Do You Have a GranuFlo or NaturaLyte Lawsuit Claim?

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.

Granuflo News

Dosing Errors Have Led to Another Lawsuit Against Fresenius

Fresenius is facing yet another lawsuit over GranuFlo, this one filed by a Louisiana man alleging harm was caused by alkali dosing errors tied to the product.

The new lawsuit involves several allegations including that:

  • Fresenius knew there were risks associated with Naturalyte and/or GranuFlo but hid that knowledge from not only the FDA, but also the public and the medical community.
  • Fresenius negligently and/or fraudulently represented that tests conducted on the products proved that the products were safe for their intended use.
  • Fresenius did not actually perform adequate testing to identify risks associated with Naturalyte or GranuFlo

The lawsuit centers on a Nov. 4, 2011 internal memo sent by Fresenius, that has been widely reported in the media. The memo, which appears very damaging, allegedly shows that Fresenius warned some of its medical directors and physicians about severe health risks tied to Naturalyte and GranuFlo. However, Fresenius did not warn the FDA about those same risks, which were reportedly identified in a case-control study on hemodialysis patients. According to the lawsuit, that November memo allegedly notes that the case-control study found “borderline elevated pre-dialysis bicarbonate levels and overt alkalosis arrest and sudden cardiac death.”

The lawsuit was filed by Ronnie Glasper, who was treated at a Fresenius Medical Care center in Louisiana. According to court documents, while undergoing dialysis, Glasper was prescribed either Naturalyte or GranuFlo. He later suffered a heart attack and stroke.

Glasper’s suit alleges that the memo was not sent to the Fresenius facility where he was treated or to the attending physician.

History of Problems
GranuFlo is a dry acid that is widely prescribed to evenly distribute elecrolytes during kidney dialysis. Fresenius is facing numerous lawsuits from patients alleging that they were harmed by GranuFlo and Naturalyte use. Eleven federal lawsuits were consolidated to MDL 2428 in the US District Court for the District of Massachusetts.

The health issues allegedly suffered by patients who used Naturalyte or GranuFlo include high blood serum bicarbonate levels, which can lead to death, cardiopulmonary arrest, cardiac arrhythmias, and stroke.

Contact an Attorney
If you or a loved one has suffered from GranuFlo dialysis treatment, you should contact an attorney immediately. Estey & Bomberger is nationally recognized for its success with product liability cases, including cases involving GranuFlo.



Granuflo News

FDA Warns Granuflo/NaturaLyte Manufacturer Again

The U.S. Food & Drug Administration (FDA) has issued another warning to GranuFlo/NaturaLyte manufacturer, Fresenius Medical Care. And the U.S. Judicial Panel on Multidistrict Litigation has decided to consolidate dozens of lawsuits against the firm.

The FDA warning, issued in March 2013, states that Fresenius failed to conduct adequate design verification studies of its electron beam (E-beam) dialyzers. The FDA also asserted that the company’s design did not meet specifications.

Dialysis is a process of filtering unwanted fluids from the blood. Patients with kidney malfunction require dialysis to remove toxins, such as urea, from their systems. Physicians use dialyzers to strain such waste products from the bloodstream and return clean blood to the body. Consequently, dialyzers are crucial to a successful dialysis procedure.

Prior recall

The FDA’s warning follows a 2012 Class 1 recall of GranuFlo and NaturaLyte, both concentrates used to treat acute and chronic renal (kidney) failure during dialysis.  Class I recalls are the most serious type of recall, used only when a product poses risks of  serious health consequences and/or death.  The recall drew attention to such risks, resulting from dosage errors.

Thousands of dialysis patients at risk

Fresenius operates more than 3,000 dialysis clinics throughout the United States, and an estimated 125,000 patients have been treated for kidney failure with GranuFlo and NaturalLyte. Low blood pressure, hypoxemia, cardiac arrhythmia and low potassium levels, which can lead to heart attack, cardiac arrest, stroke and sudden death, are all reported effects of GranuFlo and NaturaLyte dosage errors.

