Fresenius Agrees to Pay $250 Million to End GranuFlo Litigation

February 18, 2016

 

Following four years of contentious litigation, attorneys from Nix, Patterson & Roach, along with co-counsel, obtained an agreement from Fresenius Medical Care to settle the GranuFlo multi-district litigation for $250 million. NPR attorneys Nelson Roach, Neil Smith, Chris Johnson, and Chad Ihrig played an integral role in litigating the GranuFlo cases, including taking numerous depositions of scientific and medical experts and fact witnesses throughout the United States.

FDA Class I GranuFlo Recall

On March 29, 2012, the FDA issued a Class I recall of GranuFlo. Shortly thereafter, thousands of lawsuits were filed against Fresenius related to its GranuFlo product. NPR was retained by more than three thousand potential plaintiffs to investigate the potential connection between GranuFlo and the death of a loved one.

Fresenius Misconduct

In November 2011, FMC delivered an urgent internal memo to its 1,800 clinics that administered GranuFlo and NaturaLyte through dialysis treatment. The memo warned doctors that 941 patients suffered cardiac arrest in FMC clinics. A study conducted by FMC researchers discovered that patients who were treated with GranuFlo were 6 times more likely to suffer a heart attack. The memo also discussed the bicarbonate complications and urged that doctors follow correct dosing procedures in order to prevent dosing errors and subsequent complications.

However, FMC failed to notify the FDA or the thousands of non-FMC clinics that administered GranuFlo and NaturaLyte during dialysis treatment. In early 2012, the FMC memo was anonymously leaked to the FDA. The FDA launched an investigation as a response to the leaked memo. FMC may be guilty for violating federal regulations by withholding this serious and life-threatening information.

When asked why the information was withheld, FMC’s Chief Medical Officer Dr. Franklin W. Maddux claimed that the only way to communicate the information was to publish it in medical journals and papers. He noted that the findings included in the memo were preliminary, and thus did not warrant publication.

The plaintiffs are represented by NPR partners Nelson Roach and Neil Smith, and associates Chris Johnson and Chad Ihrig.