Pa. Woman Blames GranuFlo for Her Mother’s Death

Pa. Woman Blames GranuFlo for Her Mother’s Death

By Courtney Coren

A GranuFlo/NaturaLyte lawsuit has been filed against Fresenius USA Inc. by a Pennsylvania woman who claims that her mother died as a result of the dialysis additives being used in her treatments. 

Pamela Dawkins has brought a GranuFlo/NaturaLyte lawsuit against Fresenius on behalf of her now deceased mother Beverly Dawkins saying that the two acid concentrates that were used during her mother’s kidney dialysis were solely responsible for her mother’s death as they are unreasonably dangerous products. 

In 2006, Beverly began receiving kidney dialysis three times a week when she was prescribed GranuFlo and/or NaturaLyte as part of her treatment. On Sept. 30, 2006, Beverly was at Fresenius Medical Center in Philadelphia, Pennsylvania for dialysis when she suffered a cardiac arrest and died. 

During dialysis a solution passes through an artificial kidney to clean the blood, since the kidneys are no longer able to do the work themselves. The solution is made up of three fluids: ultra-pure water, bicarbonate concentrate, and acid concentrate. Fresenius makes and sells two acid concentrates — GranuFlo and NaturaLyte. 

For kidney dialysis treatment to work and do the job of filtering the blood that is normally done by the kidneys, an acid concentrate such as GranuFlo or NaturaLyte needs to be used. GranuFlo and NaturaLyte work by neutralizing the acid in the blood by providing bicarbonate. When the acid concentrate enters the bloodstream it is naturally converted to bicarbonate. Bicarbonate is how more than 90 percent of carbon dioxide takes form in the bloodstream— keeping the blood from becoming too acidic— a job normally done by healthy kidneys. 

The problem with GranuFlo and NaturaLyte is that they were allegedly not properly dosed and were linked to a potential rapid increase of bicarbonate, leading to a condition known as alkalosis—meaning that the blood has become too alkaline. If a person develops alkalosis, the risk of a catastrophic heart side effect reportedly becomes 6 to 8 times more likely and can lead to sudden death.

“Defendants’ conduct was wanton and willful and displayed a conscious disregard for the safety of the public and particularly, Beverly Dawkins,” the GranuFlo/NaturaLyte lawsuit states. 

In November 2011, Fresenius sent a memo to its own clinics stating that GranuFlo was responsible for 941 deaths due to cardiac arrest at clinics in 2010. The company notified all of the clinics where the acid concentrates were used in March 2012 after Fresenius was questioned by the U.S. Food & Drug Administration (FDA) upon receiving an anonymous copy of the November 2011 memo.

In June 2012, the FDA issued a Class I recall of NaturaLyte and GranuFlo—the most serious recall they can issue, restricted only for products that may result in severe injury or death. 

However, the GranuFlo lawsuit argues that Fresenius knew about the risks associated with the dialysis treatment additive as early as October 2004 due to a study that was published at that time in the American Journal of Kidney Diseases showed an increase of alkalosis in GranuFlo patients. 

The GranuFlo lawsuit was added to the GranuFlo multidistrict litigation currently underway against GranuFlo drug maker Fresenius in Massachusetts District Court under Judge Douglas P. Woodcock. 

The GranuFlo/NaturaLyte lawsuit is Pamela Dawkins v. Fresenius Medical Care, Case No. 1:13-cv-12409-DPW, in the U.S. District Court for the District of Massachusetts.

If you or someone you know experienced a negative side effect after GranuFlo or NaturaLyte was used during kidney dialysis, legal options are available. Learn more and get a free consultation regarding a claim’s eligibility at the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. Experienced legal professionals are available to determine whether acid concentrates played a role in your complications, so act now.