Company knew of hazards

An internal Fresenius memo, leaked to the FDA, revealed the company’s knowledge of these life-threatening complications. The 2011 memo, directed only to Fresenius clinicians, warned of more than 940 incidences of cardiac arrest among patients who received either GranuFlo or NaturaLyte while being treated at Fresenius clinics.

Dozens of lawsuits consolidated

Since the 2012 recall, approximately 40 lawsuits have been filed alleging that Fresenius failed to warn consumers and physicians at large of potential dosage risks, and, according to court documents, another 700 victims are waiting to file suit. In March 2013, the U.S. Judicial Panel on Multidistrict Litigation heard arguments in San Diego, about where to consolidate dozens of multi-state suits and decided on the District of Massachusetts.

If you or a loved one has suffered an injury due to a Fresnenius E-beam dialyzer or to use of either GranuFlo or NaturaLyte, you need to seek legal advice immediately.  Contact us for a free consultation. There is no charge to you until we win your case.


GranuFlo/NaturaLyte Heart Attacks

Hemodialysis patients are at greater risk of serious health complications, but according to a case-control study by Fresenius Medical Care, the use of GranuFlo or NaturaLyte acid concentrates had the potential to increase the risk of a heart attack by 6.3 times. During the course of the study between January 2010 and December 2010, there were 941 identified patients who suffered heart attacks that may have been related to the GranuFlo dialysate.

GranuFlo and NaturaLyte Recall

In March 29 of 2012, Frsenius Medical Care (FMC) issued a Class I recall for the NaturaLyte and GranuFlo acid concentrates. The recall cautioned clinicians of the potential for inappropriate prescriptions caused by the high bicarbonate conversion levels. The concentration of acetate and acetic acid contained in Fresenius’ NaturaLyte and Granuflo has been found to convert into bicarbonate at greater rates than other acid concentrates, thus potentially leaving patients at risk of high bicarbonate levels. Increased levels of bicarbonate may contribute to metabolic alkalosis, a significant risk factor associated with a number of serious complications, including:

  • Hypoxemia
  • Hypercapnia
  • Cardiac arrhythmia
  • Low blood pressure
  • Hypokalemia
  • Cardiopulmonary arrest (heart attack).

2010 GranuFlo Case Control Study

Having been linked to a greater number of heart complications, FMC conducted a case-control study on all GranuFlo patients. The study found that patients with bicarbonate levels greater than 28mEq/L before dialysis treatment were 4.7 times more likely to suffer cardiac arrest. In addition, patients with a pre-dialysis potassium level less than 4mEq/L faced a 6.3 times higher risk of a heart attack. While the data suggesting GranuFlo and NaturaLyte patients faced an unusually high risk of heart attacks had been available since 2010, the Fresenius waited until 2011 to inform FMC operated clinics of the dangerous risk of inaccurate prescriptions and waited until 2012 before alerting the wide public of the issue.

Nationwide Impact on Dialysis Patient Health

Some 240,000 patients receive hemodialysis treatment either at FMC dialysis centers or facilities operating with FMC devices. Of that number, approximately 125,000 patients are treated using GranuFlo dialysate in non-FMC clinics. FMC defends its decision to delay informing the FDA by claiming that there was not enough evidence until 2012. However, the internal memo that was distributed to FMC operated centers indicates the manufacturers were aware of the very serious risks linked to the GranuFlo formulation. Their decision to withhold information may have cost hundreds of lives that may otherwise have been prolonged through proper dialysis treatment.

Securing Financial Compensation

Revenue from U.S. GranuFlo sales alone is estimated at a minimum of $80 million per year. When a company makes a decision to endanger the public’s health for its profits, product liability laws provide legal options for the wrongfully harmed patients. Speaking with an aggressive trial lawyer knowledgeable in product liability law, particularly someone experienced in handling cases against medical device manufacturers, can ensure your receive the total financial compensation you deserve after being injured by a defective device. GranuFlo or NaturaLyte patients and their families are encouraged to contact a knowledgeable attorney to evaluate their legal rights to compensation.


