New GranuFlo Wrongful Death Lawsuit: Wife Faced Unnecessary Risks

New GranuFlo Wrongful Death Lawsuit: Wife Faced Unnecessary Risks

By John Curran

Daniel Ray Darnell of California says that if his wife was not subjected to the kidney dialysis chemicals GranuFlo and NaturaLyte, she would not have lost her life in 2011, according to a wrongful death lawsuit filed against Fresenius Medical Care. The case was transferred to U.S. District Court on July 15.

Fresenius Medical Care manufactured both GranuFlo and NaturaLyte, treatments that included sodium acetate to clean the blood during kidney dialysis. Unfortunately, there is medical evidence alleged in the GranuFlo lawsuit that these products can also increase bicarbonate levels. This can lead to numerous cardiac problems, including the heart failure side effects that befell Jennifer Darnell after she was administered Fresenius’s dialysis products at Da Vita, a competing dialysis clinic.

Darnell’s GranuFlo lawsuit attorney alleges that Fresenius Medical Care was aware of these issues for more than a decade prior to a FDA Class 1 Recall in 2012, listing the following memoranda and meetings:

• Dec. 7, 2000 – An internal memo indicates that clinics were unaware of the bicarbonate levels leading to NaturaLyte heart failure side effects.
• Fresenius Medical Care saw issues until 2003 and “despite knowing… that their own clinic populations were reaching dangerous levels of post-dialysis alkalosis,” did not notify other centers like the Da Vita facility of GranuFlo cardiac arrest risks.
• Between 2005 and 2009, the company’s own facilities were warned that the two kidney dialysis chemicals were linked to a 20 percent higher likelihood of fatality. In 2011, Fresenius Medical Care sent a final notice to its own centers in November 2011, according to the complaint.

Fresenius sold the two products to other companies like Da Vita that run kidney dialysis centers. However, information and the data included in those memos did not reach other companies in any form until April 2012, nearly a year after Jennifer Lee Darnell lost her life, allegedly as a result of NaturaLyte heart failure side effects.

Mr. Darnell is seeking damages for counts of negligence, failure to warn, breach of various warranties, fraud, and more.

The GranuFlo Wrongful Death Lawsuit is Daniel Ray Darnell, et al. v. Fresenius Medical Care Holdings, Inc. et al., Case No. 13-cv-05052, U.S. District Court, Central District of California.