Kelley Bernheim Dolinsky, LLC, national consumer safety law firm specializing in product liability litigation — www.duejustice.com — is alerting dialysis patients of the FDA’s Class I Recall — the most serious — for dialysis drugs GranuFlo and NaturaLyte manufactured by Fresenius Medical Care, headquartered in Waltham, Massachusetts.
Walter Kelley, managing attorney at Kelley Bernheim Dolinsky, LLC’s Boston office, explained, “Fresenius’ GranuFlo dialysis products are the subject of a Class I recall by the FDA, following discovery in 2010 that more than 900 patients suffered cardiac arrest at Fresenius dialysis clinics. GranuFlo contains elevated bicarbonate levels, considered a major risk factor in cardiac arrest. Sadly, we believe top Fresenius executives may have known of this potential problem in 2003. Even worse, when a clinical problem became evident in 2010, it appears they didn’t take appropriate measures to warn the FDA or any government agency.”
From ongoing coverage in the New York Times, Fresenius is being investigated for failing to warn customers about serious risks associated with GranuFlo and NaturaLyte. Fresenius had issued an internal memo to its own clinics on November 4, 2011, warning that 941 hemodialysis patients experienced cardiac arrest at 667 Fresenius facilities in 2010. The company’s analysis of these patients, comparing them to over 80,000 dialysis patients in the same centers, indicated excess bicarbonate, or alkalosis, significantly increased risk of heart problems in hemodialysis patients.
Attorney Kelley added, “While Fresenius alerted its own physicians and medical directors about the issue, it did not notify the general public, the FDA or other clinics using their dialysis products until the agency received an anonymous copy of the memo. Subsequently, the FDA issued a Safety Communication warning about potential dosing errors for products like GranuFlo and NaturaLyte in hemodialysis patients.”
“If there was collusion to mislead and obscure information about patients’ safety hazards, that is despicable,” Attorney Kelley continued. “Putting patients at risk in order to maintain a market share or to minimize legal responsibility would justify a Massachusetts Court to impose punitive damages against Fresenius if the evidence is there,” he said.
For more information about Fresenius dialysis heart attack claims and settlements, contact Kelley Bernheim Dolinsky, LLC at (888) 554-2889 or www.duejustice.com
For further information contact:
978-750-8000 ext. 18