Wife of Dialysis Heart Attack Victim Sues Fresenius for Negligence

A Florida woman is seeking damages as a result of her husband’s death in 2009 on information and belief that he was exposed to dangerous dialysis chemicals sold and marketed by Fresenius Medical Care, according to a recently filed GranuFlo lawsuit.

According to the complaint filed by Clavel Zialcita, her husband Mario Zialcita suffered from heart failure around the time that he was undergoing kidney dialysis treatment in Encinitas, Calif. in 2009. The case is one of hundreds of GranuFlo lawsuits filed against Fresenius since it recalled the dialysis product in 2012.

Common allegations raised in GranuFlo lawsuits include counts of strict liability, failure to warn, negligent design and misrepresentation, and breaches of various warranties. Accordingly, they allege that Fresenius Medical Care failed to adequately “label and warn about their products,” which led to hundreds of patients suffering sudden cardiac arrest. Close to 900 deaths have been linked to the dialysis drugs GranuFlo and NaturaLyte before the GranuFlo recall was issued.

>>File a GranuFlo Recall Lawsuit

Since both of the kidney dialysis chemicals include sodium diacetate, they increase levels of bicarbonate levels in the bloodstream, and without further warnings to technicians this results in an “unanticipated amount of bicarbonate” and “an unanticipated amount of total buffer.” The company allegedly should have known that the chemical would lead to the increased levels that could lead to NaturaLyte heart failure side effects, according to GranuFlo recall lawsuits.

The approval process for GranuFlo also was problematic because it used an accelerated U.S. Food and Drug Administration process that only required the chemical maker to demonstrate that it was substantially similar to those already on the market without performing treatment-specific clinical trials for humans. Fresenius alleged that there was a limited possibility of GranuFlo cardiac arrest side effects in its request for approval, asserting that “the use of sodium diacetate or acetic acid will have no effect on the final content of the solution.

The GranuFlo lawsuit is Clavel Zialcita et al. v. Fresenius Medical Care Holdings, Inc. et al. , Case No. 14-cv-10348, U.S. District Court, District of Massachusetts.

Patients who have dealt with problems regarding these kidney dialysis chemicals, or their surviving relatives, may be able to file a complaint against Fresenius as many others have. Submit your information at the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. Depending on the facts of your case, you may be eligible for a free consultation with a NaturaLyte lawsuit attorney to learn about your next steps.