Lawsuit Says Dialysis Patient Died from GranuFlo Side Effects

Lawsuit Says Dialysis Patient Died from GranuFlo Side Effects

By John Curran

Linda McDowell of Georgia is suing Fresenius Medical Care on behalf of the estate of Renard McDowell, alleging that the company provided unsafe kidney dialysis chemicals to its own treatment facilities and those of competitors. Her GranuFlo wrongful death lawsuit was filed August 27 in multidistrict litigation pending in the U.S. District Court in Massachusetts.

Renard McDowell reportedly was undergoing kidney dialysis in August 2010 when he suffered cardiac arrest and died soon after treatment. Sudden cardiac death is a reported side effect of GranuFlo and NaturaLyte, two dialysis chemicals manufactured by Fresenius Medical Care. It is unclear in the lawsuit whether or not the treatment center Mr. McDowell died at was operated by Fresenius Medical Care or another company, but the lawsuit alleges Renard was not adequately warned of the potential risks of GranuFlo side effects even though Fresenius was aware of them.

First approved in 2003, the kidney dialysis chemicals include sodium acetate, which is a precursor to sodium bicarbonates. As early as 2004, the company was allegedly aware of the likelihood of increased bicarbonate levels and cardiac arrest side effects, thanks to a study published in that year. Four years later, kidney dialysis technicians at Fresenius treatment facilities were asked to reduce the dosage by half, according to the GranuFlo lawsuit.

Fresenius finally issued a Class 1 voluntary recall of GranuFlo and NaturaLyte in 2012, but at the time of McDowell’s death in 2010, GranuFlo side effects were being researched internally. A company memo issued to its staff on November 4, 2011, noted that 941 deaths had occurred in 667 facilities in 2010. Fresenius recommended the use of other chemicals when available after years of memos requiring changes in dosages, but that information never made it to the public.

Since the company did not pass this information along to its own centers until after 2004 and to other companies’ treatment centers until 2012, counts in McDowell’s lawsuit include breach of warranty, negligence and strict liability.

The GranuFlo wrongful death lawsuit is Linda McDowell, et al. v. Fresenius Medical Care Holdings Inc., et al., Case No. 13-cv-12096, U.S. District Court, District of Massachusetts. It was filed directly into MDL No. 2428, In Re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation.