Consumer Lawyers

Granuflo News/Litigation for October 2012

In Product Recalls on October 16, 2012 at 8:34 pm

Fresenius is facing yet anotherGranuFlo 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 manufactureGranuFlo 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.

 

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