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Dialysis is supposed to be a lifesaving and life-sustaining technology for individuals with renal failure. It should not put patients at risk of heart attack or death. Unfortunately, two dialysis products by Fresenius Medical Care, known as Naturalyte and GranuFlo, contain ingredients that can cause heart attack risk to spike. And the Fresenius kept selling them without proper warnings after they knew about the risk.
If you or someone you love experienced any cardiac event during or after dialysis with GranuFlo or Naturalyte, you may have been harmed by Fresenius’ carelessness—and the cardiac event may have been completely preventable. You have a right to make a financial recovery, but there’s a tight deadline for doing so. Speak to a lawyer today. John Foy & Associates is one of the largest and most experienced medical injury lawyers in the nation. Call us at 404-400-4000 and get a free consultation.
How do GranuFlo and Naturalyte work?
Granuflo/Naturalyte are concentrates used during dialysis. Dialysis is a process of using a machine to filter the blood. It’s used for several conditions causing loss of kidney function, especially renal failure (kidney failure). The kidneys’ job is to naturally “filter” waste products from the blood, and when kidney function declines, dialysis steps in to take over.
During dialysis, a machine removes waste products and excess salt and water from the blood stream. It also has to control the pH (acid level) of the patient’s blood. A concentrate of some kind is added into the blood, which supplies the body with needed minerals like potassium, and also helps the body make an alkaline substance, bicarbonate. Bicarbonate helps neutralize the acid in the blood and bring it back to a healthy level.
GranuFlo and Naturalyte are marketed as safe and effective dialysis concentrates for use in dialysis. But both contained a fatal flaw relating to bicarbonate.
What’s wrong with GranuFlo and Naturalyte?
Although every dialysis patient needs bicarbonate, different patients have different acid levels to start with. Some patients have a high level of bicarbonate in their blood before dialysis starts, meaning they need little to none added. Others need a significant amount. This is why most dialysis concentrates contain little to no bicarbonate, and doctors add the correct amount themselves.
But Fresenius designed GranuFlo and Naturalyte differently. The two concentrates are meant to be all-in-one, saving space in the hospital. As such they contain higher levels of a substance that the body converts to bicarbonate. This is fine for some patients—but not others.
Worse, doctors were not warned that the product already contributes to bicarbonate levels. Many followed standard procedure and added more bicarbonate on top of the GranuFlo/Naturalyte. In some cases this effectively caused an “overdose” of bicarbonate, which can have serious consequences.
What kind of health effects can too much bicarbonate have?
The right amount of bicarbonate is a good thing. Too much can be very damaging. In particular, it can cause serious heart problems. The FDA has found that elevated bicarbonate levels can provoke metabolic alkalosis, a metabolic condition that puts strain on the heart. This can cause:
- Low blood pressure
- Low oxygen pressure in the blood
- Low potassium levels
- Dangerously high levels of carbon dioxide in the blood
- Cardiac arrhythmia (irregular heartbeat)
If caught early and treated, these conditions can often be reversed. But if not treated, the problem can become much more serious. It may lead to:
- Heart attack
- Congestive heart failure
- Cardiopulmonary arrest
- Sudden cardiac death
- Wide ranging and potentially permanent cardiovascular injuries
In some cases, the patient can die.
Is Fresenius liable for these problems?
Yes. Fresenius markets both products as safe, when in fact they involve greater risks for elevated bicarbonate levels than other similar products. And Fresenius did not give doctors proper instruction. There was no warning that Naturalyte/GranuFlo contribute to higher bicarbonate levels, and doctors were not instructed to consider this before adding bicarbonate manually. Many heart conditions and even deaths could have been avoided if doctors were simply given the information they needed.
Worse, Fresenius knew about the problem and said nothing. An internal memo alerted Fresenius staff to the risk of heart complications as early as 2011. The memo said that doctors need to take corrective measures, and warned, “This issue needs to be addressed urgently.” (Read the full Fresenius Medical Care internal memo.) But the company did nothing to warn the public, or even its customer clinics. In fact, the only doctors it did warn were those at its own dialysis centers—effectively saving Fresenius patients, but not patients of other clinics.
Only in 2012, when the memo was leaked to the FDA, did Fresenius take action. At that time it voluntarily alerted doctors and began to change the packaging on its products.
Approximately 125,000 patients are given GranuFlo in non-Fresenius clinics. In fact, Fresenius still brags that it is the most widely prescribed product of its kind, and “the safest choice” for hospitals to use.
What kind of action has been taken against Fresenius?
The FDA now treats the relabeling of GranuFlo and Naturalyte as a Class I recall. Class I recalls are the highest level of recall and are used for products that could “cause serious adverse health consequences or death.” This recall will not remove the product from use, but does force Fresenius to give proper warning and instructions to all doctors, whether they work at its clinics or not.
This recall is a good step going forward, but on its own it does nothing to help the thousands of patients who could have already been harmed. Multiple lawsuits against Fresenius name GranuFlo or Naturalyte as leading to the death of a loved one, or causing serious and long-lasting damage. Some of these lawsuits also suggest that the instructions provided to doctors are still not clear and don’t stress the urgency of the risks. For the many patients who have been harmed by Fresenius, legal channels are the best option.
If someone you love may have been harmed by GranuFlo or Naturalyte, you are not alone. The attorneys of John Foy & Associates are experienced, caring and ready to help. We believe in supporting individuals and families harmed by Fresenius in their battle to get a fair outcome. You could be eligible for a financial recovery that can help pay for medical bills, lost wages, pain, suffering, and the long term effects of living with a serious medical condition.
Every medical case involves tight deadlines. Don’t wait until it’s too late. We offer a FREE consultation and we charge nothing unless we get you a financial recovery. Call 404-400-4000 and get your free consultation today.