NaturaLyte is a dialysis treatment product that has been associated an increased risk of heart attacks and cardiopulmonary arrest. Fresenius Medical Care is under investigation for failing to warn about the potential hazard. The FDA only became aware of the risk when a November 2011 memo was leaked in March 2012. Since then, a Class 1 recall has been announced.
Do I Have a NaturaLyte Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a heart attack, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: Fresenius Offers $250M to Settle GranuFlo Lawsuits
February 18, 2016 —Fresenius Medical Care has reached at $250 million settlement to resolve about 4,300 lawsuits involving heart attacks that occurred in patients who were given GranuFlo or NaturaLyte during dialysis. Click here to read more.
NaturaLyte Recalled for Bacterial Contamination Linked to Death
In May 2014, the FDA issued a Class I recall for Naturalyte because it may be contaminated with bacteria. Patients on dialysis who receive contaminated Naturalyte could develop life-threatening bacterial infections, sepsis, and bacteremia (blood poisoning).In June, the FDA announced that two injuries and one death may have been caused by the products.
NaturaLyte Lawsuits Centralized in Multi-District Litigation (MDL)
In 2013, federal judges created a Multi-District Litigation (MDL No. 2428) to centralize lawsuits involving GranuFlo and NaturaLyte into one court in Massachusetts. Over the next two years, over 4,000 lawsuits were filed. All of them accuse Fresenius of failing to warn about the risk of bicarbonate overdoses.
DaVita HealthCare, another dialysis clinic that uses NaturaLyte, is also facing class actions from people who were injured. However, most of the cases are individual lawsuits, such as:
- Louisiana man has filed a lawsuit after suffering a heart attack, stroke, and severe pain following treatment at a Fresenius dialysis clinic. Click here to read more.
- Wrongful death lawsuit has been filed on behalf of a man from Texas who died of a sudden cardiac arrest after being treated with GranuFlo and Naturalyte. Click here to read more.
- Wrongful death lawsuit has been filed in Georgia, on behalf of a woman who died of a cardiovascular event during dialysis treatment in 2010. Click here to read more.
- Two wrongful death lawsuits filed in the U.S. District Court for Alabama. Both lawsuits were filed by women whose husbands died of heart attacks after being given GranuFlo or Naturalyte during dialysis treatment. Click here to read more.
What is Naturalyte?
NaturaLyte is a liquid product used during blood dialysis that is supposed to help balance blood acidity/alkalinity. NaturaLyte (and GranuFlo, which is a dry powder instead of a liquid) are manufactured by Fresenius Medical Care. Fresenius is a German company that is world’s largest provider of dialysis products and treatment centers. In the United States, Fresenius operated 5,700 dialysis clinics and serves approximately 400,000 people.
What is the problem?
Most acid-neutralizing dialysis products contain primarily acetic acid. NaturaLyte also contains sodium acetate, which is converted to bicarbonate by the patient’s tissues and liver. This means that patients given NaturaLyte may suffer significantly increased bicarbonate levels — especially if a physician is not very careful about administering the right dosage and concentration of NaturaLyte and bicarbonate.
Failure to Warn About Side Effects
On November 4, 2012, Fresenius sent a memo (PDF) to doctors at their clinics after noticing an increased number of deaths among dialysis patients, especially those with high bicarbonate levels. They warned that physicians should be careful when administering GranuFlo and NaturaLyte due to the risk of bicarbonate overdose.
Investigators found a six-fold increased risk of heart attack and death among patients who had high pre-dialysis bicarbonate levels. The study found that 941 people died of heart attack at 667 Fresenius dialysis clinics in 2010.
This memo was not sent to the FDA, doctors at other clinics, or anyone else — despite the fact that approximately 100,000 people undergo dialysis with GranuFlo or NaturaLyte at other dialysis clinics. The FDA only became aware of the memo when an anonymous source send them the memo. The FDA questioned Fresenius company executives, and in March 2012, Fresenius was forced to issue a Class 1 recall.
Fresenius issued a Class 1 recall of the NaturaLyte and GranuFlo on March 29, 2012. The company stated in the recall:
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”
Patients with a bicarbonate overdose may suffer from a condition called metabolic alkalosis. This is a life-threatening condition that can cause severe side effects, such as:
- Cardiac arrest
- Heart Attack
- Low blood pressure
- Cardiopulmonary arrest
- Heart problems
- Irregular heart rhythm
- Heart attack
- Low potassium
- Low oxygen
- Excessive carbon dioxide
Do I have a NaturaLyte Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas NaturaLyte lawsuit review.