GranuFlo and NaturaLyte

GranuFlo and NaturaLyte are chemicals used in dialysis that potentially cause serious side effects and even lead to death. The Indiana law firm, Theodoros & Rooth, P.C. represents clients or surviving family members through lawsuits, helping them to recover damages resulting from the adverse effects of GranuFlo and NaturaLyte.

FDA recall of GranuFlo and NaturaLyte

Fresnius Medical Care (FMC) manufactures GranuFlo and NaturaLyte. In March of 2012, the Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte, based on FMC’s internal communication to its own clinical centers about the drugs’ dangers. A Class I recall is the most serious recall category and indicates the probability of "serious adverse health consequences or death."

Fresnius Medical Care

The largest medical supplier of dialysis machines and products is a German company called Fresnius Medical Care (FMC). According to a New York Times article, the company provides dialysis treatment for over a third of the estimated 400,000 Americans who receive dialysis. In addition to its medical care facilities, many other clinics throughout the country use its dialysis machines and disposable products, which include GranuFlo and NaturaLyte.

FMC started noticing that improper use led to significant increases in the risk of patients dying unexpectedly from cardiac arrest, and that it could lead to strokes and other heart problems. The FMC did not alert medical centers other than their own, through an internal memo about the potential risks. They only communicated these risks publicly after the FDA issued a recall. The NY Times reported that the FDA became aware of the FMC internal communication memo because someone leaked this information to the FDA. The company’s negligence provided grounds for injured patients or their family members to pursue lawsuits.

How GranuFlo and NaturaLyte can cause harm

Dialysis is a medical process that performs the function that an individual’s kidneys are no longer capable of performing ― namely, removing toxins from the blood. The process involves passing the patient’s blood through a dialysis machine. GranuFlo is a dry concentrate that medical practitioners mix with NaturaLyte (a liquid concentrate), purified water and sodium bicarbonate. They act as cleansing agents used in dialysis. The patient's body converts chemical compounds contained in GranuFlo and NaturaLyte into bicarbonate. The danger is that bicarbonate content can reach levels beyond what is optimum. The result is a condition called metabolic alkalosis. Metabolic alkalosis is an imbalance where the body becomes too alkaline, leading to the following symptoms and conditions:

  • Slowed breathing
  • Apnea
  • Nausea and vomiting
  • Diarrhea
  • Twitching
  • Rapid heart rate
  • Irregular heart beat
  • Sudden drops in blood pressure
  • Convulsions
  • Coma
  • Heart attack
  • Cardiopulmonary arrest
  • Stroke
  • Death

Patients are most at risk when medical practitioners make dosing errors and mix dialysis products incorrectly or administer the process incorrectly.

When to seek a legal opinion

If you or a loved one suffered a stroke, heart attack, other serious heart problems or a loved one died from cardiac arrest within 48 hours of a dialysis treatment that used GranuFlo and/or NaturaLyte, seek legal help to find out about your right to pursue compensation through a lawsuit. You may be entitled to receive damages for medical treatment, lost wages, pain and suffering or, in the event of wrongful death, funeral and burial expenses, loss of consortium, society and financial support.

Committed to justice and patient safety for injury victims since 1988

Located across the street from the Methodist Hospital in Merrillville, Indiana, the injury law firm of Theodoros & Rooth, P.C. stands by your side through every step of your case. We are located just 30 miles outside Chicago. Call us at 219.769.6393 or contact us online to tell us about your injury. We look forward to speaking with you.

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