To: Ben Lipps, CEO & Chairman, Fresenius Medical Care
Rice Powell, CEO, Fresenius Medical Care North America
Dear Mr. Lipps and Mr. Powell,
Even though Home Dialyzors United members were not directly affected by the Granuflo® problem of causing alkalosis if not properly used, we are very disturbed by the accounts reported in RenalWeb on May 18th and May 23rd. We still have many friends and acquaintances dialyzing in-center whose centers use Granuflo without their knowledge. There is nothing more frightening for patients and their families than a cardiopulmonary arrest in a dialysis center.
It simply is unconscionable that Fresenius Medical Care would alert its own Medical Directors and attending medical staff with an internal memo which stated “this issue needs to be addressed urgently”, and not notify non-FMC facilities using Granuflo. Patients’ lives were at stake and Fresenius did nothing. It’s as if you were playing God with non-FMC patients. The sign of a trustworthy and responsible company is what it does when it learns of a problem. They tell all. Fresenius did not and we therefore cannot trust you. Fresenius took action to protect its own patients, but not others.
Also, legally and ethically, Fresenius Medical should have reported a known potentially fatal danger affecting dialysis patients to the FDA immediately upon learning of the issue. You did not. An external memo was sent out to other facilities only when the FDA received a complaint. Your external memo was not as detailed as the internal one, thus causing confusion of the recipients. A Fresenius statement was then released to Nephrology News & Issues that said the internal memo sent to your own people was based on a working hypothesis and was preliminary in nature. It is quite difficult to believe it was a working hypothesis or preliminary in nature when “this issue needed to be addressed urgently” in FMC facilities.
We recognize the Food & Drug Administration might also be at fault. After all, they did approve Granuflo in the first place. However, we now wonder whether they had all of the facts. But since they now have learned of the issue, we want them to act more decisively than just putting out the Medwatch alert as they did. We believe there should be an congressional investigation into Fresenius and the FDA’s actions, and we expect Fresenius to be truthful and contrite.
Patients’ lives are on the line. We expect straight answers. Fresenius will have to do much in order to redeem itself and reclaim our trust.
- When did you first learn of the Granuflo problem(s) in either the products and/or medical divisions? What have you done from those first findings?
- We are troubled that non-physicians are apparently controlling the flow of information between the different divisions within Fresenius. Who controls how the clinics and products divisions communicate about possible medical device problems?
- Will non-physicians within Fresenius continue to make decisions as to whether to notify the FDA and/or non-company clinics when problems arise with FMC medical products?
- Why did the products division provide a very watered-down version of the memo from the clinics division that contained no specific patient serum blood levels upon which nephrologists could act? Why could the FDA provide that information two months later?
- If there are no physicians on the Fresenius Medical Care Management Board, what protections exist for patients at the highest levels of your healthcare corporation?
You can respond to the letter as a comment below.
for Home Dialyzors United