Fresenius Medical Care North America knew of a serious danger to patients - Were you harmed?
Fresenius Medical Care, (FMC), was forced to admit that there was a significant increased risk of cardiac arrest and death during hemodialysis treatments to patients using their Granuflo® dialysis concentrates that contain a greater amount of sodium diacetate than competitive products. The top FMC officials knew about the source of the problem since their product’s introduction in 2003. When the problem finally became clear to the Fresenius Medical Services division around 2010, it appears that top FMC executives chose not to properly report the problem to the FDA and other involved government agencies, and decided to withhold the information from the public and non-FMC physicians and clinics that were using the Granuflo product. According to the article posted by Renal Web on May the 18th It appears there was collusion involving individuals in several FMC departments and organizations to hide, mislead, and obscure information about this patient safety hazard in order to maintain their market share as well as to minimize and diffuse the legal risks for FMC. Also possibly related to this situation, the Chief Medical Officer of FMC, Raymond Hakim, MD, PhD, abruptly left his position in a November 2011 announcement.
The slide above is from a Fresenius Presentation in 2004 presenting the risk of high bicarbonate levels
Fresenius Fails to Inform Patients and Doctors of Grave Threat
Food and Drug Administration officials have stated they are investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform patients of a potentially lethal risk connected to its products Granuflo and Naturalyte. 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. 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. “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. SEE MEMO
Fresenius, which is based in Germany, did not immediately warn other centers that use the products GranuFlo and NaturaLyte could cause harm to patients. It only did so in late March after the F.D.A. received an anonymously sent 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, stated in an interview. “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”
Fresenius offers excuses, not appologies
Dr. Thomas F. Parker III, the chief medical officer at Renal Ventures, a dialysis chain that uses the 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. Oddly, 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 non-company clinics except through publishing 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 the Fresenius’s products division, which sells GranuFlo, could have communicated with patients if it chose to do so. 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.
The existence of the internal memo and subsequent controversy was first reported by RenalWEB, a Web site devoted to dialysis. RenalWEB estimated that 125,000 patients in non-Fresenius clinics are treated with GranuFlo. Dialysis takes the place of the kidneys in clearing toxic waste from the blood. Part of this involves providing bicarbonate, an alkaline substance, to neutralize the acid that builds up in the blood. GranuFlo performs different functions. But it contains an ingredient that the body converts to bicarbonate, and it contains more of this ingredient than rival products.
Many doctors apparently have not been accounting for this extra bicarbonate contribution from GranuFlo when deciding how much bicarbonate to prescribe separately. The result can be, in effect, an overdose of bicarbonate, which some recent studies have suggested could lead to heart problems. 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.
If you or a loved one have been harmed by use of the Fresenius Liberty Cycler, or suffered heart attack stroke or death, please call Jeffrey Bowersox, the Fresnius Injury Lawyer for immediate help toll free at 855•269•3776.