GranuFlo And NaturaLyte Lawsuits
Northwest Indiana Drug Injury Lawyers
GranuFlo and NaturaLyte are chemicals used in dialysis that have the potential to cause serious side effects and even lead to death. At Theodoros & Rooth, P.C., we represent injured patients and surviving family members, helping them to recover damages resulting from the adverse effects of GranuFlo and NaturaLyte. Our Northwest Indiana drug injury attorneys are dedicated to providing personal attention and aggressive legal counsel to help our clients face more stable futures. Fresenius Medical Care (FMC) manufactures GranuFlo and NaturaLyte. In March of 2012, the Food and Drug Administration (FDA) issued a Class I recall of the two drugs, 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.”
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FMC And The FDA Recall Of NaturaLyte And GranuFlo
FMC, a German company, is the largest medical supplier of dialysis machines and products. 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 own 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 of GranuFlo and NaturaLyte led to significant increases in fatal 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 New York Times reported that the FDA became aware of the FMC internal communication memo because someone leaked this information to the agency. FMC’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, wherein the body becomes too alkaline. Metabolic alkalosis can cause the following symptoms and conditions:
- Slowed breathing
- Nausea and vomiting
- Rapid heart rate
- Irregular heartbeat
- Sudden drops in blood pressure
- Heart attack
- Cardiopulmonary arrest
Patients are at the greatest risk when medical practitioners make dosing errors and mix dialysis products incorrectly or administer the process incorrectly.
Talk To An Attorney About Your Rights And Options
If you or a loved one suffered a stroke, heart attack, cardiac arrest, or other serious heart problems 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, and, in the event of wrongful death, funeral and burial expenses, loss of consortium, society, and financial support.