Fresenius Failed To Warn About Risks Of Sudden Heart Attack, Stroke, And Death Caused By GranuFlo Increasing The Level Of Bicarbonate In Blood

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Federal court GranuFlo / NaturalLyte Multi-District Litigation / MDL No. 2428 established by means of March 2013 Transfer Order: IN RE: FRESENIUS GRANUFLO/NATURALYTE DIALYSATE PRODUCTS LIABILITY LITIGATION

(4/2/13)

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The dialysis product GranuFlo from Fresenius was used by approximately one-third of the 400,000 patients with late-stage kidney failure requiring dialysis per year at a time when Fresenius apparently knew that GranuFlo caused an increased risk of metabolic alkalosis that could result in cardiopulmonary arrest, sudden heart attack, stroke, or death.

When Fresenius first learned about the dangerous side effects associated with GranuFlo and what it did to warn doctors and patients about the nature of the problem is the subject of a growing number of GranuFlo lawsuits filed against Fresenius.

This much is known already about the GranuFlo dialysis treatment safety problem:

(1) A November 4, 2011 Fresenius internal memo about the GranuFlo safety problem was sent to Fresenius physicians and the estimated 1,800 Fresenius dialysis clinics, only.  That (some may call it "secret") memo was not sent to the 1,500 unaffiliated dialysis clinics, i.e., not owned by Fresenius, where GranuFlo may have been used nor to the nephrologists and other doctors who cared for dialysis patients.

(2) What led to this Fresenius internal memo being created and distributed selectively to only some obviously interested parties?  At an April 2009 Boston conference of nephrologists and dialysis practitioners it was noted that cardiopulmonary arrest was noted to be the leading cause of death for dialysis patients.  After this conference Fresenius did a case-control study that identified 941 patients who suffered cardiopulmonary arrest during their dialysis treatment at one of the 667 Fresenius clinics (of 1800 total) in the year 2010.  That study confirmed the use of GranuFlo was involved with those 941 patient events, such as heart attacks and sudden cardiac deaths.  These findings were presented in the Fresenius November 2011 internal memo.

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(3) The FDA came to the GranuFlo problem relatively late — compared to what Fresenius had known, before.  First there was a March 2012 FDA Class I recall – the most serious type of FDA recall — concerning GranuFlo which included this "Reason for Recall":

The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

It was only with this FDA action that Fresenius issued its March 29, 2012 notice about GranuFlo ("Subject: Risk of Alkalosis with acetate containing dialysis acid concentrates", i.e., Granuflo powder and Fresenius NaturalLyte Liquid product lines).

Later, in May 2012, the FDA issued this warning document: "FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis".

Given these facts, personal injury and wrongful death lawsuits have been filed against Fresenius for the following medical conditions, or side effects, associated with GranuFlo use by hemodialysis patients:

• Cardiopulmonary Arrest (CPA) / Cardiac Arrest
• Heart Attack / Myocardial Infarction (MI)
• Sudden Cardiac Death
• Stroke (CVA)

Most dialysis patients who suffered one of these side effects will not know whether GranuFlo was used as part of their treatment.  However, this should not stop you from contacting us about a possible case.

Likewise, it does not matter if the side effect occurred in connection with a dialysis treatment at a non-Fresenius clinic (for example, DaVita) because GranuFlo was distributed by Fresenius to "other" dialysis clinics that were not part of the Fresenius clinics system.

We would be interested in speaking with any patient who developed a heart problem or a stroke during their dialysis treatment or soon thereafter, as well as the surviving spouse or family of those unfortunate patients who died.  You can call 800-426-9535.

P.S.  Fresenius began marketing its GranuFlo Dry Acid Concentrate dialysate product here in the U.S. back in 2003.  We are interested in investigating possible cases involving any of the above serious medical conditions, or side effects, associated with GranuFlo use by hemodialysis patients going as far back as this 2003 "introduction-to-market" date and up until August 2012.

(11/5/12)

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