What You Need to Know About GranuFlo® and NaturaLyte®
The New York Times reports that the U.S. Food and Drug Administration (FDA) is investigating whether Fresenius Medical Care (Fresenius) failed to properly inform some kidney dialysis patients of their risk of cardiac arrest. The concerns involve the use of Fresenius products GranuFlo and NaturaLyte, which have been linked to alkalosis, a condition associated with an increase in death and sudden cardiac arrest in patients undergoing dialysis treatment.
On March 29, 2012, Fresenius issued an “urgent product notification” with “important prescribing information” highlighting the increased risk associated with improper use of GranuFlo and NaturaLyte.
An internal communication from within Fresenius in November 2011 confirmed that the company was aware “patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of an additive to the risk of CP arrest associated with pre-dialysis hypokalemia.”
Additionally, Fresenius indicated that in 2010 alone there were nearly 1,000 patients who suffered from cardiac arrest in dialysis clinics operated by Fresenius, an occurrence they said could be linked to bicarbonate levels in the body. Although the memo warning of the danger of improper use of GranuFlo was sent to clinics operated by Fresenius in November 2011, it is believed Fresenius did not first warn hundreds of non-Fresenius clinics that used GranuFlo and NaturaLyte of the possible problems tied to these products until months later in March 2012.
The FDA is now investigating if non-Fresenius clinic patients were put at a greater risk based on the company’s believed withholding of important safety information.
GranuFlo® in Dialysis Treatment
Dialysis is often used to help patients whose kidneys have failed. During dialysis, the acid in a patient’s blood is neutralized by bicarbonate, an alkaline substance. Products used in dialysis commonly contain ingredients that the body converts to bicarbonate, but the Fresenius product GranuFlo contains a larger amount of this ingredient. It is believed that this large amount can cause an excessive build-up of bicarbonate in the body, which can lead to heart problems—including cardiac arrest (heart attack) or death by sudden cardiac arrest.
Fresenius medical staff determined that the risk of cardiac arrest in patients with high levels of bicarbonate in their blood was six times higher than in patients with normal levels. The FDA issued an alert in May 2012 concerning this risk, and dialysis centers across the country are now checking patients’ bicarbonate levels and adjusting their dosages as necessary. If you or someone you love was injured or died from complications related to GranuFlo or NaturaLyte, the kidney dialysis lawyers at our law firm want to help you.
The U.S. Food and Drug Administration (FDA) has issued a Class One Recall for Granuflo and NaturaLyte® dialysis treatments, manufactured by Fresenius Medical Care. Granuflo and NaturaLyte dialysis treatments have been linked to serious heart problems. Fresenius dialysis concentrate could put patients at risk of cardiac arrest if it is not prescribed properly. During dialysis treatments, many patients use bicarbonate to neutralize acid build up in the blood. The problem with Granuflo is that its active ingredient turns into bicarbonate. That can lead to a bicarbonate overdose which may be responsible for metabolic alkalosis. This serious side effect may cause cardiac arrest, death, heart attack, or deadly low blood pressure.
According to the New York Times, “the Food and Drug Administration is investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products.”
Granuflo® dialysis treatments have been linked to heart problems and have been recalled. Victims may be considering Granuflo lawsuits after an injury. To learn more about Granuflo lawsuits, please contact our defective product lawyers by filling out the contact form or calling toll-free (866) 232-5777.
Is there compensation available for Granuflo injuries?
Victims of Fresenius Dialysis Treatments may be eligible for compensation from a lawsuit. If Granuflo is responsible for your injuries, you may be entitled to money for past and future medical bills. Injured people that missed time from work may be able to recover for lost wages. Some victims might receive money for pain and suffering. If your family lost a loved one from Granuflo, you may be entitled to compensation for the loss of that loved one and funeral expenses.
Should I file a Granuflo dialysis class action lawsuit?
Some victims and their families of Granuflo are considering filing class action lawsuits against the drug’s manufacturer. Granuflo class action lawsuits could provide money for medical bills, pain and suffering, lost wages, and for the loss of a loved one. However, Granuflo class action lawsuits may not provide the compensation that some Granuflo victims deserve. Class action lawsuits normally split the settlement equally between claimants. That means that you could get less than what you actually deserve. There is a better alternative: multidistrict litigation (MDL).
Granuflo Multidistrict Litigation (MDL)
Multidistrict litigation (MDL) occurs when a single court compiles lots of cases from around the country. These cases will each be decided separately. That means that your Granuflo lawsuit will be decided based upon its own merit. If Granuflo multidistrict litigation occurs, Granuflo victims and their families are more likely to get what they deserve from the drug manufacturer. Since each case will be decided individually, that means the court will determine your compensation based upon your medical bills, lost wages, and other factors that are related to you.
Can I afford a Fresenius dialysis treatment lawsuit?
Woods & Woods defective product lawyers never charge a penny unless you win. When you win, our fee is a percentage of the settlement and case expenses. If you lose your Fresenius Dialysis Treatment lawsuit, you don’t owe us a penny. Woods & Woods does not ask for money upfront and we don’t bill by the hour. Our Fresenius Dialysis Treatment lawyers never charge for phone calls.
Why call a kidney dialysis heart attack lawyer?
Since 1985, Woods & Woods defective medical device lawyers have fought for injured people. Since then, we have successfully represented thousands upon thousands of clients. We never charge for case evaluations. Call us today and we can help you explore your legal options.
Never stop kidney dialysis treatment without first consulting your doctor. GranuFlo® is a registered trademark of Fresenius Medical Care North America and is used here only for the purpose of identifying the product in question. This law firm is not associated with, sponsored by, or affiliated with the New York Times, the U.S. Food and Drug Administration, or Fresenius Medical Care.