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All GranuFlo and NaturaLyte patients who have suffered metabolic alkalosis complications are urged to consult with a professional product liability lawyer to determine eligibility for a claim. Although a lawsuit may not be suited to all GranuFlo victims, for those who have suffered cardiac arrest or lost a loved one, aggressive legal action may be the only means of seeking justice. A skilled attorney may be capable of recovering compensation for:

• Past and future medical bills
• Pain and suffering
• Lost wages/loss of income support
• Permanent disability
• Other related incidentals.

Determining Eligibility for a GranuFlo Lawsuit

Patients receiving hemodialysis also have a number of underlying conditions that can contribute to their health’s deterioration. The purpose of dialysis is to artificially filter blood to extend the life of kidney failure patients, hopefully until a kidney transplant is possible. However, when an acid concentrate used in dialysate increases the risk of complications, the manufacturer may be held liable for the damages. Some factors to consider for potential GranuFlo or NaturaLyte patient lawsuits include:

• Type of treatment
• Local product liability laws
• Statute of limitations
• Adverse event
• Amount of damages incurred

2012 FMC Acid Concentrate Recalls

A study conducted throughout 2010 revealed that GranuFlo and NaturaLyte converted into bicarbonate at higher levels than alternative products on the market. Patients are prescribed a certain amount of bicarbonate according to their pre-dialysis data. Because the higher conversion rates were unknown until the 2012 recall, dialysis clinicians may have administered excessive levels of bicarbonate, jeopardizing the lives and health.

Why Fresenius Medical Care Faces Hundreds of Potential Lawsuits

Fresenius Medical Care (FMC) may be confronted with hundreds of lawsuits in the coming months. As the manufacturer of the most widely used dry acid product in the dialysis industry, over 260,000 patients are estimated to have been treated using GranuFlo a year, bringing in at least $80 million in sales revenue every year for the medical device manufacturer. Since 2003, hundreds of dialysis patients have received inappropriate prescriptions of bicarbonate, resulting in serious complications such as:

• Cardiac arrhythmia
• Sudden heart attack
• Stroke
• Low blood pressure
• Death.

Speak with a Knowledgeable Attorney Today

A claim may be filed by or on behalf of patients who have suffered a serious injury as a result of GranuFlo or NaturaLyte, and accrued financial and non-monetary damages related to the injury. Prompt action is critical for GranuFlo patients, as the statute of limitations applicable to your claim may have begun even before you were aware of the injuries you suffered. Make sure your legal right to compensation is not compromised; speak to an attorney regarding your potential case today.

Skilled GranuFlo Injury Lawyers

With over 70 years of collective experience, Estey & Bomberger product liability attorneys are conducting free case screenings for all GranuFlo or NaturaLyte injury victims. To schedule a free consultation and determine your eligibility to a claim, please contact us today on our website or through our 24/7 hotline.

Fresenius Medical Care (FMC) not only manufactures dialysis products, but also operates thousands of dialysis centers throughout the United States. Of the 400,000 dialysis patients in the U.S., approximately 260,000 patients are estimated to receive dialysis treatment using GranuFlo or NaturaLyte solutions. Despite its widespread and long-term use, on March 2012, the FDA recalled both GranuFlo and NaturaLyte products due to higher cardiacpulmonary risks associated with the product.

FMC Acid Concentrate Products

Unlike most acid concentrate products used in dialysate, GranuFlo and NaturaLyte uses both acetic acid and sodium acetate. The additional presence of sodium acetate in the dialysate can lead to higher-than-prescribed doses of bicarbonate in the bloodstream. Unlike acetic acid, when sodium acetate is processed through the patient’s tissues, the acid is converted to bicarbonate a greater speed and higher levels, increasing the risk of cardiac problems. Since 2003, thousands of patients have unwittingly been exposed to greater health risks by undergoing regular dialysis treatment using FMC’s GranuFlo and NaturaLyte.

