The FDA has issued a Class I recall on dialysis concentrates GranuFlo and Naturalyte after it was found that the products could put patients at risk for cardiac arrest when not prescribed appropriately. Allegedly, Fresenius Medical Care failed to adequately warn doctors that the products contain – when compared to similar products – more of an ingredient which the body converts to bicarbonate, an overdose of which has been linked to heart problems.
Fresenius warned its own doctors that Granuflo seemed to be contributing to an increase in the risk of patients suffering a sudden cardiac arrest, but did not warn outside clinics which used the products until the FDA was leaked an internal memo, according to a New York Times report.
Fresenius GranuFlo Recall: What Happened?
Early in 2012, Fresenius Medical Care voluntarily changed the labels on its NaturaLyte and GranuFlo products, an action the FDA has now declared to be a Class I recall. While the GranuFlo recall will not involve removal of the products from the market, the FDA has issued the most serious type of recall for the products.
A Class I recall indicates that "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." In conjunction with the Class I recall, Fresenius announced that it would continue its process to place updated labels on NaturaLyte and GranuFlo.
Why Was the GranuFlo Recall Issued?
During hemodialysis, a machine filters waste, extra salt and water from the patient’s blood when their kidneys are no longer healthy enough to do this on their own. A necessary part of this process involves neutralizing acid in the blood by supplying the patient with an alkaline substance known as bicarbonate.
It has been reported that doctors were not accounting for the additional bicarbonate contributed by GranuFlo when determining how much bicarbonate to administer separately. As a result, patients could be at risk for the effects of excessive bicarbonate, which has been linked to heart problems.
According to the FDA, high bicarbonate levels can contribute to a metabolic condition which is a significant risk factor for the following:
- Low blood pressure
- Cardiac arrhythmia
- Low blood oxygen pressure
- Low potassium levels in the blood
- High concentration of carbon dioxide in the blood
If these conditions are not properly treated, serious adverse events, including cardiac arrest and death, may occur.
GranuFlo Cardiac Arrest Risk Noted Before Recall
Fresenius reportedly carried out its own investigation and found that high serum bicarbonate levels increased a patient's risk of cardiac arrest. According to acompany memo, 941 patients treated at Fresenius' own dialysis centers experienced cardiac arrest during 2010. An analysis of the data revealed that the patients’ risk of cardiac arrest was up to six times higher if they demonstrated high pre-dialysis bicarbonate levels.Despite this knowledge, Fresenius continued to aggressively market Granuflo and routinely combined it with other products for pricing discounts, according to GranuFlo lawsuits.
The memo warned that the cardiac arrest risk stemmed from doctors' failure to prescribe GranuFlo and NaturaLyte properly and should be "addressed urgently." While this memo was circulated to its own dialysis centers in Nov. 2011, Fresenius reportedly did not warn customer clinics about potential heart issues despite the fact that more than 100,000 dialysis patients were receiving the dialysis products at facilities not owned by Fresenius.
It only did so in March 2012 after the FDA was leaked the memo. Even then, it has been alleged that the information shared with customers and clinics was unclear and lacked the details and urgency found in the company's original, internal memo. In fact, it has been alleged that the memo contained only one of ten medical references mentioned in the internal memo and failed to discuss the most at-risk population. The FDA has launched an investigation to determine whether Fresenius broke federal laws when it failed to warn customers of the potentially deadly heart risk, according to The Times.
GranuFlo: The Allegations
The lawsuit filed against Fresenius Medical Care focusws on a number of allegations, including that the company knew or should have known about the increased risk of death and serious injuries associated with GranuFlo and NaturaLyte. Specifically, these suits are claiming that the use of GranuFlo and Naturalyte presents an increased risk of serious and potentially fatal cardiovascular injuries – risks that were concealed and misrepresented by Fresenius Medical Care. GranuFlo and Naturalyte were advertised as being safe for dialysis, even though Fresenius knew or had reason to know that the products were not safe and could, in fact, cause serious medical problems, according to the GranuFlo lawsuits.
The Fresenius GranuFlo lawsuits further claim that the company failed to adequately warn doctors and other professionals working in the dialysis field about the catastrophic risks associated with GranuFlo and Naturalyte. According to the suits, Fresenius has a responsibility to adequately instruct, train and inform medical professionals involved in dialysis treatment and ensure that these individuals understand how to properly use the dialysis products in a safe and effective manner.
A lack of clinical knowledge and proper labeling and instruction from Fresenius resulted in the prescription of Granuflo and Naturalyte in a manner that was neither safe nor effective, the suits claim. Allegedly, treating clinicians, physicians and nurses were not aware of the increased "buffer level" associated with Granuflo products which could lead to significantly increased bicarbonate levels and put the patient at risk for heart attack, cardio pulmonary arrest or sudden cardiac death.
It was been further alleged that Fresenius also failed to properly warn patients about the risks associated with GranuFlo and Naturalyte, including the potential for cardiac arrest. One suit involving the death of a patient who underwent dialysis with GranuFlo and/or Naturalyte claims that the decedent was unaware and “through diligent effort” could not discover the risk of serious injury and/or death associated with the dialysis concentrates.
The suit claims that the products were properly and reasonably used; however, shortly after use, the patient suffered a fatal cardiovascular event. According to the suit, the label, packing and instructions for the product failed to provide adequate instructions and/or warnings regarding the use of GranuFlo and Naturalyte. The company failed to include these warnings with full knowledge of the dialysis products’ risks, the suit claims.