And still another article on Fresenius' Malfeasance!!!
GranuFlo Recall: When Safety Slips through the Cracks
September 3, 2013, 02:30:00PM. By Gordon Gibb
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Washington, DC: If 2012 was a watershed year with regard to the GranuFlo recall and concern over the actions (or lack thereof) of Fresenius Medical Care, then the month of March has proven to be a watershed month spanning two years, 2012 and 2013.
GranuFlo Recall: When Safety Slips through the CracksIt was in March 2012 when the US Food and Drug Administration (FDA) first became aware of issues involving the potential for Alkali Dosing Errors that could foster GranuFlo Heart Attack and other serious health implications when a Fresenius communication to its own dialysis centers advising caution was leaked to the agency.
Given that Fresenius had decided not to issue the warning to non-Fresenius dialysis centers actively using GranuFlo and NaturaLyte (both manufactured by Fresenius Medical), the FDA stepped in and issued a Class 1 recall of the products.
For the Fresenius Medical Care recall, the Class 1 status is noteworthy, in that such recalls involve situations in which there exists a reasonable probability that the use of such products will have serious adverse health implications, and could even cause death.
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ NaturaLyte Liquid and GranuFlo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis,” the FDA said.
“This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”
That’s what happened to the wife of a GranuFlo lawsuit plaintiff. The woman, taking her standard dialysis treatment, died as the result of her treatment that involved the use of GranuFlo and/or NaturaLyte (Case # 2:13cv20858, Harris v. Fresenius, US District Court for the Southern District of Virginia, Judge Paul Zakaib Jr.).
Fresenius Medical Care is only one player in the dialysis field. There are others, such as DaVita HealthCare Partners Inc., a large operator of dialysis centers across the country. DaVita has also been implicated in lawsuits founded upon, for example, DaVita Heart Attack, through the use of NaturaLyte and GranuFlo. Thus the NaturaLyte Liquid Acid Concentrate recall would have also affected DaVita.
But Fresenius appears to have a bigger stake in the issue, in that Fresenius first identified the Alkali Dosing Errors that were arising with GranuFlo and NaturaLyte and alerted doctors and healthcare workers in their own clinics. However, Fresenius decided it could not, or should not, issue a wider alert to non-Fresenius clinics, citing the need for further studies amidst claims that the data was preliminary. Non-Fresenius clinics might never have known about the concern had the Fresenius warning letter not been leaked to the FDA, which acted swiftly with a NaturaLyte GranuFlo recall on March 29, 2012.
A year later, on March 13, 2013, the FDA was back to Fresenius with a warning letter, delivered by overnight courier, expressing concern with regard to dialyzers manufactured at the company’s Ogden, Utah plant that were found lacking in conformity with current federal good manufacturing requirements.
“Your firm should take prompt action to correct the violations addressed in this letter,” the warning letter, posted at the official FDA website, states. “Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
Dialysis patients have enough on their plate just requiring dialysis in the first place. Spending hour upon hour hooked to a machine just to survive can limit a career, amidst other frustrations. To that end, it is important for dialysis patients to be given the assurance that their procedure is safe, and does not carry the kind of potential implications that could result in a GranuFlo lawsuit.