NaturaLyte Lawsuits

On March 2012, the FDA recalled the NaturaLyte Liquid Acid Concentrate, a chemical used during dialysis treatment that can increase the risk of cardiac problems. Manufactured by Fresenius Medical Care, NaturaLyte is used during hemodialysis to reduce acid buildup in the blood of patients with kidney problems. Because Fresenius Medical operates thousands of dialysis centers throughout the United States and manufactures nearly all of the products used in dialysis centers, there may be hundreds of patients whose deaths and cardiac complications may have been caused by the defective NaturaLyte solution. Those who have suffered side effects or lost a loved one related to NaturaLyte dialysis treatment are advised to consult a professional product liability lawyer as soon as possible.


What is NaturaLyte?

There are over 400,000 dialysis patients in the United States, many of whom have been treated with the recalled NaturaLyte or GranuFlo solutions by Fresenius Medical. NaturaLyte is a liquid acid concentrate that is added to the dialysate used to filter blood during dialysis. While other acid concentrates are comprised primarily of acetic acid, NaturaLyte uses acetic acid and sodium acetate. Unlike acetic acid, sodium acetate converts into bicarbonate once it passes through the patient’s tissues or liver, thereby increasing the dose of bicarbonate prescribed by the doctor. High bicarbonate levels can cause serious health complications such as:

  • Heart attack
  • Cardiac arrest
  • Stroke
  • Low blood pressure
  • Death


2010 Fresenius Medical In-House Study

After noticing an unusually high number of complications, Fresenius Medical conducted a case-controlled study evaluating the risks associated with GranuFlo and NaturaLyte. Between January 2010 and December 2010, the Fresenius researchers identified 941 patients who suffered cardiopulmonary arrest in 667 of Fresenius dialysis facilities. In addition, the study found that patients receiving GranuFlo or NaturaLyte treatment were 4.7 to 6.3 times more likely to suffer cardiopulmonary arrest. Despite being aware of these problems as early as 2011, the FDA, healthcare providers, and patients were not notified of these problems until 2012.


Legal Options for NaturaLyte Victims

Between 2003 until 2010, Fresenius Medical did not conduct any tests ensuring the safety of its products, and when it finally discovered the higher risk of adverse events associated with the sodium acetate products, the company did not notify the FDA until March 29, 2012. Consequently, hundreds of Fresenius dialysis patients and their families are seeking compensation for the damages related to NaturaLyte related injuries. Claimants may be entitled to receive compensation for:

  • Past and future medical bills
  • Lost wages
  • Permanent disabilities
  • Pain and suffering
  • Wrongful death


Take Action Today

If you or your loved one has been harmed by NaturaLyte’s dangerous side effects, do not delay and immediately consult a professional product liability lawyer today. Depending on the product liability laws in your state, the statutes of limitations may already be in effect, making time a crucial factor in ensuring your rights are secured.



Television Advertisements

ATTENTION: Dialysis patients! The experienced personal injury lawyers at the law firm of Estey Bomberger are currently investigating cases involving GranuFlo and NaturaLyte. If you have seen TV ads warning consumers of the risk of death when undergoing dialysis treatment with either one of these dangerous drugs, our lawyers can answer your questions and provide expert legal guidance.

Inappropriate use of GranuFlo or NaturaLyte, which are both manufactured by Fresenius Medical Care (FMC), can cause:

  • Cardiac arrest
  • Sudden heart attack
  • Cardiopulmonary arrest
  • Low blood pressure
  • Hypokalemia (low potassium levels)
  • Death.

What are GranuFlo and NaturaLyte?

GranuFlo dry acid concentrate and NaturaLyte liquid are used in the treatment of acute and chronic renal failure (kidney failure) during a process called hemodialysis. These products contain either acetate or sodium diacetate, which if inappropriately administered can result in high serum bicarbonate levels in dialysis patients. High serum bicarbonate levels can cause serious complications that if not treated appropriately can lead to serious adverse health consequences, including death.

FDA Class I Recall

As mentioned in several television ads, in March 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall for GranuFlo and NaturaLyte because of the potentially life threatening injuries associated with both products. However, FMC was already aware of the dangers associated with their product as a result of an “in-house” study conducted in 2010. Shockingly, FMC did not release the findings of their study until November 2011 and even then, only warned FMC owned and operated facilities of the dangers of these drugs. It wasn’t until March 2012 when non-FMC run dialysis centers received a memo warning them of the drugs’ dangers and recall.

Filing a Lawsuit to Recover Financial Compensation

If you suffered a heart attack or any other serious complication during or after dialysis, you may be able to file a lawsuit against FMC. Even if you did not receive dialysis at a FMC run center, you may be entitled to financial compensation for the damages related to your heart attack or injury. Examples of the different types of damages you may be entitled to compensation for, include:

  • Hospitalizations
  • Doctor visits
  • Medicine
  • Medical equipment
  • Therapy
  • Caregiving services
  • Lost earnings from missed time at work
  • Lost benefits
  • Loss of quality of life
  • Shortened life expectancy
  • Loss of relations (if applicable)
  • Pain and suffering.

