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.”
 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>.