Fresenius GranuFlo and NaturaLyte Recall Lawsuit Information

Dialysis Drugs Linked to Cardiac Arrest, Stroke and Death

Information about the Fresenius GranuFlo and NaturaLyte Recall

On May 25, 2012, the FDA issued a Class I recall on dialysis products Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate, indicating that these concentrates can cause serious adverse health consequences or death. Naturalyte and Granuflo are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis, which can cause severe health complications including sudden cardiac arrest, stroke or even death.

It has been alleged that the manufacturer, Fresenius Medical Care, knew about the cardiac arrest risk, yet failed to warn the dialysis centers which were using its products. On its product website, Fresenius touts GranuFlo® and NaturaLyte® as the “most-widely prescribed dry acid product in the dialysis industry today.” The company further claims that: “With GranuFlo’s distinctive proportional component blend in each bag, you have made the safest choice for onsite concentrate mixing.”

Most patients receiving dialysis have the expectation that the products being used during dialysis are safe and, therefore, are generally unaware of the specific names of the products used during their treatment, such as GranuFlo and NaturaLyte. In addition, because many of the facilities use local names it is possible that dialysis patients do not know if they are receiving dialysis at a Fresenius Medical Care affiliated facility.

GranuFlo and NaturaLyte Product Information

The products implicated in the recall are Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. These products were manufactured and distributed from January 2008 through June 2012.

The reason GranuFlo and NaturaLyte are potentially dangerous is because other acid concentrate products consist primarily of acetic acid, but GranuFlo and NaturaLyte contain acetic acid plus sodium acetate, (sodium diacetate). Sodium acetate gets converted into bicarbonate by the patient’s tissues/liver causing an increase in bicarbonate levels beyond what was initially prescribed.

Incorrectly mixed dialysate that results in increased bicarbonate levels can place patients at an increased risk of metabolic alkalosis — a dangerous side effect of NaturaLyte and GranuFlo.

Symptoms of Metabolic Alkalosis from Improper Granuflo and Natralyte Mixing

Administration of incorrectly mixed dialysate may contribute to metabolic alkalosis (high bicarbonate levels) without the patient’s knowledge. The following symptoms may indicate metabolic alkalosis:

  • Slowed respiration
  • Cyanosis (bluish or purplish discoloration of the skin from lack of oxygen)
  • Nausea
  • Vomiting
  • Diarrhea
  • Irritability
  • Twitching
  • Confusion
  • Rapid Heart Rate
  • Irregular Heart Beat
  • Drop in Blood Pressure

GranuFlo and NaturaLyte Complications and Side Effects

Too high bicarbonate levels caused by GranuFlo and NaturaLyte can cause a variety of health problems for dialysis patients for up to two years following use. These include:

  • Low Blood Pressure (hypotension) can result in blurred vision, fainting, confusion, sleepiness and feeling lightheaded. Severe cases that are not treated promptly can damage the heart, brain and other vital organs.
  • Hypokalemia, or low blood potassium, can lead to abnormal heart rhythm in people who have heart disease. This condition also causes muscle weakness, spasms, and damage, which many include paralysis.
  • Hypoxemia, or low blood oxygen, refers to an oxygen level which is below 90 percent. This condition causes fatigue, headaches, shortness of breath, and nausea. In more severe cases, a patient may experience seizures, lapse into a coma or die.
  • Hypercapnia refers to abnormally high level of carbon dioxide in a patient’s circulating blood. Carbon Dioxide is a waste product of respiration. Hypercapnia leads to a sustained acidemia in patients with end state renal disease (kidney failure).
  • Cardiac Arrhythmia is a medical condition where a patient’s heart is beating too slowly, too quickly, or irregularly. During one of these episodes, the heart may not be able to pump enough blood to the brain, lungs and other organs in the body. Lack of blood flow can lead to serious damage.
  • Cardiac Arrest is the sudden, unexpected loss of heart function, breathing and consciousness. If this happens, blood stops flowing to the brain and other vital organs. Cardiac arrest usually causes death if not treated within minutes.
  • Heart Attack is the death of, or damage to a patient’s heart muscle because the supply of blood is severely reduced or stopped. Heart attacks can be fatal if not recognized and treated immediately.

These GranuFlo and NaturaLyte side effects can potentially be FATAL.
If you suspect that either GranuFlo or NaturaLyte is being used to formulate yours or your loved ones dialysate, immediately speak to your doctor, and ask what dialysis products are being used.
If you or a loved one has suffered a heart attack, cardiac arrest, low blood pressure, stroke or death during dialysis, contact WETHERALL GROUP today.

Legal Rights of Victims of Fresenius GranuFlo and NaturaLyte Complications

When pharmaceutical and medical device companies place a product on the market, they are obligated to provide proper warnings and instructions to both patients and the medical community. Should they fail to do so, they may be held accountable for any resulting damages. In light of reports that Fresenius discovered the cardiac risk of GranuFlo and NaturaLyte, and neglected to warn those outside its internal clinics, legal action may be viable.

Information about GranuFlo and NaturaLyte class actions and individual lawsuits.

The attorneys at WETHERALL GROUP are reviewing potential GranuFlo and NaturaLyte class action lawsuits and individual injury lawsuits for people throughout the United States. We believe, at this time, it may be more beneficial to file individual lawsuits since every person will have different injuries. To have a case evaluated by one of our GranuFlo and NaturaLyte lawyers, request a free consultations and case evaluation.

Free GranuFlo and NaturaLyte case evaluation by our qualified drug injury lawyers.

Our intakes are always confidential. By submitting information to our firm you are not obligated to hire our attorneys to represent you in a potential lawsuit. We handle all cases on a contingency fee basis. In simple terms, this means that you will make no payment for our legal services until after we have succeeded in getting legal compensation for you.

If you or a loved one has suffered a heart attack, cardiac arrest, low blood pressure, stroke or death during dialysis, contact WETHERALL GROUP today.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case please contact us.