GranuFlo identified as a story to watch in 2013 as GranuFlo lawsuits mount

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According to court documents, use of Granuflo and NaturaLyte in kidney dialysis treatments has allegedly resulted in high bicarbonate levels, leading to serious harm--and even death--for some dialysis patients. In a recent interview with LawyersandSettlements.com, attorney Ben Stewart weighs in on the Granuflo lawsuit allegations that claim GranuFlo manufacturer, Fresenius Medical Care, waited too long to own up to problems, including reports of cardiac arrest and dialysis death.

As we approach the one-year anniversary of the US Food and Drug Administration’s (FDA) mandated Class 1 recall of GranuFlo and NaturaLyte on grounds that prescribing information needed to be changed, the legal battles are heating up. While plaintiffs allege they have been harmed from the use of GranuFlo and NaturaLyte in concert with their dialysis treatments, manufacturer Fresenius Medical Care (Fresenius) asserted in a court filing in early January that in Fresenius’ view, plaintiff’s case has no merit. “The plaintiff’s claims will fail on their merits because the plaintiffs cannot show that Fresenius’s products are unreasonably dangerous or that Fresenius failed to provide adequate warnings and instructions to the intermediaries who used GranuFlo and NaturaLyte to treat dialysis patients,” Fresenius is reported to have said in a petition filed January 3 with the US Judicial Panel on multi District litigation (In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL no. 2428).

However, Florida-based attorney Ben Stewart, of Ben Stewart Law in Riverview, tells LawyersandSettlements.com in a recent interview on Granuflo lawsuits that such a stance on the part of Fresenius is not a surprise, but rather somewhat expected.

“We see things differently, much differently,” Stewart said in a recent interview. “These negative reactions happened when the patients were actually hooked up to the dialysis machines [or] shortly after.”

The number of dialysis patients in the US has grown since the early 1970s, when President Nixon enacted a bill, the Medicare End Stage Renal Disease Program, that saw Medicare and Medicaid provide dialysis services to anyone who requires it. Manufacturers have lined up in kind to provide the service – and Fresenius is one of the largest manufacturers and providers of dialysis in the country. According to a USA Today article, for example, in 2009, Fresenius boasted more than 1700 dialysis centers in the US, with revenues of $1.57 billion in the first quarter of 2009 alone.

But there have been allegations of serious problems with Fresenius’ GranuFlo (powdered) and NaturaLyte (liquid) compounds that are used in dialysis to create the bicarbonate needed to facilitate dialysis. According to one of the initial complaints, filed July 27, 2012, (Arthurine Williams vs. Fresenius USA, Inc., Case No. 2:12-vc-02576-KOB, U.S. District Court of Northern Alabama, Southern Division), "Fresenius had knowledge that there was a significant increased risk of cardiac arrest and death during hemodialysis treatments associated with their Granuflo dialysis concentrate product".

The complaint also alleges that, due to the Granuflo formulation using sodium diacetate, the product could "lead to significantly increased bicarbonate levels and the associated risks of heart attack, cardio pulmonary arrest, and/or sudden cardiac death."

What forms the basis of the Granuflo lawsuit is not so much the danger to patients posed by the inordinately high levels of bicarbonate, but an alleged failure by Fresenius to share its findings beyond its own doctors and dialysis centers after becoming aware of the problem in November, 2011.

“Look, if you tell someone we are going use this chemical on you and it might be harmful and you choose to accept that risk there’s no harm – no foul,” says Stewart. “But that’s not what happened. There are probably lots of people out there who were injured by this that we have not heard from yet.”

A memo issued by the Chief Medical Officer for Fresenius November 4, 2011 (The New York Times, 6/14/12) identified no fewer than 941 dialysis patients having suffered cardiac arrest while at Fresenius clinics in 2010 – information that was not immediately shared beyond Fresenius’ own facilities and technicians.

Steven Silverman, director of compliance for the FDA’s medical devices division, told The New York Times (6/14/12), “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern. Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”

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