September 27, 2012 — Fresenius is facing yet another GranuFlo wrongful death lawsuit, this one filed in the U.S. District Court for the Southern District of Georgia. The lawsuit was filed by Waddell Bishop, on behalf of his mother, Frances Carol Bishop. She died of a severe cardiovascular event in September 2010, after she was given GranuFlo during dialysis treatment.
The U.S. Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo and NaturaLyte earlier this year, after the products were linked to hundreds of deaths. Most of the deaths were caused by heart attacks, sudden cardiac arrest, cardiopulmonary arrest, or congestive heart failure during dialysis treatments.
In the complaint, which was filed on September 14, the plaintiff alleges that “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.” Furthermore, the lawsuit alleges that if Fresenius had provided adequate instructions or warnings, the plaintiff and her doctors never would have used the product.
Fresenius is the global leader in dialysis treatment and products, and they manufacture GranuFlo and NaturaLyte. The products are intended to be added to a patient’s blood during dialysis treatment (when the blood is removed, cleaned, and returned to the patient’s body). Dialysis naturally disrupts the balance of acid in the bloodstream, so doctors have to add products to the blood to balance the acidity before returning it to the patient. GranuFlo and NaturaLyte both contain chemicals that the patient’s liver rapidly converts to bicarbonate. If a healthcare professional does not adjust the dosage to compensate for this, the patient can easily suffer a life-threatening bicarbonate overdose, cardiovascular event, and death.
Fresenius staff first identified the issue in 2011, after more than 900 people died at Fresenius dialysis clinics. After investigating the unusual spike in patient deaths, the company sent an internal memo in November 2011 to warn about the risk of bicarbonate overdose associated with NaturaLyte and GranuFlo. However, the company did not make this information public, nor inform the U.S. Food and Drug Administration (FDA) as is required by law.
Many people have been injured or killed by GranuFlo or NaturaLyte, and the number of wrongful death lawsuits continues to grow against Fresenius. Mr. Bishop’s GranuFlo lawsuit alleges that Fresenius “intentionally, recklessly, and/or negligently concealed, suppressed, and/or misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte.”
Mr. Bishop 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.”
Do I have a GranuFlo Wrongful Death Lawsuit?
The Schmidt Firm, PLLC is currently accepting GranuFlo induced injury and wrongful death cases in all 50 states. If you or somebody you know has been injured or killed by GranuFlo or NaturaLyte dialysis treatment, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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