Granuflo and Naturalyte
Fresenius is the manufacturer of Granuflo and Naturalyte, product used during dialysis. About 400,000 people with Kidney problems receive dialysis treatment in the United States, and Fresenius is the largest company providing these services and related products.
In 2010, Fresenius studied 941 patients who had died of cardiopulmonary arrests in over 600 of their facilities. The study revealed that patients with elevated bicarbonate levels before dialysis were up to six times more likely to experience cardiopulmonary arrests.
In 2011, Fresenius circulated an internal memo to its facilities explaining the results of their study and making recommendations to doctors for better screening before dialysis and better use of Granuflo and Naturalyte. Fresenius did not inform the FDA on their findings.
When the internal memo was finally leaked to the authorities, however, the FDA issued a Class I recall. It noted that Class I recalls "are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
The FDA's most current warning explains that "…inappropriate prescription of [Granuflo and Naturalyte] can lead to a high serum bicarbonate level in patients undergoing hemodialysis." High bicarbonate levels can contribute to metabolic alkalosis and increase a patient's risk of the following conditions, all of which could lead to cardiopulmonary arrest:
- Low blood pressure;
- Hypercapnia; and
- Cardiac arrhythmia.
On January 3, 2013, Fresenius agreed to the consolidation of numerous cases against it in a Mulit-district Litigation to be handled in Massachusetts. Arguing that most cases related to Granuflo have been filed in the Southeast U.S., however, some plaintiffs are pushing for the MDL to be set up in Mississippi.Services And Costs
If you or a loved one has been a dialysis patient affected by Granuflo or Naturalyte, our firm can help. We are experienced in handling personal injury and products liability cases, as well as multi-district litigation.
We are available 24/7 for a free consultation. For your convenience, our Miami defective product attorneys work on a contingency basis, so you don't pay for services unless you receive compensation for your injuries.