GranuFlo Heart Attack: When Dialysis Is Anything but Routine

Waltham, MAThe stories that originate from many a GranuFlo lawsuit are both compelling and heartbreaking, such as that of a woman who reportedly died while being wheeled from her dialysis station after receiving GranuFlo as part of her treatment. The dialysis clinic worker described her death as instantaneous, succumbing to a massive heart attack in mid-sentence.

Such is the legacy of GranuFlo heart attack, which has been alleged by many plaintiffs following standard dialysis procedure with products (GranuFlo and NaturaLyte) that were subject to a Class 1 recall by the US Food and Drug Administration (FDA) in 2012. The manufacturer of the two products routinely used in dialysis, Fresenius Medical, has been the target of much public scorn following reports that the company withheld troubling information about Alkali Dosing Errors related to GranuFlo and NaturaLyte, until an internal memo was leaked to the FDA.

The manufacturer is also the target of many a Fresenius lawsuit. One such lawsuit, filed back in the summer of last year, claims just that - according to court documents, Fresenius Medical Care is alleged to have knowingly concealed health risks associated with its GranuFlo dry acid concentrate, putting patients at risk for heart attack and stroke. The twist in this particular lawsuit is the fact that it is framed as a false advertising lawsuit.

GranuFlo, as mentioned above, is a dry (powdered) product that is designed to be mixed with NaturaLyte (a liquid) in order to facilitate dialysis, a process that is required by thousands of patients who have limited kidney function. When the kidneys no longer do an adequate job in cleaning the blood of impurities, the task has to be undertaken mechanically via dialysis. Many patients require dialysis upwards of three times per week.

The regulation of bicarbonate levels in the blood is an integral part of the process. In the fall of 2011, GranuFlo and NaturaLyte manufacturer Fresenius identified inconsistencies with the product labeling that could potentially result in bicarbonate levels spiking too high in the bloodstream during dialysis. Bicarbonate levels that are too high can, in heart patients, pose a heightened risk for sudden cardiac arrest and stroke. Numerous lawsuits allege just that.

Fresenius, which also operates a chain of dialysis clinics, noted the troubling issue in an internal memo directed to clinicians in its own facilities, but withheld the information from the wider medical community and competing, non-Fresenius clinics that also employed the use of GranuFlo and NaturaLyte. Nor did the company voluntarily report its finding to the FDA until the memo, originally issued in November 2011, was leaked to the FDA in March 2012 and the FDA launched an investigation. At the time, Fresenius defended its action, noting that its findings were preliminary, and that it was premature to issue a communique for wider distribution. Fresenius also noted that such a statement would require publication in professional journals, which would take time.

However, once it was aware the FDA was involved, Fresenius apparently reversed its initial decision and issued a directive to all clinics using GranuFlo and NaturaLyte, including competitor DaVita. The latter is also the target of lawsuits alleging DaVita Heart Attack resulting, allegedly, from the use of GranuFlo and NaturaLyte.

The GranuFlo lawsuit filed in August in California doesn’t buy Fresenius’ claim that releasing its concerns to a wider audience was premature. “Despite knowing the serious risk factors associated with GranuFlo,” states the complaint, “and in efforts to increase sales of [the product], defendants embarked on a comprehensive and carefully-orchestrated scheme to promote the safety, and effectiveness of GranuFlo through a fraudulent and deceptive marketing program to plaintiffs, class members, their respective physicians and the public.”

The plaintiffs are seeking class-action status.

In the meantime, a wrongful death lawsuit filed in June alleging GranuFlo death was filed by the heir of a dialysis patient, and is a further example of the kinds of lawsuits that have been emerging from this issue. The victim, identified as Filmon Brysten, underwent dialysis at Langhorne Health Center in November 2011 - the same month that Fresenius issued its internal memo with regard to the dangers of GranuFlo and NaturaLyte. Brysten subsequently died. The executrix of his estate, Carmen Brysten, and an heir to the estate, alleges GranuFlo and NaturaLyte is to blame for Brysten’s death, and that Fresenius shielded the link between use of GranuFlo/NaturaLyte and the risk for heart attack and stroke from patients, medical providers and the FDA.

That GranuFlo lawsuit (Brysten v. Fresenius Medical Care Holdings Inc., Case No. 130601961, Court of Common Pleas for Philadelphia County) contends that Fresenius employees knew of the link between GranuFlo/NaturaLyte and the risk for GranuFlo heart attack and stroke prior to May 2005. Were that to be true, as it is alleged, the manufacturer would have issued its Fresenius Medical Care recall seven years later, and only after the FDA became involved following the leak of the Fresenius internal memo in March of that year.

That was two years ago. In the meantime, some 400 lawsuits alleging Alkali Dosing Errors have since been consolidated in multidistrict litigation in US District Court, District of Massachusetts (MDL# 2428). And the lawsuits keep coming; one recent lawsuit was filed by the family of a woman who died from metabolic alkalosis and cardiac arrest, allegedly a GranuFlo heart attack. The case is Gracey Goff, Individually and as Representative of the Estate of Beulah Mae Goff, Deceased v. Fresenius Medical Care Holdings, Case No. 3:13cv05065-B and was recently filed in US District Court, Northern District of Texas.

The Fresenius lawsuit alleging false advertising is Rodriguez et al. v. Fresenius USA Inc. et al., case number BC519374, in the Superior Court of the State of California, County of Los Angeles.