Fresenius Medical Care Internal Memo

There are thousands of patients estimated to have suffered fatal cardiac arrests related to the Fresenius Medical Care (FMC) GranuFlo and NaturaLyte Acid Concentrate products. Approximately 240,000 patients receive hemodialysis treatment using GranuFlo dry acid concentrate, a dialysate that has been linked to higher rates of cardiac arrest and other serious side effects. Although both products have been recalled in March 29, 2012, an internal memo circulated amongst FMC facilities indicate that the medical device manufacturer may have been aware of the problems long before the recall was issued.

GranuFlo Case-Control Study

An End-Stage Renal Disease conference in 2009 identified that cardiac death as the number one cause of death for dialysis patients and that the deaths were primarily due to uremic cardiomyopathy, a side effect of dialysis. Following the results of this conference, FMC conducted a yearlong case-control study and found 941 patients in 667 FMC facilities with records of cardiac arrest between January 1st and December 31st of 2010. The study concluded that GranuFlo patients faced greater risk of cardiac arrest, especially those with sodium levels higher than 28mEq/L. The risks were even greater for patients with lower potassium levels, 6.3 times greater.

Concerns Regarding GranuFlo Safety

Before the study was published in November, FMC began to alert its staff of the risks associated with GranuFlo as early as January of 2011. In the Medical Staff Newsletter, the higher risk of heart attack was presented as a working hypothesis. In early November, internal data analysis supported the conclusion that GranuFlo significantly increased the risk of cardiopulmonary arrest. The internal memos that were published warned FMC facilities of the dangers of causing alkalosis through incorrect prescription of GranuFlo.

2012 Recall and Public Warning

Despite having the data on hand since November 2011, FMC failed to notify the FDA until March 29, 2012. While GranuFlo and NaturaLyte have both been recalled, the delayed action may have caused hundreds more unnecessary cardiac arrests in dialysis patients. Thousands of patients have been unnecessarily put at risk between the period when FMC had conclusive evidence indicating the deadly GranuFlo side effects and until the FDA were finally notified. Although the firm denies allegations of conflict of interest, GranuFlo is estimated to raise over $80 million a year in revenue, a significant portion of FMC profits.

Screening Cases Against FMC

The loss or suffering of a loved one is always difficult. When coupled with the knowledge that the devastating cardiac event could have been prevented if FMC decided to conduct a study earlier or even release their study findings earlier, coping with the life-long damages are even more difficult. For such cases, Estey & Bomberger attorneys are offering free case evaluations and contingency fee based legal representation to help grieving families secure compensation and justice from FMC. Schedule a free consultation today to learn whether your GranuFlo or NaturaLyte caused event may be eligible for compensation.


About Kidney Dialysis

There are approximately 400,000 patients in the United States who visit a dialysis center three times a week. Patients suffering from chronic kidney disease or kidney failure require artificial means to filter blood, which is done through dialysis. The process removes waste and excess water from the blood stream via a dialysis machine, and is then circulated back into the patient’s body. Because patients’ lives depend on this treatment it is critical for the system and products used in the procedure to be safe.

Risks Associated With Dialysis

Although artificial filtration is nowhere near as effective as the kidneys, this process prolongs life for many people, hopefully until a kidney transplant is possible. But as it is an artificial process, complications can arise either from hemodialysis or the underlying kidney disease. Some of the most common complications linked to hemodialysis patients include:

  • Hypo/hypertension
  • Fluid overload
  • Inflammation of membrane
  • Bone diseases
  • High potassium levels
  • Amyloidosis.

Dialysate and Bicarbonate

As the blood passes through the dialysis machine, a chemical solution called dialysate is circulated in the opposite direction across a permeable membrane. Through the permeable membrane, waste is filtered from the blood and a prescribed dose of bicarbonate is absorbed into the blood before entering the body. Bicarbonate is an important component that prevents blockages in the blood stream and maintains a balanced pH level. However, too much bicarbonate in kidney patients can be fatally dangerous, especially because without functioning kidneys, the excess cannot be filter out without another dialysis session.

