The Economist reported that in 2010, Fresenius Medical Care “sold 55% of new dialysis machines.”  An international healthcare giant, Fresenius Medical Care also designs and manufactures dialysates – chemicals used to clean the blood of patients whose kidneys no longer function and therefore must undergo dialysis – such as GranuFlo.

 

Tragically, in 2010, 941 people died from cardiac arrest while using GranuFlo.  And while GranuFlo had been named as the cause of these cardiac arrests by November of the following year, this information was kept secret until anonymously leaked to the U.S. Food and Drug Administration, prompting a recall.  Read more on FMC’s role in the dialysis industry here.

The condition metabolic alkalosis occurs when the blood is excessively alkaline (or basic, as opposed to acidic).  This condition has a variety of known causes, including fever,[1] “being at a high altitude,”[2] “lack of oxygen”[3] and by excess bicarbonate in the blood.[4]  In the case of GranuFlo, metabolic alkalosis is caused by excess bicarbonate.

As stated by MedlinePlus, a service of the U.S. Library of Medicine and the National Institutes of Health, symptoms include:

  • Confusion
  • Hand tremor
  • Light-headedness
  • Muscle twitching
  • Nausea, vomiting
  • Numbness in the face, hands, or feet
  • Prolonged muscle spasms[5]

Possible complications of metabolic alkalosis include irregular heartbeat,[6] “coma”,[7] and “electrolyte imbalance”[8], and according to Fresenius Medical Care, the nation’s leading dialysis provider, alkalosis may result in cardiac arrest and death.[9]

If you or a loved one have experienced these symptoms or incurred injury while undergoing hemodialysis, please do not hesitate to contact our law firm at (855) 452-5529 or e-mail me at justinian@dangerousdrugs.us.


[1] “Alkalosis: MedlinePlus Medical Encyclopedia” © A.D.A.M. 1997-2013 MedlinePlus, U.S. National Library of Medicine, National Institutes of Health.  Page updated 27 December 2012. Available at <http://www.nlm.nih.gov/medlineplus/ency/article/001183.htm> Accessed 3 January 2013

[2] Ibid

[3] Ibid

[4] Ibid

[5] Ibid

[6] Ibid

[7] Ibid

[8] Ibid

[9] Fresenius Medical Care Memorandum “RE: Dialysate Bicarbonate, Alkalosis and Patient Safety” FMS Medical Office; November 4th, 2010

On May 29th, 2012 the U.S. Food and Drug Administration issued a Class 1 recall of Fresenius Medical Care’s GranuFlo and Naturalyte, products used to clean and filter the blood in patients undergoing hemodialysis for chronic kidney failure.  As reason for the recall, the FDA writes:

“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 health consequences, including death.”

Read the rest of the FDA recall of GranuFlo and Naturalyte here.

On June 14th, 2012, the New York Times published an article describing failure by the healthcare giant Fresenius Medical Care to warn doctors and patients of the dangers of two of its dialysis products: GranuFlo and Naturalyte.

GranuFlo and Naturalyte are mixes of chemicals used in hemodialysis procedures to fill the role of kidneys no longer able to clean and filter the blood as they normally would.  Because patients undergoing dialysis are at risk for excess acid building up in the blood, dialysis drugs (dialysates) contain alkaline chemicals to neutralize that acid and maintain a healthy blood pH – between 7.35 and 7.45.

GranuFlo and Naturalyte, however, can make the blood excessively alkaline, leading to a condition known as metabolic alkalosis, which places people at risk of cardiac arrest and even death if not treated appropriately.

Fresenius Medical Care not only designs and produces dialysates and dialysis machines (dialyzers), but also owns and operates about 1,800 dialysis clinics across the United States.  Additionally, Fresenius sells its dialysis products to independent clinics across the country.  RenalWEB, a website dedicated to dialysis, writes that about 125,000 Americans are prescribed GranuFlo at clinics independent of FMC.

Based on an internal memo anonymously leaked to the US Food and Drug Administration, we learn that Fresenius Medical Care knew that GranuFlo and Naturalyte could cause a four- to six-fold increase in likelihood of cardiac arrest during dialysis in certain patients by at least November 4th, 2011.  Upon receiving this information, however, FMC did not warn any of the independent clinics using GranuFlo or Naturalyte of this hazard, only circulating that memorandum to FMC-owned clinics.

Once the November 4th, 2011 memorandum was leaked to the FDA, Fresenius came under pressure to notify independent clinics of the dangers of its products, finally doing so albeit in a vague way through this FMC memorandum to external clinics.

An excerpt from the New York Times piece on the GranuFlo:

“‘Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,’ Steven Silverman, director of compliance for the F.D.A.’s medical devices division, said in an interview this week. …

Dr. Thomas F. Parker III, chief medical officer at Renal Ventures, a dialysis chain that uses Fresenius products, agreed.  ‘If the data was sufficient to warn their doctors, then all users of the product should have been made aware of it,’ he said.”[1]

 


[1] Pollack, Andrew. “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry.” New York Times on the web 14 June 2012.  7 January 2013 <http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0>

The prominent online pharmaceutical news publication, Pharmalot, has published an insightful overview of the GranuFlo scandal that took place over the last year at Fresenius Medical Care, the world’s leading supplier of dialysis products, a company that not only produces dialysis drugs and products for external sale, but also curates its own dialysis clinics, staffed by its own doctors, using its own products.

Two of its dialysis products, GranuFlo and Naturalyte, were found in 2010 to cause 941 cardiac arrest deaths in patients while undergoing hemodialysis procedures at FMC-owned clinics, prompting a great deal of research within the company.  It was found that patients whose blood is a bit alkaline (basic) before undergoing dialysis are placed at a risk of cardiac arrest during treatment 4-6 times higher than the average patient.  While this information, along with more accurate prescription recommendations, was circulated to clinics owned by Fresenius, none of the external clinics purchasing and prescribing GranuFlo and Naturalyte were informed, and thus the 125,000 patients using these products at external clinics were placed at unnecessary risk of serious adverse health effects, including death.

Though Fresenius eventually circulated an abbreviated memorandum to its customers on March 29th, 2012, relaying some of the pertinent information on the danger of GranuFlo and Naturalyte, it may have been too little, too late.  If you believe this “morally indefensible” inaction by FMC has affected you or a loved one, please contact our team at (855) 452-5529 or by e-mail at Justinian@dangerousdrugs.us.