GranuFlo Naturalyte Recall
When patients undergo dialysis for acute or chronic kidney failure, they often need fluid and nutrient replacement during the treatment process. Fresenius Medical Care manufactured two types of fluid replacements, called GranuFlo and Naturalyte.
In 2011, the Food and Drug Administration (FDA), which regulated these fluids as medical devices, received an alert regarding concerns about serious health complications stemming from GranuFlo. This led to a Class I recall and subsequent legal claims by patients who suffered injuries. A similar recall followed for Naturalyte, though this product had slightly less severe effects.
If you or a loved one suffered injuries following dialysis treatments using GranuFlo or Naturalyte, you might have important legal rights to compensation from Fresenius Medical Care. Contact our Florida products liability and mass tort attorneys at Ged Lawyers, LLP, to discuss a possible case today.
Harmful Effects of GranuFlo and Naturalyte
Both products are acid concentrates added to a dialysis solution, though there are some differences between the two. Naturalyte is a liquid containing acetic acid, while GranuFlo is a dry powder containing both acetic acid and sodium acetate, which is a combination referred to as sodium diacetate.
While these substances help to balance the nutrients and electrolytes in dialysis patients, they can also result in numerous side effects. Some of the less severe include:
- Eye irritation
- Muscle cramps
- High or low blood pressure
- Vomiting and diarrhea
- Lung irritation
- Skin irritation
- Heart palpitations and irregular heartbeat
Some dialysis patients might develop a condition called metabolic alkalosis, which involves having excessive levels of bicarbonate in the bloodstream. When patients with alkalosis underwent dialysis supplemented with GranuFlo or Naturalyte, the condition intensified.
An internal memo went around Fresenius Medical Care in 2011, stating that these products increased the risk of metabolic alkalosis, which in turn increased the risk of cardiopulmonary arrest - more commonly known as heart attacks. In short, the manufacturer was aware that its products were significantly increasing the incidence of heart attacks in dialysis patients.
This information stayed within the company, and it did not alert dialysis centers unaffiliated with Fresenius about these risks of its products. Someone from within Fresenius leaked the information to the FDA a few months later, beginning the process of the recall.
Resulting Mass Tort Claims
When numerous people are affected by medical products in the same manner, they can join together to file a class action lawsuit, also referred to as a mass tort claim. These lawsuits claimed that GranuFlo and Naturalyte caused serious side effects in patients, including sudden and sometimes fatal cardiac arrest or other cardiopulmonary events. Claims also alleged that Fresenius continued to produce and market GranuFlo despite knowing about these risks to patients.
Contact Our GranuFlo Naturalyte Recall Lawyers for Help
Patients who suffered serious adverse effects from GranuFlo or Naturalyte can recover damages for their losses, including medical expenses and pain and suffering. Families of patients who suffered fatal heart attacks might be able to recover for wrongful death. If you think you might have a case, consult with Ged Lawyers, LLP. Call 561-995-1966 or contact us online today.