuit plaintiffs that Massachusetts is the best venue, they believe that these complaints will ultimately fail due to lack of evidence linking GranuFlo and NaturaLyte to dangerous or fatal injuries.

Fresenius lawsuit MDL venue up for debate

A potential multidistrict litigation would consolidate hundreds of cases from around the nation. Currently, at least 732 plaintiffs from 46 states have filed GranuFlo lawsuits, the first in September 2012. Many plaintiffs, however, favor Alabama or Mississippi, not Massachusetts, as venue for an MDL. Either of these locations could prevail, as a disproportionate number of plaintiffs hail from the southeastern U.S. Another factor on their side: few MDL cases are currently docketed in the region.

In December 2012, 11 plaintiffs filed to transfer pending claims to U.S. District Court for the District of Massachusetts. In the last month, 26 additional cases have been filed in federal court, including Louisiana, Illinois, Colorado and New York. These plaintiffs would be prime candidates to join future multidistrict litigation.

Fresenius denies its products can be linked to dangerous side effects

While Fresenius purports to support MDL proceedings, the company denies that involved plaintiffs will have any success in proving their cases. In part, the company bases its argument on the fact that its products have been safely used since receiving FDA approval 20 years ago. A representative for Fresenius stated, “The plaintiffs’ claims will fail on their merits because the plaintiffs cannot show that Fresenius’ products are unreasonably dangerous or that Fresenius failed to provide adequate warnings and instructions to the ‘learned intermediaries’ who used GranuFlo and NaturaLyte to treat dialysis patients… Although the injuries alleged by these plaintiffs are serious, the plaintiffs will not be able to prove that those injuries were actually caused by Fresenius products or the information that Fresenius provided about those products.”

GranuFlo lawsuits filed after leaked internal memo

Despite Fresenius claims to the contrary, there is at least one piece of evidence that points to a dangerous product: the company’s own internal memo. In November 2011, a Fresenius Medical Care internal memo reported that 941 patients had suffered heart attacks while prescribed NaturaLyte and GranuFlo products at the company’s clinics. The public did not learn of the risk until the memo was anonymously forwarded to the FDA in early 2012, prompting a recall of both dialysis additives. The plaintiffs’ GranuFlo lawyer teams will surely cite the memo, which quoted “troubling findings” that called for “urgent address.”

  1. National Kidney Foundation. (2012). Hemodialysis.

  2. Dual-concentrate bicarbonate-based hemodialysis: know your buffers.