Health Risks Associated with High Bicarbonate Levels

Patients with kidney problems undergo hemodialysis three times a week to filter their blood artificially. Each time a patient receives treatment using either GranuFlo or NaturaLyte, the patient may be at risk of serious complications due to increased levels of bicarbonate caused by the sodium acetate. Excessively high levels of bicarbonate may result in life-threatening side effects such as:

• Cardiac arrest
• Cardiopulmonary arrest
• Heart problems
• Metabolic alkalosis
• Stroke
• Low blood pressure
• Death

Cardiovascular Deaths for Dialysis Patients

For years, cardiovascular-related deaths have been the number one cause of death for dialysis patients, and in 2009, the medical community began to tie dialysis treatments to increased risks of heart problems. Since 2003, the acid concentrate products manufactured and sold by FMC had remained untested until 2010, when an internal study found that GranuFlo increased the risk of cardiac arrest by 4.7 times greater under certain conditions. The findings, based on the data of 941 patients who had died at FMC dialysis facilities, were not shared with the FDA or the general public until 2012, after thousands more patients have continued to receive GranuFlo and NaturaLyte dialysis treatments. While it is unclear how many patients have died because of the defective dialysate solution, at least some patients were unnecessarily put at 6.3 times greater risk of cardiopulmonary arrest.

Investigating GranuFlo and NaturaLyte Lawsuits

Because there are many legal issues involved in each case that is specific to the claimant’s state, it is important to take action and consult an attorney experienced in negotiating and litigating large medical companies such as Fresenius Medical Care. A prompt case review can ensure the statutes of limitations will not compromise your rightful compensation. The skilled product liability lawyers at Estey & Bomberger are currently screening potential lawsuits pertaining to GranuFlo and NaturaLyte complications or death. To learn how our attorneys can help you maximize your claim, please contact us today for a free consultation.

GranuFlo and NaturaLyte has been linked to inducing higher than normal levels of bicarbonate. Because bicarbonate is alkaline (or basic), excessive amounts of the chemical in the bloodstream can cause metabolic alkalosis. The human blood has a very narrow pH range of 7.35 to 7.45, when the blood pH reaches anything lower or higher than those two numbers, a healthy kidney can filter out the excess bicarbonate or carbonic acid. However, for hemodialysis patients, a natural filtration is not possible, leaving patients at risk of metabolic alkalosis. Symptoms of the dangerous condition includes:

• Cardiac arrhythmias
• Weakness
• Low blood pressure
• Muscle pain
• Polyuria.

Complications from Metabolic Alkalosis

Maintaining homeostasis is critical for the regular function of the body. When the kidney is unable to excrete the excess bicarbonate, the blood reaches a higher than normal pH. The resulting metabolic alkalosis has been associated with a number of very serious health problems, including:

• Hypokalemia
• Hypercapnia
• Cardiac arrest
• Sudden cardiac death.

GranuFlo and Metabolic Alkalosis

Fresenius Medical Care (FMC) has long been the leading provider of dialysis products, from machines to acid concentrates used in dialysate solutions. Recently, FMC’s most widely used acid concentrate, GranuFlo and its liquid form counterpart, NaturaLyte have been recalled due to dangerous risks of metabolic alkalosis. Since its release in 2003, GranuFlo has been used in thousands of hemodialysis treatments, with over 3,300 dialysis centers using the dry acid concentrate. Unfortunately for the 260,000 patients who receive GranuFlo dialysis treatments a year, the metabolic alkalosis risk factors have only just been released to the public.

How GranuFlo Causes Metabolic Alkalosis

Because metabolic alkalosis is simply the build-up of bicarbonate, it can easily be avoided in renal disease patients by closely monitoring the pre-dialysis bicarbonate levels in the bloodstream. As patients with kidney failure have no functioning blood filtration capabilities of their own, any over-prescription can cause serious health problems. In the case of GranuFlo, the acetic acid and sodium acetate formula converts into bicarbonate at greater speed and percentage than formulas composed of only acetic acid. Consistent overdose overtime can have deadly consequences for patients with serious renal disease.

