September 27, 2012 — Another GranuFlo wrongful death lawsuit has been filed against Fresenius, manufacturers of GranuFlo and NaturaLyte dialysis treatments. The lawsuit was filed by Waddell Bishop, son of Frances Carol Bishop, who died of a severe cardiovascular event while she was undergoing dialysis treatment in September 2010. The complaint was filed this month in the U.S. District Court for the Southern District of Georgia.
The use of GranuFlo and/or NaturaLyte is associated with an increased risk of death and cardiovascular injuries, including heart attack, cardiovascular death, sudden cardiac arrest, cardiopulmonary arrest, congestive heart failure, and more.
According to the complaint, “neither the product label, packaging, instructions, nor the packages containing the product, provided adequate instructions and/or warnings regarding the use of GranuFlo and/or NaturaLyte.” The lawsuit also alleges that the plaintiff and her healthcare providers never would have used the product had the risks been fully disclosed beforehand.
GranuFlo is a dry acid and NaturaLyte is a liquid acid concentrate that are used during dialysis (when a person with kidney failure has their blood removed, mechanically cleaned, and returned to their body). During the dialysis process, acids naturally build up in the blood. Doctors typically add bicarbonate, GranuFlo, or NaturaLyte to balance the acidity of the blood before returning it to the patient. Unfortunately, both GranuFlo and NaturaLyte contain an ingredient that the patient’s liver rapidly turns into bicarbonate. If a doctor is not very careful with the dosage, the patient can easily suffer a bicarbonate overdose, which can cause a life-threatening cardiovascular event.
The risk of bicarbonate overdose was first identified by Fresenius’s own staff, who noticed a sharp increase in the rate of patient deaths at Fresenius dialysis clinics. The company sent an internal memo in November 2011 to warn about this risk, but they failed to inform the U.S. Food and Drug Administration (FDA) or doctors at other clinics about the safety hazard.
As a result, many people who were injured by GranuFlo or NaturaLyte are now seeking justice and compensation for their injuries by filing a lawsuit. Waddel Bishop’s lawsuit alleges that Fresenius “intentionally, recklessly, and/or negligently concealed, suppressed, and/or misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte.”
The lawsuit also alleges that Fresenius “had reason to know, and/or did know, that GranuFlo and NaturaLyte were not safe and was associated with an increased risk of death and serious injuries.”
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