Fresenius Medical Care North America is the company that manufactures and distributes GranuFlo and NaturaLyte dialysate products. The products were used during kidney dialysis treatments at medical centers owned by both Fresenius and DaVita Healthcare Partners. Lawsuits filed against the companies allege patients suffered severe health problems, including cardiac arrest, cardiopulmonary arrest and death, because of issues with the dialysis products. In 2011, Fresenius allegedly sent an internal memo warning about potential issues with GranuFlo and NaturaLyte, but did not warn other medical centers about those issues until the US Food and Drug Administration (FDA) received a copy of the internal memo.
Patients and their family members filed lawsuits against both Fresenius and DaVita Healthcare partners. On April 9, Judge R. Brooke Jackson found that plaintiffs could not make certain claims against DaVita Healthcare partners because the company was not a manufacturer of the dialysis products; it merely added water to the products when they were used.
“Plaintiffs are free to allege that DaVita acted negligently in its creation of the solution or monitoring of the patient blood pH, but they cannot pretend that by adding water to a product manufactured by someone else (a step that is necessary to use the product for its intended purpose) DaVita thereby became a manufacturer of the product,” the judge wrote.
The judge also dismissed other claims, including product liability and breach of warranty, according to court documents.
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Despite dismissing some claims, the judge noted that the lawsuit includes tragic stories and said that the people who were hurt or killed due to the use of GranuFlo/NaturaLyte suffered harm while believing they were safe.
The lawsuit is Thornton et al v. DaVita Healthcare Partners, Inc. Consolidated Civil Action No 13-cv-00563-RBJ-KMT in the US District Court for the District of Colorado.