Texas GranuFlo Lawyer

November 12, 2012 — The son of Harold Bolton has filed a lawsuit against Fresenius Medical Care, the company that manufactures GranuFlo and Naturalyte, two acid concentrate products that are commonly administered during kidney dialysis. Unfortunately, the products contain sodium diacetate, which doubles the amount of acetate compared to other products containing acetic acid. Because acetate is converted to bicarbonate, patients who are given GranuFlo or Naturalyte are highly susceptible to bicarbonate overdoses, cardiac arrest, and death.

 

The deceased plaintiff in the lawsuit, Harold Bolton, was given GranuFlo and Naturalyte three times a week beginning in approximately 2006. On October 24, 2010, he received dialysis treatment at a Fresenius dialysis clinic in Clarke County, Georgia, where he was given GranuFlo. On October 26, he died from a sudden heart attack. The lawsuit alleges that GranuFlo was directly responsible for his death.

The lawsuit also alleges that GranuFlo and Naturalyte were “unreasonably dangerous and therefore, defective.” The products have been associated with sudden cardiac death, heart attack, cardiac arrest, and death.

Furthermore, the lawsuit alleges that the warnings on GranuFlo and Naturalyte were not sufficient to warn the patient or healthcare professionals about the extent of the risks and dangerous side effects associated with GranuFlo. The lawsuit alleges that Fresenius was negligent because they “failed to provide adequate warnings and instructions after the Defendant knew or should have known of the significant risks.”

As evidence for their argument, the lawsuit cites a November 4, 2011 memorandum Fresenius circulated among its employees, which warned of a significant increased risk of cardiac arrest and death associated with GranuFlo and Naturalyte. This memo was not reported to the FDA, other government agencies, non-Fresenius physicians and clinics that were using GranuFlo and Naturalyte, or the public.

The memo specifically warned that “borderline elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associated with 6 to 8 fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility.” The memo also recommended that the issue “needs to be addressed urgently.”

The November 2011 memo did not reach the FDA until March 2012. When the FDA inquired about the memo, Fresenius quickly issued a 2-page memo to non-Fresenius physicians. However, they did not stop manufacturing the products until the FDA issued a Class 1 recall in June 2012, after thousands of people were exposed to these products.

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The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free GranuFlo lawsuit review.

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Collen A. Clark

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

“Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

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