Wrongful Death Lawsuit Stemming From a Dangerous Drug

If your loved one died during or after dialysis, you may also be entitled to financial compensation and should seek the counsel of a dangerous drug lawyer at the law firm of Estey Bomberger immediately. The sooner we are contacted, the sooner we can get help you begin to put the pieces of your life back together following a heartbreaking loss.

Call our firm 24 hours day to schedule a free consultation. We will gladly meet you at your home, office or hospital room to discuss your case.



Main Page

GranuFlo Dialysis Lawsuit Information

The U.S. Food and Drug Administration (FDA) is investigating Fresenius Medical Care, largest operator of dialysis centers in the U.S. and manufacturer of dialysis equipment and products, over a potentially very serious problem with its GranuFlo dialysis treatment, and a failure to warn doctors at dialysis centers about the potential of dialysis related heart attacks and death. It is possible that this failure to warn could have led to numerous preventable injuries or deaths, which the FDA is investigating. If you or someone you love has suffered from GranuFlo dialysis treatment, it is advisable to contact a lawyer right away.

Failure to Warn All Doctors

The New York Times has reported that, according to a November 4, 2011 memo from Fresenius Medical Care to doctors practicing at the company’s dialysis centers, at least 941 people have suffered sudden cardiac arrest while undergoing dialysis with GranuFlo. While doctors at the company’s own dialysis centers were warned about the risks of failing to properly use the products, doctors at other centers were not immediately warned.  Other doctors were warned only in late March 2012, after the FDA received an anonymously submitted copy of the company’s internal memo.

What is GranuFlo?

GranuFlo is a widely prescribed dry acid used to evenly distribute electrolytes during kidney dialysis. Dialysis does the kidneys’ job of clearing toxic waste in the blood, and part of the dialysis process involves taking bicarbonate to neutralize acid in the blood. Many dialysis patients are prescribed bicarbonate, however, an active ingredient in GranuFlo converts to bicarbonate. Too much bicarbonate from the combination of prescribed bicarbonate and that produced by GranuFlo could result in metabolic alkalosis.   This can cause numerous negative and potentially fatal effects including cardiopulmonary arrest, heart attack and stroke. Fresenius’ medical staff determined that patients with high levels of bicarbonate in their blood had about a six times higher risk of adverse effects.

Potential Liability for Failure to Warn

Based on the information reported in the New York Times and other news reports, the failure of Fresenius Medical Care to warn dialysis clinics, physicians and patients about the significant health risks associated with elevated bicarbonate levels could have led to numerous preventable heart attacks and other health problems.  If you or a loved suffered cardiac arrhythmia, cardiopulmonary arrest, heart attack or death while undergoing dialysis treatment, you could be entitled to compensation in a lawsuit. Contact the law firm of Estey Bomberger for a free consultation with one of our experienced defective product lawyers. If you have a valid claim, we will handle your case on a contingency fee basis. There are no up-front fees and we advance all costs. We are only paid if and when we recover compensation for your case.

About Estey Bomberger

Estey Bomberger attorneys are nationally recognized for success in product liability cases, and have the skills, experience and resources necessary to take cases to trial. Our track record of successful case results includes many precedent-setting victories. Contact us today to see how we can help you.


What is Metabolic Alkalosis?

Fresenius Medical Care’s (FMC) dialysis concentrate – GranuFlo – has been linked to a condition known as metabolic alkalosis. Metabolic alkalosis is a condition in which the body accumulates too much of an alkaline substance like bicarbonate. Elevated alkaline levels make it difficult for the body to produce enough acid to neutralize the effects of alkali and patients with unbalanced levels of acid and alkaline may begin to show symptoms of metabolic alkalosis.

Symptoms of Metabolic Alkalosis

One of the first symptoms of metabolic alkalosis can be slowed breathing. Individuals suffering from metabolic alkalosis may also have episodes of apnea (not breathing), develop a bluish or purplish discoloration of the skin, and feel nausea, irritable, and confused. Other symptoms of metabolic alkalosis are: irregular heart beat, drop in blood pressure, and rapid heart rate.

If recognized early and treated promptly, people with mild cases of metabolic alkalosis usually do not suffer long-term complications, however, severe cases of metabolic alkalosis can lead to convulsions, coma, cardiac arrest, and death.

GranuFlo Dialysis Concentrate

GranuFlo is the most prescribed dry acid concentrate used in hemodialysis (process of filtering blood through a machine outside of the body). Reportedly, in early 2010, FMC became aware of a significant risk of cardiac arrest and death associated with the use of GranuFlo. Although GranuFlo is used globally in both FMC owned dialysis clinics and non-FMC clinics, FMC only notified doctors working in their clinics of the risks linked to the company’s dialysis concentrate. It wasn’t until the Food and Drug Administration launched an investigation to determine whether or not the company violated federal regulations in March 2012 that FMC warned non-FMC dialysis clinics of the potentially life threatening side effects linked to GranuFlo.

