On March 2012, the FDA recalled the NaturaLyte Liquid Acid Concentrate, a chemical used during dialysis treatment that can increase the risk of cardiac problems. Manufactured by Fresenius Medical Care, NaturaLyte is used during hemodialysis to reduce acid buildup in the blood of patients with kidney problems. Because Fresenius Medical operates thousands of dialysis centers throughout the United States and manufactures nearly all of the products used in dialysis centers, there may be hundreds of patients whose deaths and cardiac complications may have been caused by the defective NaturaLyte solution. Those who have suffered side effects or lost a loved one related to NaturaLyte dialysis treatment are advised to consult a professional product liability lawyer as soon as possible.
What is NaturaLyte?
There are over 400,000 dialysis patients in the United States, many of whom have been treated with the recalled NaturaLyte or GranuFlo solutions by Fresenius Medical. NaturaLyte is a liquid acid concentrate that is added to the dialysate used to filter blood during dialysis. While other acid concentrates are comprised primarily of acetic acid, NaturaLyte uses acetic acid and sodium acetate. Unlike acetic acid, sodium acetate converts into bicarbonate once it passes through the patient’s tissues or liver, thereby increasing the dose of bicarbonate prescribed by the doctor. High bicarbonate levels can cause serious health complications such as:
- Heart attack
- Cardiac arrest
- Low blood pressure
2010 Fresenius Medical In-House Study
After noticing an unusually high number of complications, Fresenius Medical conducted a case-controlled study evaluating the risks associated with GranuFlo and NaturaLyte. Between January 2010 and December 2010, the Fresenius researchers identified 941 patients who suffered cardiopulmonary arrest in 667 of Fresenius dialysis facilities. In addition, the study found that patients receiving GranuFlo or NaturaLyte treatment were 4.7 to 6.3 times more likely to suffer cardiopulmonary arrest. Despite being aware of these problems as early as 2011, the FDA, healthcare providers, and patients were not notified of these problems until 2012.
Legal Options for NaturaLyte Victims
Between 2003 until 2010, Fresenius Medical did not conduct any tests ensuring the safety of its products, and when it finally discovered the higher risk of adverse events associated with the sodium acetate products, the company did not notify the FDA until March 29, 2012. Consequently, hundreds of Fresenius dialysis patients and their families are seeking compensation for the damages related to NaturaLyte related injuries. Claimants may be entitled to receive compensation for:
- Past and future medical bills
- Lost wages
- Permanent disabilities
- Pain and suffering
- Wrongful death
Take Action Today
If you or your loved one has been harmed by NaturaLyte’s dangerous side effects, do not delay and immediately consult a professional product liability lawyer today. Depending on the product liability laws in your state, the statutes of limitations may already be in effect, making time a crucial factor in ensuring your rights are secured.