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Aug 08 2012

Dialysis Patients At Risk For Sudden Cardiac Death Since 2003 When Granuflo Utilized

Posted in Community Service, Nursing Home, Product Liability
Conflicts of interest in a vertically-integrated, for-profit healthcare corporation had a multiplying effect, resulting in risks and dangers for dialysis patients that are at a minimum, highly unacceptable and could have resulted in death, says Alabama liability attorney Keith T. Belt .

Were the lives and continuing health of thousands of dialysis patients put at risk, unbekown to them and their family, since the FDA approval of Fresenius powdered Granuflo in 2003 and the utilization of Granuflo formulations at kidney dialysis clinics in North America? Additionally, once the higher risk of cardiopulmonary (CP) arrest, due to the use of powdered Granuflo became evident, did Fresenius Medical Care take the necessary steps to ensure every kidney dialysis clinic was made aware of this situation so that patient testing could take place?

At the end of the 2009 Boston ESRD Conference Summary (RenalWEB™), a novel finding was reached. “It was concluded that cardiovascular-related deaths were not due primarily to atherosclerotic (plaques and arterial stiffening) disease, but rather uremic cardiomyopathy, characterized by left ventricular hypertrophy (LVH), LV dysfunction, and LV dilatation. The enlarged muscle walls of the left ventricle become fibrotic and fail to conduct electrical impulses correctly due to repeated and continual fluid overloads in the body (most dialysis patients don’t produce urine). The conference’s conclusions have driven many efforts involving several leading nephrologists to reduce sodium levels in dialysate, end sodium profiling, improve body water volume control, and more.”
“The Boston conference’s findings regarding sudden cardiac death appear to have driven investigations within (FMC) Fresenius Medical Care, the world’s leading company devoted to patient-oriented renal therapy with over 2,700 kidney dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, providing 32 million dialysis treatments to more than 215,000 patients worldwide.. This is very evident in the 6-page internal memo from Fresenius Medical Services (FMS) to FMC’s medical directors and attending physicians dated November 4, 2011. The memo’s subject line is “RE: Dialysate Bicarbonate, Alkalosis, and Patient Safety.” This memo refers to a FMCNA analysis, a case-control study that evaluated risk factors in hemodialysis patients who suffered from cardiopulmonary arrest in the dialysis facility compared to other hemodialysis patients within the same facilities between Jan. 1 and Dec. 31, 2010.”
“This case-control study identified 941 patients in 667 FMC facilities between Jan. 1 and Dec. 31, 2010 that had cardiopulmonary (CP) arrests within the facilities. Looking at the data for these 941 patients, the study found a 4.7 times higher risk of CP arrest with pre-dialysis bicarbonate levels >28mEq/L. If the patient also had a pre-dialysis potassium that was <4 mEq/L, they had a 6.3 times higher risk of CP arrest.”


In the Final Comments from the 2009 Boston ESRD Conference Summary (RenalWEB™) Gary Peterson stated:

“86% of the variables that effect patient outcomes are currently not known or routinely considered in the routine corporate reports. Talk about opportunities for improvement. Anyone that claims they are providing the highest possible quality care for patients simply doesn’t know what they don’t know.”

“This conference was held because the survival rate for dialysis patients has not significantly improved in the last twenty years. I think it is always good advice to “follow the money” in trying to understand a complex situation. Currently, corporate profit-sharing with doctors and nurses probably works against the patients. The corporate model that dominates US dialysis care today is based on paying back enormous junk-bond debt, keeping the stock price up by minimizing spending on patient care, and ultimately serving stockholders instead of patients. Not unlike the financial markets, it will fail us spectacularly, if it hasn’t already.”
“If you consider the bad science, poor transitional care, high mortality rate, a deadly prevalent modality, excessive catheter use, and the fact that virtually no US nephrology professional would dialyze in their own facilities, I think everyone in this industry has to ask themselves whether we are worthy of the patients’ trust …or respect”


“It appears that the FMS division of FMC concluded in October or early November 2011 that their internal data supported a conclusion that a significant risk of cardiopulmonary arrest existed for patients with the use of Granuflo. On Nov. 4, 2011, the FMS office released the 6-page memo, entitled “Dialysate Bicarbonate, Alkalosis, and Patient Safety,” that emphatically stated the need to take action if a patient’s pre-dialysis serum bicarbonate was >28 mEq/L and especially if the patient also had a pre-dialysis serum potassium of <4 mEq/L. It also recommended “immediate attention to decreasing the prescribed dialysate bicarbonate in patients with pre-dialysis bicarbonate level of >24 mEq/L.”