Estey Bomberger – Success in Complex Product Liability Cases

At Estey Bomberger, our California product liability attorneys have the legal expertise, dedication, and financial resources needed to successfully litigate a case against large corporations like Fresenius Medical Care. As proof of our success in complex product liability cases, we ask you to view our case results page located on this website. We have recovered large settlements and verdicts for injured clients’ damages and can do the same for you. Let us put our years of experience to work for you recovering maximum compensation for medical bills, lost wages, and pain and suffering. Please call our law firm today to discuss your case for free wherever it is most convenient for you – home, office or hospital.



Manufacturer of GranuFlo – Failure to Warn

Fresenius Medical Care (FMC), makers of the most prescribed dialysis concentrate – GranuFlo – is currently under investigation by the Food and Drug Administration (FDA). The FDA is investigating whether or not FMC failed to warn consumers of the potentially life threatening risks associated with GranuFlo.  Allegedly, FMC knew of an increased risk of cardiac arrest for GranuFlo users as early as 2010, but did not warn doctors or consumers of this risk until late 2011. Even then, FMC only issued a warning to company owned dialysis clinics. Not until March 2012 did FMC issue a GranuFlo warning to non-FMC doctors and clinics.

Manufacturing companies like FMC are required to warn consumers of the potential risk and possible side effects associated with the use of a product. A warning should explain to consumers why a risk exists with the use of a product, what the possible side effects are if the warning is not followed, and how a consumer can avoid danger. Manufacturers who fail to warn consumers may be liable for the damages related to an injury or death caused by the use of a dangerous product.

Victims’ Legal Rights

If you or a loved one suffered a serious complication after using GranuFlo, your legal rights may entitle you to financial compensation from the manufacturer. To learn what your legal rights are, consult a trusted California dangerous product attorney at the law firm of Estey Bomberger. We can explain to you what your rights are and quickly determine if your rights allow you to file a product liability (area of law governing dangerous products) lawsuit. Product liability law is a complex area of law and can be difficult to navigate. We have more than 70 years of experience handling product liability cases and have obtained millions of dollars for clients harmed by a dangerous or defective product. Our case results include a $17 million verdict for a client who suffered a serious spinal cord injury as a result of using a defective loader/back-hoe.

Passionate about Helping Clients 

The California product liability attorneys at Estey Bomberger are passionate about helping clients get maximum compensation for medical expenses, lost wages from missed time at work, loss of quality of life, impaired earning capacity, emotional anguish, and physical pain. Please contact our firm today to arrange a free consultation with one of our attorneys. We do not require a retainer fee and will not ask you for any out-of-pocket expenses. We only collect payment when you collect compensation.


GranuFlo Wrongful Death Lawyers

GranuFlo dialysis concentrate, which is manufactured by Fresenius Medical Care (FMC), is the most prescribed dry acid concentrate used in hemodialysis. FMC treats approximately 400,000 patients at its dialysis clinics and of those; about 260,000 of them are treated with GranuFlo. In non-FMC dialysis clinics, approximately 126,000 patients are treated with GranuFlo. In late 2011, FMC notified doctors practicing in the company’s dialysis clinics that use of GranuFlo significantly increased the risk of a patient dying suddenly from cardiac arrest. According to FMCs findings, patients treated with GranuFlo were approximately six times more likely to suffer cardiac arrest than when treated with other dialysis concentrates.

Unlike rival products, GranuFlo contains more of an ingredient that the body converts to bicarbonate, which is an alkaline substance. When alkaline levels are elevated, the body cannot produce enough acid to neutralize the alkali and patients can develop a condition known as metabolic alkalosis. Metabolic alkalosis can lead to heart problems and worse, death.

Fresenius Medical Care – Failure to Warn

Alarmingly, FMC failed to notify non-FMC clinics of the dangers associated with GranuFlo until March 2012 and is currently being investigated by the Food and Drug Administration as to whether or not they violated federal regulations. Manufacturers like FMC are required to warn consumers of the risks associated with the use of a product and may be liable for the damages related to a tragic death if found to have acted negligently in the marketing of their product.

If your loved one’s death was attributed to the use of GranuFlo, you may be able to file a wrongful death claim against FMC. In a wrongful death claim, you can pursue monetary compensation for the damages associated with your loss, including:

  • Final medical bills
  • Deceased’s future earnings
  • Deceased’s anticipated savings
  • Funeral and burial expenses
  • Lost benefits of the victim (pension, 401K, etc.)
  • Loss of love, companionship, and guidance (if applicable).

Fostering Change 

At Estey Bomberger, our California dangerous product lawyers know that no amount of money could ever replace the life of a loved one. Our goal when helping surviving family members is to simply make sure they have the tools they need to begin putting the pieces of their life back together following a tragic loss. By filing a claim, our clients can also make sure the negligent wrongdoer is held accountable and made to pay for the harm they have caused. We feel strongly that our job is to not only help clients obtain full and fair compensation, but also to foster change in the way large corporations like FMC do business.

Call Estey Bomberger for Free, 24 Hours a Day 

For a free and confidential consultation, please call our office at no charge anytime of the day or night. When you call, your call will be taken by one of our caring wrongful death lawyers and not a case manager or paralegal. You can also reach one of our experienced lawyers by submitting a free online case consultation request form. We understand the physical, emotional and financial effects an unexpected loss can have on victim’s family members and are dedicated to helping families see justice served.