GranuFlo Lawsuits Keep Flowing

Washington, DCLawsuits can be complex animals even at their basic core. To that end, one has to wonder how the folks at DaVita healthcare clinics would handle the connection to Fresenius Medical Care, in light of the latter’s alleged failure to notify competing dialysis clinics of a suspected, but serious problem with GranuFlo and NaturaLyte, two products commonly used in kidney dialysis.

GranuFlo sudden death has been alleged in various lawsuits, including that of a plaintiff who filed a GranuFlo class-action lawsuit March 6 of this year, alleging that his wife suffered cardiac arrest and GranuFlo sudden death following use of GranuFlo at a DaVita healthcare clinic (case no. 1:2013cv00573, Colorado District Court). There are several others - including more than 200 lawsuits pending (In re Consolidated Fresenius Cases, No. MICV2013-03400-0, Middlesex County Superior Court).

Where things could get potentially complicated is the role allegedly played by Fresenius Medical Care in delaying an alert to non-Fresenius dialysis clinics with regard to a problem with GranuFlo and NaturaLyte side effects that Fresenius - the manufacturer of the two products - identified and articulated to its own clinics in November 2011. Dosing errors inherent with the two products could cause a rapid rise in bicarbonate in the bloodstream, which in turn could lead to cardiac arrest in some patients.

It is estimated that 125,000 patients underwent regular dialysis with GranuFlo and NaturaLyte at non-Fresenius clinics such as DaVita healthcare clinics. But clinics such as DaVita were not alerted to the problem until four months later, when the initial Fresenius bulletin to its own clinics was leaked to the US Food and Drug Administration (FDA). Concurrent to the involvement of the FDA in the matter, Fresenius then put out a wider alert in March of last year.

The question then, is how many deaths due to GranuFlo side effects were there at DaVita healthcare clinics (and others) in the four months between November 2011 and March 2012, while Fresenius tarried? The issue involving alkali dosing errors involving GranuFlo and NaturaLyte was serious enough for Fresenius Medical Care to issue an Urgent Product Notification. Pursuant to that notification, the FDA later deemed the notification as a Class 1 recall.

Serious stuff. Fresenius has always maintained that its delay in notification was due to incomplete data that was preliminary in nature, and there was insufficient opportunity to publish the data, preliminary as it was deemed to be by Fresenius, in scholarly journals.

But where does that leave DaVita health clinics, which may be facing GranuFlo class-action lawsuits alleging GranuFlo sudden death during the four months GranuFlo and NaturaLyte were used without knowing the problem? It will be left to the attorneys to sort that one out.

DaVita is no stranger to litigation. Earlier this year, DaVita Healthcare Partners Inc. set aside $300 million in funding to settle allegations of kickbacks to doctors. And in 2011, the New York Times (7/25/11) reported on a lawsuit faced by DaVita with regard to alleged overbilling of Medicare related to unavoidable waste of medicine. The lawsuit, filed by a former nurse and a doctor, was originally brought against DaVita in October 2007, but was unsealed in 2011, after the federal government declined to become involved.

Meanwhile, the lawsuits keep coming. On August 27, a plaintiff filed a GranuFlo class-action lawsuit in California Northern District Court (case no. 4:2013cv03986), alleging her late husband suffered GranuFlo cardiac arrest and NaturaLyte side effects. And in July, another plaintiff filed a GranuFlo sudden death lawsuit in West Virginia Southern District Court following the death of his wife, alleged to have been caused by GranuFlo side effects and/or complications stemming from NaturaLyte. That case is no. 2:2013cv20858.