The Delicate Dance of GranuFlo Litigation

Denver, COThe recent dismissal of certain claims against defendant DaVita in a GranuFlo DaVita lawsuit provides a window into the dance that GranuFlo recall lawsuits may become, given the nature of the GranuFlo portfolio and the backstory that involves Fresenius Medical Care.

The latter is the manufacturing entity of the powdered GranuFlo that is then mixed with water by the dispensing dialysis provider for use in kidney dialysis. There have been numerous allegations of GranuFlo Heart Attack due to Alkali Dosing Errors inherent with the labeling, or so it is alleged, of GranuFlo and a related product, NaturaLyte.

The foregoing products are routinely used in the dialysis process and play a role in delivering optimum levels of bicarbonate in the bloodstream deemed to be in the safety zone. However, reported labeling problems with GranuFlo manufactured between January 2008 and June 2012 resulted in higher levels of bicarbonate in the bloodstreams of dialysis patients, in some cases resulting in GranuFlo heart attack and for some patients, even death.

Lawsuits have been launched against DaVita, which operates a network of kidney dialysis clinics throughout the country, and Fresenius Medical Care, the manufacturer of GranuFlo (powder) and NaturaLyte (liquid). Fresenius also operates its own network of dialysis clinics, and thus serves as a competitor to DaVita in the dialysis arena.

There are several overlaps. Fresenius competes with DaVita on the dialysis front, while vending GranuFlo and NaturaLyte to DaVita as the manufacturer and supplier. Thus, Fresenius wears two hats in what can easily be described as a complex relationship.

That complexity is further vexed by the Fresenius admission, in spring 2012, that it had detected problems with GranuFlo and NaturaLyte months earlier - problems that resulted in a recall of the products over labeling issues. The issue, of course, also resulted in a DaVita recall, as DaVita was using GranuFlo and NaturaLyte as well and allegedly was only following the directions on the product labels when mixing.

Thus, would DaVita - an end user - carry the same liability as the manufacturer and supplier, identified as Fresenius?

The portfolio could increase even further in complexity

That’s the point a judge overseeing Thornton v. DaVita HealthCare Partners Inc.; Case No. 1:13-cv-00573, in the US District Court for the District of Colorado, recently dealt with. To that end, US District Judge R. Brooke Jackson dismissed strict liability, breach of warranty and product liability claims in a putative class action against DaVita, due to the fact that DaVita is an outpatient facility only and is not the manufacturer.

The judge did allow that plaintiffs “are free to allege that DaVita acted negligently in its creation of the solution or monitoring of patient blood pH.” The judge also refused to deny plaintiffs the opportunity to accuse DaVita of failure to notice problems with its dialysis treatment stemming from the yet-to-be-recalled GranuFlo and NaturaLyte, together with an alleged failure to take timely corrective action in order to spare harm to patients who otherwise might have been spared a DaVita Heart Attack, stroke or other cardiovascular incident. However, plaintiffs must stop short of any allegations pertaining to manufacture.

Thus, the lines are beginning to be defined. But there are some definite challenges ahead concerning liability.

DaVita, for example, may have to answer allegations of negligence over its administering of a problematic substance and an alleged failure to protect dialysis patients from harm.

However, on the surface, Fresenius Medical Care may face a bigger problem, with more issues at play.

That’s because of an internal memo, composed and issued by Fresenius in November 2011 and distributed exclusively to its branded dialysis facilities, noting a potential problem with GranuFlo and NaturaLyte that appeared to be having an adverse effect on dialysis patients. The issues were described in the internal memo as potentially serious.

The communique, however, was not distributed outside the Fresenius “family,” as it were. It wasn’t until the memo was leaked to the US Food and Drug Administration (FDA) in the spring of 2012 that the proverbial manure hit the fan, with Fresenius getting busy subsequent to an FDA investigation. Other end users and outpatient clinics deploying GranuFlo and NaturaLyte - including DaVita - were alerted, with a formal recall issued in early 2012. The story began making headlines at that point.

Fresenius defended its initial decision not to publish its findings based on its view that results and observations were preliminary, and more time would be needed to verify those findings and facilitate publication of those concerns in medical journals.

What really motivated Fresenius?

Critics of that decision, however, find that position curious and feel that Fresenius had a duty to inform all users of GranuFlo and NaturaLyte of its concerns as soon as they surfaced, in an effort to protect patients from potential harm.

Is it possible that Fresenius was not initially forthcoming about its observations with regard to GranuFlo and NaturaLyte - and resulting bicarbonate levels - given that DaVita, for example, was a dialysis competitor as well as a client in the Fresenius supply chain?

How will DaVita liability play out, when compared with Fresenius liability? Will a GranuFlo lawsuit play out differently, depending upon if it is against DaVita v. Fresenius? And how big a role will Fresenius’ delayed admission of potential problems with the recalled GranuFlo and NaturaLyte play, given its role as manufacturer and supplier, in the portfolio overall?

The recent decision with regard to the Colorado DaVita lawsuit striking down allegations of manufacturing could have a ripple effect. Will more GranuFlo heart attack lawsuits gravitate toward Fresenius? And how will this ruling impact the Fresenius lawsuit portfolio?

Stay tuned…