Say It Ain’t So, GranuFlo…

Waltham, MAWhen does being tactful depart from the simple observance of good manners, arriving instead at a point of deception? That’s the question any fair-minded individual is left with in regard to alkali dosing errors inherent with GranuFlo and NaturaLyte, and the seemingly endless stream of lawsuits that have followed.

GranuFlo and NaturaLyte are two products employed in the process of kidney dialysis and made by Fresenius Medical Care, a manufacturer based in Waltham, Massachusetts, and an enterprise that also operates dialysis centers. The two aforementioned products are used as part of a carefully choreographed dance during the dialysis process designed to properly undertake the life-saving process of dialysis for patients with weak or failed kidneys.

The kidney, as most learned in science class, is the organ that does the lion’s share of purging impurities and other nasty business from the bloodstream. When a kidney fails to perform this task, the process is instead undertaken by mechanical means upwards of several times per week. Doctors and health care professionals, when administering dialysis, must ward against the buildup of bicarbonate in the bloodstream. Too much bicarbonate can lead to dire consequences to the heart - even death by way of a GranuFlo heart attack.

Fresenius, in defending its products, notes that the products themselves are fine, and that any GranuFlo recall - and related recalls pertaining to NaturaLyte - were inherent with the product labeling, and not pertaining to the products themselves. GranuFlo and NaturaLyte remain on the market and are interpreted by Fresenius as continuing to be integral to the dialysis process.

It’s what happened in the fall of 2011 that has fostered over 5,000 lawsuits alleging GranuFlo heart attack, and drawn the ire of thousands.

In November of that year, Fresenius issued an urgent warning to doctors and health care staff in its own clinics over problems Fresenius had been seeing with the deployment of GranuFlo and NaturaLyte, together with health issues that patients were exhibiting either during or immediately following the dialysis process.

However, that communiqué initially did not find its way to the US Food and Drug Administration (FDA). Nor was the urgent warning sent to competing dialysis centers, such as those run by DaVita. Dialysis centers in the DaVita group were also using GranuFlo and NaturaLyte for the dialysis process.

Why did Fresenius remain mum?

Would DaVita not appreciate knowing there was a potential problem with the labeling of GranuFlo and NaturaLyte? Why did Fresenius not inform its competitor, which was also its client? Risk for DaVita heart attack from GranuFlo and NaturaLyte might have been mitigated in the process. Why would Fresenius not inform the FDA?

To that end, many a GranuFlo lawsuit contends that Fresenius knew about potential problems with its products for some time prior, but kept quiet about it. The allegation is that Fresenius only took action when consequences were such that they could not be ignored - and then, confined its alert to its own dialysis operation, ignoring everyone else.

It might have all ended there and the situation not come to light were it not for a leak of the communication to the FDA, which immediately launched an investigation. Fresenius soon triggered a GranuFlo recall, with the FDA’s blessing of course. And that GranuFlo recall, and a related recall for NaturaLyte, also became a DaVita recall due to the fact that information key to the health and survivability of dialysis patients was finally coming to light and shared throughout the dialysis community.

At the time, Fresenius Medical Care defended its decision not to take its concern to a wider audience, noting in its view that the most appropriate forums remain the medical journal and other related professional publications. Fresenius stated that such submissions would not only take time, but the concern was still preliminary in nature - and therefore it was premature to take it to a wider audience.

There are some who agree with the Fresenius decision, to initially not trigger a Fresenius Medical Care recall. However, the more prevalent view is that Fresenius blew it - and plaintiffs in many a Fresenius lawsuit claim that Fresenius Medical Care’s inaction needlessly put thousands of patients at risk.

Sometimes it is tactful not to say something - such as that dress makes you look fat or those pants really place increased attention to your beer gut. And sometimes what you don’t know won’t hurt you: little Johnny has not seen that big spider inches from the heel of his foot and in the process of innocently crawling away - a spider that would scare the pants off the poor child, so we just won’t tell him. What he doesn’t know, truly, won’t hurt him.

Is this the case with Fresenius? Were they just trying to be tactful? Was Fresenius Medical Care a purveyor of ”what you don’t know won’t hurt you?”

Or was it blatant mismanagement?

Those who feel it was the latter and that a NaturaLyte Liquid Acid Concentrate recall came way too late, number into the thousands. According to court documents, more than 1,800 cases have been filed in US District Court in Boston, with another 3,694 cases pending in Middlesex Superior Court.

“We stand by the detailed allegations in the complaint that for years Fresenius knew about the dangers associated with GranuFlo and NaturaLyte, but turned a blind eye to the injuries the products could and would cause,” said the lead attorney in the case. “By doing so, the company allowed thousands of individuals and their families to suffer significantly and needlessly.”

For them, the NaturaLyte GranuFlo recall should have occurred much sooner…

There is, thus far, no class action. A bellwether case will he heard instead, to determine if Fresenius is at fault, as thousands are embroiled in a Fresenius lawsuit claim.