Fresenius Medical Care, the world’s largest dialysis services provider, is facing several wrongful death lawsuits alleging that one of its products caused sudden cardiac death in patients. The dialysis company is accused of being aware of but withholding information from the Food and Drug Administration (FDA) and its customers about the serious health risks associated with its GranuFlo dialysis concentrate products.
In response to the allegations, a spokesperson with Fresenius issued this statement: “As a result of the office’s (the chief medical office of Fresenius) efforts, its review of data may sometimes identify a working hypothesis or preliminary concern that it wants its medical directors and admitting clinicians to consider, but which it does not view as sufficiently developed to support peer reviewed or general external publication.
“In this case, with respect to ‘total buffer,’ the Chief Medical Office distributed to FMS medical directors a working hypothesis relating to dialysate mix products in general, but also specifically citing our products Granuflo and Naturalyte, that – pending further data collection, analysis, and development – might or might not eventually support conclusions warranting general external or peer reviewed publication.
“When this circular to FMS medical directors was brought to the attention of the FDA, the agency invited a dialogue with Fresenius Medical Care in which we have been pleased to participate and that is continuing, and which encompasses ways that the kidney care community can be reminded and encouraged more aggressively to consider the implications of all sources of ‘total buffer’ in the dialysis process. In consultation with the FDA, we have refined our already-existing warnings and reminders about ‘total buffer’ connected to our products and, we anticipate, have provided a foundation for broader publication by the FDA to the entire community.
“We look forward to the successful conclusion of this dialogue with the FDA and are proud of our role in these developments.”
Last week, a group of plaintiffs filed a petition to form a federal multi-district litigation (MDL) against Fresenius Medical Care Holdings, Inc., and its subsidiaries for the wrongful deaths of dialysis patients who received toxic amounts of Granuflo and NaturaLyte, another concentrate made by Fresenius.
Source: Nephrology News & Issues