By Courtney Jorstad  |  November 14, 2013

Category: Pharmaceuticals


Patient sits by dialysis machine.A Mississippi woman has filed a GranuFlo and NaturaLyte wrongful death lawsuit against Fresenius Medical Care alleging that the kidney dialysis additive was the direct cause of her husband’s death.

Ricky Wilson Sr. received regular dialysis treatment at a Fresenius clinic in Aberdeen, Mississippi three days per week. On Jan. 11, 2011, Mr. Wilson died at age 53 of cardiac arrest after his dialysis treatment. His wife, Betty Wilson, believes the heart attack that took her husband’s life was the result of Fresenius’ negligence and wrongful acts she detailed in the lawsuit she filed against Fresenius in federal court on Aug. 30, 2013.

GranuFlo and NaturaLyte are used to remove impurities from the blood during kidney dialysis treatment. During dialysis a solution goes 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.

GranuFlo and NaturaLyte work by neutralizing the acid in the blood by providing bicarbonate. 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 need to be used. When the acid concentrate enters the bloodstream they are 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 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 becomes 6 to 8 times more likely and can lead to sudden death.

In November 2011, Fresenius sent a memo to its own clinics — not all of the clinics that use GranuFlo and NaturaLyte — stating that GranuFlo was responsible for 941 deaths due to cardiac arrest at clinics in 2010. They didn’t notified all of the clinics where the acid concentrates were used until March 2012, after Fresenius was questioned by the U.S. Food & Drug Administration (FDA) upon receiving an anonymous copy of 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.

Mrs. Wilson is charging Fresenius with negligence, negligent misrepresentation, product liability, failure to warn, breach of express warranty, fraudulent misrepresentation, and fraudulent concealment.

She is suing for compensatory and punitive damages.

The GranuFlo/NaturaLyte lawsuit is Betty Wilson v. Fresenius Medical Care Holdings, Inc. et al., Case No. 1:13-cv-00211-SA-DAS, in the Circuit Court in Clay County, Mississippi.

If you or someone you know experienced a negative side effect after GranuFlo or NaturaLyte were 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 acid concentrates played a roll in your complications, so act now.

 

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