Statements and Warnings Regarding Alkalosis in the Internal FMC Memo

The memo begins with a one paragraph conclusion:
“Recent analyses performed using FMCNA hemodialysis (HD) patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of and additive to the risk of CP arrest associated with pre-dialysis hypokalemia. The major cause of metabolic alkalosis in dialysis patients is inappropriately high dialysate total buffer concentration. As recommended in previous communications, physicians should individualized dialysate bicarbonate and total buffer prescriptions. We further recommend that predialysis serum bicarbonate level of >24 mEq/L should prompt immediate review of dialysate bicarbonate prescription.”

Some excerpts from the “summary of findings:

“The current analysis determined that: “borderline elevated pre-dialysis bicarbonate levels and over alkalosis are significantly associated with 6 to 8 fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility.” “ (italic type emphasis is theirs)
“In light of these troubling findings, we strongly recommend that physicians adjust dialysate bicarbonate prescriptions monthly for individual patients, with immediate attention to patients with serum pre-dialysis bicarbonate level of >24 mEq/L.”
“The recommendations section of the memo begins by stating that “pre-dialysis alkalosis and hypokalemia are modifiable risk factors associated with CP arrest.” The memo urges that this issue “needs to be addressed urgently.”
The memo acknowledges that many facilities have converted to Fresenius powdered Granuflo formulations and that the total buffer level equals “prescribed bicarbonate plus 8.” It continues:
“There are instances whereby the physicians’ bicarbonate prescriptions were kept the same when shifting to power (sic) concentrate (Granuflo) (failing to account for the additional 8 mEq/L of sodium acetate), thus exposing patients to a higher total buffer load than intended. While 60% of current dialysate prescriptions are for 37 mEq/L of bicarbonate, it may be prudent to initially target a prescription of 31-33 mEq/L of dialysate bicarbonate (with total buffer greater by up to ~8 mEq/L from acetate) and adjust accordingly to patients’ monthly bicarbonate level. Please recall also that an additional source of bicarbonate may be the phosphate binders that are prescribed to patients.”
Among the ten cited references at the end of the memo are two medical articles that include “sudden death” in their titles. Another is entitled, “The faster potassium-lowering effect of high dialysate bicarbonate concentrates in chronic hemodialysis patients.”
Currently there are over 5700 dialysis centers and approximately 400,000 dialysis patients in the United States. It is estimated that 3300 of these clinics use Granuflo formulations and that approximately 260,000 patients are using the product. It is estimated that slightly less than half these patients, or approximately 125,000 patients, are using Granuflo in non-FMC clinics. Total revenues from Granuflo sales per year in the U.S. are estimated at a minimum of $80 million.
“If a company fails to notify the FDA of a known problem with an FDA-approved medical device, it can result in severe fines and penalties, including being prohibited from marketing products for use in facilities that treat Medicare patients.”
“It is believed that the FDA received information concerning the alkalosis problem with Granuflo, most likely the internal FMC memo, from an anonymous source. The FDA then contacted all four dialysis concentrate manufacturers, FMC, Rockwell Medical, Diasol and Minntech Renal Systems, for information on this topic on March 27, 2012.”
“There is no evidence that FMC attempted to contact either the FDA or any of the non-FMC clinics until March 29, 2012. On that date, the FMC medical products division provided a 2-page memo to non-FMC clinics that used much of the same language from the FMS division memo of Nov. 4, 2011. The memo from the medical products division, however, lacked most of the detail and all of the urgency of the FMC internal memo of Nov. 4, 2011 on the same topic.”
“This is a story not about just one physician’s conflict of interest, but about multiple persons’ conflicts of interest in a vertically-integrated, for-profit healthcare corporation. All these conflicts of interest had a multiplying effect, resulting in risks and dangers for patients that are at a minimum, highly unacceptable, and at worst, criminal.”
New York Times GranuFlo


About Belt & Bruner, P.C.