For Victims of GranuFlo Heart Attack, It’s No Ordinary Day at Dialysis

Boston, MAAny GranuFlo lawsuit will feature a common backdrop: a patient attends a kidney dialysis clinic for the regular filtering of his or her blood through a machine. This is done on a regular basis, generally a few times per week. And it happens like clockwork. You build your weekly schedule around your dialysis appointments, after which you attend for the treatment for a few hours at a time, with a good book. Then they unhook you, and you go home. Pretty standard stuff.

No one would ever expect the possibility that you might not make it home again.

However, that’s the thrust of many a GranuFlo lawsuit, alleging that problems with the manufacture of - and subsequent dosing errors related to - products routinely used in the process of kidney dialysis, lay at the root of unexpected GranuFlo heart attack.

And sometimes death.

Given the headlines that have percolated throughout the media over the past 18 months, most are aware of the situation surrounding an alleged failure by Fresenius Medical Care, the manufacturer of GranuFlo and NaturaLyte, to alert dialysis clinics about a problem involving Alkali Dosing Errors inherent with products manufactured within a four-year time span ending in early June 2012.

To that end, Fresenius issued an urgent communique to employees in its own Fresenius-branded clinics urging caution with regard to the possibility of such dosing errors and the potential for dire consequences, but failed to issue a wider alert to non-Fresenius clinics such as those operated by DaVita Healthcare Partners. Many a DaVita lawsuit has been filed by plaintiffs alleging that DaVita Heart Attack could have been prevented had DaVita been aware of the problem. Plaintiffs allege that DaVita should have known or could have known about the problem, as plaintiffs having filed a Fresenius lawsuit similarly allege.

Most are also aware that Fresenius, for reasons which it is prepared to defend, chose not to issue a blanket alert but was eventually mandated to do so after the original Fresenius alert to its branded clinics was leaked to the US Food and Drug Administration (FDA). The regulator investigated and eventually issued a Class 1 GranuFlo recall and similar recall for NaturaLyte. Over the interim, with the FDA now aware of the problem, Fresenius issued an urgent product alert to all clinics using its GranuFlo and NaturaLyte products.

Falling a bit under the radar are issues the FDA has been having with Fresenius apart from the DaVita recall and that of other clinics using GranuFlo and NaturaLyte. About a year after Fresenius finally issued its more substantive alert to dialysis clinics in March of last year, the FDA was back with a warning letter dated March 13, 2013, taking Fresenius to task with regard to dialyzers manufactured by the company at its plant in Ogden, Utah, that had failed to conform to good manufacturing protocols.

The FDA, in its communique to Fresenius Medical Care, referenced three previous warnings as to the company’s manufacturing practices and noted that it had found Fresenius responses to be inadequate.

According to Legal Monitor Worldwide (9/23/13), the FDA opined to Fresenius, “Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”

The failure of Fresenius to issue an industry-wide alert over the NaturaLyte GranuFlo recall last year provides fodder for critics of the company, not to mention plaintiffs who have filed lawsuits over injuries or death alleged to be associated with Alkali Dosing Errors, or the timing of the Fresenius Medical Care recall.

GranuFlo heart attack lawsuits and similar litigation involving the NaturaLyte Liquid Acid Concentrate recall have been consolidated before Judge Douglas P. Woodlock in US District Court, District of Massachusetts under order by the US Judicial Panel on Multidistrict Litigation (MDL No. 2428).