Where were regulatory agencies in all this? How did Fresenius get away with its behavior?

In a New York Times article, “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry,” reporter Andrew Pollack wrote that “the Food and Drug Administration is investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products [GranuFlo].” The article quoted Steven Silverman, the FDA’s Medical Devices Division’s Director of Compliance, who said “personally, I’m troubled by the fact that Fresenius on its own initiative did not notify its entire customer base of this particular concern, [that one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest].” The article also quoted Dr. Daniel Coyne, Director of Hemodialysis at St. Louis Washington University, who said that nearly one-third of his patients had overly high blood bicarbonate levels. Dr. Coyne wrote in an email that “a four to six fold increased risk of in-center cardiac arrest is very concerning…my partners are all trying to figure out a fix to this problem.”

Not every regulator or observer has been critical of Fresenius, curiously. A Professor of Medicine at the University of Louisville, Dr. Richard Ward, said “there are a lot of people who have a responsibility here in using a product how it is meant to be used… to dump all the responsibility on the manufacturer is not quite right.”

In some ways, Dr. Ward’s assessment is correct — or at least, it hits upon a bigger truth. The problem appears to be much bigger than a single big company running wild, ignoring science and suppressing data that it doesn’t like. In fact, the root cause of Fresenius’s bizarre, inhumane behavior can likely be traced back to fundamental problems in the dialysis industry.

• How did these massive breakdowns in communication about patient safety occur?
• Was Fresenius the only dialysis company to engage in negligent practices?
• How did the system get so out of control in the first place?

To understand these bigger picture questions, we need to dial back to the birth and growth of the modern dialysis industry. More on that next time…

Do you have a GranuFlo case? Connect with the Davis & Crump team now at 800-277-0300 or info@daviscrump.com for a free, confidential case evaluation.