Sodium Acetate in Acid Concentrates

Acid concentrates can come in either dry or liquid form, which is then diluted by health technicians according to individual prescriptions and used as dialysate. Fresenius Medical Care (FMC) manufactures two of the most widely used acid concentrate solutions, GranuFlo and NaturaLyte, both of which have been recalled in early 2012. Unlike many other brands of acid concentrates, GranuFlo and NaturaLyte include both acetic acid and sodium acetate. Findings from an internal study conducted in 2010 concluded that the sodium acetate has a tendency to convert into bicarbonate once it passes through the body, putting patients at risk of higher-than-prescribed levels of bicarbonate, and increasing the risks of cardiac arrest.

GranuFlo and Cardiac Arrest Risks

Whether in dry or liquid form, sodium acetate can lead to unintentionally high levels of bicarbonate that can increase the risk of cardiac arrest by as much as 6.3 times. In 2010, while the study was being conducted, over 941 patients died from cardiac arrests that may have been related to the unexpected sodium acetate conversion. In light of the FDA recall of the FMC acid concentrates and hundreds of adverse event reports, patients or families of patients who have suffered cardiac arrest while undergoing dialysis treatment at a FMC facility are strongly urged to consult a professional product liability lawyer. A knowledgeable attorney may be capable of helping you recover compensation for additional medical bills and other damages related to any adverse event.


Carbon Dioxide Poisoning

An excessively high level of carbon dioxide in the blood is one of the main health risks associated with Fresenius Medical Care’s (FMC) GranuFlo and NaturaLyte acid concentrates. Findings from a 2010 internal study found that the acetic acid and sodium acetate formulation used in GranuFlo and NaturaLyte converted into bicarbonate at greater levels than alternative acid concentrates that only used acetic acid. As such, patients were at risk of being dosed with greater levels of bicarbonate than prescribed.

What is Bicarbonate?

Bicarbonate is the form carbon dioxide takes when the compound enters the blood stream. Because bicarbonate is alkaline, it functions in the bloodstream as a vital component of the pH buffer. The blood is regulated within a narrow range, between 7.35 and 7.45, at slightly alkaline levels. When the blood becomes too basic, bicarbonate is quickly converted into carbonic acid to lower the pH, and when the pH is too low, carbonic acid is converted into bicarbonate to raise the pH back to homeostasis. Maintaining a constant pH is critical for protecting the tissues throughout the body.

Side Effects from High Levels of Bicarbonate

Metabolic alkalosis is a condition where the pH is raised above the normal range maximum of 7.45. This is extremely dangerous for patients undergoing hemodialysis because the patient’s damaged for failed kidneys can do nothing to filter the excess bicarbonate out of the blood stream. Elevated levels of bicarbonate has been strongly associated with serious health complications such as:

  • Cardiac arrhythmia
  • Hypercapnia
  • Hypoxemia
  • Low blood pressure
  • Hypokalemia

Hemodialysis for Kidney Patients

The kidney serves to filter all of the waste and excess water out of the blood, when both kidneys fail or are too damaged to function properly, hemodialysis can prolong a patient’s life by artificially filtering the blood three times a week. The process draws the patient’s blood out and into a dialysis machine, where the blood and dialysate is circulated in opposite directions against a permeable membrane. In the machine, the waste is removed and a prescribed dose of bicarbonate diffused into the blood before reentering the body. Until the next dialysis session, the patient will be unable to filter any excess or waste out of his or her bloodstream. Making it essential that each dialysis treatment provides the patient with the proper dose of bicarbonate.

GranuFlo and NaturaLyte Recall Attorneys

Although GranuFlo was introduced to the U.S. market in 2003, because of the lack of any clinical trials or case studies, the formula’s high bicarbonate conversion rates were left unknown to the public until 2012. If you or a loved one has suffered from carbon dioxide poisoning linked to the GranuFlo or NaturaLyte acid concentrates, make sure to speak with a skilled product liability lawyer regarding your potential case. Estey & Bomberger attorneys are currently screening GranuFlo and NaturaLyte carbon dioxide poisoning cases to help wrongfully injured patients seek justice against a negligent medical device manufacturer. To schedule a free consultation, please contact us today on our 24/7 hotline or on our website.


GranuFlo/NaturaLyte Side Effects

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.


Signs of Metabolic Alkalosis

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.


Which Patients are at Risk?

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.