November 29, 2012 — An Ohio woman has filed a lawsuit on behalf of her husband, who died of a sudden cardiac arrest while undergoing dialysis treatment at a clinic operated by Fresenius Medical Care. The 56 year-old man, Charles M. Swigert, died in 2010 after being given GranuFlo, a dialysis treatment product that was recalled in June 2012 after being linked to hundreds of deaths. The complaint was filed earlier this month in the U.S. District Court for the Southern District of Ohio.
The complaint alleges that Fresenius was aware of the risks associated with GranuFlo but failed to adequately warn doctors, the public, or the FDA. According to the complaint, the “warnings and instructions were inadequate.” The lawsuit also alleges that Fresenius is responsible for Mr. Swigert’s death, which was:
“…a direct result of Defendants’ refusal to conduct a single safety study, Defendants’ suppression of clinical data revealing life-threatening risks, and Defendants’ flagrant disregard for safety by failing to disclose the risks to health care providers.”
Fresenius is facing dozens more lawsuits with similar allegations. The company created GranuFlo and used it on hundreds of thousands of dialysis patients. Fresenius also sold GranuFlo to dialysis clinics operated by other companies. When Fresenius identified life-threatening risks associated with GranuFlo, they did not immediately warn doctors at other clinics who were also using the product.
The problem is that GranuFlo contains sodium diacetate, which is rapidly converted into bicarbonate by a patient’s liver. When a physician administers GranuFlo to a patient, it is typically mixed with bicarbonate plus water. If the physician does not compensate for the converted bicarbonate in GranuFlo, the patient can easily suffer a bicarbonate overdose. This can cause a sudden, deadly cardiac arrest.
Fresenius allegedly became aware of the risks associated with GranuFlo sometime in 2010, after 941 people died at their clinics. The company sent an internal memo dated November 4, 2011, to doctors at their own clinics. The memo was not revealed publicly until an anonymous source sent it to the FDA in 2012. Fresenius is now facing many lawsuits from people who allege that the company did not adequately warn about the risks associated with GranuFlo.
Do I have a GranuFlo Lawsuit?
The Schmidt Firm, PLLC is currently accepting GranuFlo induced injury cases in all 50 states. If you or somebody you know has been injured by GranuFlo during dialysis treatment, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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