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.