The dates specifically are January 11 and February 16, 2016 for the trials slated for Massachusetts Federal Court (In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL No. 2428). US District Judge Douglas P. Woodlock will be presiding over the two cases that will serve as a test, for lack of a better word, on behalf of over 2,000 similar cases consolidated in multidistrict litigation. As of October 15, those cases numbered 2,127 and climbing.
The Fresenius lawsuit centers on the alleged failure of Fresenius Medical Care Inc. to alert dialysis clinics outside its own cadre of branded Fresenius clinics of potential Alkali Dosing Errors inherent with its dialysis products GranuFlo and NaturaLyte. Fresenius is in the unique positon of manufacturing the two products that it uses in Fresenius-branded clinics, as well as competing clinics such as DaVita.
The problem is rooted in apparent errors, or confusion in the product labeling that could foster incorrect levels of bicarbonate in the bloodstream during dialysis that could, in turn, produce a GranuFlo heart attack or any number of other side effects. For some patients, the errors proved deadly. And because competing clinics were exposed to the potential problems with what eventually became a GranuFlo recall, DaVita heart attack was also an issue for some patients.
The recall of a product, or its label, is not new. However, what appears to set this case apart are the actions of Fresenius in the fall of 2011. To that end, a focus will be on deaths or injury that may have occurred either before or after November 4, 2011.
That’s the day when Fresenius issued an internal memo to health care professionals in its own facilities urging caution when using GranuFlo and NaturaLyte, and to carefully monitor bicarbonate levels. Fresenius, however, for reasons and positions understood only to them, decided against notifying other dialysis operators using GranuFlo and NaturaLyte. Thus, those facilities - and their patients - were in the dark with regard to the cautions, with dialysis patients at alleged risk for potentially serious health issues.
Fresenius eventually did issue a more widespread Fresenius Medical Care recall in March 2012 - four months after notifying its own clinics - but not before the internal Fresenius memo was leaked to the US Food and Drug Administration (FDA), which in turn launched its own investigation and subsequent Class I recall of GranuFlo and NaturaLyte in June of that year.
Plaintiffs charge Fresenius with failure to notify, and withholding important medical information vital to the health and safety of dialysis patients.
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There were some 1,500 non-Fresenius dialysis clinics that did not receive information about potential Alkali Dosing Errors, when Fresenius issued its initial internal memo on November 4, 2011. By the time other facilities were notified four months later, it may have been too late for some patients.