Fresenius Imperils Dialysis Patients Administered GranuFlo or Naturalyte

As reported by the New York Times earlier this year, Fresenius Medical Care failed to warn thousands of dialysis patients about the increased risk of cardiac arrest associated with the use of its products Granuflo and Naturalyte. Fresenius operates a number of dialysis clinics across the U.S., but it is also the leading supplier of dialysis products and equipment to other dialysis centers.

In November 2011, Fresenius discovered a sharp increase in the number of patients suddenly dying from cardiac arrest when its Granuflo and Naturalyte products were not used properly. After learning of these risks, the company sent an urgent memo warning doctors working in its own clinics of this problem, but did not take any action to warn other dialysis centers that use these products.

The six-page memo from Fresenius to its own clinics detailed the company’s findings that increased levels of bicarbonate found in patients using Granuflo and Naturalyte, as opposed to rival products, posed a significant safety risk to patients. Doctors apparently needed to account for the extra bicarbonate when using Granuflo or Naturalyte in patient prescriptions or else patients were at six times the risk of cardiac arrest and other heart problems.

The Food and Drug Administration (FDA) apparently received an anonymous copy of the internal Fresenius memo and began an investigation into this matter. As a result of the FDA investigation, in late March 2012, months after learning of their findings, Fresenius then warned other centers that use its products of the increased risks. Steven Silverman, the FDA’s Director of Compliance for the Medical Devices Division, was quoted in the NYT article that he was “personally…troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern” and that he believed it was “…not in the interests of public health to sit on information about risks.”

When Fresenius’ Chief Medical Officer was asked why the company didn’t warn all the users of its product about the risks, he responded that the company’s findings were “too preliminary too warrant publication” for “general consumption.” Dialysis centers that used Granuflo and Naturalyte disagreed – if the data was important enough to warn their Fresenius’ own doctors, then everyone who used Fresenius products should have been warned. Hundreds of thousands of patients were treated with Granuflo in non-Fresenius clinics.

If you’ve experienced heart problems after using Granuflo or Naturalyte, seek immediate medical care. Patients who would like to learn more information about their legal rights are encouraged to call our law firm, Audet and Partners, LLP, at (800) 965-1461 or visit our website at http://www.granuflodialysisrisks.com.

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