Timeline Indicates Fresenius Knew of GranuFlo’s Dangers Long before Information Became Public
A “toxic tort” is a lawsuit in which a plaintiff claims that exposure to a chemical caused serious injury or disease. The strength of the lawsuit often depends upon the behind-the-scenes “story.” For example, did the manufacturer know about the risk associated with the chemical, but conceal or misrepresent the information?
Fresenius Medical Care North America has more than 2,100 dialysis facilities in the U.S., including 29 here in Oklahoma. In addition to performing dialysis, Fresenius manufactures GranuFlo and Naturalyte, chemical compounds using in the dialysis process in their own clinics, as well as in many other dialysis facilities.
Fresenius is now the defendant in almost 400 federal lawsuits that claim that GranuFlo and Naturalyte contribute to metabolic alkalosis, which can lead to cardiac arrest and death.
Since GranuFlo and Naturalyte are used in the dialysis process, the FDA treats the products as “medical devices” rather than pharmaceuticals. However, from a legal standpoint, the most important questions are the same:
• Did the use of GranuFlo and Naturalyte cause increased cardiac arrest and death? FMC’s own November 2011 internal memo confirms that it did.
• Did FMC know about the risk, but conceal or misrepresent the information? That question is where the battle will be fought in the hundreds of pending lawsuits.
I have done some research on Fresenius and GranuFlo. One of the best websites I have found on the subject is RenalWeb.com by Gary Peterson. According to the site, Peterson is a former registered nurse who worked in the dialysis industry for almost four decades and was an employee of Fresenius for at least seven years.
Peterson published a lengthy analysis and commentary on Fresenius in May 2012. It makes excellent reading for any dialysis patient considering a legal action against Fresenius, as well as any attorney who has a Fresenius/GranuFlo client.
Peterson provides an explanation in layman’s language of how dialysis works and of the function of a dialysate (a chemical compound used in dialysis) such as GranuFlo. Peterson also explains the interaction of bicarbonate concentrates and acid concentrates. GranuFlo is an acid concentrate which contains sodium diacetate, which increases the bicarbonate level in the blood during dialysis. The GranuFlo lawsuits allege that the product causes an excessively high level of bicarbonate, leading to alkalosis.
One of the most helpful things Peterson provides is dates for various events, which are crucial in understanding “the GranuFlo story,” in order to determine what Fresenius knew and what it concealed.
Peterson makes no secret of his own conclusion. He accuses FMC of “collusion … to hide, mislead, and obscure information about this patient safety hazard in order to maintain their market share as well as to minimize and diffuse the legal risks.”
Here are some key dates and events that I have drawn from Peterson’s report:
• 2003: The FDA approves the use of GranuFlo.
• April 2009: Harvard Medical School hosts a conference, “ESRD: State of the Art and Charting the Challenges for the Future.” ESRD, End State Renal Disease, is kidney disease that requires a transplant or dialysis. A focus of the conference was how to reduce the incidence of sudden cardiac death in dialysis patients. Dr. Raymond Hakim, who was chief medical officer of FMCNA at the time, was one of the speakers at the conference.
• 2010: In this year, 941 patients in FMC facilities experienced cardiac arrest during dialysis. An FMC Nov. 4, 2011, internal memo (see below) on dialysate bicarbonate and alkalosis focuses on data in FMC facilities during 2010. Peterson alleges that FMC “knew a early as 2010 that there may be a link between high total buffer levels and the risk of cardiac arrest.”
• Nov. 4, 2011: FMC sends out its six-page internal memo to the directors of its own dialysis facilities. FMC did not send the memo to the thousands of non-FMC physicians and dialysis facilities that were using GranuFlo.
The memo is titled “Dialysate Bicarbonate, Alkalosis, and Patient Safety.” (A link to the internal memo is provided above). The memo indicates that FMC has been educating its staff on this issue since at least January 2011.
Peterson points out that some of the contents of the November memo would have been preceded by preliminary data analyses, internal communications and educational programs. The point, of course, is to establish how long FMC knew about the link between GranuFlo and sudden cardiac arrest.
• Nov. 10-12, 2011: Annual Meeting of the American Society of Nephrology. Information is presented at the meeting about dialysate bicarbonate levels and increased mortality. Peterson suggests that at this conference, Hakim became “more convinced than ever” that FMC needed to alert non-FMC clinics to the same dangers that FMC clinics had been warned about in the Nov. 4 memo. However, there is no indication that FMC ever sent such an alert to non-FMC facilities.
• Nov. 16, 2011: FMC announces that Dr. Hakim is stepping down as FMC medical director. Peterson suggests that Hakim left because of FMC’s refusal to warn non-FMC clinics about GranuFlo.
• Early 2012: FDA receives a copy of FMC’s November 2011 memo from anonymous sources.
• March 29, 2012: FDA issues a Class 1 recall of GranuFlo and Naturalyte.
• March 2013 (after Peterson’s report): A federal panel establishes a multidistrict litigation for federal GranuFlo lawsuits.
For more information about Fresenius and GranuFlo, see our webpage: Fresenius’ GranuFlo, Naturalyte Dialysis Products Linked to Sudden Cardiac Arrest, Death.