In the United States, there are approximately 400,000 Americans receiving dialysis. Unfortunately, those Americans were put at risk in 2012 because of a failure on the part of a company called Fresenius to warn doctors that its GranuFlo contained more of an ingredient that the body converts to bicarbonate. This was a problem because doctors failed to account for the extra bicarbonate, leading to a potential overdose.
Our Boston dialysis malpractice attorneys want to make sure patients and care providers are aware of the dangers of GranuFlo. We also want patients to understand that they may have legal rights due to the failure of Fresenius to act in making sure the risks of their products were properly disclosed.
FDA Investigation Into Fresenius After Reports of Trouble
In July of 2012, the New York Times published an article informing the public that Fresenius was under investigation as a result of their behavior surrounding GranuFlo. The New York Times succinctly summarized the problems that had arisen with GranuFlo and the failures of Fresenius to keep patients safe.
The Times article pointed out that in November, the medical office at Fresenius sent an internal memo to doctors practicing in the company’s own dialysis clinic. The memo contained a warning that the failure of doctors to use GranuFlo properly was leading to a sharp increase in the risk of patients suffering a sudden and fatal cardiac arrest. The memo urged doctors to address the issue “urgently.”
Despite the fact that the memo clearly acknowledged that GranuFlo could be extremely dangerous when doctors failed to account for the extra bicarbonates being produced, Fresenius did not issue a widespread warning to other dialysis centers. Fresenius Medical Care not only treats around a third of all U.S. dialysis patients, but it is also the leading supplier of dialysis products. Their failure to issue a warning on the GranuFlo risks, therefore, led to a serious and widespread risk for all dialysis patients throughout the country.
The New York Times explains that this failure on the part of Fresenius came to the attention of the Food and Drug Administration, who launched an investigation into whether the company violated federal operating regulations. Although the FDA is the regulatory agency in the United States responsible for overseeing the safety of drug and alcohol products, they do not have the resources to individually test for problems and monitor for every single potential complication for every drug on the marketplace. They rely, in large part, on data from manufacturers as well as reports from independent studies and details on consumer complaints in overseeing the drugs already for sale. Fresenius’ failure to alert the public, therefore, is a major problem since they may have failed to fulfill their obligations under federal law.
The New York Times indicates that a spokesperson for the company argued that they had no way of getting in touch with the dialysis centers using their product except by medical journal and that the findings were still too preliminary for publication. The problem, however, is that the company could have made the effort to communicate with customers and instead they failed to do so, putting patients at serious risk.
If you or a loved one has experienced dialysis complications in the Greater Boston area, contact the Boston dialysis malpractice attorneys at Jeffrey Glassman Injury Lawyers, LLC for a free consultation to discuss your claim. Call (617) 777-7777.
Additional Resources:
New England Meningitis Watch: Compounding Pharmacy Troubles Nothing New, Boston Personal Injury Lawyer, November 13, 2012