Delayed FDA Notice

In addition to the recall, the FDA issued a warning to all dialysis centers in regards to inappropriate prescriptions and alkali dosing errors in the dialysate. But for thousands of patients, the recall and warnings have come much too late. In 2010 alone, during the period FMC was conducting its internal case-control study, 941 patients died from cardiac arrest, possibly due to GranuFlo related bicarbonate overdose. And despite having sent an internal memo informing all of the FMC operated dialysis facilities, the FDA was not notified until March 29, 2012.

Liability for GranuFlo Related Damages

FMC continues to deny a conflict of interest, and asserts the delayed FDA notice was due a lack of sufficient evidence. But the estimated $80 million per year revenue from GranuFlo sales strongly contests those claims. Already hundreds have decided to seek financial compensation for GranuFlo and NaturaLyte related damages. If you would like to determine whether FMC may be held liable for the damages incurred as a result of metabolic alkalosis complication in a patient receiving GranuFlo dialysis treatment, contact a trusted product liability lawyer today.

Approximately 260,000 dialysis patients receive treatment either at Fresenius Medical Care (FMC) dialysis centers or facilities that use FMC products. Because the nature of GranuFlo and NaturaLyte acid concentrates, all patients receiving treatment using these products may be at risk of serious health complications. Patients or families of patients who have suffered serious side effects while receiving GranuFlo or NaturaLyte dialysis treatments are advised to consult a professional lawyer in order to determine whether the FMC acid products may have been a contributing factor to the injuries.

Greater Bicarbonate Conversion

GranuFlo and NaturaLyte are the acid concentrate products that are used in its diluted form as dialysate. The dry and liquid formulas are set apart from other acid concentrates because of the sodium acetate used in the formulas. Most dialysate products use strictly acetic acid. However, the unconventional ingredient in the FMC solutions acid concentrates can cause bicarbonate overdose in patients. When sodium acetate passes through the patient’s tissues and liver, the chemical compound converts into bicarbonate in greater amount and speed. Although bicarbonate has an important function in the bloodstream, by maintaining the blood pH at proper levels, too much can put the patient at risk of serious complications.

Health Risks Associated with GranuFlo and NaturaLyte

Higher than prescribed bicarbonate levels can cause damage to the heart and lungs. Some of the complications GranuFlo and NaturaLyte has been associated with includes:

• Cardiac arrest
• Heart problems
• Sudden heart attack
• Alkalosis
• Low blood pressure
• Death

According to the internal studies conducted by FMC, depending on the patient’s internal conditions, dialysis treatment conducted using GranuFlo may actually increase the risk of cardiac arrest by 6.3 times. The increased risk of death was found to be independent from any underlying heart conditions.

Take Immediate Action

Dialysis patients are advised to contact their healthcare provider to determine which chemicals are being used during treatment. If you are one of the thousands of patients who have been regularly undergoing treatment at an FMC dialysis center, make sure to monitor your health closely for any signs of bicarbonate overdosing. If you or a loved one has in fact been harmed by the dangerous GranuFlo or NaturaLyte chemicals, protect your legal rights by seeking prompt legal counsel.

Fresenius Medical’s Liability

GranuFlo has been available in the markets since 2003, but it was not until 2010 when in the face of overwhelming adverse event reports the medical device manufacturer decided to test the formulation for safety. And despite knowing of the increased risks associated with the products as early as 2010, the company failed to notify the FDA and its patients until 2012 when GranuFlo and NaturaLyte were finally recalled.

Seeking Justice Against Medical Device Manufacturers

In a for profit health care system, companies sometimes put profit above the safety and health of the public. When this occurs, it is critical to retain an attorney skilled enough to face negligent firms at the negotiating table or before a jury, willing to fight to see justice served. For information on how Estey Bomberger’s lawyers can fight on your behalf against FMC, contact us today for a free consultation regarding your GranuFlo or NaturaLyte injury claim.

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.

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.

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.