Fresenius is facing yet another lawsuit over GranuFlo, this one filed by a Louisiana man alleging harm was caused by alkali dosing errors tied to the product.
The new lawsuit involves several allegations including that:
- Fresenius knew there were risks associated with Naturalyte and/or GranuFlo but hid that knowledge from not only the FDA, but also the public and the medical community.
- Fresenius negligently and/or fraudulently represented that tests conducted on the products proved that the products were safe for their intended use.
- Fresenius did not actually perform adequate testing to identify risks associated with Naturalyte or GranuFlo
The lawsuit centers on a Nov. 4, 2011 internal memo sent by Fresenius, that has been widely reported in the media. The memo, which appears very damaging, allegedly shows that Fresenius warned some of its medical directors and physicians about severe health risks tied to Naturalyte and GranuFlo. However, Fresenius did not warn the FDA about those same risks, which were reportedly identified in a case-control study on hemodialysis patients. According to the lawsuit, that November memo allegedly notes that the case-control study found “borderline elevated pre-dialysis bicarbonate levels and overt alkalosis arrest and sudden cardiac death.”
The lawsuit was filed by Ronnie Glasper, who was treated at a Fresenius Medical Care center in Louisiana. According to court documents, while undergoing dialysis, Glasper was prescribed either Naturalyte or GranuFlo. He later suffered a heart attack and stroke.
Glasper’s suit alleges that the memo was not sent to the Fresenius facility where he was treated or to the attending physician.
History of Problems
GranuFlo is a dry acid that is widely prescribed to evenly distribute elecrolytes during kidney dialysis. Fresenius is facing numerous lawsuits from patients alleging that they were harmed by GranuFlo and Naturalyte use. Eleven federal lawsuits were consolidated to MDL 2428 in the US District Court for the District of Massachusetts.
The health issues allegedly suffered by patients who used Naturalyte or GranuFlo include high blood serum bicarbonate levels, which can lead to death, cardiopulmonary arrest, cardiac arrhythmias, and stroke.
Contact an Attorney
If you or a loved one has suffered from GranuFlo dialysis treatment, you should contact an attorney immediately. Estey & Bomberger is nationally recognized for its success with product liability cases, including cases involving GranuFlo.