Fresenius Medical Care, a German-based company, is the largest provider of dialysis services and products in the U.S., providing dialysis to over a third of the patients in need of the treatment. The FDA is looking into allegations that the company knowingly failed to notify patients of a possible heart risk with the use of their products, GranuFlo and Naturalyte. The company issued a warning about the product to consumers in late March 2012 and a Class 1 recall was issued but this only occurred after internal sources within the company leaked a memo to the FDA that indicates that the company knew of the problem months earlier.
The internal memo that was leaked to the FDA was written in November 2011, over four months before the recall of the products in the end of March 2012. The memo was addressed to physicians within the organization’s dialysis centers, stating that improper use of one of their products was attributing to an increased risk of cardiac arrest in their patients. In fact, 941 patients had a cardiac arrest episode within their centers in 2010. However, they did not warn any other dialysis centers or doctors externally that use their product of the increased risk of heart problems to their patients.
The issue with the GranuFlo and Naturalyte products is that if used improperly, they can create an over-abundance of bicarbonate in the body that can cause heart problems, cardiac arrest or even death. Dialysis is used to remove toxins from the blood when the kidneys are no longer able to do so. Part of this process is to provide bicarbonate to neutralize the acid in the blood. GranuFlo contains ingredients, acetic acid plus acetate, which are converted to bicarbonate at higher levels then other similar products. If the patient is then also given a bicarbonate supplement, the levels can become dangerously high. The risk of cardiac arrest while having dialysis is up to six times higher for patients that were given these products.
Fresenius defends its position on the basis that the findings were preliminary and that they has no way to communicate the issue with outside clinics except in medical journals. However, the information was deemed relevant enough to send out a memo internally and they were able to communicate to outside vendors in March when the recall was issued, so the points seem moot. In the mean time, many people already suffering from kidney disease were unnecessarily put at even further risk of heart problems and even death due to this lack of communication.
Although the products have now been recalled and the FDA has issued a warning for other similar products on the market, there are many people who have already lost their lives due to the use of GranuFlo and Naturalyte. It appears that Fresenius will be under continuing scrutiny as thousands of civil lawsuits are filed on behalf of the patients who have been harmed by their products, due in part to their lack of warning of the dangers when they came to light.
Want more information about your legal options?
If your loved one suffered a heart attack or suddenly died following a dialysis procedure, there is a chance that this could be related to Granuflo or Naturalyte. The Granuflo litigation team at Rosenfeld Injury Lawyer is reviewing these cases and can advise you of your legal rights and options. We have numerous Granuflo lawsuits on file and are preparing others for filing. Call us NOW to ensure your legal options aren’t impaired by a statute of limitations defense. Resources related to Granuflo and Naturalyte complications: