A company is in some hot water with the FDA as they have been accused of not properly informing the public with an issue with one of their products that could have potentially lead to unnecessary deaths.
The company, Fresenius Medical Care, treats more than a third of the estimated 400,000 Americans receiving dialysis. It also is the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own. And, the FDA 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, an F.D.A. official has stated.
Last November, Fresenius’s medical office sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that failure to properly use 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 Fresenius memo, dated Nov. 4, found that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. By comparing these patients with others, the company’s medical staff concluded that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels.
“In light of these troubling findings,” the memo said, doctors should take corrective action. “This issue needs to be addressed urgently,” the memo added later.
But Fresenius did not immediately warn other centers that use the product, which is known as GranuFlo. It did so only in late March after the F.D.A. received, anonymously, a copy of the internal memo and questioned the company about it.
“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.
Mr. Silverman said the agency could issue a warning letter to Fresenius if it determined the company should have reported the safety concerns. But even if the company had no legal obligation, he said, “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”
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.
Dr. Franklin W. Maddux, the chief medical officer for Fresenius in North America, said his office, which wrote the memo, was in charge of the company’s own centers and had no way of communicating with noncompany clinics except through papers in medical journals. He said the findings of the internal memo were too preliminary to warrant a publication.
“I felt that it was not in a condition for general consumption,” he said in an interview.
But Fresenius’s products division, which sells GranuFlo, could have communicated with customers. A company spokesman said that the division did not think a notice was necessary because the internal memo did not contain specific reports of adverse events related to GranuFlo.
Fresenius has its defenders. Dr. Richard Ward, a professor of medicine at the University of Louisville, said that GranuFlo’s label provides enough information for doctors to figure out how to adjust dosing appropriately. “There are a lot of people who have a responsibility here in using a product how it is meant to be used,” he said. “To dump all the responsibility on the manufacturer is not quite right.”
After Fresenius notified its customers in late March, the F.D.A. issued an alert in late May that applied to all products like GranuFlo.
Dialysis centers across the nation are now checking bicarbonate levels in patients and adjusting doses if necessary.
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