GranuFlo Recall Still Rankles

November 23, 2012, 2:00PM. By Gordon Gibb

Lehigh, PAThe closure of a billing office by Fresenius Medical Care does not appear to be in any way related to a GranuFlo lawsuit or alkali dosing errors related to the recalled GranuFlo, a product used in association with kidney dialysis.

And aside from a recent GranuFlo lawsuit launched against the manufacturer of the now-recalled product, there are few new developments in an issue that still make for a bitter pill.

That bitterness, amongst dialysis patients and health advocates in general, stems from a situation last year in which GranuFlo manufacturer Fresenius, it is alleged, failed to notify anyone save for its own shops that there was a problem with its GranuFlo product.

While a Fresenius Medical Care recall was eventually undertaken, its occurrence was not before hundreds of thousands of dialysis patients were administered a product that could have caused them serious difficulty. While the manufacturer was not only allegedly aware of the problem, it apparently took pains to advise its own clinics but made little to no effort to share the information with other clinics not under the Fresenius banner, but using GranuFlo nonetheless.

The lack of thorough warning—something that lay at the foundation of several Fresenius lawsuits—appears to stem from an internal memo circulated to doctors and other practitioners at Fresenius-owned clinics in November of last year. The memo, according to a report in the New York Times (6/14/12), referenced a concern over the incorrect use of GranuFlo and its role in producing seemingly sharp spikes in the risk for sudden cardiac arrest.

In other words, dialysis patients could suddenly be stricken with an increased risk of metabolic alkalosis that could result in cardiopulmonary arrest, sudden heart attack, stroke, or death.
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"In light of these troubling findings," the memo said, doctors should take corrective action. "This issue needs to be addressed urgently," the memo added ominously.

While the memo was distributed to about 1800 Fresenius clinics and physicians, it was never circulated to a further 1800 clinics not directly associated with Fresenius but were nonetheless using the GranuFlo product.

The US Food and Drug Administration (FDA) appeared to have been left off the mailing list as well. The agency was notified by way of a leaked copy of the now infamous memo. The FDA, in turn, questioned Fresenius about the issue. Not long after the FDA was brought up to speed, Fresenius issued a more wide-ranging communiqué and triggered the Naturalyte GranuFlo recall.

Plaintiffs and their lawyers want to know exactly when Fresenius first learned of the problem, and why the manufacturer decided against issuing a blanket communiqué to all users of GranuFlo.

Beyond the actual Naturalyte Liquid Acid Concentrate (GranuFlo) recall, health advocates want to address the responsibility charged to a manufacturer, to alert all users of a potential problematic product, rather than a select few.

The Morning Call (11/14/12) reported that a consolidation of billing in Ohio and Georgia resulted in the closure of the Fresenius billing office in Lehigh County, Pennsylvania. A total of 92 people will be out of work when the closure takes effect January 14th of next year.